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Webinar 2: Clinical Research and Data management during the pandemics Clinical trial is a premiere method in testing and validating new drug or method Important point in conducting clinical trial Timely recruitment Adherence to protocol-specified procedure High retention participants Proper statistical analyses Minimal risk of bias due to informative missing data Adherence to study should be consistent with the international levels, clinically achievable in non-pandemic settings If situation not possible, best course of action is to delay or pausing clinical trials Re-initiation of enrollment once deems capable to adequately manage risk of COVID-19 The approach is important if concurrent disease is related to COVID-19 Minimizing risk to trial integrity FDA guideline Safety Contingency plan Inform patient the status and impact Pause/delay/ extend study Alternative form of data collection Access to investigational medical products (IMPs) COVID screening Documentation of protocol changes Best practice: Keep participants informed Perform ongoing risk assessment Pivot to remote study visits Switch to remote monitoring Document with COVID-19 tag Taking patients’ perspective into account Safety Sense of urgency Analytical issue Treatment effect: use confident interval rather than p value Analyses should aim to make inferences relevant to post-pandemic period Assessment of missingness MCAR (Missing complete at random) Suggested analysis: any complete case analysis MAR (Missing at random) Suggested analysis: multiple imputation (include post-randomization) MNAR (Missing not at random) Controlled multiple imputation (combines pattern mixture modelling and multiple imputation) Missingness must be reduced as much as possible Alternative: Do meta-analysis Summary: Clinical trial are essential tools in medical research COVID-19 has exposed challenges in term of Design Conduct Reporting of study findings Important to incorporate these lessons to ensure the highest quality of research   Recommended readings: Cro, S., Morris, T.P., Kahan, B.C. et al. A four-step strategy for handling missing outcome data in randomised trials affected by a pandemic. BMC Med Res Methodol 20, 208 (2020). https://doi.org/10.1186/s12874-020-01089-6 McDermott MM, Newman AB. Remote Research and Clinical Trial Integrity During and After the Coronavirus Pandemic. JAMA. Published online April 22, 2021. doi:10.1001/jama.2021.4609. https://cutt.ly/ObNNStZ Órlaith Burke. The future of clinical trials. Accenture. SEPTEMBER 19, 2019. https://www.accenture.com/cz-en/insights/life-sciences/future-clinical-trials

Updated:: 21/07/2023 [intanbasirah]