Is it too soon to Define Best Practice When it Comes to the Practical Implementation of Risk-Based Monitoring?

By April 25, 2016Blog

Last week CluePoints launched its eight-part Q&A blog series which aims to explore the current talking points in Risk-Based Monitoring (RBM). We’ve been gathering insights from a number of CluePoints’ partners but are keen to open up the discussion to the wider industry. The first question we put to our partners was centered around the practical implementation of Risk-Based Monitoring and where they feel current best practice lies amongst different sizes of companies and CROs. As expected, opinions varied but our discussions revealed some interesting common themes.

When it comes to current best practice, Jamie O’Keefe at Paragon Solutions said that many companies are simply, “dipping their toes in the water,” and there was a general consensus from the other partners that this is the case. All agreed that while some in the industry are starting to utilize RBM within their study programs, there is a huge variety in how they are approaching implementation, and for that reason, it is difficult to define current best practice.

Many of our partners also agreed that when, if, how and the speed at which Risk-Based Monitoring is currently being implemented, very much depends on the size of the organization. For larger companies, many of whom are now starting to utilize elements of Risk-Based Monitoring, the ability to make it standard practice across all studies is a complex challenge involving many stakeholders. Existing infrastructure, processes, technology etc means the transition to Risk-Based Monitoring will take considerable time and investment, and significantly alter their business. While on paper it may seem more practical for smaller organizations to integrate Risk-Based Monitoring across their business, many perhaps don’t have the same financial support as big pharma. As a result, smaller companies tend to be implementing RBM on a program-by-program basis or relying on third-party vendors to support them.

The pace at which Risk-Based Monitoring is being adopted across the industry was also highlighted as an issue – despite being actively encouraged to do so by the regulators, there still seems to be a lack of urgency. Bracket Global’s Adam Butler commented that, “as it is often the case with our industry, it just doesn’t seem like anyone is embracing the new approach fast enough.” With Craig Serra from Pfizer, agreeing with him and quite rightly pointing out the irony that despite operating in a very risk-averse industry current working practice is more risky by not adopting Risk-Based Monitoring quicker.

In my opinion, the industry in general recognizes the importance of mitigating risk and improving data quality and it is heartening to see the adoption of data interrogation techniques that have been used in other industries for many years, but we could be doing more. The ICH E6 guidance, which is due to be published in its final form in November, will insist that all companies adopt comprehensive risk management plans. This will be the turning point for adoption and we can already see many organizations who are embracing initiatives to prepare themselves for these requirements.

What’s your experience of current best practice of Risk-Based Monitoring implementation? Is it too early to say? Is more guidance needed for organizations? We’d be really interested to hear your thoughts on this topic so please do get involved with the discussion.

 

Leave a Reply