For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships that have been forged between the public and medical science? Never have the words “clinical trial” been used so much in the lay community. The emergence of clinical innovation, medical knowledge and epidemiology as day-to-day conversation topics has brought science and data into the public spotlight. We must therefore ensure that the way we communicate the results of trials embraces this public thirst for information, and also acknowledges the challenges that running a trial will have during this pandemic.
Plain language summaries (or PLS) report clinical trial results and are now compulsory for sponsors in the EU to provide to participating patients and a lay audience once a trial has completed.1 Providing a PLS is even more crucial in this global health crisis, where in excess of 100 clinical research studies are being carried out to find a new drug – either to prevent or treat COVID-19. Sponsors who are conducting clinical research into COVID-19 should ensure that a PLS is included as part of their commitment to data transparency.
The development of PLS needs to evolve in the following ways to ensure that the new environment in which all clinical trials are taking place is reflected in true data transparency and reporting of results:
“[Parexel]… is a CRO that is really ‘walking the walk’ when it comes to putting patients at the heart of what they do.” - Trishna Bharadia, Patient Engagement Champion; attendee at Parexel Patient Advisory Council Meetings
Information dissemination is fast-paced within the clinical research community and has gathered unbelievable speed during the COVID-19 pandemic. Regular and transparent communication with patients and study staff is even more essential during this global health crisis, and Parexel’s Patient Communications team of experts can support with the development of truly patient-centric study engagement materials and PLS outputs. With the necessary adjustments and enhancements to ensure that the patient continues to be at the heart of everything we do, Parexel is uniquely placed to support the clinical trial process during the COVID-19 global health crisis.
1European Union Clinical Trials Regulation (EU CTR) 536/2014.
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