Who Can Take Part in Clinical Trials?

Phase 1 clinical trial

If you?ve ever wondered whether you?re eligible to take part in a clinical trial, and what the benefits and risks might be, read on to find out more about whether you might be able to take part in clinical drug development or some other type of clinical study:

Who Decides The Eligibility?

Eligibility for medical research studies is decided in the protocol for the clinical drug development or treatment development. Sometimes, participants will need to be within a certain age range, of one sex or the other, or have a specific illness or medical condition. Some studies need healthy participants. Some studies will advertise for anyone who may meet the criteria to apply, while others will depend on researchers to recruit just the right participants. Even if you meet the basic criteria, it?s possible you could be ineligible due to other factors, like your previous history of treatment or having another condition that might interfere with the study.

What are the Benefits of Taking Part?

There are a number of possible benefits to taking part in clinical drug development or something like a Phase 1 clinical trial. Of course, one of the biggest benefits is knowing that you?re doing something to advance the cause of medicine and health. Interviews reveal that 46% of people asked agree that taking part in this kind of clinical study is just as important as donating blood. Other advantages include getting early access to promising new treatments and having your health closely watched by a strong team of doctors, nurses, and researchers. Even if you end up in the placebo group and are not receiving the new treatment, you may still receive the standard treatment, which can be as good or even better then the experiment.

What are the Risks of Taking Part?

Of course one danger if you have an existing illness is that the medication or treatment going through clinical drug development won?t be effective, and could even be less effective than standard treatments. There is also the risk of unforeseen side effects, and health insurance may not always cover care and costs for these sorts of clinical studies

How Long Will it Take?

This will depend heavily upon the specific study in question. In 1999, the average trial lasted 460 days, but in 2005 the average clinical studying was about 780 days. When you give your informed consent, which is required before any such study, you will learn specifics about the protocols and how long the study is set to take.

What Protections Are in Place?

All medical and research personnel are required to conform to what is known as good clinical practice, or GCP. These practices are in place to protect the safety and rights of patients taking part in trials, and researchers are overseen by the Institutional Review Board, the Data Safety Monitoring Board, and the Office for Human Research Protections.

Taking part in clinical trials is a possible way to access new and experimental treatments and to advance the cause of medicine. Only about 4% of people in the United States ever take part in a clinical study, so if you do, you’ll be part of a very small group doing a great deal of good.

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