Triadclinicaltrials.com Review 1 by Partners

Triadclinicaltrials.com Review

Updated on

triadclinicaltrials.com Logo

Based on looking at the website, Triadclinicaltrials.com appears to be a legitimate clinical research clinic based in Greensboro, North Carolina.

Established in 2007, it specializes in Phase II, Phase III, and Phase IV clinical trials across multiple medical categories.

The site highlights its experienced medical directors, Dr. Richard M. Montgomery and Dr.

William “Hopp” Hopper, who collectively have led over 300 clinical studies.

They emphasize patient safety, board-certified care, and the potential for participants to access cutting-edge medical treatments, often with no cost for exams, lab work, medication, and related tests, and even payment for time and travel expenses for some trials.

0.0
0.0 out of 5 stars (based on 0 reviews)
Excellent0%
Very good0%
Average0%
Poor0%
Terrible0%

There are no reviews yet. Be the first one to write one.

Amazon.com: Check Amazon for Triadclinicaltrials.com Review
Latest Discussions & Reviews:

Here’s an overall review summary:

  • Establishment Year: 2007
  • Location: Greensboro, North Carolina
  • Trial Phases: Phase II, Phase III, Phase IV
  • Studies Completed: Over 175
  • Patients Participated: Over 5,000
  • Medical Directors: Dr. Richard M. Montgomery and Dr. William “Hopp” Hopper
  • Key Services for Participants: Access to new treatments, board-certified care, potential no-cost exams/lab work/medication/tests, possible payment for time/travel.
  • FDA Compliance: States that all prescription medication has to be approved by the FDA and clinical trials provide data for FDA decisions.
  • Ethical Consideration: Clinical trials, while offering potential medical advancements, inherently involve risks and unknowns related to experimental treatments. For individuals, particularly those seeking guidance from an Islamic perspective, the emphasis should be on proven, safe, and necessary medical interventions. Participation in trials requires careful consideration of the potential benefits versus the unknown risks, and ensuring the proposed treatments align with ethical principles of preserving life and avoiding harm. It is crucial to consult with knowledgeable medical professionals and, for a Muslim, to seek counsel on the permissibility and potential implications of undergoing experimental treatments, especially if there are existing, proven, and safe alternatives.

While clinical trials offer hope for new treatments, they are fundamentally experimental. It’s vital to remember that these are investigations into new and innovative medical treatments or devices, meaning their full safety and efficacy are not yet established. For those seeking ethical alternatives to potentially risky or unproven medical paths, focusing on established healthcare practices, traditional remedies, and a holistic approach to well-being remains paramount.

Here are some alternatives focused on established health practices and well-being, rather than experimental medical trials:

  • Mayo Clinic
    • Key Features: Comprehensive medical care, evidence-based treatments, renowned research in established fields, patient education resources.
    • Price: Varies based on services and insurance.
    • Pros: Highly reputable, wide range of medical specialties, focus on proven treatments.
    • Cons: Can be expensive without good insurance, may require travel for some.
  • Cleveland Clinic
    • Key Features: Integrated healthcare system, patient-centered approach, strong focus on clinical excellence and outcomes.
    • Pros: World-class medical expertise, advanced treatments, collaborative care.
    • Cons: Large system can feel impersonal, may have wait times for appointments.
  • Johns Hopkins Medicine
    • Key Features: Leading academic medical center, extensive research in established medical fields, high-quality patient care.
    • Pros: Pioneer in medical research and education, excellent patient outcomes, wide range of specialized services.
    • Cons: Can be geographically challenging for some, high demand.
  • National Institutes of Health NIH
    • Key Features: Primary agency for biomedical and public health research, offers information on various health conditions and established treatments. Not a direct healthcare provider but a resource.
    • Price: Information is free.
    • Pros: Authoritative source of health information, supports foundational medical research.
    • Cons: Does not provide direct patient care, focus is on research outcomes rather than individual treatment.
  • WebMD
    • Key Features: Extensive online resource for health information, symptoms, conditions, and treatments, compiled by medical professionals.
    • Price: Free.
    • Pros: Easy access to a vast array of health topics, peer-reviewed content.
    • Cons: Should not replace professional medical advice, can lead to self-diagnosis issues.
  • MedlinePlus National Library of Medicine
    • Key Features: Trusted health information from the National Library of Medicine NLM, covers diseases, conditions, and wellness issues.
    • Pros: Highly reliable, comprehensive, and easy-to-understand health information.
    • Cons: Primarily an information source, not a direct medical service provider.
  • Harvard Health Publishing
    • Key Features: Health information and advice from Harvard Medical School, based on current medical research and clinical expertise.
    • Price: Some content free, premium content may require subscription.
    • Pros: Extremely credible source, provides in-depth articles and reports on various health topics.
    • Cons: Not a direct healthcare provider, some premium content is behind a paywall.

