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Effective trial data management even more vital during COVID-19, says study

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COVID-19 has underlined the importance of efficient, secure data management in clinical trials, according to research by IBM and US-based CRO Veristat.

The study – available here – used two of the 4,846 COVID-19 related clinical trials registered on clinicaltrials.gov to gauge how industry is using protocol innovations and data management technology to accelerate research.

The first study under considerations was a Phase I open-label, non-randomized trial evaluating the safety, tolerability, and immunogenicity of a candidate vaccine in 120 healthy volunteers across three US sites.

The second trial was a Phase II open label, randomized control, proof-of-concept study testing a candidate therapeutic in 50 patients hospitalized with COVID-19 across eight US sites.

According to the authors “The COVID-19 pandemic presents a unique opportunity for understanding technologies that can enable trial data management and their effects on streamlining and expediting clinical trial design and implementation.”

Results

The focus of the research was the IBM Clinical Development (ICD) data management system, which Veristat used for the two studies.

According to the authors, “The average time to design and release the study database for a COVID-19 trial was 11 business days.

“This was a 63.3-72.5% reduction compared to the CRO’s typical 30-40 day timeline and an 83.9% reduction compared to an industry benchmark of 68.3 days for a non-COVID trial.”

The researchers also quizzed staff running the studies about the impact the system had on the research and the results were positive with 100% of participants reporting that it “saved time for study startup, data collection, study closeout, and overall.”

“Of the survey respondents, 100% thought the CDMS somewhat or quite a bit helped to avoid cost, reduce manual errors, and decrease delays from mid-study updates.”

Data management during COVID

The study findings are in keeping with the conclusion of a separate industry-funded survey published last December that urged sponsors and CROs to set up a data management committee (DMC) for each trial.

According to the authors “The sponsor should assess the impact of the regulations on clinical trials from the relevant regulatory authorities that apply to the study to evaluate if to set up a DMC for the study, if not already constituted.

“The DMC should assess the impact of COVID-19 and new regulations, if any, on the study. Any activity and decision of the DMC must be documented and appropriately stored in the Trial Master File (TMF).”

They argue that because instances of protocol deviations and missing data will likely increase during the pandemic the DMC should set out clear instructions for investigators and closely monitor the trial at all times.

Image: iStock/maxkabakov

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