No matter where you live in the world, your daily activities have likely been impacted in recent months, possibly dramatically. At the very least, you probably have much better awareness of what a six-foot distance looks like.
The current global health crisis has not spared clinical research. When the COVID-19 pandemic began, the industry needed to focus immediately on business continuity and determine how to mitigate the impact on clinical trials while protecting participant safety. Sponsors made rapid decisions to change study protocols, and implement process and technology changes such as introducing decentralized clinical trial (DCT) technology to enable remote trial activities. Regulations for clinical trials were also impacted, notably with the decision to delay the E.U. Medical Device Regulation (MDR).
The technology was already there, so what slowed pre-crisis innovation?
It has been almost ten years since the first DCT-enabled clinical trial. The Pfizer REMOTE study was entirely home-based for the participants. Pfizer obtained informed consent online with an electronic signature, delivered the study drug directly to participant’s homes, and recorded adverse event reports and efficacy outcomes with mobile devices and web-based measurement tools.
What delayed more rapid DCT adoption in the ensuing years before the crisis? A variety of cultural factors including the industry mindset and regulatory approach likely played a role. Industry decision-makers were perhaps cautious due to the initial investment required for new systems, and the challenges of business transformation and regulatory change has traditionally been perceived as slow and often recognized as a top challenge to clinical trial professionals.
The crisis caused the industry to make a rapid change with technology adoption and regulatory response. Travel and social distancing restrictions kept clinical research associates and participants from going to sites. Sponsors quickly implemented DCT components such as remote monitoring and eConsent, to allow for crucial trial participant and enrollment activities to take place remotely.
On the regulatory front, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicine and Healthcare Products Regulatory Agency (MHRA) issued guidance early in the crisis to assist sponsors with trial continuity. U.S. federal officials relaxed telemedicine rules and waived some Medicare requirements allowing doctors to practice across state lines and virtually prescribe more medications.
To move forward, rethink your paradigm
The clinical research industry often fails to ask, “why are we doing this way?” “What purpose is this piece of the process serving? Is it effective?” This lack of introspection is evident in the story of source data verification (SDV).
The FDA and EMA marked the official supplanting of SDV by Risk Based Monitoring (RBM) in 2013 when they released final guidance for RBM. However, since that time, SDV has been proven to have little or no effect on quality, yet is still the most used for data quality before the crisis sponsors may have stayed with status quo behaviors because it was easier than change.
Selecting technology to support social distancing in trial enrollment
For some medical offices reopening in the crisis, protocols are numerous. They may include COVID-19 tests, mandatory face coverings, spacing visits to reduce waiting room crowding, hand washing upon arrival, temperature, and blood oxygen level checks, stringent sanitizing procedures between visits, and more. Some trial participants may not be willing to put up with this additional burden, and the fears that might surround contact, to participate in or stay in a clinical trial.
Sponsors can use DCT methods to ease participant burden and mitigate trial dropout. Consider:
- Implementing eConsent to allow remote participant enrollment and consent
- Adding remote monitoring to enable remote participant engagement
- How a telemedicine solution might enable more remote participant visits with caregivers
eConsent is of particular importance, since historically-low industry adoption means that most organizations will be implementing the practice for the first or second time. A flexible, user-friendly, and secure eConsent solution is critical, especially if it can integrate with a robust EDC platform to centralize all study activity. This approach reduces errors, improves efficiency, and eliminates administrative overhead involved in the processing of physical documents. It will be important for researchers to document how their eConsent program will ensure participants are adequately informed about their consent, where they can obtain support using the eConsent platform, and how they might revoke their consent if desired. This can be a complicated process, so choose a technology partner that can assist you in the implementation and address any deficiencies that might arise.
Post-crisis, clinical trials may migrate towards a hybrid approach, with some trial activities such as participant enrollment and consent handled remotely. In contrast, other activities such as monitoring visits that might require a procedure, observation, medical diagnostic, or imaging process to be conducted in person with a clinician, may still be undertaken all in person, or only partially remote.
It’s not one or the other
The question post-crisis is not, “Do we go back to traditional ways?” or “Do we completely change our research operations?” The industry will need to adopt a flexible mindset that encompasses a variety of solutions. Post-crisis, some components of trials may remain remote. In contrast, others may go back to more traditional methods depending on region, therapeutic area, specific attributes of the participant population, and other study needs.
What started as crisis continuity could become a valuable addition to the research toolkit. Careful consideration of the unique design, conduct, and challenges of decentralized clinical trials will be essential as more researchers move toward this model. The tools are here; now, it’s time to shift the mindset, embrace a new paradigm, and move forward with a better way of doing clinical research.