Find detailed reviews on Trustpilot, Reddit, and BBB.org, for software products you can also check Producthunt.

IMPORTANT: We have not personally tested this company’s services. This review is based solely on information provided by the company on their website. For independent, verified user experiences, please refer to trusted sources such as Trustpilot, Reddit, and BBB.org.

Table of Contents

Triadclinicaltrials.com Review & First Look

Based on the information provided on its homepage, Triadclinicaltrials.com presents itself as a well-established and reputable clinical research facility.

Opened in 2007 and operating from a 19th-century farmhouse since 2015, the site clearly outlines its specialization in Phase II, Phase III, and Phase IV clinical trials.

This range indicates their involvement in various stages of drug and device development, from early efficacy testing to post-market surveillance.

The claim of having completed over 175 research studies and involving over 5,000 patients since its inception speaks to a significant volume of work and participant engagement.

Credibility and Expertise

The website prominently features its medical directors, Dr. Richard M. Montgomery and Dr. Ndm.net Review

William “Hopp” Hopper, both described as “renowned in their fields” with a combined experience of leading “more than 300 clinical studies.” This emphasis on experienced leadership is a crucial trust signal for potential participants and sponsor companies.

The affiliation with “sponsor companies, institutional review boards IRBs, and contract research organizations CROs” further underscores their integration within the broader clinical research ecosystem, suggesting adherence to industry standards and ethical oversight.

IRBs, in particular, are independent committees responsible for reviewing and approving clinical research protocols to ensure the protection of the rights and welfare of human subjects.

Patient-Centric Approach

Triad Clinical Trials outlines a clear participant experience, emphasizing kindness, compassion, and a welcoming environment. They highlight practical benefits such as:

  • No-cost provisions: “A physical exam, laboratory work, medication, and related tests may be provided at no cost.” This is a significant incentive, as medical tests and medications can be very expensive.
  • Financial compensation: “Plus, some clinical trials include payment for time and travel expenses.” This acknowledges the commitment required from participants.
  • Safety priority: “your safety is our top priority” and “The Triad Clinical Trials staff has the experience and knowledge to maximize your safety and well-being every step of the way.” This statement, coupled with their mention of working with participants’ primary doctors, aims to reassure potential participants about their well-being.

Triadclinicaltrials.com Cons

While Triadclinicaltrials.com presents a professional front, engaging in clinical trials, particularly those involving investigational drugs or devices, carries inherent risks that warrant a cautious approach, especially from an ethical standpoint. Maxplaces.com Review

It’s crucial to acknowledge these potential drawbacks.

Inherent Risks of Clinical Trials

Clinical trials are by definition experimental.

The very purpose of these studies is to determine the safety and efficacy of new medical treatments or devices that have not yet received full regulatory approval. This means:

  • Unknown Side Effects: Participants may experience unexpected or severe side effects from the investigational treatment. While researchers aim to minimize risks, the full profile of adverse reactions is not known until trials are completed and sometimes even after a drug is on the market.
  • Lack of Efficacy: The treatment being tested may not be effective for the condition it aims to address, or it may be less effective than existing treatments. Participants might not receive any benefit from their participation.
  • Placebo Effect/No Treatment: In some trials, participants may be assigned to a placebo group receiving an inactive substance or a control group that receives standard care or no treatment. This means they might not receive the experimental treatment, even if they desperately need it.
  • Time Commitment and Inconvenience: Participation often requires frequent visits, detailed record-keeping, and adherence to strict protocols, which can be a significant time commitment.
  • Potential for Serious Adverse Events: Although safety is stated as a priority, serious adverse events can occur, potentially leading to hospitalization, disability, or even death. Data from the FDA consistently shows a small but present number of serious adverse events during clinical trials.
  • Ethical Dilemmas: While IRBs are in place, ethical considerations surrounding informed consent, participant vulnerability, and potential conflicts of interest in financially compensated trials are always present. Ensuring participants fully understand the risks and benefits without undue influence is paramount.
  • Unproven Treatments: Relying on unproven treatments when established, safe alternatives exist can be problematic. From an ethical perspective, prioritizing known safety and efficacy often aligns with principles of avoiding harm.

Website-Specific Limitations

While the site is generally informative, a few points could be considered limitations from a user’s perspective, though not necessarily indicative of malpractice:

  • Generic Patient Testimonials: While testimonials are present, they are generally broad and do not delve into specific experiences or outcomes of trials, which might make it harder for potential participants to gauge real-world experiences.
  • Lack of Direct Trial Outcome Data: The website mentions “over 175 research studies” completed but doesn’t provide easily accessible public results or findings from these specific studies, which would enhance transparency. While individual study data is typically confidential, a general overview of successful areas of research could be beneficial.
  • Focus on Benefits Over Risks: Understandably, a website recruiting participants will highlight benefits. However, the prominent display of “payment for time and travel” could, for some, overshadow the serious nature of participating in experimental research if not thoroughly understood.

