What are the Benefits and Risks of Participating in Clinical Trials?

Depending on the type and purpose of the trial, th Understanding Clinical Trials | Drug Trials & Studies/Drug Approval Process | Imaginis - The Women's Health & Wellness Resource Network

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Understanding Clinical Trials

What are the Benefits and Risks of Participating in Clinical Trials?

Depending on the type and purpose of the trial, the benefits and risks vary significantly. The following table summarizes possible benefits and risks that patients should carefully consider before enrolling in a clinical trial.

Possible Benefits of Trials Possible Risks of Trials
  • having access to potentially more effective therapies than those currently available
  • receiving quality medical care from leading physicians
  • being closely monitored for possible negative effects
  • sometimes receiving treatment at a reduced rate or free of charge
  • helping to further new research that may result in significant medical advances
  • for patients in cancer therapy trials assigned to control groups, they still receive the top standard therapy available today
  • patients may not receive the therapy under investigation (may receive a placebo—inactive pill—instead)
  • the new therapy may not be more effective than the standard, thoroughly tested therapy
  • in Phase I trials, not knowing the safety consequences of the new therapy (risk is less in Phase III trials)
  • new therapy may have unexpected, possibly severe side effects or may be less effective than standard of care
  • insurance companies may not cover all costs of clinical trials

What Should Patients Know Before Entering a Clinical Trial?

Patients interested in participating in clinical trials should ask their physicians to thoroughly explain the trial, including its risks and benefits. Patients should learn:

  • The purpose of the trial
  • How many people will participate
  • What type of tests and treatments patients must undergo
  • How long the trial will last
  • The potential side effects of tests or treatments
  • What type of long-term follow-up care is provided
  • Whether patients will have to cover any costs of the trial. If so, whether the patient’s insurance cover the costs or if financial aid is available

The following terms may be helpful to patients who are considering participating in clinical trials:

Protocol The planned course of action for the clinical trial. The protocol is established prior to the start of the trial and states the number of participants, eligibility requirements, agents that will be used, dosages, duration, how data is collected, etc.
Investigator A researcher in a clinical trial.
Sponsor The party or parties responsible for funding the clinical trial.
Institutional Review Board (IRB) An independent board of scientists, physicians, and nurses who review the clinical trial protocol to ensure patient safety.
Informed consent A patient’s decision to participate in the clinical trial after being informed of the potential benefits and risks of participation. Participants may withdraw their consent at any time and leave the trial.
Double blind Term used to describe a clinical trial in which neither the patient nor the researcher knows which agents are being administered to which patients. This helps prevent bias.
Intervention group The group of participants receiving the new preventive or treatment agent that is being evaluated in the clinical trial.
Control group The group of participants receiving a standard treatment or placebo (see below) that is being compared to the new agent in the clinical trial.
Randomization Assigning participants by chance to either the intervention group or the control group. Randomization is often done with a computer.
Placebo An inactive substance that may be given to participants in a clinical trial. Sometimes called a sugar pill.
Follow-up Monitoring of participants for a specified time after the clinical trial is completed.
Prospective study A study of a group of patients that is conducted as they are undergoing a treatment or preventive measure.
Retrospective study A study of a group of patients after they have already undergone a treatment or preventive measure. "Recall bias," unintentional inaccurate reporting of certain information, can sometimes influence a retrospective study.

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Updated: August 2010