Dealing with possible missing data and statistical analyses
Due to the changes in scheduled visits or patient’s discontinuation, there may be missing information for the protocol specified procedures. Nonetheless, it is important to capture all details in the case report form that explains the basis of this missing information. This information should be summarized in the study report. If changes in protocol, including missing data, will lead to amending the data collection and statistical analysis, the sponsor should consider informing the local review board before locking their databases. A pre-specified plan for analyses should be constituted to tackle the protocol deviations related to COVID-19.
The need to apply new processes or to modify existing ones will vary based on the protocol and local situation. Some considerations need to be made whether it is appropriate to delay assessments for an ongoing trial or to discontinue or withdraw participants if the study cannot be properly conducted under the existing protocols.
It is important to keep the measures going that yield the most information for the least effort and resources. Sponsors should describe the measures instituted in view of the ongoing pandemic that may include:
References
1. Q&A on the impact of COVID-19 on research funded or supported by NIHR [Internet]. [cited 2020 Apr 16]. Available from: https://www.nihr.ac.uk/documents/qanda-on-the-impact-of-covid-19-on-research-funded-or-supported-by-nihr/24467
2. guidanceclinicaltrials_covid19_en.pdf [Internet]. [cited 2020 Apr 16]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
3. Research C for DE and. Clinical Trial Conduct During the COVID-19 Pandemic. FDA [Internet]. 2020 Apr 7 [cited 2020 Apr 16]; Available from: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct-during-covid-19-pandemic
4. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards. :16.