Report: Fixing trial start-up woes requires new way of thinking

March 19, 2010 – 6:28 pm by Michael Christel

Life sciences R&D is becoming an increasingly networked and externalized practice – just see the latest merger, licensing deal, or joint venture for proof. Therefore, experts say, it is even more critical for drug companies to rethink the way they mange the various components of a clinical trial, where several players are involved, including CROs, sponsors, site managers, and other vendors. Juggling all these elements and their related technologies is a difficult task, particularly in costly Phase III trials, where problems with patient recruitment and study start-up have long hampered drug development timelines.

In a new report by Deloitte Consulting, its authors contend that clinical partners need to significantly evolve their thinking. The paper suggests that companies integrate all the services in a clinical-trial cycle in a more end-to-end approach. They call the model “services thinking.�

“it’s really a business and technology marriage,� Dan Ressler, a principal with Deloitte’s Healthcare & Life Sciences practice, tells me. Mr. Ressler and two colleagues authored the report, which you can view here.

“Technology can sometimes be intimidating,� he says. “What we’re really looking at is simplifying the technical environment by integrating what previously were a bunch of individual vendor solutions and making the activities that these key people perform happen more smoothly.�

According to Mr. Ressler, the process requires a sponsor or CRO to tap into the mindset of a customer, with the investigator being a good example. He notes that there are often several individuals that make up an “investigator,� from the primary investigator to the study coordinator to the study nurses. These people may all serve multiple roles in a development project. The services thinking model, Mr. Ressler says, requires a sponsor to view the experience of working with the company from the perspective of the investigator.

He points out that the number of qualified investigators to help conduct clinical trials has not increased as quickly as the amount of new medicines being developed, and, therefore, demand for their services is high.

“As you’re designing and building your capabilities – all of the different systems that touch that investigator – it requires thinking about the experience of the investigator, by taking a services thinking approach across all those steps in the process in which they’re involved,â€� Mr. Ressler says. “How do you remove some of the complexities, remove confusion, make the process of capturing and sending information easier?”

Just how much has pharma, an industry often set in its ways, embraced Deloitte’s services thinking model? Mr. Ressler says companies have begun to catch on.

“The differences have been in degree of scope,� he tells me. “It’s not a one-size-fits-all solution; every client has their own specific needs. Different life sciences companies want to realize value and achieve those goals at different speed or at different timing.�

Some companies are taking a more phased approach in integrating clinical-trial services. For example, according to Mr. Ressler, an organization might start by incorporating patient recruitment and study start-up processes and then later address more operational components and integrate electronic data capture, supply-tracking services, and other similar capabilities.

Tags: clinical trial management, Deloitte