ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).
The reflection paper is available for download via the following link:
The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain. ICH’s decision to invite stakeholder comment on the proposed renovations at this early stage, ahead of guideline development efforts, recognises the considerable stake and relevant expertise in the research community beyond ICH.
The seeking of stakeholder comment on the current reflection paper is seen as a first step in an enhancement of the ICH process with respect to public consultation for the revision of ICH E8 and E6. The GCP Renovation reflection paper outlines additional steps that are also being considered to enhance stakeholder engagement.
Stakeholders are invited to submit any comments to firstname.lastname@example.org. All comments should be submitted before the closing date for public comment, which is March 11, 2017. ICH will review the comments received to determine whether to make revisions to the currently proposed approach. The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.
NOTE – THE REFLECTION PAPER ALSO DISCUSSES THE ROLE OF RWE, PRAGMATIC TRIALS AND OBSERVATIONAL STUDIES
Excerpt from Reflection Paper
Clinical trials initially were often conducted in only a few clinical sites, often of a single type (e.g., academic medical practices) in a highly controlled setting. Over time, that has evolved to include multiple sites, often including sites from multiple countries. Accordingly, regulatory agencies have embraced a more flexible risk-based approach to the monitoring of clinical trials. This is based in part on the recognition of challenges of the increasing number and complexity of clinical trials and opportunities to use electronic systems with improved statistical assessments for centralized monitoring of clinical sites. A risk-based approach can enable the sponsor to focus oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity.4
Recently, there has been a further shift to leverage the large amounts of available data from the “real world” (e.g., electronic health records, hospital discharge summaries, claims data, patient/disease registries, etc.), collected and stored for other purposes, that could inform regulatory decision-making. A patient registry has been defined as an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).5 Other possible sources of real world data include electronic medical records (EMRs) sometimes referred to as electronic health records (EHRs) generated by ongoing patient care, as well as health care administrative data sources. However, it should be noted that there are no universally accepted standards currently in use for formatting data from these different real-world sources, and this is probably the single biggest impediment to large-scale use of existing health care records in clinical trials. The adoption of standardized electronic formats for health care administrative data, and patient EMRs will greatly improve the ability of researchers to use these data to address health care and policy questions.
There have also been efforts to better integrate clinical studies into regular health care delivery by interfacing the electronic case report form with EMRs to minimize duplicative collection of patient/study participant data. This could facilitate performance of pragmatic clinical trials conducted under everyday clinical conditions and designed to test two or more treatments using more flexible study protocols and local customization, with less strict eligibility criteria, with less collection of data beyond the norm in routine clinical practice.6
6 See for example: Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry – May 2016 –