COVID-19 and Impacts on Clinical Research
COVID-19 has presented healthcare professionals, patients, caregivers and researchers across all disciplines, in all phases and types of research with unforeseen challenges. However, we are also seeing unprecedented innovation, collaboration and opportunities. Our September 17 and 18th Cannabis Forum will dive into some of these themes through the lens of researching medical cannabis during COVID.
In our own company, we have noticed that the COVID-19 pandemic has significantly affected the way the world has to work and do clinical research. Over the past months CROs, investigators and sponsors worked quickly to factor-in unprecedented social distancing measures and the risk of virus exposure into the day-to-day workings of clinical trials. In view of new risks, some have decided to halt, suspend or hold study recruitment and visits.
In response to a substantial number of questions, regulatory authorities recently put forward some guidance documents. To comply with social distance measures Health Canada, for example, advises: using electronic signatures; implementing remote monitoring strategies; using remote methods for obtaining consent; using telemedicine for safety and efficacy assessment; and shipping investigational products straight to research subjects, all depending on context and feasibility.
The US-FDA went further and elaborated on the use of alternative locations for assessments (such as clinics or specialized labs that would present a lower risk of virus exposure when compared to hospitals), delaying outcome assessment while extending investigational product treatment, adding COVID-19 screening procedures for the safety of personnel and participants, or even adding COVID-19-related endpoints if there is a justifiable rationale. Both authorities have stressed that following Good Clinical Practice is still paramount; all changes in protocol must be documented and the regulatory authority kept in the loop via applicable procedures. Moreover, sponsors and CROs are advised to consult with their Research Ethics Board for actions that may put research participants at risk. You may find the full guidance documents here and here.
As new outbreaks appear and subside, social distancing measures may be on and off again. At Santé Cannabis, we are presently discussing adding a force majeure / pandemic clause in our research protocols. Such clauses would be triggered by government-imposed social distancing measures and automatically switch the way data is collected, adopting many of the actions mentioned above. Anticipating this is the most logical way to avoid delays to important clinical studies. Santé Cannabis is continuing with our clinical services via telemedicine, and with our research projects during this time. Our CRO services range from expert consultations, to regulatory support, data and market analysis, protocol development to patient recruitment to publishing. If you are interested in working with us, you can find out more here or contact us
