Adjust CSR reports to reflect impact of disruption on clinical studies say industry groups
CROs and sponsors should adjust clinical study reports to reflect the impact of any disruption – be it Vladimir Putin’s war on Ukraine or the COVID-19 pandemic – had on the research according to ACRO and Transcelerate Biopharma.
The industry organizations made the recommendation in a “point to consider” document issued this month, suggesting companies involved in drug trials need to learn from the events of the past few years.
“Both ACRO and TransCelerate member companies, as well as industry stakeholders generally, have faced unprecedented interruptions to clinical trials over the past three years. We have seen the COVID19 global pandemic, geopolitical disruptions like the war in Ukraine, and natural disasters such as hurricanes and wildfires.
“These are some examples of the types of unforeseen disruptions that may have significant impacts on how a clinical trial is operationalized and how clinical trial data are collected and reported.
Such incidents can affect drug research in a variety of ways according to ACRO and Transcelerate, which said sponsors and CROs need a framework that takes all potential types of disruption into account.
“An agreement between trial sponsors and regulatory agencies on what mitigation strategies to expect and consistent reporting guidelines would be useful for those involved in preparing and reviewing Clinical Study Reports (CSRs).”
Adjustment
Such agreements aside, the organizations want sponsors to revise how they plan clinical trials.
“ACRO and TransCelerate take the lessons learned from these unprecedented interruptions and propose that contract research organizations (CROs) and sponsors adjust how they develop CSRs for those clinical trials that have been impacted by any unforeseen disruption, whether it be a war, a pandemic or other public health emergency, or any geospatial disruption.”
However, as the organizations point out, there is a lack of uniformity in CSRs produced by the industry. For example, while things like the International Council on Harmonization (ICH) E3 Guideline is widely used across the industry, reports vary study-to-study.
“Our members generally have reported that most companies use these resources as a foundation and then tailor the structure of the CSR, creating their own individualized template. As a result, the way clinical trial disruptions are reported in a CSR varies from one company to another.”
To try and address this, ACRO and Transcelerate provide three key points sponsors and CROs should consider including in reports.
For example, they suggest it should be noted if a disruption occurred, but it did not cause a major impact to the conduct of a clinical trial program.
They also suggest that, in the event a trial program is disrupted, sponsors and CROs continue using the ICH-based CSR and report disruption-related information within each relevant section of the CSR unless they feel the specific disruption would be better described in a self-contained summary.
Finally, when companies determine disruptions should be reported throughout various sections of the CSR, they should work to improve the navigation of this content according.
“ACRO and TransCelerate propose including a subsection in the introduction of a CSR that summarizes for the reader the disruption at a high-level, including a tabular summary that includes links to all the subsections in the CSR where the disruption0related information is being reported.”
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