Provide a Framework for New Product Planning Groups to Influence Clinical Trials
A common theme running through a lot of what we at Cutting Edge Information learn while conducting research on the pharmaceutical industry is the need for more consistent and productive communication between internal groups, ranging from regulatory affairs and clinical development to marketing and medical affairs. However, simply saying “communicate better” falls far short of actually helping companies operate more efficiently. A framework needs to be in place that allows for such communication. Groups also need to be reminded of the value of working closely with other parts of the organization for the greater good.
Clinical and R&D groups, as the research hub of most companies, have to manage demands from almost every other department. But one of the easiest steps they can take to assist in a products long-term future is to incorporate ideas from new product planning (NPP) and other market access-oriented teams. New Product Planning groups supporting specific brands or therapeutic areas are very well positioned to understand what kind of data will be most beneficial in supporting value propositions for payer reimbursement as well as getting data for successful regulatory approval.
However, a framework must be established to facilitate this communication. In some cases from our research, this required a top-down approach from management that put NPP and R&D at the same table throughout development. This approach ensured that the NPP perspective was understood and that R&D was able to effectively communicate its own needs and limitations. In other cases, a more organic development of NPP groups role occurred. They were able to make a strong value case directly to clinical groups regarding the dividends that the modified trial designs have when a product reaches the market.