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What Does Clinical Trials Success Look Like After a “Sink or Swim” Year?

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What Does Clinical Trials Success Look Like After a “Sink or Swim” Year?

SPECIAL FEATURE

Elizabeth Weeks-Rowe, LVN, CCRA

 

COVID-19 forced many unprecedented changes upon our day-to-day world—some of which still have us reeling. It has impacted our health, our economy, and our peace of mind. We don masks to guard against transmission; our body language becoming ever more an adjunct to communication limited by muffled words and hidden expressions. We wave through windows to neighbors and family members as our personal connections may put us at risk. In almost every way, “virtual” has replaced “actual” human interaction in our traditional workplaces and neighborhoods.

Meanwhile, an overwhelming “sink or swim” survival narrative has played in the background for the past year, amplifying our anxieties about the strategic choices available to us. Pivot or fail. Advance or retreat. Change or…die? The pandemic robs us of so many things, yet our ingenuity has remained steadfast and it will assure our survival as a society.

Beyond our individual home and office lives, COVID-19 impacted the core infrastructure of the entire clinical trials community with operational pauses at both industry and institutional levels. Stay-at-home orders resulted in studies halting, institutions furloughing, and brick-and-mortar offices uneasily transitioning to virtual workplaces to preserve safety. Everything and everyone was affected while ever-changing regulatory guidances complicated early efforts to rebound.

We had to develop effective alternatives to traditional study conduct to continue treating participants and to ensure credible data practices—all the while needing to limit exposure to the very people we want most to help. Telemedicine emerged as a viable replacement for non-critical study visits. Remote patient consenting facilitated preliminary screening efforts. The majority of investigational sites mandated administrative staff to work remotely, while clinical staff rotated shifts to ensure onsite study visit coverage.

There were radical alterations in traditional site management and monitoring practices. For example, video conferencing platforms have replaced in-person meetings and facilitated critical industry conferences. Further, remote monitoring/data review is the new normal, with institutions providing remote electronic medical record access to clinical research associates (CRAs) and sites using portals and/or electronic source systems to create/upload source documents for remote review. For many stakeholders, “virtual trials” and “patient centricity” have morphed from merely being buzzwords into their new status as successful elements of study design.

Sponsors, academic health centers, site management organizations, contract research organizations, patient recruitment firms, training organizations, independent consultants, and more—all levels and roles in the clinical research enterprise were forced to alter well-established processes to ensure business continuity amidst the fierce restrictions. This was a rapid-fire assimilation offering little time for adequate preparation, and yet our response to the devastation wrought was remarkably innovative. We accelerated activation strategies and reinvented execution to deploy investigational products and staff at “warp speed,” resulting in sites opening in days and enrollment goals accomplished within months. The miraculous fruit of this collective effort includes several vaccines created and distributed in less than a year of the pandemic’s first strike.

Sharing Our Successes

Through all of this turmoil, the clinical research community has once again demonstrated its passion to continue drug development, no matter the circumstances. The rest of this feature is devoted to examples (sometimes paraphrased for clarity) of successes that have arisen from the challenges, as graciously shared by a variety of experts in the field.

Joel M. Gelfand MD, MSCE, professor of dermatology, professor of epidemiology, vice chair for clinical research at the University of Pennsylvania’s Perelman School of Medicine, and a principal investigator on the front lines of study patient treatment, describes the rapid adaptation to the pandemic that was necessary to continue critical studies in a large academic setting:

The COVID-19 pandemic has caused major disruption for clinical research. First, many academic centers have put institutional holds on any research not related to COVID-19. Second, there has been tremendous pressure on clinical research staff, who often need to balance work with increasing family demands, such as attending to their children’s educational needs as schools go from in-person to hybrid learning to fully remote as the pandemic conditions spike.

Moreover, there is limited space to see research patients in person, as many centers are trying to move in-person care to telemedicine to maintain physical distancing in the clinics and waiting areas. To manage these issues, we have developed remote electronic tools so our coordinators can manage study patients without needing to be physically in the clinic. We now consent patients remotely and have remote coordinators manage many of our visits virtually. This approach reduces the demand on personal protective equipment, which is still in tenuous supply, lowers their risk for getting infected when commuting to work, and increases flexibility.

