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    Using the Internet to Improve Participation in Clinical Trials

    News Release
    Contact: Dean Fryer

    San Francisco CA—April 20, 2017—The Internet offers promising opportunities to gain more, and better informed, participants in clinical studies, according to researchers with the California Pacific Medical Center Research Institute (CPMCRI).
    In an article recently published in the New England Journal of Medicine, CPMCRI researchers Steven R. Cummings, MD, and Michael C. Rowbotham, MD, discuss how electronic informed consent and Internet-based trials can expand the possibilities for broader and more knowledgeable participation in clinical trials.

    Electronic Informed Consent
    Electronic informed consent, or e-consent, provides participants with more information than is feasible with paper-based consent forms. They can click on links to pop-up definitions for unfamiliar terms, take built-in quizzes to ensure that they understand trial parameters, and graphics and videos can demonstrate detailed aspects of a trial. These features can be especially useful for people with limited education or literacy. Participants also have the chance to ask questions, reassuring the research team that each participant is fully informed before enrolling.

    Drs. Cummings and Rowbotham cite studies showing that participants are also more likely to recall key facts with e-consent than with paper-based consent forms. However, the researchers point out that there are potential disadvantages to e-consent: there are additional costs in the initial set-up, though re-use of templates can reduce later expenses. Also, in the case of multi-center trials, individual institutional review boards (IRBs) may not be familiar with the e-consent process.

    Internet-Based Trials
    Conducting trials through the Internet also makes them accessible to a broader range of people, and this can be less expensive, say the researchers. By allowing anyone with Internet access to participate, individuals who live far away from research sites can join a study without having to make regular visits. Identities can be confirmed by online verification methods and mobile research nurses can conduct home visits to draw blood or administer tests. Treatments can be sent to participants through secure delivery or brought by nurses. (The FDA allows sending approved but not investigational treatments to participants.)

    Dr. Cummings points out that certain types of Internet-based research are fairly common, such as studies for smoking cessation or weight loss. But Internet-based clinical trials for drugs or nutraceuticals are more unusual, though several have already begun. One example is an aspirin-dosing trial, ADAPTABLE, which is being conducted entirely through the Internet.

    “The future of Internet-based clinical trials is very bright,” says Dr. Cummings, noting potential for saving money and expanding participation. Few studies have been published, he notes, “and we need a lot more experience in how to do them, how to do them efficiently, and with issues that might arise in the course of doing drug-based trials online.”

    For more information, view a video on Facebook by Dr. Cummings and read the NEJM review article: The Changing Face of Clinical Trials.

    Steven R. Cummings, MD, is Director of the San Francisco Coordinating Center and a Senior Scientist at the California Pacific Medical Center.
    Michael C. Rowbotham, MD, is the Scientific Director of the California Pacific Medical Center Research Institute.

    About Sutter Health’s California Pacific Medical Center (CPMC)

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