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What Are Clinical Trials and What Can I Expect If I Enroll?

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Published on January 26, 2016

Dr. Alan Burnett from Cardiff University, Cardiff, UK describes different phases of clinical trials and what enrolling patients can expect.

Recorded at the American Society of Hematology (ASH) Annual Meeting 2015, in Orlando, Florida.

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Transcript | What Are Clinical Trials and What Can I Expect If I Enroll?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Dr. Burnett:
There are different types of trials.  Some are where the drug, not a lot is known about the drug and how it works when it’s given to humans, and so the first stage in the development of a drug is to find out what dose is suitable.  And so that’s done by taking groups of patients and gradually giving them an increasing dose of drug until they start seeing side effects, and then that defines the maximum dose that patients can be given.  That’s a so-called phase 1 trial.

And then the next thing that people try to do is find out, and they may see some responses in a trial like that, but then they would take that dose they discovered and then look at more patients and see what proportion of patients got a response.  And if that’s encouraging, they would say, well, we’ve got a drug here that’s really worth further development, and they would take that into what’s called a phase 3 trial, or a randomised trial anyway, where they compare it maybe with the standard care that’s already available, plus either the standard of care with this drug, or this drug on its own.  And that’s the big phase 3 trials that take, you know, 3, 4, 5 years.

So it’s quite an expensive and quite a long procedure, and patients can back out of it at any time, they don’t, they’re not imprisoned in a trial just because they volunteer at the beginning.   As I say, it’s pretty unusual for patients to be worse off being in a clinical trial, but they may, the drug may not work, and so they may not benefit.   Everybody goes in optimistic but, you know, they don’t always work.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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