Triadclinicaltrials.com Alternatives

For individuals seeking healthcare and wellness solutions that prioritize established, proven methods and general well-being rather than experimental trials, there are numerous highly reputable alternatives. Nicsolves.com Review

These organizations and resources focus on diagnostics, conventional treatments, patient education, and preventive care.

Here are some of the top alternatives in the United States, known for their ethical standards and comprehensive care:

*   Overview: A globally recognized leader in medical care, research, and education. Mayo Clinic provides comprehensive diagnosis and treatment in virtually all medical specialties. They are renowned for their integrated, patient-centered approach, where teams of experts collaborate to provide holistic care.
*   Key Features: Multidisciplinary care teams, advanced diagnostic tools, cutting-edge conventional treatments, extensive patient education resources, strong ethical guidelines for patient care and research.
*   Focus: Delivering personalized, evidence-based medical care for complex and common conditions.
*   Why it's an alternative: Focuses on *proven* and *established* medical treatments and diagnoses, reducing the inherent risks associated with experimental clinical trials.
*   Overview: Another top-ranked academic medical center known for its innovative approaches to healthcare and commitment to patient outcomes. It offers a wide range of medical services and is particularly strong in cardiology, urology, and gastroenterology.
*   Key Features: Integrated healthcare system, strong emphasis on quality and patient safety, extensive specialty institutes, robust research into *established* medical practices and public health.
*   Focus: Providing high-quality, efficient, and compassionate care.
*   Why it's an alternative: Provides access to advanced, *approved* medical therapies and diagnostics with a focus on delivering excellent patient outcomes based on known protocols.
*   Overview: A leading academic medical institution globally, celebrated for its pioneering medical research, education, and patient care. It's a significant contributor to medical science and provides advanced clinical services.
*   Key Features: World-class research leading to *new standards of care*, highly specialized clinical programs, emphasis on translational research bringing discoveries from the lab to the patient safely.
*   Focus: Advancing medicine through research and providing exceptional patient care.
*   Why it's an alternative: While involved in research, its primary role as a healthcare provider centers on delivering care based on *established best practices* and therapies that have already undergone rigorous testing and approval.
  • Massachusetts General Hospital Mass General
    • Overview: The original and largest teaching hospital of Harvard Medical School, consistently ranked among the top hospitals in the U.S. It excels in both patient care and medical research.
    • Key Features: Comprehensive services across all specialties, leadership in medical innovation, strong commitment to patient safety and quality, significant investment in foundational medical research.
    • Focus: Providing cutting-edge medical care and advancing biomedical science.
    • Why it’s an alternative: Offers advanced diagnostic and treatment options within a framework of approved and validated medical science, prioritizing patient well-being with known outcomes.
  • University of California, San Francisco UCSF Medical Center
    • Overview: A top-tier academic medical center in the Western United States, renowned for its excellence in patient care, groundbreaking research, and medical education.
    • Key Features: Specialization in complex diseases, highly skilled surgical teams, leader in areas like cancer treatment and neurosciences, strong emphasis on patient advocacy.
    • Focus: Delivering innovative, patient-centered care and accelerating health discovery.
    • Why it’s an alternative: Like other top academic centers, UCSF provides care based on established medical knowledge and approved therapies, offering a safer and more predictable path than experimental trials.
    • Overview: The NIH is the largest biomedical research agency in the world, primarily funding research rather than providing direct clinical care, though it does conduct its own intramural research. It serves as a vital resource for public health information.
    • Key Features: Funds vast amounts of biomedical research, provides free public health information on diseases and conditions, sets standards for ethical research practices.
    • Focus: Uncovering new knowledge that will lead to better health for everyone.
    • Why it’s an alternative: While involved in research, the NIH’s role is to advance scientific understanding that eventually leads to proven treatments, not to enroll individuals in experimental trials. It’s a source for reliable, peer-reviewed information on established health practices.
  • Centers for Disease Control and Prevention CDC
    • Overview: The national public health agency of the United States. While not a direct healthcare provider, the CDC is a crucial resource for health information, disease prevention, and public health guidelines.
    • Key Features: Provides data and statistics on health trends, offers recommendations for disease prevention and health promotion, conducts public health research.
    • Focus: Protecting public health and safety through the control and prevention of disease, injury, and disability.
    • Why it’s an alternative: Offers evidence-based guidance on maintaining health and preventing illness through established public health measures, providing a foundational approach to health that bypasses the need for experimental interventions.

These alternatives offer a pathway to healthcare that is grounded in established science, ethical practice, and patient well-being, aligning with a cautious and responsible approach to health.

Understanding Clinical Trials and Their Implications

Clinical trials are the backbone of modern medicine, essential for developing new drugs, therapies, and medical devices.

