What you should know about clinical trials.

What is a clinical trial (also known as a clinical research study)?

A clinical trial is a scientific investigation designed to answer important questions about an intervention, such as:

  • Is it generally safe?
  • What are the side effects?
  • How well does it work?
  • Which dose works best?

All investigational drugs must be tested in clinical trials before they may be considered for approval and become available to be prescribed by doctors.

People take part in clinical trials for a number of reasons. For example, they may:

  • Want to help others like them or add to our knowledge of their disease or condition
  • Be interested in the close monitoring they receive when in a clinical trial

When participating in a clinical trial, it’s important to know:

  • Participation is always voluntary
  • You may withdraw at any time and for any reason
  • If you decide you do not want to participate, it will not affect your care now or in the future

An investigational drug is not approved by a regulatory authority, as its safety and efficacy have not been established.

Even before a study starts, safety is our highest priority. Every study must be reviewed and monitored by either an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC). These groups, which are made up of both scientists and non-scientists, review the study’s plan to make sure that:

  • The rights of participants will be protected
  • There are no unnecessary risks involved
  • The study answers important unanswered medical questions

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