It’s Not the Heat, It’s the “Sunshine”
The clinical trial industry has traditionally been a conservative one—slow to adapt. The past few years have presented challenges ranging from the patent cliff to new regulations to a sluggish worldwide economy, all collectively forcing the industry to not only adapt but also to come up with efficient and innovative ways to get new life-enhancing products to patients. You have probably seen a lot of reports over the past few years citing rising costs of clinical trials, particularly in investigator site costs. However, as has been discussed on this blog before, our analyses using Medidata’s PICAS® database show that, as an industry, we are developing more complicated protocols that require more tests and procedures. Of course, it’s crucial that sponsors accurately interpret these more complicated protocols to build and negotiate budgets and then subsequently administer payments to research sites. This trend, combined with tighter sponsor budgets, has placed extraordinary pressure on budgeting departments at sponsor organizations and contract research organizations (CROs). In a couple of weeks, the Summit for Clinical Operations Executives (SCOPE) will provide an ideal forum for leading experts in clinical operations to discuss these and other challenges. One of the big topics we hope to hear about there is the impact of the Sunshine Act on clinical trial budgeting. As my colleague and I wrote elsewhere, it will likely be expensive and complicated for clinical trial sponsors. So the big question I want to find answers to is whether the industry is ready, willing and able to adapt to the new world that the Sunshine Act will usher in. Will you be in attendance at SCOPE? What are some challenges you or your organization face regarding the topics mentioned above? *Stop by Medidata booth #44 to meet Jessica Dolfi and the team and pick up your complimentary copy of our new report, “Top 15 Procedure Costs” and the latest edition of the Medidata Insights Metrics Compendium. For more on SCOPE, check out this blog post by summit presenter and Medidata expert Igor Altman. Igor‘s presentation, For Optimized Study Design, Three’s Company, is scheduled for 1:30 p.m on February 7 during the “Clinical Trial Forecasting, Budgeting, and Project Management” track. He will also moderate the round table discussion, Assessing Trial Execution via the Trial Protocol Design, February 6 at 4:30 p.m. Guest blogger Jessica Dolfi is a Business Consultant at Medidata Solutions, responsible for supporting sponsor companies in the trial planning stages. Jessica collaborated with Medidata’s Sondra Pepe on the Journal for Clinical Studies article, “The Impending Sunshine Act: A Review for Clinical Trial Sponsors.” You can reach Jessica by email or follow her on Twitter @JessD_MDSOL.