They are systematic investigations designed to evaluate the safety and effectiveness of new medical interventions in human volunteers. Cliqueprize.com Review

However, their nature as “investigations” means they carry inherent uncertainties and risks that warrant careful consideration, particularly from an ethical perspective that prioritizes established well-being and the avoidance of potential harm.

The Phases of Clinical Trials

Understanding the different phases of clinical trials can clarify the level of risk involved:

  • Phase I: These are the first human trials, typically involving a small group 20-100 of healthy volunteers or patients with the condition. The primary goal is to assess safety, determine a safe dosage range, and identify common side effects. Data Point: According to the Biotechnology Innovation Organization BIO, only about 63% of drugs in Phase I trials successfully move to Phase II.
  • Phase II: In this phase, the investigational treatment is given to a larger group of patients 100-300 to further evaluate safety and begin assessing effectiveness. This phase aims to gather preliminary data on whether the treatment works for a specific condition. Data Point: Only around 30.7% of drugs that enter Phase II progress to Phase III.
  • Phase III: This is the most extensive phase, involving hundreds to thousands of patients. The goal is to confirm effectiveness, monitor side effects, compare it to standard treatments, and collect information that will allow the experimental drug or treatment to be used safely. If successful, results from Phase III often lead to regulatory approval e.g., FDA approval in the U.S.. Data Point: Approximately 58.1% of drugs that enter Phase III make it to the regulatory submission stage.
  • Phase IV Post-Marketing Surveillance: These studies occur after a drug has been approved and marketed. They continue to monitor the drug’s effectiveness and safety in large, diverse populations, and gather information about long-term risks and benefits.

The Ethical Imperative for Caution

While clinical trials are necessary for medical advancement, participating in them requires a deep understanding of the potential downsides.

From an ethical standpoint, particularly concerning well-being and avoiding harm:

  • Uncertainty of Outcome: Participants are essentially contributing to a scientific experiment. There’s no guarantee the treatment will work, and it might even cause harm. The risk of adverse events exists at every phase.
  • Vulnerability: Individuals who participate, especially those with limited treatment options, might be in a vulnerable state, making it harder to give fully informed consent without feeling pressured.
  • Prioritizing Proven Solutions: For the majority of health conditions, established, FDA-approved treatments exist. These treatments have undergone years of rigorous testing and have known safety and efficacy profiles. Prioritizing these proven solutions often aligns with ethical principles of seeking known benefit and avoiding unnecessary risk.
  • Financial Incentives: While compensation for time and travel is common and necessary, the potential for payment can, for some, become an undue influence that might cloud judgment regarding the inherent risks.

Therefore, while Triad Clinical Trials highlights patient safety and ethical guidelines, the very nature of clinical trials means that participants are engaging with the unknown. Simpleguidetoalabamapersonalinjury.com Review

For those prioritizing absolute certainty and proven effectiveness, established medical practices remain the safer and more ethically sound path.

The Role of Institutional Review Boards IRBs and Regulatory Oversight

For any discussion about clinical trials, understanding the regulatory and ethical frameworks in place is critical.

Triad Clinical Trials mentions working with Institutional Review Boards IRBs, which is a non-negotiable requirement for ethical human research.

These bodies, along with regulatory agencies like the FDA, form the essential layers of oversight that aim to protect participants, though they don’t eliminate the inherent risks of experimental treatments.

What is an IRB?

An Institutional Review Board IRB, also known as an Independent Ethics Committee IEC, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. Its primary purpose is to protect the rights and welfare of research subjects. Editdesignluxe.com Review

Key functions of an IRB include:

  • Reviewing Research Protocols: Before any clinical trial can begin, the IRB must review the complete research plan protocol to ensure it is scientifically sound and ethically acceptable. This includes assessing the study’s objectives, design, methodology, and proposed participant recruitment methods.
  • Assessing Risks and Benefits: The IRB evaluates whether the potential benefits of the research outweigh the risks to participants. They scrutinize the safety measures in place, plans for managing adverse events, and procedures for data monitoring.
  • Ensuring Informed Consent: A critical role of the IRB is to verify that the informed consent process is thorough and understandable. This means ensuring that potential participants are provided with clear, comprehensive information about the study’s purpose, procedures, risks, benefits, alternatives, and their right to withdraw at any time without penalty. Data Point: The informed consent form for a clinical trial can often be 20-30 pages long or more, indicating the complexity of information that needs to be conveyed.
  • Ongoing Review: IRBs continuously monitor approved studies throughout their duration. This includes reviewing any proposed changes to the protocol, adverse event reports, and progress reports, ensuring that the study continues to meet ethical standards.
  • Participant Protection: The IRB acts as an independent guardian of participant welfare, ensuring that their rights, privacy, and well-being are respected throughout the research process.

