Guest article

The challenges of adopting a risk-based approach in pharma: 2017 Avoca Group survey results

By Dennis Salotti, vice president of operations, The Avoca Group

- Last updated on GMT

(Image: Getty/gustavofrazao)
(Image: Getty/gustavofrazao)
Making the shift in the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is – quite frankly – earthshaking.

The tremors are being felt by sponsors and providers alike. The fact is, we are still new to having such massive amounts of data and intelligence available. We are not fully at ease with the technologies that can synthesize data to assess and predict risk. And we certainly don’t have all the processes down pat to make risk-based monitoring and oversight a normal way of life.

Yet a risk-based approach is mission-critical for sponsors and providers alike. The shift has been mandated by the International Council on Harmonization (ICH) in its November 2016 release of ICH E6 (R2) guidance ​and for good reason: with a risk-based approach, it is possible to use objective data to understand the areas of greatest risk, and even predict risk so that remediation can be performed to alleviate trouble before it happens.

The Avoca Group’s 2017 Avoca Industry Report​ specifically examined how sponsors and providers assess and manage risk in clinical trials. Of key importance, we see that there is a knowledge gap in the industry regarding risk-based oversight.

While approximately two-thirds of sponsors and providers report familiarity with best practices in risk-based provider oversight and inspection preparedness, one out of three people admit to a limited understanding of what is required. And while providers are much more likely to express having a “good” or “very strong” understanding as compared to sponsors with respect to risk-based quality management and site monitoring, the numbers still show room for improvement.

Figure 1

When you drill down further, the numbers get even more interesting. For example, 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.

Figure 2

It is probable that this discrepancy is due to two main factors. First, 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.

Quality, on the other hand, is focused on ensuring that quality and compliance are built into the process and product of the work performed by Clinical Operations. Considering these different objectives – and therefore the different performance measures the functions are incented to achieve – it isn’t surprising to see Quality voice greater confidence in its knowledge of evolving risk-based requirements and practices.

Second, 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 instead in a perception of Quality as a ‘policing’ function. This mindset is one that can literally pit Clinical Operations and Quality against one another– reducing collaborative possibilities and knowledge-sharing, as indicated by the knowledge gaps referenced above.

This must be changed if sponsors and providers are to succeed in implementing an efficient, effective risk-based approach to clinical oversight. Collaboration, communication, and connectedness form the tripartite solution.

By working together, the various functional areas can align with and support one another to realize a greater impact on quality, timeliness, and resource efficiency. Such improvement is vital, as currently less than 50% of sponsors and providers feel that adopting risk-based oversight has generated “extremely” or “very impactful” positive results. Sustainable improvements must be realized for sponsors and providers to commit themselves to a risk-based approach.

Figure 3

The 2017 Avoca Industry Report​ illustrates that there is still a great deal of work to be done by both sponsors and providers to actualize the potential contained in a risk-based approach to overseeing clinical trials.

Integrating the data, technologies, and analytics required for this approach into our cultural mindset and daily tasks will not be accomplished in an instant. Rather, we should view this as an iterative process – one that will have multiple reviews, redirects, and refinements along the way. 

To access the full 2017 Avoca Research Report, and all other Avoca Research Reports, visit their website​. 

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