Writing in the July issue of DIA’s Global Forum magazine Serene Ong and Gaurang Majmudar of clinical trial logistics specialists Marken outline why the shift to decentralised clinical trials brought about by COVID-19 is likely to stay in place post-pandemic.
The face of clinical trials has been changing rapidly, and while decentralised clinical trials have been explored by the industry for many years, the COVID-19 pandemic has exponentially accelerated the shift towards such trials with increased urgency. The most dramatic shift in this direction has been on logistical and at-home services, as they were needed to support the ongoing studies.
Unanticipated deviations to clinical research protocols became unavoidable, as subjects were unable to attend study visits due to travel restrictions, clinic closures, and quarantine requirements. Regulatory bodies around the world were forced to quickly revise their regulations or guidances to minimise disruptions to clinical research.
Quickly Evolving Regulatory Landscape
New guidance documents were rapidly issued by national regulatory bodies seeking to balance patient safety with continued access to trial medications. Barriers to participation and acceptance of remote healthcare have been reduced to ensure patients can still receive their much-needed medications via direct-to-patient delivery; home visits helped prevent health risks.
A technical guidance paper was published by the World Health Organization (WHO) in April 2020 on strengthening health systems against COVID-19. This paper recognised telemedicine as an alternative model for delivery-of-care to ensure the continuity of essential healthcare services.
In Singapore, the Health Sciences Authority (HSA) also issued guidance (revised July 2020) to provide general considerations to sponsors and investigators to ensure the safety of trial participants, compliance with the clinical trials regulations, and ICH GCP (R2) Guidelines to minimise risks to trial integrity.
Regional travel restrictions were imposed and had a major impact on the National Cancer Centre Singapore, as many of its patients on trials come from other SEA countries (Malaysia, Indonesia, the Philippines, and Vietnam). The implementation of telemedicine, local laboratories and IP (Investigational Product) delivery were all utilised to mitigate the impact of these restrictions.
Adapting to the Unknown
When COVID-19 first emerged in early 2020, many areas in China went into quarantine overnight and strict travel restrictions were imposed. There were also numerous flight delays and airline cancellations into and out of China. Pharmaceutical companies, central labs, and clinical research organizations all risked losing clinical trial patients who could not travel to the investigator sites. Regulatory, compliance, quality, and shipping challenges related to import, export, and customs clearance were also prevalent. Patients and investigators faced the prospect of not receiving the clinical trial medications upon which they relied.