EDC Guru left a comment on the Top 10 mistakes made when implementing EDC posting. In this comment, it is suggested that one of the potential failure areas is not leaving sufficient startup time when switching from Paper to EDC. I fully agree, although, from a sales perspective, the alternative is the sponsor goes to another CRO or Vendor that will offer the required timeline.
If you speak to an EDC company, one of the metrics they often pride themselves in is the time to First Patient In. 12 weeks, 10 weeks, 8 weeks or even 6 weeks are banded about. This is clearly a metric worth considering, but, what actually is included in these weeks? Is that how long it takes the vendor or CRO to *do* the study build, or is that how long it takes for a sponsor to be ready for EDC.
I would put forward that any sponsor company that goes from no experience to executing EDC studies in 12 weeks will not demonstrate the full benefits with EDC. In fact, there is a danger that the experience will be sufficiently poor as to impact the ongoing acceptance of EDC in an organization.Unwisely implementing EDC can result in similar metrics to paper studies, but at considerably extra cost.
So - what is the solution? Do I think that drug programs be delayed for the benefit of EDC technologies? Well - no, but, should an EDC based study be delayed until the organization is sufficiently in tune to the experience - yes.
So taking the above as accepted, what are the boundaries to achieving a better prepared company?
1). Senior Management within sponsor organizations will measure the success of a drug development program but the compounds that go in the various phases of study. Placing a delay in startup will appear like a failure
2). It is very difficult to develop effective EDC processes :-
- Sponsor companies new to EDC do not have the experience to determine where the eClinical tools brings benefits and where other methods are better.
- Vendor companies tackle the process problems from the perspective of technology rather than by tackling the actual business requirements.
- Consulting companies deliver non adventurous palatable process solutions based on regurgitated generic concepts.
3). Silo structured organizations may not offer broad department support for process changes that will make a company wide eClinical approach successful.
Ok, so I have managed to point out 3 potential problem areas, so, what is the solution.... or rather, what is my take on a potential solution?
1) Senior Management -
the measurement of success is as important as the success itself. I have seen this attempted, but I have not seen a lot of success. If everything changes, how do you compare 'apples with apples'. If nothing changes, then what is the point. You need to look for the lowest common denominator. Faster development, lower costs is a start...
2) Processes -
How many readers go along to DIA or similar conferences, and either avoid, or sleep through Process topics. That is a shame, as it is still the Process, Workflow and Change elements of eClinical that are causing bottlenecks.
You get Technology Guru's that create brilliant eClinical systems. Why not empower a Change Guru that 'gets' the technology and 'understands' the potential for changing an organization.
3). I have just answered 3) with 2).
So - back to EDC Guru's comment. There is a place for rapid start EDC where the vendor or CRO acts just as they did for an old Paper study, and takes on the bulk of the work to make an effective deployment. Some benefits will be realized, but certainly not all. I don't think the term 'Start Up' should be defined as study start up. It should implementation program start-up. A study will appear, down the road, but, not in the same sentence.