Gilead Sciences sponsored a two-day workshop in Good Clinical Practice (GCP) and Research Management on May 16 & 17, 2017 for its project managers, held in Dubai, UAE. Henry Silverman and Marwan Felaefel led the training that was organized by Samer El-Ali from Gilead Sciences.
The workshop was motivated by the new addendum to ICH-GCP (E6 -R2) that was issued in late 2016. The new GCP addendum represents the biggest revision of the international ICH GCP guidelines for over 20 years, and has the potential to fundamentally alter the way in which clinical research is managed. The revision was in response to the European Medicine Agency (EMA) report summarizing its findings of 398 GCP inspections carried out by the agency for the period of 2000-2012. Most of the Critical and Major findings concerned the monitoring, data management, and clinical trial documentation. The obligations for those results are assigned to inadequate quality control and decreased sponsor oversight.
The section regarding the sponsor experienced the largest modification, with a total of 16 new items added to the R2 version. The revised part offers a very detailed view of the sponsor’s responsibilities, including quality management, CRO, trial management, data handling, record keeping and noncompliance. In regards to quality management, the new guidelines state that “the sponsor should implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials”, and that the sponsor “should focus on trial activities essential to ensuring human subject protection and the reliability of trial results”. An additional important responsibility of the sponsor is to “ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection”. The sponsor must also employ a risk-based approach to monitor the clinical trial. The GCP R2 Addendum outlines in detail how to identify, evaluate, control, review and report the risks when developing quality management systems (QMS). Furthermore, the sponsor must “ensure oversight of any trial-related duties”, and “should document approval of any subcontracting of trial-related duties and functions by a CRO”. The further responsibilities of sponsors concerning the CRO will give them greater control and management over clinical trials. Finally, the control of information collected from data capturing programmes was also covered, as now the obligation of the sponsor is to have written procedures in place for all electronic systems used in the trial. A standard operating procedure should be in place for “validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning and decommissioning” .
Regarding investigators, they should assure that there is a suitable monitoring plan in place to supervise the different individuals engaged in the study. The various stages should also be tracked to ensure that adequate procedures are adopted to protect data integrity. The investigator must maintain records of the documents for critical processes and clear documented evidence of the PI’s oversight and involvement in the trial. Additionally, the PI needs to make certain that a clinical investigation is carried out according to the protocol, the investigational plan and applicable regulations.
EMA welcomed the R2 changes, stating that these new guidelines “will provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting”. The new ICH GCP E6 (R2) Addendum introduced 26 new items covering three main areas of clinical research: data management, and sponsor and investigator responsibilities.