The shift within the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is “earthshaking”, a 2017 Avoca Group survey published on Outsourcing-Pharma.com states. A November 2016 guidance from the International Council on Harmonization (ICH), ICH E6 (R2), triggered the risk-averse to risk-based shift with which both sponsors and providers now cope.
The copious amount of data and intelligence available to sponsors and providers is still a relatively new factor, as are technologies that can synthesize data to assess and predict risk. Additionally, the industry does not yet have “all the processes down pat to make risk-based monitoring and oversight a normal way of life.”1 However, ICH E6 (R2) was introduced for a reason. A risk-based approach allows for the use of objective data to understand high-risk areas and predict risk so that remediation can be performed to alleviate problems before they occur.
How sponsors and providers assess and manage risks in clinical trials
The Avoca Group’s 2017 Avoca Industry Report specifically examined how sponsors and providers assess and manage risks in clinical trials. A knowledge gap in the industry regarding risk-based oversight is one of the key findings within the report. Two-thirds of sponsors and providers report familiarity with best practices in risk-based provider oversight and inspection preparedness, but 1/3 of respondents admit to a limited understanding of what is required.
Peeling back another layer, the results become more intriguing. For example, the Avoca Group report reveals that “a higher percentage of sponsor employees working in the Quality functional area indicate that they have a ‘good’ or ‘very strong’ understanding of best practices in the areas of Quality Management, Provider Oversight, and Inspection Preparedness compared to their counterparts in Clinical Operations.”1 The report identifies two factors that may contribute to this discrepancy:
- Clinical Operations is predominantly concerned with execution of the clinical trial according to schedule and budget, and may not be immediately aware of leading quality practices using risk-based approaches.
- The organizational divide that tends to exist between Clinical Operations and Quality has hindered the creation of a true cross-functional culture of quality, resulting in a perception of Quality as a ‘policing’ function.1
The latter factor must be changed if “sponsors and providers are to succeed in implementing an efficient, effective risk-based approach to clinical oversight [because] collaboration, communication, and connectedness form the tripartite solution.”1 Working together will allow the various functional areas to align and support each other to more significantly improve quality, timeliness, and resource efficiency. These improvements are vital, for the report reveals that less than 50% of sponsors and providers feel that adopting risk-based oversight has generated “extremely” or “very impactful” positive results. Once sustainable results are realized, sponsors and providers will more fully commit to a risk-based approach.
Significant work remains for sponsors and providers to integrate the data, technologies, and analytics required for the risk-based approach to bear its full potential. However, the potentially transformative impact it will have on clinical trials cannot be understated. If you are a sponsor or provider and would like to discuss your current clinical trial oversight process, contact Pearl IRB today.
The full report can be accessed at The Avoca Group’s website.