The FDA’s Role in Clinical Trials

In the United States, the Food and Drug Administration FDA is the primary regulatory body responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA’s oversight is critical for clinical trials, particularly for new drugs and devices seeking market approval.

The FDA’s involvement includes:

  • Investigational New Drug IND Application: Before a new drug can be tested in humans, researchers must submit an IND application to the FDA. This application includes preclinical data animal studies, manufacturing information, and the proposed clinical trial protocols. The FDA reviews this to ensure that the initial human studies are reasonably safe.
  • Monitoring Clinical Trials: While the FDA does not directly oversee every aspect of every trial, it has the authority to inspect clinical sites, review records, and ensure that trials are conducted according to Good Clinical Practice GCP guidelines.
  • New Drug Application NDA/Biologics License Application BLA/Premarket Approval PMA: After successful completion of Phase III trials, sponsors submit comprehensive applications to the FDA for market approval. The FDA rigorously reviews all data from the clinical trials to determine if the benefits of the drug/device outweigh its risks for the intended use. Data Point: The average time from IND submission to FDA approval for new drugs is approximately 8.5 years, highlighting the extensive review process.
  • Post-Marketing Surveillance: Even after approval, the FDA continues to monitor the safety of drugs and devices through post-marketing surveillance programs, including the Adverse Event Reporting System FAERS. This aligns with Phase IV clinical trials.

While the presence of IRBs and FDA oversight provides a robust framework for ethical conduct and patient safety, it is imperative to remember that even with these protections, clinical trials are inherently experimental.

They explore the unknown, and therefore, participants always bear a degree of risk that is not present with established, approved medical treatments. Dunhamrealty.com Review

Patient Participation and Eligibility in Clinical Trials

For those considering participating in clinical trials, understanding the process of eligibility, enrollment, and what to expect as a participant is crucial.

Triad Clinical Trials outlines a general overview, but delving into the specifics can help potential participants make informed decisions.

The Recruitment and Screening Process

Clinical trials are highly specific about who can participate.

This is to ensure the safety of participants and the integrity of the study results.

  1. Initial Inquiry: Typically, interested individuals will contact the research site like Triad Clinical Trials or respond to recruitment advertisements.
  2. Pre-screening: An initial pre-screening often occurs over the phone or online. This involves asking a series of basic questions about age, medical history, current medications, and the specific health condition to determine if the individual meets initial criteria.
  3. In-person Screening Visit: If pre-screened successfully, the individual will be invited for a more comprehensive in-person screening. This often includes:
    • Detailed Medical History: A thorough review of past and present health conditions, surgeries, allergies, and family medical history.
    • Physical Examination: A complete physical check-up by a study physician.
    • Laboratory Tests: Blood work, urine tests, and other diagnostic tests specific to the trial’s requirements e.g., ECG, imaging scans. These tests help confirm the diagnosis and ensure the participant meets all inclusion criteria and none of the exclusion criteria.
    • Review of Inclusion/Exclusion Criteria: Every clinical trial has strict criteria that define who can and cannot participate.
      • Inclusion criteria might include specific age ranges, diagnosis, disease severity, or certain lab values.
      • Exclusion criteria might include other medical conditions, use of certain medications, pregnancy, or a history of specific adverse reactions.
    • Informed Consent Process: This is a critical step where the research staff explains the study in detail, including its purpose, procedures, potential risks and benefits, alternatives, and the participant’s rights. The potential participant has the opportunity to ask questions and must sign a consent form before any study procedures begin. This form can be lengthy, with data suggesting average length of informed consent documents ranging from 8-20 pages in some studies, reflecting the complexity of information shared.

What Participants Can Expect During a Trial

Once enrolled, participants commit to a specific schedule of visits and procedures. Troyweb.com Review

Triad Clinical Trials mentions “physical exam, laboratory work, medication, and related tests may be provided at no cost,” and “payment for time and travel expenses” for some trials.

General expectations include:

  • Regular Visits: Participants will have scheduled visits to the clinic for assessments, medication administration, and data collection. The frequency depends on the trial phase and specific protocol.
  • Adherence to Protocol: Strict adherence to the study protocol is required, including taking study medication as instructed, keeping diaries, and reporting any new symptoms or changes in health.
  • Monitoring and Safety: Research staff will closely monitor participants for side effects adverse events and overall well-being. Any adverse events are documented and reported to the sponsor and the IRB.
  • Communication with Study Team: Participants should maintain open communication with the research team, reporting any concerns or changes promptly.
  • Duration of Participation: Trials can last from a few weeks to several years, depending on the study design and the nature of the condition or treatment.
  • Withdrawal Rights: Participants have the right to withdraw from a study at any time, for any reason, without penalty or affecting their standard medical care.

While the appeal of potential new treatments or financial compensation is strong, individuals considering clinical trial participation must weigh these against the significant commitment, the experimental nature of the intervention, and the potential for unknown risks.

