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TMF Expert Insights
Wednesday, July 18, 2018 | 8:50 AM
I don’t know about you, but when I look at the costs associated with the drug development lifecycle, I can’t help but be astonished. Recently, I read that the cost of developing a new drug and bringing it to market is estimated to be more than $2.5 billion, not including the costs involving post-approval development. It is no small feat to bring a treatment to market. According to Pharmaceutical Research and Manufacturers of America, out of every 10,000 chemical compounds discovered, only one is eventually approved by the FDA—with the entire process taking up to 15 years!
The above figures really come into perspective when you consider a 15-year cycle, the number of clinical trials that need to be successful, and the mountains of safety and efficacy evidence that needs to be amassed. This gives pharmaceutical companies a very short window to recover the cost of drug development before the patents expire. Moreover, these facts don’t even account for the sunk costs of discovered compounds that do not make it to market.
Cost and the drug development lifecycle go hand in hand. Longer lifecycles mean more associated expenses. So, what can pharma companies do to reduce costs and shorten the drug discovery lifecycle? Referring to the same study by Pharmaceutical Research and Manufacturers of America, if we analyze the timeline for each stage of drug development, we find Phase 3 studies to be the most time consuming—lasting almost half of the fifteen-year cycle.
Before a study even begins, teams have to navigate critical and mandatory pre-study processes, including site selection. The long timelines and other pain points of site selection and activation are well documented and discussed openly in the research community. These initial work streams are full of challenges and opportunities. During site selection, not only are pharma and research organizations dependent upon the sites to provide the appropriate clinical staff and a pool of potential patients with the right indications, but also the ability of the selected sites to provide high-quality and reliable data. It is not uncommon for CROs to assess far more sites than they plan to enroll—oftentimes they will approach 20 times the required enrollment. In this illustrative study, 266 sites were contacted before final selection of only 12 sites. This low rate of site selection to identification adds significant workload for pharma companies and CROs.
While CROs are adopting technology for activating and monitoring sites, many companies still rely on traditional methods of approaching sites for conducting feasibility. These methods include sending physical, paper questionnaires to the sites (by mail or fax). Not only is this method time consuming, it also creates inefficiencies due to the manual nature of the process. Compound this with the process of tracking responses and follow-ups with spreadsheets—which is prone to human error and cannot be updated in real time—and it becomes extremely tedious when dealing with hundreds of sites.
All of these individual inefficiencies add up to delay site activation in clinical trials, often by several months. According to Cutting Edge Information, more than 70% of the studies end up running behind schedule, with the cost of such delays running into millions of dollars per day.
Pharma companies and CROs are recognizing the need for focused electronic feasibility solutions to resolve challenges with processes managed in Excel trackers. E-Feasibility technology can eliminate the manual processes involved in sending and tracking feasibility questionnaires, saving upwards of 35% in time (which can mean months in some cases). This translates to the savings of millions of dollars and enhanced overall enrollment performance.