May 2005
ACDM Debate "This House Believes Large DM Operations will Disappear in the Next Ten Years"
For the first time at an ACDM Conference, the floor was opened up for an interactive and topical debate on the future of Data Management operations within the industry. Speaking for the motion were Nick Lucas and Adrienne Motion and speaking against, Mark Harvill and Robert Schall.
Proceedings started with a pre-vote within the audience to determine how many people were for and how many against the motion. The consensus prior to the debate was against the motion i.e. that large DM operations will not disappear in the next ten years.
The pace of the arguments for and against was fast and furious, as each speaker only had a strict allocated time to convince the audience to change or keep their opinion.
Nick Lucas spoke first and made the following points in support of the motion: Data Entry is already being out-sourced to India; RDC, electronic labs and electronic diaries will inevitably lead to a decrease in headcount; CRO's are leading the way in streamlining Data Management resourcing solutions; technology and economics are drivers for the change; in a bid to increase efficiency, no paper CRFs and on-line validation will lead to a decrease in Data Management resource requirements; automation reduces the need for manual resource; other groups can be re-skilled to cover the gap in resource therefore there is less need for large DM groups.
Nick also tried to pre-empt the arguments that the "against" team would put forward and suggested that smaller teams of Data Managers would focus on core tasks (e.g. database build) and other efforts will pass to clinical teams.
First up for the "against" team was Robert Schall, whose argument was based on the concept that the future is based on what has happened in the past. If current trends are extrapolated into the future and also take into account the rate of change in the past, there will still be large teams within Data Management. The volume of Data Management activities to perform will be much higher in the future with more drugs being developed and trial designs changing with larger, more complex trials which will require intensive Data Management to handle the higher volume of data.
In response to this, Adrienne Motion took to the podium to present the final argument for the "for" team. Adrienne put forward the arguments that more data doesn't mean more people; companies want to manage more studies with less resource and are looking for efficiency and productivity; large groups carries a large overhead and associated costs, and more and more companies are looking to make these savings; although there is always going to be a need to collect and handle data, ways of managing data are changing with outsourcing and automation; EDC is happening and becoming the norm with large groups adopting it; with a move to global working and standardising processes, it makes sense to centralise and specialise DM resource to enable easier delivery of databases. Adrienne acknowledged that large DM groups do currently exist, but asked the question whether companies would prefer to keep these people as part of their skills set, or offload to a cheaper cost. A large group is also difficult to keep going when workload dips, therefore companies would prefer to downscale to smaller, more specialised groups with Data Managers moving towards roles that blend previous skills to create broader roles.
Mark Harvill was last, but by no means least, to persuade the audience to change their opinion. His argument against the motion was based on the fact that Data Management is changing but existing Data Manager's will be part of a large group in new structures. He warned that EDC is just a tool and the use of EDC will not equate to the size of DM groups. An increase in the number of studies for new compounds for smaller specialist patient populations will ensure that large DM operations are still needed. The emphasis of the role and DM actions will shift with EDC, but DM will still always be required to drive and complete these actions. Mark concluded that offshore resource is a short-term opportunity and not a long-term solution for DM activities.
The arguments proposed "for" and "against" sparked a good deal of discussion and questions from the audience. Other points also made were that Pharma companies are also starting to question and push back on what data is collected and why, in a bid to streamline efficiencies. This argues against the "against" point that more studies means more data, which will require large groups to handle.
The debate ended with another audience vote. Although there was some move in the voting towards "for", the motion was not carried – the house believes that large scale DM operations WILL NOT disappear in the next ten years.
This was a fun, interactive session and one that I hope will continue at future conferences for some thought provoking and contentious discussions about changes happening in our industry.
Lisa Goodwin