Interview with Heather Wakelee, MD
Dr Wakelee is Assistant Professor of Medicine in the Division of Oncology at Stanford University in Stanford, California.
Investigator perspective on patient clinical trial involvement
DR LOVE: What’s your experience been in terms of when people are interested in being in a study like this. Are they usually doing it to help future patients? Or – I mean I guess in this situation if the computer assigns them to receive bevacizumab, they’re getting a therapy they wouldn’t have gotten and if it does turn out a few years from now that we know it helped, they would have benefitted. But what are people usually thinking when they consider this?
DR WAKELEE: I think it’s a little bit of both. I try to ask people not to go into it with the idea completely that it’s going to have an impact on them because I don’t know. The real impact is going to be on future people with lung cancer and being able to tell them five years from now, hopefully, the bevacizumab is beneficial, or to be able to tell them that it isn’t, but we know that and that’s because we did the study. And so that’s a difficult thing and each person is certainly go at it from a slightly different perspective.
I think most people do have some hope that it is going to benefit them personally and I certainly would hope that as well, but we just don’t know. And so I do think that there is a component of altruism.
DR LOVE: What about if the patient decides they want to go on the trial, that at some point along the line they want to get out of it. Is that a problem?
DR WAKELEE: Oh, no. Every clinical trial patients have the choice to decide to stop participating at any time.
DR LOVE: Now also, patients have to sign what’s called an informed consent, which is a paper document that goes through all the details, a lot of what you’ve talked about today. What’s the reason for that?
DR WAKELEE: It’s to make sure that patients are fully aware of what the potential risks are. In the setting of a trial, we don’t know what the potential benefit is. We can’t promise any benefit and so it’s very important to make sure patients understand what all of the potential risks are. And the only way to know that is to have it in writing. I know that when I have a discussion with a patient, particularly a long one, what I’m sure we covered is not always what they’ve heard and so the point of having it in writing is so that patients can go back and refer to it, have time to really read and digest, and ask questions based on that.
DR LOVE: And of course, even in the informed consent document it reinforces the fact that it’s totally up to the patient. They can receive therapy, the chemotherapy as would be standard without being part of the trial. And that it’s really just totally up to them.
DR WAKELEE: Yes.