Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
Although UK and US legislation around clinical trials is different, the main principles of good clinical practice (GCP) which are the protection of the rights, safety and well-being of trial subjects and the production of credible data, are the same for both Regulators. If either Regulator had concerns with data reliability this could lead to rejection of data used in submission of a marketing application, but it can also pose significant subject safety risks.
The paper, which is published in the Journal of Clinical Pharmacology and Therapeutics discusses both Agencies’ perspectives on how to ensure Data Integrity in clinical trials. The paper talks about the need for robust processes to manage data, throughout its Lifecyle, using a risk-based approach. Data integrity also relies on organisations having an open culture with regards to reporting any issues, with proportionate management of those failures.
The paper then goes on to discuss some specific areas where Regulators have seen issues that impact data integrity, such as audit trails, maintaining the study blind and general data management practices. Each section includes case studies where MHRA and FDA have raised concerns during GCP inspections.
MHRA and FDA GCP Inspectors enjoy close collaboration; we share information relating to non-compliances, we have observed each other’s inspections and are working towards a programme of collaborative and joint inspections. We have quarterly teleconferences and annual face to face meetings, where we discuss issues of interest to both agencies and how we might want to approach them.
This paper is an excellent outcome from our collaboration with the FDA, which will be useful to our stakeholders undertaking global clinical trials.
The second joint symposium was held in London in February 2020, covering international collaboration, sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs. MHRA hope to publish a further paper jointly with the FDA discussing these topics in the near future.
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