Driving Insights to Action

“Driving insights to action” formed the theme of this year’s DIA member meeting at the Boston Convention & Exhibition Center. This global collaborative platform of life sciences and healthcare professionals is one of the fastest growing events on the healthcare calendar.

This year’s meeting theme was partially inspired by United Nations’ World Drug Report 2017 that reported about 190,000 drug-related deaths globally in 2015. The 2018 report continues the discussion on the expansion of prescription drug abuse:

The non-medical use of prescription drugs is becoming a major threat to public health and law enforcement worldwide with opioids causing the most harm and accounting for 76 per cent of deaths where drug use disorders were implicated.

This trend dramatically underlines the urgent need for access to safe medicines globally and so driving insights to action. Insights that potentially could be deployed through novel disruptive technologies such as artificial intelligence, block chain and wearable technology. This year’s discussion therefore revolved around three key questions; how can we reverse the current situation; how can the industry get convinced of return on investments in the digital healthcare economy and how can patients benefit from these revolutionary technologies?

Being an innovative leader in intelligent Risk-based Quality Management (RBQM) and Risk-based Monitoring (RBM) services, our Cyntegrity executives Dr Johann Proeve and Dr Nimita Limaye were invited to join the conversation as speakers and workshop co-chairs. They share their takeaways with us:

Johann, you supported the session “The letter and spirit of Risk-based Monitoring: How to creatively implement Risk-based Monitoring and unlock the potential of the team.”, were people interested in this topic?

Johann: Certainly, the session was well attended, and the room was completely occupied (150 people). It was my pleasure to provide guidance on the implementation steps of RBM and how to move from RBM to RBQM. Since the presentations were running on the Quality and Compliance track, the audience were mainly from the R&D Quality functions. They were supportive of the idea to move from RBM to RBQM, a trend that still requires nurturing, since the concept is broadening the ideas of RBM.

As you were not the only speaker, what was your personal takeaway from this session?

Johann: Suzanne Lukac from Merck USA gave a great presentation on the TransCelerate best practices and observations. It is certainly worthwhile to regularly look at the TransCelerate homepage to see how this topic develops and which new supportive documents are made available.

Teresa Ancukiewicz presented on the implementation of RBM at Boston Scientific and provided very useful hints and advice on the things to do and to avoid when starting to implement RBM. Teresa emphasized that RBM implementation is a team effort covering many functions and not a single function exercise. She also recommended to start small and then expand RBM rather than using the ‘big-bang’ approach. Since Boston Scientific is a medical device company, Teresa also provided valuable guidance on the RBM implementation for medical device companies, which – as we all know – are slightly different from the standard pharma drug development processes.

You also chaired a round table session that addressed the implementation of Risk-based Monitoring, what were the topics that raised most interest?

Johann: The RBM implementation process map triggered major interest so did the aspect of getting expert support for the implementation of RBM. The need for support from RBM experts also surfaced during our conversations with pharma representatives.

What do people perceive as the “biggest hurdle” to take in this context?

Johann: Where to start and how to get to the right risks, risk indicators and related assessment, these questions surfaced many times.

Nimita: During my round table sessions I found that not many companies knew what KPIs (Key Performance indicators) were, nor were they tracking them. Also, there seems to be quite a lot of ambiguity about QTLs (Quality Tolerance Limits). Education is key here.

Johann: Some company representatives stated that their monitors still do 100% SDV and it seems to be rather difficult to change a process that had been established 30 years ago and trained for decades.

Gilead, a US Biotech company, seemed to be quite advanced with respect to the RBM implementation and explained that Biostats, DM, Safety, Regulatory Affairs, and Clinical Operations are involved in their case. The implementation was required by Senior Management, a top-down approach, which seemed to work for them.

In addition, people expressed their concern about the future role of monitors, that they would become no longer needed. Companies indicate that they are hesitant to reduce on-site monitoring visits, even though they are performing RBM.

Do you think this is a reason for concern, would monitors become redundant in scope of RBM?

Johann: Not at all. Source Data Review still has to be done, may be even more so in future since the sources are more diverse than in the past. On-site monitors will be able – due to a reduced and more focused Source Data Verification – to put more emphasis on more important and relevant aspects of monitoring, such as site staff training, enrollment of the right, suitable patients, and on-time data entry into the data capture system. Those activities certainly add more value than source data verification.

Nimita, you mentioned another interesting observation; some think that investigators should not be briefed about the change in the model. Isn’t it the case that the use of RBM must be described in the protocol, as for the use of EDC and eCOA? Why do some feel that investigators should not be briefed?

Nimita: The underlying reason was that they felt that they could leverage RBM to monitor fraud and that they thought that by sharing insight about the implementation of RBM on the study, they would be alerting the investigator about the same.

What is your conclusive observation regarding the current level of adoption of a risk-based approach to monitoring?

Nimita: We observed that many companies are still piloting RBM. Others feel that they do not have the internal expertise to select an RBM vendor. Furthermore, their biggest challenges are change management and costs.

Johann: Indeed, overall, many companies are still struggling with the first steps of an RBM implementation and how to get started. The technical implementation of RBM and the change management that goes along with it, are certainly areas that we at Cyntegrity can continue to provide guidance on. We are a well-equipped and experienced partner for those companies that require a proper basis to get RBM started. Technology and expert consultancy are two inseparable services in my mind, which together form a fit-for-purpose solution.