Industry Update: The Future of Clinical Trials
An estimated 1 out of every 5,000 experimental compounds achieve FDA approval, and bringing medial products to market costs about $1.3 billion. With research and development costs skyrocketing, bringing a medical product to market is a constant battle. As a result, bio-pharmaceutical commercialization and approaches to clinical trials are shifting to maximize success. With the current number of clinical trials, many disease areas are experiencing market saturation, which forces bio-pharmaceutical companies to focus on patients with rare diseases.
Additionally, clinical trial IT has shifted drastically with electronic consenting and virtual clinical trials. Since many bio-pharmaceutical companies are recruiting patients with rare diseases, selecting feasible sites has become more difficult, as many of these patients live in remote regions. In resresponse to this problem, many companies have begun to focus on virtual clinical trials to attract patients.
Here’s how a virtual clinical trial works:
Sponsors engage potential recruits through online avenues, such as social media and email updates. Once a patient agrees to learn more about a trial, the sponsor mails the patient a package of mobile health devices that collect diagnostic data. This data is sent back to the sponsor and automatically uploaded to its EDC database.
Patients sign an electronic consent form, which includes a video of a physician explaining the details of the trial. Throughout the clinical trial, each patient is able to access live physicians either virtually or through nearby medical centers. Remote nurses visit the
subjects at home to collect study samples. The benefits of this strategy include reduced site initiation fees, fewer subject visits, remote access to study subjects, accurate medical data, the elimination of source document verification, lower subject dropout rates, and higher patient retention. The biggest challenge for virtual clinical trials is developing the level of trust required to engage remotely with patients. Pharmacies and doctors’ offices typically build this trust in person, not on social media and the Internet.
As patient enrollment and engagement becomes more and more challenging, it remains to be seen whether virtual clinical trials will succeed. However, it is crucial to keep reinventing the way we conduct studies for greater success.