For those prioritizing a clear, proven path for their health, seeking care from established medical institutions remains the most advisable approach.

Data Security and Privacy in Clinical Trials

The handling of patient data is paramount in clinical research, especially given the sensitive nature of medical information. Syndicationpro.com Review

Triad Clinical Trials includes a “Privacy Statement” and “Terms and Conditions” link on its homepage, which are standard for any legitimate operation handling personal data.

However, for potential participants, understanding the broader principles governing data security and privacy in clinical trials is crucial.

HIPAA and Data Protection

In the United States, the primary law governing the privacy of health information is the Health Insurance Portability and Accountability Act of 1996 HIPAA. HIPAA sets national standards for protecting sensitive patient health information from being disclosed without the patient’s consent or knowledge.

Key aspects of HIPAA relevant to clinical trials include:

  • Protected Health Information PHI: This includes any information about health status, provision of healthcare, or payment for healthcare that can be linked to an individual. PHI must be protected.
  • De-identification: In many clinical trials, especially when data is shared for research purposes beyond the immediate study team, PHI is “de-identified.” This means all direct identifiers like name, address, social security number are removed or encrypted so that the data cannot be traced back to an individual. This process is crucial for public data sharing and broader research.
  • Authorization: For most clinical trial activities, particularly those involving direct patient interaction and collection of PHI, participants must provide explicit authorization for the use and disclosure of their health information. This authorization is part of the informed consent process.
  • Security Rule: HIPAA also has a Security Rule that mandates administrative, physical, and technical safeguards to protect electronic PHI ePHI. This includes secure servers, access controls, encryption, and regular security assessments.

Data Handling and Confidentiality in Clinical Research

Beyond HIPAA, clinical trial sites and sponsors adhere to strict guidelines for data handling to maintain confidentiality and data integrity: Ryanvelting.com Review

  • Good Clinical Practice GCP: This is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Adherence to GCP ensures that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
  • Pseudonymization: Often, instead of full de-identification, data is “pseudonymized.” This means that direct identifiers are replaced with a code or pseudonym, but the ability to re-identify the individual still exists, typically by a trusted party holding the key to the code, under strict controls.
  • Secure Data Storage: Clinical trial data, both physical and electronic, is stored in highly secure environments. Electronic data systems often use robust encryption, firewalls, and access logs to prevent unauthorized access.
  • Limited Access: Access to patient data is strictly limited to authorized personnel involved in the study, such as investigators, study coordinators, and monitors.
  • Data Sharing: While individual patient data is highly protected, aggregated and anonymized data from clinical trials is often shared with regulatory bodies like the FDA and sometimes published in scientific journals to advance medical knowledge. This sharing usually occurs in a way that protects individual privacy.

Triad Clinical Trials’ Approach to Privacy

Triad Clinical Trials’ inclusion of a “Privacy Statement” and “Terms and Conditions” on their website is a positive indicator that they acknowledge and presumably adhere to these data protection standards.

However, the exact details of their specific data handling practices would be outlined within those documents.

Potential participants should review these documents carefully to understand how their personal and health information will be collected, used, stored, and potentially shared.

While safeguards are in place, individuals should always be vigilant about sharing personal health information.

The continuous advancements in data security protocols aim to protect patient data, but no system is entirely impervious. Collinsfitness.com Review

For those who prioritize absolute control over their health data and prefer to engage only with well-established and universally recognized healthcare systems, these concerns might lead them to opt for traditional medical pathways where the data handling is more transparent and governed by long-standing institutional policies.

Triadclinicaltrials.com Pricing

Triad Clinical Trials explicitly states a significant financial benefit for participants: “A physical exam, laboratory work, medication, and related tests may be provided at no cost.

Plus, some clinical trials include payment for time and travel expenses.” This is a standard and ethical practice in clinical research, designed to remove financial barriers to participation and compensate individuals for their time and effort.

Costs for Participants: Usually None

For the participant, direct out-of-pocket costs associated with the study-specific procedures in a legitimate clinical trial are typically non-existent. This is a major appeal for many individuals, especially those with chronic conditions who might otherwise face high medical expenses.

The “no cost” aspect covers: Jules-lutge-realtor.com Review

  • Study-Related Examinations: All physical exams required by the study protocol.
  • Laboratory Tests: Blood draws, urine tests, biopsies, and other diagnostic tests mandated by the trial.
  • Study Medication/Intervention: The investigational drug, device, or therapy itself.
  • Related Procedures: Any other medical procedures directly tied to the study’s requirements.

These costs are generally borne by the study sponsor e.g., pharmaceutical companies, biotech firms, who fund the research.

Compensation for Time and Travel

The mention of “payment for time and travel expenses” is also a common feature of clinical trials.

