If They Cooperate, They Will Cure
My father suffers from a blood disease that has no cure. This disease is Polycythemia Vera and is a disorder in which your bone marrow makes too many red blood cells. This causes the blood to thicken to the point where regular visits to the phlebotomist are necessary to drain your blood. Failure to do so could result in clots or even strokes. Side effects of current treatment options include leukemia. There is no upside here. While this is an unfortunate state of affairs for my family, I take comfort in the fact that I work in an industry where I am surrounded by some of the best research minds in the world, many of whom are working on diseases like the one my father has. The people I meet on the road come from all kinds of backgrounds and professions, like the VP of clinical research at a pharmaceutical company working towards their next drug approval, or the head of bioinformatics for one of the NCI Clinical Trial Cooperative Groups. These cooperative groups work on multicenter trials not for commercial purposes but to directly benefit the citizens of the United States and ultimately the world by pushing forward scientific questions that fall outside the purview of commercial interests. This community of research organizations sits in what is classified as academic, not-for-profit and the government sector. From single site investigator-initiated studies to the new National Clinical Trials Network, this community thrives on cooperation, collaboration and a common goal to advance research. The CBI 3rd Annual Collaboration with Cooperative Groups conference in Philadelphia this week is dedicated to this very topic. The sessions are focused on improving the collaboration of the commercial drug industry (Big Pharma) with the cooperative groups (Academic Research Organizations.) The goal is to create a new National Clinical Trials Network for cancer research. The cooperative groups have standardized on Medidata Rave as their new technology platform for electronic data capture (EDC) and clinical data management (CDM). Approximately 14,000 investigators across 3,100 research sites in the United States will all use the same system to capture and manage their clinical data and be self-sufficient to configure the system themselves for their needs, in accordance with industry and group standards. I think trends set by industry-sponsored commercial clinical trials and the collaborative nature of the cooperative groups have already had positive effects on each other and have set a good example for other players with respect to technology:
- Secure, single access to data, everywhere. In the past, the cooperative groups maintained their own customized clinical data management system (CDMS) individually, inside their own firewalls. The commercial industry realized that collecting data on paper and hosting the applications internally was not a scalable future, and thus moved away from these inefficient practices. The solution was a centralized package hosted in the cloud that utilized a a Software as a Service (SaaS) model for continuous improvement. A common data management platform brings along new harmonized policies and procedures that help with FDA-related issues, provide a single source of truth for adverse event reporting and enable single sign-on user access to clinical trials in a community shared by the commercial industry. “I am now a member of the community. Now invite me to a study.”
- Share your work to improve productivity. The groups will share their global libraries of standard forms, edit checks, data dictionaries and reports to help everyone avoid "reinventing the wheel" whenever possible. Why isn’t this more common? One example that springs to mind from the commercial sector is Eli Lilly and their public CDISC ODM library of forms. Are there other examples of life sciences companies sharing their work from EDC to help the industry be more efficient? Leave a comment below!
The goal here is to optimize patient accruals across research and increase efficiencies across the entire network to conduct trials faster, with world-class data quality. Eventually, the outcomes of these research studies can be made available to the commercial industry to support the licensing of their products while leveraging the same clinical research platform that a significant portion of the commercial drug development world is utilizing. So where does this hit home? Right before Christmas 2011, I met with a top researcher inside the NIH in Bethesda, MD, who would be considered one of the top experts in blood diseases in the country. He told me that my father’s disease was one of those under-researched diseases and that no major companies were investing any real money behind advancement of new treatments. However, government funded research grants are handed out to those who have a vested interest themselves—in this case, the resident experts on Polycythemia Vera reside at the Mayo Clinic and Johns Hopkins University. Both are academic research institutes, collaborating together and sharing research data using the latest technology to help find a cure—one Dad at a time. Guest blogger Joe Dustin is a senior business consultant at Medidata Solutions. You can reach Joe by email or follow him on Twitter @eClinical.