Meanwhile, with COVID-19 eliminating face-to-face meetings, clinical research training organizations and business owners were left scrambling to replace their classroom/conference educational curricula with a virtual equivalent that would still accommodate their diverse client base.

Liz Wool, CCRA, FACRP, president, chief learning officer, and chief learning strategist of Wool Consulting Group and the Wool Training Institute, describes a speaking engagement in early 2020 that was the catalyst for the changes to come:

At the end of January, as I watched what was emerging from China regarding the virus and tapping into my nursing background and experience in AIDS research in the 1990s, I cancelled my invitation to speak in-person for the Japan Clinical Trials Research Society on principal investigator supervision in early February 2020. This was, unbeknownst to me at the time, my first “pivot” that required adjustment, customer focus, and doing what it takes to keep my commitment. This pivot ensured I delivered my presentation “live,” but remotely, to the attendees in Japan—managing the meeting at midnight my time and conducting an on-camera question-and-answer session with the attendees.

“Pivot” became the theme for me and our team. When we pivot, we focus on what is most important at the time for each client and on providing solutions and timelines that sometimes result in less work for our team, but are still the right thing to do.  

The pivots and clients’ needs in 2020 also provided new opportunities. Our training services via eLearning grew and we shifted our live courses to interactive, engaging virtual training classrooms (not a webinar format).

Another result of the pandemic was the increased need for clinical researchers, due to the quick growth of the COVID-19 trial sector. Clinical research training programs, that were able to swiftly transform their core curriculum delivery, retained their clients and attracted new business in the process.

David Siberman, cofounder and CEO at Clinical Research Fastrack, a bootcamp training center that provides intensive education for professionals preparing to enter the clinical research enterprise, describes the rapid-fire curriculum delivery transformation required to keep his business afloat:

Our training program was completely in-person, hosted at eight locations around the country: Phoenix, Atlanta, Raleigh, Philadelphia, Chicago, Orlando, Dallas, and Austin. By the middle of March 2020, I knew my business might soon be on life support, with bankruptcy not far behind. I called my business partner and my National Program Director to share my fears. We could go down. Our entire business model was focused around in-person training. When the pandemic hit, everything had to change. Our survival was on the line.

We began by making several critical decisions. We would shift all our in-person classes to Zoom training. We started within our own team, offering coaching to help them find their inner strength and lead with optimism. We sent our team home to work remotely, providing information and guidance on how to effectively work and maintain sanity and productivity in the home setting. We were in this together and would not lay anyone off, unless facing total insolvency. We told our staff to take whatever time and space they needed to cope during the crisis. We shared information transparently with our team, offering honest assessments of everything that was happening. At the same time, I offered a vision of credible hope and projected optimism. We cut all spending possible other than payroll.

We transformed our entire program to be delivered via video conferencing. The model that we had developed over the prior four years was completely re-created in just four days, and then we had 16 days of delivering 10 hours of back-to-back classes each day. Not a single student dropped from those sessions. In fact, extra students signed up because of the added convenience of training on Zoom. Our newly minted curriculum was at a higher quality than anything we had ever delivered and, shockingly, our students were getting hired out of class faster than ever before. Since then, we have focused on successfully helping hundreds of our students embrace new hope and begin fulfilling careers in clinical research.

Lastly, Dan Sfera, cofounder of The CRA Academy, describes the service changes implemented in his organization due to the pandemic and the positive outcome for students:

For the pandemic, we have switched our entire CRA Academy internship remotely. Students now monitor a breast cancer study completely electronically and submit their interim monitoring visit reports this way, as well. Many have been able to secure industry positions due to having this remote monitoring experience on their CVs.

It all goes to show how we continue the work no matter the obstacle in clinical research, swimming strong rather than sinking, because our passion for drug development leads us to pivot, refocus, and succeed.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is a former clinical research coordinator who now works in site selection and education in the contract research organization industry. She last wrote for Clinical Researcher as a contributor to “Career Advice from Research Veterans, Part 2: Finding Meaning in the Mission” in the November 2020 issue.