In May 2020, Tools4Patient presented a webinar entitled “The impact of COVID-19 on the Clinical Trial Conduct: The Importance of Considering Patient Stress, Coping and Perceptions”. This webinar aimed to explain the impact of COVID-19 crisis on patient behavior in ongoing clinical trials, introduce the application of COV-IQ technology and describe how it may improve interpretation of clinical trial results. During the webinar, questions from the audience were addressed; the main ones are compiled below.
How is COV-IQ implemented in an ongoing clinical trial?
Implementation of COV-IQ only involves the addition of a simple questionnaire to the trial. The timing of the questionnaire can be optimized for each trial depending on current status. Tools4Patient has standardized language for protocols and informed consent documents to make this addition as easy and seamless as possible.
What would is/are the real impact(s) of COV-IQ on sponsor data analysis?
COV-IQ considers factors that may influence patient behavior and efficacy evaluation in ongoing clinical trials – including patient psychology, expectation, patient perception of clinical trial environment and social support structures. The added value of the COV-IQ method will depend on the unique situation of each clinical trial. To address this for a specific trial, the Tools4Patient team would first propose to thoroughly evaluate and discuss the details of trial, including enrollment status, geography, indication, etc. This analysis would help both parties determine the potential benefit to a given trial. Importantly, using COV-IQ adds no risk to the trial or data analysis.
What is the regulatory status of the COV-IQ approach?
As this pandemic was unexpected and unprecedented, this technology has not had the opportunity for full regulatory review. However, COV-IQ is a conservative approach that only aims to provide additional data that can contribute insight to data analysis and interpretation. Of course, any utility of COV-IQ for calculation of primary endpoints should be discussed with the regulatory agencies. However, this approach can certainly be used for internal sponsor information to better understand the impact of the pandemic crisis on the trial patients and its consequence on data interpretation.
Can patient data during and after the COVID-19 pandemic be compared to historical data?
Tools4Patient has compiled psychological profiling data from more than 1,000 clinical trial patients who have completed our Multi-Dimensional Psychological Questionnaire. These data can be used as a core database to which post-pandemic data can be compared.
The COV-IQ methodology can be used for trials ongoing during the COVID pandemic – but may also be useful to understand the impact of any stressful event on clinical trial patients. For more information, contact us.