Trust, transparency aided COVID-19 vaccine partnership: Praxis
Tricia Barrett, senior vice president and managing director for Praxis, is one of the two presenters (the other Diane Montross, senior director of patient recruitment and retention at Moderna) for Operation Warp Speed: Recruitment and Retention, Launching a Recruitment Strategy for a Phase III COVID-19 Vaccine Trial, taking place online Tuesday, March 2 at 2:20 pm EST. She shared how the partnership between the two companies formed, patient recruitment challenges involved, and lessons learned along the way.
OSP: During SCOPE 2020, coronavirus (now COVID-19) was just starting to appear on the clinical trial industry’s radar. Can you think back to then and remember what those first weeks and months were like, and what you thought?
TB: As someone who is used to traveling for business several times each month, that was my last trip, so it is hard to forget! I honestly didn’t really have COVID-19 on my radar screen at the conference but was worried in the weeks that COVID-19 was likely at SCOPE.
As reality set in and personal and professional life changed for what was expected to only be weeks, I couldn’t help but think this was a make-or-break moment for the clinical research industry. Would we be able to step up and rise to the occasion? Would we work together to embrace decentralized trials? How quickly could a vaccine be developed? While totally daunting, it was also motivating.
OSP: When did the virus start showing up in more serious discussions around Praxis, in terms of how your company specifically and the industry in general might be affected, and should react?
TB: For Praxis it was the week of March 9, 2020 – almost one year ago today. Our employees were getting nervous and the news was painting a bleak picture. Being headquartered in New York (even though we are in Buffalo, not NYC), there were also stricter regulations being put in place.
We sent all of our employees home on Friday, March 13, 2020 (ironic that it was Friday the 13th!) and told them we were going to “test” being remote the following week. And here we are 50 weeks later still at home. As a service-oriented business, we also knew we had to move quickly to communicate the recruitment effects of COVID-19 with our sponsors and adjust our campaigns accordingly.
OSP: Could you please describe how your company and Moderna got to collaborate on the COVID-19 vaccine? What were early discussions like, and how did they jell into a more solid partnership?
TB: Diane Montross, who joined Moderna in June 2020 as their senior director of patient recruitment and retention, invited us to collaborate on their Phase III COVID-19 vaccine trial. We had worked with Diane in the past, and to be honest, had never even heard of Moderna when she called us in early June. I’ll never forget that first conversation when she told me we had an opportunity to change the world – and boy, was she right.
Since there was already established trust and a solid working relationship together, we jumped right in and moved fast to brand the study with a name/logo and create campaign concepts that would resonate with potential trial participants.
OSP: Could you please share how Praxis and Moderna worked to optimize patient recruitment and retention? What goals, concerns, obstacles, etc. did you outline at the outset?
TB: The program evolved quite a bit from our initial discussions. We knew we had to create core materials, but everything was moving at warp speed, so we had to adapt as the program changed. For example, there weren’t any sites selected when we kicked off the creative development, so as we learned more from the sites on what they needed for recruitment and retention, we moved quickly to accommodate.
Site selection also sparked the need to accelerate the translation process so we could include US Spanish in our materials. We also knew how important diversity and inclusion would be to the study, so we created unique materials targeted in reaching minority populations.
Retention and compliance were critical to the study success, and it was imperative that we show appreciation for both the participants and the sites who helped make the COVE Study a successful recruit.
OSP: As the trials started rolling, did the team encounter any surprises (pleasant or otherwise) regarding patient identification, recruitment, retention and engagement?
TB: The most pleasant surprise was seeing the importance of clinical research on an international stage. I hope we look back and see that this pandemic helped to improve the general public’s perception of clinical research – especially among minority populations.
I also want to congratulate and thank the 30,000 heroes that participated in the COVE Study. Had a site been available in my town I would have been the first to sign up, but these people are truly heroes and I can’t thank them enough.
OSP: Congratulations on Praxis helping play a part in launching the Moderna vaccine. Can you share any additional thoughts on what aspects of your strategic partnership with Moderna helped fuel the success?
TB: There has been trust and transparency from the start, and as a vendor, that’s all we can ever ask for. We also never felt like a vendor. Everyone at Moderna treated us as a partner from the start, which was equally motivating. Moderna’s mRNA technology is truly offering a new approach to medicine, so I am excited to see what that means for the rest of their pipeline and other therapeutic areas.
OSP: Why should people sit in on Operation Warp Speed: Recruitment and Retention, Launching a Recruitment Strategy for a Phase III COVID-19 Vaccine Trial? What notable insights and lessons will you and Diane Montross be sharing with attendees?
TB: Diane and I will be taking attendees through a timeline of what it took to pull off a recruitment and retention campaign in record speed, as well as some of the unique materials we ended up creating as a result of the protocol and participant profiles. We will also be discussing the role of the COVE Diversity and Inclusion Advisory Committee, which was created for this trial given the importance of recruiting a diverse population.
OSP: Anything to add about this collaboration, strategic partnerships in general, what SCOPE 2022 might look like, etc?
TB: I know everyone has Zoom/Teams/WebEx fatigue, but I must say, I’ve never felt closer to my colleagues, clients, or strategic partners. Having that quality “face time” has gone a long way to establish new relationships and reaffirm existing ones. Trust me, I want nothing more than to be together again and I genuinely miss work travel, but until then, I’ll keep enjoying seeing everyone on screen knowing they are safe and sound.
Operation Warp Speed: Recruitment and Retention, Launching a Recruitment Strategy for a Phase III COVID-19 Vaccine Trial is scheduled Tuesday, March 2 at 2:20 pm EST. For more information about the presentation or other SCOPE Summit sessions, visit scopesummit.com.