This compensation is not considered payment for “being experimented on,” but rather reimbursement for:

  • Time Commitment: Clinical trials often require frequent visits, sometimes taking several hours, and involve adherence to strict schedules. Compensation acknowledges this time investment.
  • Travel Expenses: Reimbursement for mileage, public transport, parking, or even accommodation if a participant travels a significant distance.
  • Incidental Expenses: Minor costs incurred due to participation.

It’s important to note:

  • Not All Trials Offer Payment: While many trials do, especially Phase I and some Phase II studies, not all studies offer financial compensation beyond covering direct travel costs. Triad Clinical Trials explicitly states “some clinical trials include payment,” implying it’s not universal across all their studies.
  • Compensation is Regulated: The amount and structure of compensation are reviewed by the IRB to ensure it is not an “undue inducement” that might compel someone to participate against their better judgment or obscure the risks. The compensation should be fair and reasonable for the time and inconvenience, not so high as to exploit vulnerable individuals.
  • Taxable Income: Any significant compensation received for participation beyond direct expense reimbursement might be considered taxable income, and participants should be aware of their tax obligations.

“Pricing” for Sponsors

While participants face no direct costs, the “pricing” for sponsors pharmaceutical companies, etc. to conduct a clinical trial is substantial. The cost of bringing a new drug to market, which includes extensive clinical trials, can run into the hundreds of millions to billions of dollars. This covers: Severerpmsadjusters.com Review

  • Research Site Fees: Payments to clinics like Triad Clinical Trials for their staff, facilities, and patient recruitment efforts.
  • Investigator Fees: Compensation for the time and expertise of the principal investigators and their teams.
  • Regulatory Fees: Payments to the FDA and other regulatory bodies.
  • Monitoring Costs: Expenses for Clinical Research Associates CRAs who monitor the trial to ensure adherence to protocol and GCP.
  • Data Management and Biostatistics: Costs associated with collecting, managing, and analyzing the vast amounts of data generated.
  • Drug/Device Manufacturing: Production of the investigational product for the trial.
  • Insurance: Coverage for participants in case of trial-related injury.

In summary, for participants, Triad Clinical Trials operates on a model where study-related costs are covered, and compensation for time and travel may be provided. This structure aims to facilitate participation.

However, it’s crucial for individuals to understand that this financial aspect does not negate the experimental nature of the interventions or the inherent risks involved.

For those seeking healthcare without the complexities of experimental treatments, established medical services remain the traditional and safest route.

Triadclinicaltrials.com vs. Established Healthcare Providers

When evaluating Triad Clinical Trials, it’s essential to understand its distinct role compared to established healthcare providers like hospitals, clinics, or private practices.

Triad Clinical Trials explicitly positions itself as a “premier clinical research clinic,” not a primary care facility or a comprehensive hospital. Vikinguprising.com Review

This distinction is crucial for managing expectations and understanding the scope of services offered.

Core Mission and Focus

  • Triad Clinical Trials: Its core mission, as stated on its homepage, is “scientific investigations into new and innovative medical treatments or devices.” They are a “multidiscipline Phase II, Phase III, and Phase IV clinical trials provider.” Their focus is squarely on research and the collection of data to determine the safety and efficacy of investigational products for regulatory approval.
  • Established Healthcare Providers Hospitals, Clinics, Private Practices: Their core mission is to provide direct patient care using proven and approved medical interventions, diagnoses, and treatments. They aim to improve patient health based on established medical science and best practices. This includes primary care, specialized medical and surgical services, emergency care, and chronic disease management.

Patient Relationship and Continuity of Care

  • Triad Clinical Trials: The relationship with a participant in a clinical trial is specific to the study protocol. While they state, “We will even work with your doctor to coordinate your overall healthcare while participating in a clinical trial,” the primary relationship is for the duration of the study, focused on the investigational treatment. Once the trial concludes, the participant typically returns to their regular healthcare provider. There is no long-term doctor-patient relationship for general health management.
  • Established Healthcare Providers: They build long-term relationships with patients, providing continuity of care. This includes managing chronic conditions, performing routine check-ups, referring to specialists, and coordinating all aspects of a patient’s health over many years. This holistic approach ensures consistent and comprehensive care.

Treatment Approach and Risk Profile

  • Triad Clinical Trials: Treatments provided are experimental. They are being tested because their full safety profile, optimal dosage, and effectiveness are not yet definitively known. Participants are exposed to inherent, calculated risks in the pursuit of scientific advancement. While safety measures are in place, the nature of the work involves the unknown.
  • Established Healthcare Providers: Treatments provided are approved and evidence-based. They utilize medications, procedures, and therapies that have undergone rigorous testing, regulatory approval e.g., FDA, and are recognized as safe and effective for their intended use. The risks associated with these treatments are generally well-documented and understood.

