Steven Cummings, M.D., on Electronic Informed Consent and Internet-Based Trials

Steven Cummings, M.D., on Electronic Informed Consent and Internet-Based Trials

I’m Dr. Steve Cummings. I direct the San Francisco Coordinating Center and I’m a senior investigator at the California Pacific Medical Center Research Institute and a professor of medicine and epidemiology at UC San Francisco. We just wrote a paper in the New England Journal of Medicine about electronic informed consent and Internet-based clinical trials. Doing consent electronically allows you a number of other capabilities; for example, you can embed links in a consent form that allows a patient to check that link or click that link and go to a page where they learn more about the study. It’s important as well to understand that the patient really comprehends the research since you are not there talking to the patient in person. Just as informed consent can be done electronically and done from home, clinical trials can also be done remotely and done from patients’ homes. So the second part of our article is about Internet-based clinical trials. Internet-based clinical research is now done commonly for things like smoking cessation or weight loss where patients signs on, gets advice, and then measures or reports their smoking history or weight later on. But trials that involve drugs or nutritional supplements have been done much less commonly. There are a few examples that have been successful and Internet-based clinical trials have a couple of important advantages: one, it allows the opportunity for patients to participate who don’t live near traditional clinical sites where drug trials are done; and secondly, since they’re done from home without a clinical site, such trials can be much less expensive than standard trials. So I’m going to use an example of a clinical trial to illustrate Internet-based trials that is being done by a young faculty member at UC San Francisco. It’s a trial of melatonin, an over-the-counter sleep aid to treat migraine headaches in adolescents. So imagine in this case the first step is to reach your patients who might qualify; you can do that using medical records, searching medical records for patients who may have the diagnosis, and offering them the opportunity to go to a website, for example, to participate or reaching out to patient communities, again online with a link to a website. And on the website get more information about the proposed trial, and if there is interest, the patient may click on an opportunity to provide informed consent, informed consent to then give name and address and some basic information to determine whether or not they would be eligible for the trial. I think the future for Internet-based clinical trials is very bright. However, only a few have been published, others are underway, we need a lot more experience with how to do them, how to do them efficiently, and with issues that might arise in the course of doing drug-based clinical research online. However, I think that it has a lot of potential saving money, making trials more accessible to a broader range of patients particularly those who can’t get to clinical sites where such trials would be done. We’ve covered these topics — electronic consent and Internet-based clinical trials — in our article in the New England Journal. I hope you take the opportunity to read the article, and if you’re interested in this line of research, I hope that you consider using electronic consent, and where appropriate, Internet-based means to conduct clinical trials.

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