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A Clinical Trial Survival Guide

We’ve sorted through the clinical trial essentials.  We have met the basic types – prevention trials, early detection trials, diagnostic trials and the like.  We’ve taken a look at the various study phases and common elements.  We’ve considered the placebo mystery.  Now we’ll take a look at the protections in place for study participants.

Keep in mind that clinical trials are a very important part of modern medical research.  Scientists use them to find ever-better ways to treat, prevent, detect and perhaps even cure diseases and medical conditions.  But clinical trials are not simply experiments run in labs.  Merriam-Webster’s Medical Dictionary defines a clinical trial as

…a scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug or vaccine) using consenting human subjects…

The ‘consenting human subjects’ part is the important bit.  Here’s what the NCCAM wrote about the historical context of participant safety:

The National Institutes of Health (NIH) has established policies and procedures to protect people involved in research studies.  The foundation of the NIH protections is The Belmont ReportEthical Principles and Guidelines for the Protection of Human Subjects.  Published in 1979, the Belmont Report provides the philosophical basis for current Federal laws governing research that involves people.  It established three fundamental ethical principles for such research: respect for persons, beneficence (maximizing benefits and minimizing harms), and justice (treating subjects fairly).

Another document in the history of protections for research participants is The Declaration of HelsinkiRecommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, issued in 1964 by the World Medical Association.  The Declaration of Helsinki broadened concepts initially set forth after World War II in The Nuremberg Code, which named 10 conditions that must be met to justify research involving people.  The two most important conditions were the need for voluntary informed consent of participants and a scientifically valid research design that could produce fruitful results for the good of society.

The Federal Government has many requirements for the protection of participants in any federally funded clinical trials:

  • Before a clinical trial can start, the written protocol must be approved and monitored by an institutional review board (IRB), an independent group of health care providers, community members and other experts who make sure the study is set up and directed safely and fairly.
  • Consent documents signed by any study participants must also be IRB-reviewed, and approved.
  • An IRB can stop a clinical trial if it determines that a researcher is not following the protocol or if it appears that the trial is causing unanticipated harm to participants.
  • An IRB can also stop a clinical trial if it is clear from the evidence that the treatment or therapy is so effective that it can be made widely available as soon as possible.
The NIH requires additional safety and data monitoring as well.  A Data Safety Monitoring Board (DSMB) is used for some studies, particularly Phase III trials, which often involve a number of institutions.  A DSMB is an independent committee made up of physicians, statisticians and patient advocates who regularly review data from the trial to minimize risks to the participants.  Patient safety is a DMSB’s first priority.  A committee can stop a study or trial if safety concerns develop.  They can also stop a trial if the study’s objectives are met.
The informed consent process is another way to protect clinical trial participants.  When someone who is thinking about taking part in a study meets with a member of the research team, important facts about the study will be discussed, including:
  • Who is sponsoring and conducting the research
  • What the research team wants to learn
  • Who reviewed and approved the study
  • What any participants will be required to do during the study, and for how long
  • How participants’ health and safety will be monitored
  • Risks and benefits of participating
  • Other treatment options for the disease or condition being studied
  • How the privacy of any participant’s medical information and records will be protected.
Some things to keep in mind about the informed consent process:
  • You have a right  to have all of your questions answered during the process.
  • A consent form can often be intimidating – long, complex, even tedious.  Take it home; review and study it carefully.  Go over it with friends or family.
  • If you are still interested in participating in the study, go over it with your primary care physician before you commit.
  • Signing the form indicates you are consenting to participate in the trial.  However, the consent is completely voluntary.  You can leave the trial at any time, for any reason, even after signing the consent form.  
Next: what happens during a trial and CAM trials (and tribulations!)
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