Overcoming Inertia for Improved Clinical Trial Designs
I must admit that I feel a degree of chagrin when I stop to think that we in the pharmaceutical industry took over 20 years (yes, over two decades) to fully embrace electronic data capture (EDC). To me, it seems to be at odds to work in an industry that is focused on scientific advances in medicine, yet to be so conservative when it comes to adopting new technologies designed to help the clinical trial process. Yes, there has been significant progress in developing a wide array of solutions addressing specific elements of the trial process, from data collection through to submission. However, if we are completely candid with ourselves, most of these changes have been incremental and have applied technology to improve the efficiency of particular steps without questioning if there should be some basic underlying trial design improvements. The need to improve trial design has been intuitively known for a long time; and has been confirmed by research conducted by Tufts Center for the Study of Drug Development (CSDD). While various initiatives have been started towards this goal, including Standard Protocols Items for Randomized Trials (SPIRIT), Protocol Representation Model (PRM), and tools including Medidata Designer; it is not uncommon to find hesitation to adopt necessary changes within sponsor organizations. When talking to industry colleagues about addressing trial improvements, it is a bit unsettling to hear echoes of hesitation that led to the extended adoption timeline for EDC. We shouldn’t wait another 20 years to fully adopt improved processes for designing clinical trials. We need to apply lessons learned during EDC adoption to trial design improvements, so we can realize the benefits now. We will explore this topic in greater depth at the Medidata Symposium 2014 and encourage you to join us in San Francisco on April 23rd -25th. *Guest blogger Robert Musterer is president of ER Squared, Inc., an eClinical consulting and services company. ER Squared is also a Medidata Services Partner and the first Medidata Designer accredited partner.