Clinical Trials 101

There are strict guidelines and safeguards that are designed to protect everyone who participates in clinical trials. They include the following:

• FDA guidelines
  • The FDA reviews and approves the overview and the details of the guidelines to be used in a clinical trial before any clinical trial can start.
• Institutional Review Boards (known as IRBs)
  • Most clinical trial in the U.S. must be approved and periodically monitored by an IRB.  The IRB is an independent board composed of research scientists, doctors, and local community members. 
  • It is the job of the IRB to insure that clinical trials are conducted in an ethical manner and that the rights of study participants are protected. This includes insuring that risks are minimized as much as possible and that the possible benefits outweigh the known risks.
• Data Monitoring Committees
  • Data Monitoring Committees are primarily used for studies comparing one treatment with another and in cases where treatments are selected for patients at random. The participation of the committee is especially important for treatments geared toward very serious illness.
  • Information is reviewed to ensure that treatment study is performed as safely as possible for the trial volunteers. If the committee determines that a treatment is harmful or ineffective, the study will be discontinued.  Likewise, if it is determined that one treatment is more effective, the committee will halt the study and all volunteers will be provided with the more beneficial treatment.
• FDA Periodic Inspections
  • In order to protect volunteers and confirm that studies are being conducted correctly, the FDA periodically inspects clinical trial records as well as the research scientists and facilities conducting the trial.
  • Inspections may also be conducted in response to filed complaints.

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