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Mythbusters: Participating in a Clinical Trial

Posted on July 21, 2020

  • A clinical trial is a way to evaluate the safety and effectiveness of a drug in people with a certain illness. Some clinical trials evaluate drugs that doctors cannot yet prescribe.
  • Before joining a clinical trial, you will be provided with detailed information to help you make an informed decision about participating.
  • In order to participate in a clinical study, specific eligibility criteria must first be met. These criteria help researchers identify appropriate candidates for participation and are designed to promote safety and accuracy of study results. Based on the criteria, you may or may not be eligible to participate.1 Participating in a clinical trial is an opportunity to advance knowledge about possible new treatments. As a clinical trial participant, you may also have access to new investigational treatments not otherwise available.

Clinical trials involve multiple steps of testing called phases. Phase I trials focus on safety and side effects. Phase II trials further study safety and also focus on treatment effectiveness.1 A Phase III trial is designed to confirm the effectiveness and safety of a treatment. In some Phase III trials, the trial treatment is compared to existing treatment options.1 A new treatment will only advance to the next phase if it shows promising results for effectiveness and safety.2

Clinical Trial Mythbusters

Misunderstandings about what clinical trials involve and how participants are treated may make some people less likely to consider participating in a study. Here are a few common myths about participation in clinical trials and the facts behind them.

Clinical trial participants are treated like “guinea pigs” and aren’t informed about the potential risks of participation.
Historically, many participants in medical research were not told the truth about what was happening to them or risks to their health. Today, informed consent is a key component of all clinical studies. Before agreeing to participate in a trial, you must be provided with sufficient information to make an informed decision, sufficient time to read and review consent materials, and the opportunity to ask any follow-up questions. Here is some of the information that must be provided:3
Explanation of research study
Procedures involved in the study
Privacy protections
Potential risks
Possible benefits
Duration of the study and time commitment required

The informed consent process will also ensure you understand any additional responsibilities of clinical trial participation, for example, having photographs taken of skin areas.4 You will also be informed of any travel-related expenses that may be eligible for reimbursement.

As in most clinical studies, Phase III participants are expected to thoroughly review all information about the study before agreeing to participate, attend required appointments, provide accurate and truthful information about their health, and follow directions for applying the study treatment at home.4,5

If I participate in a clinical trial, my private health information won’t be protected.

The same law that protects your health information at the doctor’s office or in the hospital (Health Insurance Portability and Accountability Act, or HIPAA) creates guidelines for how your health information must be protected if you participate in a clinical study.6

Research privacy rules allow scientists to use and disclose coded health information (meaning your name and direct identifiers have been removed) for the purposes of achieving their scientific goals. In most cases, your identifiable health information is private unless you sign documents authorizing sharing. There are limited situations where a research entity is allowed to disclose coded health information. As a research participant you must be informed of all the ways your health information may be used and your rights to access your health information.6

If I join a clinical trial, I can’t change my mind later and withdraw.

You can withdraw from a clinical trial at any time. Signing consent documents and agreeing to participate is not a binding contract.2 If you do choose to withdraw from a study, you should inform the research staff and follow the protocol for leaving the trial.5

In all clinical trials, there is a chance I will receive a placebo instead of the investigational treatment.

In order to test the effectiveness of a new treatment, clinical trials may assign a group of trial participants a placebo – a pill, cream, or injection that resembles the trial treatment but does not contain the active ingredient. You will always be informed if there is a chance you will receive a placebo. You will not be given a placebo in a clinical trial if foregoing treatment would put your health at risk.1

In most trials, who receives the trial treatment and who receives a placebo or existing treatment is determined randomly (known as randomization) in order to avoid any bias. Many clinical studies are also double-blind – meaning neither the trial participant nor the researchers know which participant is receiving which treatment.1

Joining a clinical trial means I don’t have to see my regular doctor(s).

You should still see your regular health care providers even if you’re participating in a clinical trial. While you will be in contact with medical providers as part of the trial, it doesn’t replace comprehensive health care.2

Clinical Trials for Patients with Vitiligo

Currently, there are ongoing clinical trials sponsored by Incyte to study the effectiveness and safety of an investigational drug for patients with vitiligo. Investigational means the drug is not approved by the U.S. Food and Drug Administration for use in vitiligo.

Among other things, clinical trials for vitiligo can evaluate whether the investigational treatment:

May or may not improve the symptoms of vitiligo
May or may not improve patients with vitiligo become clear or almost clear of symptoms on the face
May or may not improve the symptoms of vitiligo on the whole body
May or may not cause any side effects

Every clinical trial has guidelines to help determine if a person is eligible to take part or not.

Treatments can depend on what type of vitiligo you have. Check your type of vitiligo and find out you if may be eligible for an ongoing study for an investigational drug.

References

  1. National Institutes of Health. Clinical Research and You: The Basics. (2017, October 20). Retrieved April 16, 2020, from https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
  2. ClinicalTrials.gov. Learn About Clinical Studies. (n.d.). Retrieved April 16, 2020, from https://clinicaltrials.gov/ct2/about-studies/learn
  3. U.S. Food and Drug Administration. (2018, January 4). Informed Consent for Clinical Trials. Retrieved April 16, 2020, from https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
  4. Why Participate in a Clinical Trial? (n.d.). Retrieved June 8, 2020, from https://www.incyteclinicaltrials.com/patient/benefits-of-participating
  5. Resnik, D. B., & Ness, E. (2012). Participants' responsibilities in clinical research. Journal of medical ethics, 38(12), 746–750. https://doi.org/10.1136/medethics-2011-100319
  6. U.S. Department of Health and Human Services. (2018, June 13). Health Information Privacy. Retrieved April 16, 2020, from https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
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