Why does it take so long to get new vaccines and medicines to market?
It is not a new question, but as governments, communities, and medical professionals around the world focus their energy and resources on containing the COVID-19 pandemic, it’s one that is being asked with heightened levels of frustration and urgency. It deserves—in fact, it requires—our collective attention and effort.
The good news amidst so many troubling headlines is that the technologies we need to improve patient access and experience are here now. The smart application of those technologies can overcome barriers to trial execution and improve data-sharing and process efficiency across organizations. Most urgently, those technologies can be used immediately to ensure progress for thousands of clinical trials in an environment where patients are expected to stay at home.
Decentralized Trials—The Time Has Come
At a recent congressional hearing, National Institute of Allergy and Infectious Diseases Director Anthony Fauci gave a frank assessment about the shortcomings of the U.S. system for coronavirus testing: It’s “not really geared to what we need right now.”
The same can be said for our traditional clinical trial model. Limiting trials to a handful or two of physical sites inherently limits patient access, while limiting interaction to in-person visits is not only grossly inefficient in many cases, but also limits data frequency and quality. During a crisis like the COVID-19 pandemic, it’s simply infeasible.
By contrast, decentralized clinical trials look more compelling than ever.
The Clinical Trials Transformation Initiative (CTTI) defines decentralized trials as those trials executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model. In layperson terms, the trial is conducted remotely with the participant remaining at home.
The industry has been looking to decentralize trials for years. Now, as health authorities worldwide struggle to contain the COVID-19 outbreak, there is a renewed push to rapidly implement remote healthcare delivery capabilities.
There are currently more than 55,000 interventional clinical trials actively enrolling and providing care for participants worldwide. In light of the current outbreak, it is critical that we continue to deliver high-quality healthcare to research participants, while also continuing to advance clinical drug development programs.
Decentralized trials are largely “geared” for exactly this type of situation. Of the 55,000 trials in flight, some are good candidates for a fully decentralized model, while others can be managed in a hybrid model. Patients can be recruited and consented remotely. Physician “visits” can be conducted remotely via telemedicine. Data can be captured remotely (and frequently) via medical devices and mobile technology.
All of this expands our ability to conduct research by “untethering” it from physical sites, which is critical when people around the world are being told to “stay home” due to the COVID-19 pandemic. It reduces the risk of pathogen exposure to research participants, while potentially accelerating drug and vaccine development.
Shifting to decentralized or hybrid trials often requires changes to study design or regulatory approvals. While that’s no small task, it’s an urgent one for many clinical trial leaders right now. We need to take collective action as an industry (including regulators) if we want to ensure productive clinical trial progress and avoid significant loss of patient participation.
With all of this in mind, there is an immediate need for decentralized and hybrid trials to help us through these challenging times, using digital and mobile technologies to improve patient access, experience, and outcomes. Let’s work together as a community to drive forward faster, whether it’s accelerating trials for COVID-19 vaccines, reducing trial timelines for other therapies, or initiating new trials to address the 7,000 rare diseases that have no therapies on the market.
The COVID-19 outbreak has made it crystal clear: Decentralized trials are no longer a nice-to-have. Reducing trial timelines has to be a long-term industry imperative, and digital technology can help valuable research continue to move forward while keeping participants safe. Let’s start now, and let’s move faster together.
Author: Alison Holland, Head of Virtual Clinical Trials, Medable
If you want to join this effort, please contact Covid19@medable.com or reach out to anyone on the Medable team at www.medable.com. We’re working closely with regulators, pharma sponsors, biotech sponsors, clinical research organizations, and other tech companies worldwide in an effort to mobilize and accelerate decentralized trial adoption.
[Editor’s Note: This blog was updated significantly on 3/18/20 following its original publication.]