I stumbled across an article posted in ClinPage back in May 2008 that reported on a presentation given by Ron Waife. I cannot say I always agree with Ron’s assessments, however I believe he is 100% accurate with his analysis on this occasion. Steve Woody also made an interesting point regarding a potential solution to the problem.
The crux of Ron’s position is that Sponsor companies are fundamentally failing in taking advantage of eClinical technologies, primarily due to a failure to embrace new processes, and to break down silo based working models.
Ron makes a sensible suggestion regarding a potential mode that will work – a skunk work approach – that I fully share.
If there are any Pharma execs out there with the power to make change happen – they would do very well to listen to Ron’s advise.
An interpretation of the proposal is defined as follows – purposely greatly simplified! ;
- Take an adaptive friendly drug program…
- Create a skunk work team comprising of a small number of open minded individuals from each existing department – Protocol Writer, (e)Study Builder, Statistician, Safety Manager, Clinical Lead etc.
- Put them in a ‘virtual’ room, and ask them to work tightly together.
- The team must work on an ‘Agile’ style development approach – [ I will expand on this in a later post ]
- The program / studies will be adaptive – the data will be available early and the decisions made rapidly.
- The Statistician – playing an active, leading role throughout the program – will model the original program, assess the ongoing (daily) execution against the model and adapt accordingly.
- A leader of this team should be measured based on the effectiveness of the Program – positive or negative – against a plan.
Sometimes, I think we are too focused on shaving a few days of the time to DB Lock. With an agile adaptive approach – could we not be thinking months and even years of savings?
Steve’s suggestion was that a focus on a business model approach might focus the minds of the sponsor companies. His statement regarding the CRO industry;
… which was created and is sustained by the inefficiency of clinical research, is hooked on the heroin (money).
may come across as rather strong, but I believe there is a degree of truth here. CRO’s are often the most conservative when it comes to change… ‘lets do whatever the client that pays the money wants…’ even if it is not necessarily good for them…
However, and this is a big ‘however’… CRO companies do act on a conservative basis due to a need to provide a low risk solutions. How many sponsor organizations want to hear about a new ‘high risk’ implementation method that will be applied to the trial they are responsible for? So – I don’t think the blame is entirely merited.
Moving off topic now, so I will close this post… I am interested in hearing comments…