Clinical Trial Practices—Safeguards in Research

Published on Jul 22, 2014

If you or a loved one is considering joining a clinical trial, you may be happy to know that research studies today have strict safeguards, standards of ethics, and are highly regulated. In many cases, participating in this type of research may be one of the most closely monitored types of medical treatment available. The clinical trial process is different than it used to be, yet unfortunately the accounts and memory of practices that no longer exist may still make people uneasy about considering a clinical trial.

Reforms have been made to help safeguard clinical trial participation, so that you can play your role as an important contributor to science and be reassured that your human rights are being protected. Though continued improvements may still be on the horizon, federal agencies, patient advocates and the private sector have joined forces to create a variety of enhanced protections and to improve the quality of clinical trials. These include:

  • Updates to the Institutional Review Board (IRB) system. An IRB is an ethics review committee comprised of members with diverse backgrounds who focus on both scientific and non-scientific concerns. It is formally assigned to review and allow (or reject) a clinical trial to be conducted at the place where the research is planned
  • Specific clinical trial education and training of all clinical investigators, IRB members, and institutional staff
  • Clearly outlined requirements for informed consent that must occur before you agree to participate in a trial

Clinical trials on the whole are closely monitored by a number of official bodies. These may include the IRB, clinical trial monitoring committees, and officials at the US Food and Drug Administration (FDA) and/or at the National Institutes of Health (NIH). They oversee the clinical trial sponsors to make sure that all proper safety checks are in place. This helps to ensure that participants are being appropriately treated and data, including safety data, are being properly reported. These official bodies and the sponsors have the authority to stop or change the trial for a number of reasons, including:

  • Early results that offer a large enough difference between groups in the trial that may warrant giving the experimental treatment to everyone in the trial, including those on placebo or standard therapies
  • Too many serious side effects and complications that occur may be related to the experimental therapy
  • Noncompliance with federal regulations that may put patient safety at risk
  • Emerging evidence that there will not be a big enough difference between treatment and placebo or standard therapies to warrant continuation of the trial

This oversight supports better scientific practice as well as professional and ethical standards.

We who run the trials have put a lot of time, effort, resources, and heart into doing a high-quality job in order to get high-quality data. All therapies being tested in clinical trials are thought to have promise. It is hoped that they will prove to be better than those therapies that already exist or an option for diseases that don’t have any approved treatments.

There are many things to consider when you are thinking about joining a trial, and the good news is that regulations and oversight are in place to protect you and may encourage more participation in clinical research. Advances in medical science count on your contribution and commitment.

Alan Clucas is a physician scientist who was Head of Clinical Sciences in the Pfizer Global Innovative Pharmaceuticals Medicines Development Group.

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