Janis Bernat
Director, Scientific & Regulatory Affairs, IFPMA
Clinical trials during a pandemic have shown that a “quality by design” mindset can future-proof and better clinical research.
The COVID-19 pandemic has taught us a lot and yet we can still keep learning. While the pandemic has impacted everyone globally in ways that could never have been imagined, it has provided a spark for further exploration into how clinical trials should be improved, strengthened and better coordinated globally.
To ensure this happens, we must first acknowledge the critical role of well-designed clinical trials. During the pandemic, there were many examples of small, under-powered clinical trials that lacked coordination and did not deliver scientifically meaningful results.
Governments recognised this early on and helped lead the development of the G7 Therapeutics and Vaccines Clinical Trials Charter to avoid proliferation of such trials in the future. When you are looking for hope in the form of prevention, treatment or cure, such outcomes can be tragic and/or disheartening at best.
Implementation of regulatory guidance
Broader implementation of ICH Good Clinical Practice (GCP), specifically E6 R3, is key here. This regulatory guidance is critical to future-proofing clinical trials and seeks to support their modernisation by installing a ‘quality by design’ mindset.
For those of us involved in clinical research (e.g., national regulatory authorities, academia, biopharmaceutical industry), ICH GCP may be the best way to promote greater capacity and capability building around the world.
ICH GCP may be the best way to promote greater capacity and capability building around the world.
Role of digitalisation
Secondly, we must look more extensively into the benefits of digitalisation and the use of virtual tools and methodologies within the context of clinical trials. Digitalisation can help clinical research to be more efficient and coordinated, principally via telemedicine, use of innovative health technologies, virtual healthcare visits, e-documents, etc.
Digitalisation can also support clinical researchers with the conduct of decentralised (or hybrid) clinical trials by increasing recruitment, reducing screening failures and allowing for remote monitoring of patients. Thus, offering the best guardianship of patients’ time and resources.
Benefitting those in greatest need
Finally, we need to ensure that the clinical trials we design benefit those who need it most. With a spotlight on patient centricity, best practices for greater diversity and inclusivity of under-served populations must underpin the development of all future clinical trials. The pandemic highlighted the ongoing disparity within clinical research and in the end, we must strive to make sure that these good principles become routine.
Bettering clinical research, in a more innovative and sustained fashion, has the potential to accomplish far greater results for global health that will be felt well beyond the present pandemic.
