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:
- Contingency measures to manage study conduct during disruption
- Document and list all participants affected by COVID-19 and describe
how the participation as altered
- Analyze and discuss the impact of the contingency measures on safety
and efficacy
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.