SAMRC contributes to global clinical trial reporting guidelines amidst the COVID-19 pandemic
Cape Town | Nearly every aspect of health care has been affected since the emergence of COVID-19, including health research – many trials were suspended, others revised and altered, and some stopped entirely. The South African Medical Research Council (SAMRC) has been part of a global initiative seeking to improve the transparency, quality, and completeness of reporting of trials and trial protocols affected by the pandemic.
Randomized clinical trials (RCTs) drive everyday healthcare decisions worldwide, and thousands of such trials involving millions of patients were disrupted by COVID-19 – as at January 2021, 2043 trials registered with ClinicalTrials.gov had been terminated, withdrawn, or suspended because of COVID-19, affecting more than 129 000 participants and interrupting plans to recruit over 4 million future participants.
The implications for study participants, for medical innovation and practice, and for the health sciences enterprise are significant. What should be done with the data? How should these unanticipated changes be reported? This is new territory for medical science, and a new challenge for researchers and health scientists.
Although some health regulatory agencies released guidance on trial modifications due to the COVID-19 pandemic, no consensus exists on how such changes and their implications should be reported.
To this effect, last week an international team of clinicians, scientists, editors, funders, regulators and patient representatives, including Professor Nandi Siegfried, a Chief Specialist Scientist at the SAMRC’s Alcohol Tobacco and Other Drugs Research Unit (ATODRU), published the CONSERVE Statement in the prestigious Journal of the American Medical Association (JAMA), which seeks to address these difficult questions.
CONSERVE, short for: CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances, provides practical guidance for researchers so that data is not lost from the research enterprise. It builds on prior trial reporting standards and offers guidance for reporting trials and trial protocols that undergo important modifications in response to extenuating circumstances such as the COVID-19 pandemic. Importantly, while COVID-19 brought about the need for such guidance, the team looked to the future and ensured that the guidance has relevance for all extenuating circumstances, not only for a pandemic.
One of the key recommendations of CONSERVE is that rather than abandoning trial data and the investments that contributed to data collection, it is better to report the unanticipated circumstances and trial modifications rigorously and transparently.
Prof Siegfried, “We were able to ensure widespread African contribution into the standards by utilising our continental trial networks to ensure African scientists had an opportunity to comment.” CONSERVE guidance should ultimately improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances.
She also adds that although CONSERVE was developed in the context of the COVID-19 pandemic, it applies to reporting on other important modifications to trials. “This could help address a gap in existing trial reporting guidance that predates the COVID-19 pandemic and will persist beyond the pandemic. For example, CONSERVE might have enhanced reporting on trials modified by public health emergencies such as the 2014-2016 Ebola virus epidemic, natural disasters, or other unavoidable logistical concerns”, said Prof Siegfried.
SAMRC President and CEO, Prof Glenda Gray welcomed and described these developments as a great feat for the health research community, saying that the COVID-19 pandemic has placed a tremendous strain on sustaining the clinical research enterprise and was also likely to affect key study outcomes. “These effects must be considered during data analysis, interpretation and reporting” Prof Gray said.
NOTE TO THE EDITOR:
For the full CONSERVE Statement | Read More