Navigating Clinical Trial Recruitment in the Midst of COVID-19
Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.
The COVID-19 pandemic has created a complex set of clinical trials recruitment challenges for medical affairs teams. First, there is the rapid, global spread of the virus, which has been pushing frontline healthcare providers to the very brink in terms of resources, fatigue, and organization. Second, every interaction with this increasingly diffuse group of providers and patients must be managed remotely.
Barriers to clinical trial recruitment in the era of social distancing have pushed many life sciences companies to pause recruitment altogether to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.
Yet, solutions to COVID-19 are too important to allow these barriers to halt progress. It’s crucial to find a new path forward that addresses these new obstacles and speeds the recruitment process.
Karyopharm Therapeutics set out to launch a clinical trial to determine whether their cancer medicine, selinexor, could also be effective at treating patients with severe COVID-19 based on potential anti-viral and anti-inflammatory properties of the therapy.
In order to get the trial moving quickly, Karyopharm’s medical affairs team needed to identify hundreds of providers and institutions with the highest at-risk populations. But many providers are working in makeshift intensive care units, and detailed diagnosis coding is barely keeping pace with triage. In this rapidly changing situation, conventional models of recruitment would have been a best-guess scramble to line up infectious disease specialists, with no real visibility into which physicians are actively seeing the largest segment of patients with COVID-19.
Tapping real-world patient data
Karyopharm decided to turn the traditional patient recruitment model upside down. Instead of starting with launching research to identify which physicians have written the most highly-cited papers on coronavirus, Karyopharm’s medical affairs team started with the patients-tapping into real-time de-identified patient data to find out who is most at risk, where they are located, and which providers are treating them.
This methodological flip on COVID-19 trial recruitment was made possible through Karyopharm’s collaboration with Komodo Health, a healthcare technology company that has built a natural history platform of real-time patient data. Komodo Health’s healthcare mapping technology tracks the complete healthcare experience of more than 320 million individuals, nationwide. That includes a combination claims data with specific diagnosis codes, data from individual electronic medical records (EMRs) and socioeconomic variables, which capture the full patient journey, going beyond individual episodes of care to stitch together the entire healthcare experience. Most importantly, the data is tracked real-time, which gave Karyopharm’s medical affairs team a precise reading of the COVID-19 virology landscape as the disease has spread across the country.
Armed with this level of patient-level detail, Komodo Health was able to identify trends in COVID-19 diagnoses and related symptoms, including pneumonia, bronchitis, and other variants between January 2019 and March 31 of this year to pinpoint the largest populations of at-risk patients. Based on this data, Karyopharm was able to shortlist 500 key providers including internal medicine, pulmonary disease, virologists and infectious disease providers alongside the top 100 healthcare organizations based on the affiliations of these providers.
Within just hours of initiating the project, Karyopharm’s medical affairs team had a clear map of clinical sites, physician engagement and relevant diagnoses.
Evolving toward a patient-centered approach to medical affairs
This level of patient-level data was critical to helping Karyopharm’s medical affairs team target the most at-risk populations more quickly than would have been possible via traditional means of physician engagement. This sped up the traditional timeline in sync with the urgency of the situation. In fact, thefirst patient1 to be enrolled in the trial is already receiving the low-dose selinexor, less than two weeks after the launch of the study.
There has been a lot of talk recently about how the COVID-19 crisis will be a catalyst to the shift to new innovation in the way that medical affairs teams engage with physicians and patients. Karyopharm illustrates how making this transition will be about much more than Zoom meetings or email targeting. With the right approach, medical affairs teams will be able to create more personalized, patient-centric strategies by tapping into real-time clinical practice patterns and fast-evolving epidemiology data.
The data and analytics platforms that can unlock these patient-centric ideals are right here, right now-and the stakes couldn’t be higher.
Aswin Chandrakantan, MD, is the Chief Medical Officer at Komodo Health
References
How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial Research
July 24th 2020While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
