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By: Jakki James, Patient Communications Director, Parexel and Sarah Yelling, Patient Communications Account Manager, Parexel
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:
- Acknowledgement of the impact COVID-19 had on the clinical trial – as a caveat box within the introductory section and at pertinent touchpoints throughout the PLS. Impacts could be delays in trial timelines, the temporary closure of a study site, or adapting the trial to be partly or fully decentralized, for example.
- Clarification on trial findings affected by COVID-19 – examples being the extension of trial periods to take COVID-19 disruption into account, increased drop-out rates due to patients not wishing to participate due to COVID-19, an increase in hospital admissions or potential study drug MOA changes if administered to a participant who subsequently finds out they were infected with the virus.
- Transparency in study results reporting – exposition of data changes in the context of COVID-19 and how this affected the overall clinical trials results. Further information on how these data changes were captured, any data capture challenges, and how data integrity was maintained is also crucial for inclusion.
- Unambiguous reporting of side effects – a fundamental section of any PLS is side-effect reporting; this will need to be expanded as a result of COVID-19 to capture both physical side effects of any investigational study drug and mental health side effects of participating in a clinical trial during a pandemic. Validated tools already used in clinical research, such as the ePRO, EQ-5D-3L and SF-36 questionnaires, could be used to capture this additional data.
- Opportunity to find out more – contact details for those interested in finding out more about what impact COVID-19 had on a particular clinical trial.
“[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.