By William Tobia, M.S., M.B.A
Clinical trials are an integral part of the drug development pipeline, with profound effects for our sickest patients. Anyone who has been involved in clinical trials and had to attract potential subjects for participation knows how difficult this process can be. And patients, particularly those with major illnesses, often struggle to find the trials that could offer lifesaving treatment. Given the integral role that mobile devices have played in helping patients and physicians find medical information, clinical trials seem like a natural extension.
Players in the clinical trials process are either considering this unique approach or have made the move already. However, the “FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process.” So how do recruiters using such apps strike a balance between providing enough information to make it attractive to the subject, without making it study-specific, thus requiring compliance with the regulations? In other words, how do researchers improve the process of trial discovery for patients without crossing into territory that requires the oversight of the FDA? Clinical Trials Mobile is one free app that tries to fill precisely that need, but its not clear whether it crosses into that potential treacherous territory.
PPD Development, an international company involved in clinical trials, recently released their “Clinical Trials Mobile” app, “designed to provide easy access to search the National Library of Medicine (www.clinicaltrials.gov) database of available clinical trials worldwide, find studies near you matching specified categories and keywords, and view detailed information about specific clinical trials.” The home screen, pictured above, has several options but the most useful is the search. Shown below are the search screen and a sample search for prostate trials for adult men.
The features and functionality of the app are easy enough to use, with a straight-forward launch page that allows one to search for clinical trials of interest by indication and geography, and subsequently save these searches. However, as you can see from the sample search, this app may be a bit too detailed for patients to use. Some other sample searches, such as for cardiomyopathy, yielded trials with information a patient could potentially interpret. However, for this search, the app seemed to be far more useful to clinicians interested in learning what is actively being studied in their topic of interest or looking for trials on behalf of a particular patient.
There are also options for physicians and patients to register with PPD to receive relevant updates, though this is based on the PPD website rather than the app. The registration section of the app includes numerous reasons why people volunteer to participate in clinical trials. But it is in the specific wording of this information that PPD ventures into “uncharted waters” that seem to be potentially at odds with the FDA Guidance.
• “access to investigational treatments before they become widely available” – seems to draw the foregone conclusion that all investigational treatments will be found approvable by the FDA
• “access to free physical examinations and diagnostic tests related to the clinical study” – seems to ignore the FDA Guidance which states that “Advertisements should not promise “free medical treatment,” when the intent is only to say subjects will not be charged for taking part in the investigation.”
• “potential compensation for time and travel related to the clinical study” – again, seems to ignore the FDA Guidance which states that “Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.”
As we’ve talked about, the FDA has indicated that “they will be starting regulatory review of medical apps starting in 2011.” Whether CDRH or DDMAC or both become involved, remains to be seen. Regardless, it will be interesting to follow the developments of apps such as PPD’s “Clinical Trials Mobile”. Particularly worth watching will be signs of revisions in the content of the apps in response to regulators mandates. Given the resource constraints faced by the FDA, it is anybody’s guess as to how long new medical apps will be in the FDA’s waiting room.