NON THEMED
Patricia Henley
Louise Mawer
Lucy Saunderson
COMPLIANCE IN SCIENCE – A JOB FOR MISS MARPLE?
An investigation into the reporting of randomised clinical trials RESEARCH PRACTICE GROUP PROFILE The RQA Research Practice Group (RPG) was put together through volunteers from the RQA as a means of disseminating best practice across the commercial and non-commercial worlds; highlighting differences between the two and learning from the methodologies employed by the different worlds. We held our first kick-off meeting in London in January 2019, alongside a teleconference to one member in the USA. Unfortunately, this was prior to all-consuming work activities overtaking two of our team, reducing us to just three amigos! The relationship, similarities and differences in research approaches between commercial and academic or non-commercial organisations were discussed, with the conclusion that not all differences resulted from resources and costs, but that culture, attitude to risk and the ultimate fate of the data were key in these aspects. The non-commercial world is concerned with looking for the ‘right’ answer to the study question, regardless of the impact
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on the product, or the impact on the clinical development area. The commercial world, whilst still looking for the ‘right’ answer, must also answer to shareholders which creates a slightly different focus. Rightly or wrongly, there is a perception that non-commercial organisations follow different rules for the conduct of their trials, which just highlights the disparity between the two worlds. In looking to explore these similarities and differences, the RPG identified differences in the adopted approach between commercial regulatory submissable reports and scientific publication guidelines. This resulted in a group hypothesis that compliance and quality issues were more commonly reported in regulatory submissions than research publications used by healthcare professionals to inform treatment and prescribing guidelines. The RPG proposed to research this hypothesis and then develop potential underlying causes (beyond cost and resource) which may influence the willingness to report on non-compliance. This article forms a summary of the work completed to date.
INTRODUCTION Academic clinical trials are routinely published according to the Consolidated Standards of Reporting Trials (CONSORT) statement, a minimum set of recommendations for reporting randomised trials. In contrast, pharmaceutical and biotech organisations predominantly use the ICH E3 Guideline for registration study reports, as required by the regulatory receiving authorities. What are the similarities and differences between these standards? Does science prevail over compliance issues in research? Do scientific research articles give an accurate snapshot of a clinical trial? The RQA RPG set about investigating this mystery…
RULES AND MORE RULES: ICH E3 AND CONSORT GUIDANCE Auditors and those involved in clinical trial research in the commercial setting will be most familiar with the ICH E31 guidance: Structure and Content of Clinical Study