In the early weeks of the novel coronavirus pandemic, the United Kingdom’s NHS organized a trial, called RECOVERY, that sought to identify and vet possible treatments for COVID-19. That trial explored everything from azithromycin to convalescent plasma drawn from recovering COVID-19 patients whose blood has antibodies.
By June, the RECOVERY team had identified the steroid dexamethasone as a useful treatment for lowering the mortality rate among the most respiratorily impacted patients. Importantly, the RECOVERY team got these insights out to hospitals and other HCPs as quickly as possible. Concurrently, the team published its insights in a variety of ways:
- Key insights were published online for public viewing.
- Those insights were also made available via statements and press releases.
- Detailed articles were published as preprints.
- Detailed articles were also submitted for peer review.
Nicole Mather, a partner and life sciences lead at IBM in the U.K., wrote about the RECOVERY trial in an August 2020 article for Nature. Mather also serves on the board for DigiTrials, a research hub created by the NHS designed to “to provide data, expertise and infrastructure specific for clinical trials.”
That data and infrastructure helped speed up the RECOVERY team’s research, and in doing so the NHS has provided a model for expedited clinical research during times of uncertainty. Mather lays out how in her article:
- Recruitment was streamlined. The consent form for participants was just two pages long.
- The NHS DigiTrials platform made it easier for researchers to collect (and process) reliable data.
- Results were published quickly across multiple channels. Insights were elaborated upon or distilled based on the communication channel.
This work helped the U.K. and the world identify a crucial treatment for COVID-19. Furthermore, the RECOVERY trial has provided a test case for how researchers can address the potential for public mistrust during a pandemic.
When people are getting sick by the thousands and a pandemic becomes a political concern, communicating trust is essential for researchers. Mather notes how one aspect of that trust-building involves collaborating with institutions in which the public has confidence.
During a pandemic, trust-building should be a consideration throughout the trial, from trial design to data collection to the publication of findings. This requires the engagement of a variety of stakeholders throughout the trial.
Fortunately, there is one team in the healthcare ecosystem uniquely positioned to bring those stakeholders together. That’s medical affairs.
By leveraging the medical affairs network and working collaboratively with those teams, clinical researchers can efficiently address the question of public trust in their work.
Building off of Mather’s assessment of the RECOVERY trial, we have identified three aspects of clinical research where MA collaboration would be especially helpful.
Tap Into the Right Health Data
Because the NHS had been building its own repository of trial data, HCPs could trust that the RECOVERY trial’s research had a reliable foundation. That’s an important point, too, when rapidly deploying a treatment for a public that could be mistrustful of, fearful of or just simply exhausted by pandemic-related news.
Since March 2020, researchers around the world have been doing a great job of curating such databases:
- The National Institutes of Health Office of Data Science Strategy maintains a list of open-access data for anyone researching COVID-19.
- The Rare Diseases Network is conducting a study to help COVID-19 researchers understand how the pandemic is impacting patients with rare diseases.
These collaborative databases are especially important because there’s evidence to suggest the human networks of researchers has shrunk during the pandemic. Caroline Wagner, a science and policy researcher at the Ohio State University, examined co-authorships on scientific papers in January 2020 and April 2020 — before and after the WHO declared the novel coronavirus outbreak a pandemic.
Wagner’s research found that those co-authorship links became less numerous and representative of fewer nations after the pandemic, which means researchers have been relying on established research connections rather than branching out. This makes sense given the quarantines and canceled scientific events the world began to experience in March 2020.
Therefore, the infrastructure of collaborative networks take on greater importance during a pandemic, as they help researchers share insights when less formal means of connection get severed.
Again, this is where medical affairs and their networks can step in.
Certainly, collaborative networks began to coalesce in the spring of 2020. In late March, the COVID-19 Healthcare Coalition was created to provide “real-time insights to aid healthcare delivery and help protect U.S. populations.” Members of that coalition include, the MITRE Corporation, the Mayo Clinic, Leavitt Partners and several MIT faculty members.
Further, Esther Krofah, executive director of FasterCures, notes how competitors have been coming together to collaborate and break down information silos in pursuit of COVID-19 treatments. Krofah points to one alliance, which includes Gilead, Novartis and WuXi AppTec, whose members are collaborating on research into antivirals.
By leveraging and sharing the data of established organizations like these, clinical research can begin with a solid, trustworthy foundation.
Let Partners Help You Communicate the Research’s Potential
Trial recruitment can be a major challenge during a pandemic. Having trusted partners who can speak on behalf of your research can go a long way toward overcoming that challenge.
In June 2020, Kathryn Stephenson and Bisola Ojikutu, respectively the director of the clinical trials unit in the Center for Virology and Vaccine Research at Harvard and the director of the Community Engaged Research Program in the Harvard Center for AIDS Research, wrote in STAT about the importance of recruiting Black and Latinx patients for COVID-19 research.
After all, Stephenson and Ojikutu note, those populations represented about 40 percent of COVID-19 cases in the United States at the time of writing. Extra trust-building must go into reaching those participants, they write.
“Address research mistrust by engaging communities now, at the beginning, not when it’s time to share the final results. This means investigators need to meet with local stakeholders in Black and Latinx communities, host webinars and virtual town halls, do interviews on community radio, and put themselves out there on social media.”
Note the diversity of community entry points that Stephenson and Ojikutu recommend. It’s not enough to work with one city council member to host a town hall, or to work with one religious leader to reach their congregation. “Including a variety of community stakeholders from the start to the close of a trial has revealed other recruitment strategies, such as ‘refer-a-friend,’ that may ease the recruitment process of specific subpopulations,” Yaritza Peña, Mary Jo Lamberti, Geraldin N. Batista, Kate Wilson and Narinder Chopra write at Applied Clinical Trials.
Those five authors represent a collaboration between Tufts Center for the Study of Drug Development and Biogen, the latter of which has its own outreach program into Black and Latinx communities in the United States. That team, Global Clinical Operations UP Champions, works with communities and stakeholders to facilitate an ongoing dialogue between the company and patient populations.
Again, that’s the kind of trust-building necessary to get representative patient groups when a pandemic is disproportionately affecting certain communities.
Get the Results to the Right Stakeholders Quickly
Finally, the RECOVERY trial’s approach to insight dissemination is reflective of a wider trend in clinical research, one that has the potential to engender greater trust in the work.
Even before the pandemic, researchers were exploring alternatives to a time-consuming, linear publication model in which insight generation followed peer review. Preprints, for example, were becoming increasingly popular.
Ewen Callaway, a senior reporter at Nature, notes how the pandemic has accelerated innovations in publication, examples of which include a Review Commons for faster peer review and the curation of preprints.
But the fluidity of knowledge in the early stages of the COVID-19 pandemic generated too much noise, and confusion proliferated quickly. As a response to that problem, Kumari Priyanka and Tejas Thomas at Indegene Pvt. Ltd. in Bangalore propose a multi-pronged approach to engaging stakeholders:
- For regulators, clinical research teams should make trial data fully and quickly available.
- For sponsors and other researchers, access to some of the trial data is necessary to facilitate collaboration and spur new research.
- For HCPs, distilling insights helps them make therapeutic decisions and earn patients’ confidence.
- For patients and the public at large, access to real-time data can engender confidence and give people the tools to be better stewards of their own health.
Again, all of this can be done in parallel by leveraging the networks that medical affairs teams naturally create.
That’s why we believe a collaborative relationship between clinical trial leaders and medical affairs can be potent at each stage of a trial — from data collection to patient recruitment to insight dissemination.
Images by: langstrup/©123RF.com, Jaime Lopes, National Cancer Institute