At the SCDM Annual Conference in Orlando in September last month, I had the opportunity to discuss the current relevance of SDV with fellow panelists Doug Pierce, Maryanne Rizk and Rick Morrison.
The topic, ‘SDV – What is it good for? Absolutely nothing!’ was coined by Jonathan Andrus, our panel’s Chair-with-Flair.
So here’s the premise of the topic under discussion.
STATISTICS INDICATE THAT THE COST OF AND BENEFITS FROM SDV ARE DISMALLY DISPROPORTIONATE.
THE ERA OF RBM, SUPPORTED BY THE WHOPPING LEVEL OF TECHNOLOGY AVAILABLE TO THE CLINICAL TRIAL INDUSTRY TODAY, MAKES THE ARGUMENT TO DO AWAY WITH SDV ALL THE MORE CONVINCING.
SDV’S REDUNDANCY CONTINUES TO GROW AS TECHNOLOGIES LIKE ESOURCE COMPLETELY REMOVE THE NEED FOR PAPER, AND SUBSEQUENTLY FOR DATA TRANSCRIPTION TO EDC.
Here’s some highlights:
- While statistics from Transcelerate indicate that SDV is responsible for only about 2% of changes to trial data, machine learning now allows patient similarity charts to alert Data Managers to the likelihood of fraud. Patterns within data can identify if data for two patients entered six months apart are identical. Human monitors would be hard pressed to not let this one slip through the cracks.
- Gargantuan as the joint potential of RBM and automation may be, trials will not magically turn more successful overnight. The enthusiasm around RBM and current technological potential needs to be tempered with clearly defined Change Management strategies and Quality Control for workflows.
- Beautifully described by a panelist as ‘The 5 stages of Clinical development enlightenment’, most sponsor/CROs have moved past ‘Traditional’ and ‘Experimental’, and hover somewhere between the ‘Operational’ and ‘Progressive’ stages. We have a distance to go before we can reach Stage 5, ‘Fully Engaged’, with a unified command centre, proactive RBM workflows and metrics designed to forecast problem areas before they occur. Sites currently play little or no part in sponsor/CRO decisions regarding trial conduct methodologies. Artificial intelligence cannot eradicate the need for emotional emotional intelligence. It is imperative to consider sites as stakeholders in decisions to change work processes and introduce automation, and to engage in a two-way dialogue that ensures cooperation.
- Sites need to see the ‘win’ in adapting to novel technologies. Strong communication channels and ongoing site training is essential to reduce resistance, and explain to sites the benefits from newer methodologies in terms of site effort and speed. As an example, that eSource can drastically improve data reliability while easing the site’s workload remains is a fact that many sites are not aware of yet.
What are a few outputs to take away for the roll out of a more robust RBM methodology?
- Change Management applies just as much to SDV as any other process of extinction.
- During the roll out of a trial, it can be essential to its success that your Risk Assessment include risks from stakeholder isolation and hostility and opportunities from stakeholder cooperation. A stakeholder analysis may be a useful tool to feed your RACT.
- Implementing RBM is a matter of evolution. Processes and metrics will continue to be more clearly defined as organizations learn from and adapt previously adopted methodologies.
- Communicating what’s in it for the sites and how technologies such as eSource make life easier at the site allows us to harness the awesome power of automation as we continue to evolve in bringing better drugs to the market faster.