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jmunda@firstanalysis.com
- The COVID-19 world of social distancing, shelter-in-place orders, travel limitations, and geographical lockdowns has intensified the already substantial challenges of bringing a drug through clinical trials and commercializing it, given these processes traditionally have involved much face-to-face interaction among patients, healthcare professionals, and pharma company personnel.
- However, the cloud of COVID-19 has a silver lining – it is accelerating adoption of clinical trial software and technology-based commercialization solutions that overcome many of the COVID-19 obstacles as well as increase the speed and efficiency of clinical trials and commercialization efforts. Recent regulatory relief in response to COVID-19’s impact on clinical trials has only added to this momentum.
- We discuss the key relevant enabling technologies for clinical trials, such as telehealth in-home patient visits, direct-to-patient drug dispensing, remote data capture, and remote monitoring to maintain oversight of trial sites and highlight some of the innovative companies bringing them to market.
- We also highlight solutions that address COVID-19’s challenges to the commercialization process. These include specialized virtual meeting solution providers, a remote physician engagement device, and an AI-driven recommendation engine for identifying key opinion leaders.
TABLE OF CONTENTS
Includes discussion of three public and 14 private companies
COVID-19 a major obstacle to clinical trials
COVID-19 driven regulatory relief means increased adoption of remote technology for clinical trials
COVID-19 also hinders drug commercialization
Impact well beyond the pandemic
Commercialization and eClincial indices regaining ground lost during COVID-19
Pharma services 2Q20 M&A activity to date consistent with previous two quarters
Clinical trial software a prevalent theme in 2Q20 private placements to date
COVID-19 a major obstacle to clinical trials
As society deliberates over the short- and long-term impacts of COVID-19, the pharmaceutical industry is adjusting to a new world, a world driven by social distancing, shelter-in-place orders, travel limitations and geographical lockdowns. While these measures are mitigating the spread of the virus, they have created obstacles and challenges to clinical research. Since the beginning of March about 100 companies, including Pfizer, Bristol-Myers Squibb, and Eli Lilly, have reported delays or disruptions of clinical trials. The industry’s shift in focus to developing vaccines and treatments in response to COVID-19 along with restricted travel for patients, trial sites closures, and the redeployment of research personnel to treat COVID-19 patients have disrupted clinical trials for diseases other than COVID-19. The pharmaceutical industry has traditionally relied heavily on on-site monitoring, including frequent source data verification (SDV), to help ensure clinical trial processes, procedures, and records satisfy requirements for protocols, standard operating procedures, good clinical practices and regulatory compliance. Even under normal circumstances, achieving 100% SDV for trial sites can be a laborious and costly task. COVID-19 has only added to the complexity. On its first-quarter earnings conference call, industry bellwether IQVIA noted 80% of its clinical trial sites were inaccessible to clinical research associates for on-site visits, while competitor Syneos Health estimated 85% of its sites were inaccessible.