The U.S. Food and Drug Administration (FDA) recently announced that its MyStudies app is available to investigators in the form of a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face meetings is not possible or feasible considering the COVID-19 pandemic-based controls now in place. Moving forward, investigators have a powerful digital tool to support virtual trials in the context of the “new norm” of clinical research. Just as importantly, the Agency has given this approach their blessing with guidance. Sites should use this crisis to understand just how far they can progress their organizations using technology-driven digital transformation. Sites—don’t let sponsor clinical quality assurance groups tell you different!
Since the pandemic, many studies of course have been placed on hold while others were given greenlight to modify and become at least partially remote or virtual. That is because of the control measures due to COVID-19, lockdowns, social distancing and the like. Investigators were increasingly confronted with situations where patients may be in isolated patient rooms in provider facilities—or even at stuck at home not able to travel to the clinical investigational sites. Investigators and their staff were increasingly confronted with a difficult reality—how to securely obtain informed consent that adhered to FDA rules.
The FDA Steps Up
The FDA has been quite active during this pandemic—working with sponsors, providers and research sites, individual investigators and patients to help this important industry sector adjust and progress despite obvious hurdles and constraints.
Hence, recently the FDA made available their MyStudies app for investigators as an absolutely free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contract isn’t feasible or practical due to the pandemic and all of the new rules in place.
What is FDA MyStudies app?
Leveraging this app, investigators can now send their site-specific informed consent document electronically to the patient or his or her legally authorized representative, reports the Agency on their website. The patient or representative receives a digital document they sign and the built-in rules rout a copy of the digital document back to the investigator. Thereafte,r the digital informed consent document is stored and managed in an FDA GcP compliant system. They can access the signed instrument, print it out, or transfer the file electronically. Investigators can find the app on Google Play and Apple App stores under the title COVID MyStudies.
Value Proposition Moving Forward
There is one less excuse now for a study delay thanks to the FDA. COVID-19 has been tough on everybody—a true public health emergency—but the Agency truly has worked to make running studies easier. In fact, during a recent FDA guidance, the Agency reintroduced Conduct of Clinical Trials of Medical Products in a bid to help encourage investigators to consider using electronic methods of obtaining informed consent if possible.
The MyStudies app Partner
The FDA signed up Harvard Pilgrim Health Care Institute, responsible for the operations of Sentinel (national product monitoring system) and Catalyst Systems on behalf of the agency providing the technical assistance required for the COVID-19 MyStudies app. The FDA is actually funding the technical assistance during the COVID-19 pandemic period, so clinical investigational sites should capitalize on this opportunity should it align with their site strategies.
Note that prior to COVID MyStudies app, investigators must provide their informed consent documents to the COVID-19 MyStudies team to be uploaded to the app. Investigators will be afforded the opportunity to review the informed consent documentation prior to incorporating into actual clinical trials.
In a nice value-add, investigators can take care of some system configuration capabilities, enabling sites to incorporate clinical trial-specific branding within the app. Of course, there are policies and rules associated with IRB review and approval that investigators must understand and comply with—so those should be reviewed.
A World on Sponsors
TrialSite News principals have had extensive dealings with industry sponsors (pharma) and a word to sites: the clinical quality assurance groups within these companies can be more uptight and stringent than the FDA. We have been through audits where old-school auditors seek to identify server numbers in a world of cloud computing! Try explaining database “sharding” concept and see their eyes thinking about how many ways their data can be gone forever—and the leverage afforded in the audit inspection dance.
Sites should be at the forefront in using process and digital systems to drive new efficiency and flexibility. In fact, the FDA is often very open and willing to consider new technologies, such as cloud-based systems, faster than industry itself. This seems hard to believe but it is true. There is a significant amount of restructuring that big pharma (especially) will need to go through post COVID-19 and such transformation will be supported by a change in paradigm in clinical operations.