This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s consultants’ roles is execution of audits. For each inspectorate it is important to have the latest topics and trends and to be able to interact with international bodies such as the MHRA and FDA. During the event there were multiple opportunities to speak to inspectors where specific questions were discussed.
In summary, these were the most important topics covered at the events:
GPvP – February 11, 2020
- Current challenges in pharmacovigilance faced by industry, including Brexit
- The latest MHRA inspection metrics
- Common inspection findings
GCP – February 13-14, 2020
- Key aspects regarding sponsor oversight of clinical investigator sites and laboratories
- Impact of eSource on clinical data
- Investigator control of their data
- Impact of data quality on decision making
- How handling of protocol deviations impact data reliability and subject safety
- The challenges faced in ensuring data quality in novel clinical trial design
Looking back at the GCP event
During the sessions, the speakers resolved doubts regarding typical inspection findings and how to avoid and resolve them. As an example, it was mentioned that it is expected that clinical trial protocols will define the sources of data that confirm the trial subjects’ eligibility criteria. That is, not only add in the clinical history that the patient meets the criteria. Another example relates to the trial oversight of the sponsor: for which inspectors do not only expect minutes of the meetings to be in place, but these minutes should also have content.
We summarise the most striking findings of the event as follows:
- Protocol deviations: The Sponsor is expected to clearly determine pro-actively what might be considered important deviations and which deviations would (potentially) lead to exclusion from the trial (efficacy) analysis.
- eSources and Electronic Health Records should have data integrity controls for electronic systems used in the clinical trial, including the maintenance of those systems. The MHRA referred to the next statement in relation to Electronic Health Records.
- Use of new technologies in Clinical Trial management: The Sponsors/CROs should ensure that electronic systems (owned and controlled by sponsors/CROs) employ data security and integrity controls (e.g., access controls, audit trails, encryption, risk-based approach to validation). The Sponsors/CROs are also expected to audit the security and integrity of those systems, including regular review of audit trails.
Finally, in many topics reference to quality risk management was made. Risk-based monitoring and pro-active identification, mitigation and continuous monitoring of critical quality attributes are essential in clinical research nowadays and is expected to become even a bigger part in the upcoming renovation of ICH-GCP.
In general, the event was very useful, since the open questions were answered in great detail and, in most cases, with examples. The point of view of the inspectors of both agencies is very interesting, since it facilitates the work of the pharma industry during their own audits, which is highly recommended.