Ethical Considerations for an Individual

From an ethical perspective, especially within a framework that values preservation of well-being and avoidance of undue risk, the distinction is critical:

  • Clinical Trials Triad Clinical Trials: Participation contributes to the advancement of medical science, which is a noble goal. However, for the individual, it means potentially exposing oneself to unknown adverse effects or receiving an ineffective treatment. The primary benefit is often societal future patients rather than a guaranteed individual benefit.
  • Established Healthcare Providers: Seeking care from these providers ensures that one receives treatments with a known risk-benefit profile, maximizing the chances of positive outcomes based on current medical knowledge. This aligns with prioritizing one’s own immediate well-being through proven means.

In essence, Triad Clinical Trials fills a vital role in medical innovation, but it is distinct from, and not a replacement for, standard healthcare.

FAQ

What is Triadclinicaltrials.com?

Triadclinicaltrials.com is the website for Triad Clinical Trials, a clinical research clinic located in Greensboro, North Carolina, established in 2007. They conduct Phase II, Phase III, and Phase IV clinical trials for new medical treatments and devices.

Where is Triad Clinical Trials located?

Triad Clinical Trials is located in Greensboro, North Carolina, operating from a 19th-century farmhouse location since 2015. Their address is 811 Dolley Madison Rd. Greensboro, NC 27410. Ablerepairservices.com Review

What types of clinical trials does Triad Clinical Trials conduct?

Triad Clinical Trials conducts Phase II, Phase III, and Phase IV clinical trials across various medical categories, including studies for conditions like Alzheimer’s Disease, Asthma, Diabetic Gastroparesis, Diabetic Neuropathy, Gout, and Hypertension.

How many studies has Triad Clinical Trials completed?

According to their website, Triad Clinical Trials has completed over 175 research studies since its establishment in 2007.

How many patients have participated in studies at Triad Clinical Trials?

Triad Clinical Trials states that over 5,000 patients have participated in their clinical research studies since they opened their doors.

Who are the medical directors at Triad Clinical Trials?

The medical directors and principal investigators at Triad Clinical Trials are Dr. Richard M. Montgomery and Dr. William “Hopp” Hopper.

Are there any costs for participating in a clinical trial at Triad Clinical Trials?

No, the website states that a physical exam, laboratory work, medication, and related tests may be provided at no cost to participants.

Do participants get paid for clinical trials at Triad Clinical Trials?

Yes, some clinical trials at Triad Clinical Trials include payment for participants’ time and travel expenses, though this is not guaranteed for all studies.

Is my safety a priority if I participate in a trial?

Yes, Triad Clinical Trials explicitly states that participant safety is their top priority, and their staff has experience and knowledge to maximize safety and well-being.

Does Triad Clinical Trials work with my personal doctor?

Yes, the website indicates that Triad Clinical Trials will work with your personal doctor to coordinate your overall healthcare while you are participating in a clinical trial.

What is the purpose of clinical trials?

Clinical trials are scientific investigations into new and innovative medical treatments or devices to gather data needed by regulatory bodies like the FDA to approve new prescription medications.

What are the benefits of participating in a clinical trial?

Participating can give you access to leading-edge medicine, board-certified care, promising new alternatives, and contribute to making healthcare better for everyone.

It also offers potential no-cost medical services and compensation.

What are the risks of participating in a clinical trial?

Yes, clinical trials inherently involve risks because they test experimental treatments whose full safety and efficacy are not yet known.

Participants may experience unknown side effects, the treatment may not be effective, or they might be assigned to a placebo group.

How does Triad Clinical Trials ensure ethical conduct?

Triad Clinical Trials works with Institutional Review Boards IRBs and sponsor companies, which are independent bodies responsible for ensuring ethical research practices and protecting the rights and welfare of human subjects.

Does Triad Clinical Trials have a privacy policy?

Yes, Triad Clinical Trials has a “Privacy Statement” and “Terms and Conditions” available on their website, indicating their adherence to data protection standards.

How do I sign up or view enrolling studies at Triad Clinical Trials?

You can sign up or view enrolling studies by visiting the “Enrolling Studies” section of their website or clicking the “VIEW OUR STUDIES” button.

What is a Phase II clinical trial?

A Phase II clinical trial involves a larger group of patients to further evaluate safety and begin assessing the effectiveness of an investigational treatment.

What is a Phase III clinical trial?

A Phase III clinical trial is a large-scale study involving hundreds to thousands of patients to confirm effectiveness, monitor side effects, and compare the investigational treatment to standard ones before regulatory submission.

What is a Phase IV clinical trial?

A Phase IV clinical trial occurs after a drug or device has been approved and marketed, continuing to monitor its long-term safety and effectiveness in diverse populations.

Can I withdraw from a clinical trial at any time?

Yes, participants in clinical trials typically have the right to withdraw from the study at any time, for any reason, without penalty or affecting their standard medical care.



Comments

Leave a Reply

Your email address will not be published. Required fields are marked *