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While the future of the industry is still uncertain, a slew of uplifting ideas around innovation could help turn things around.
When you read this, it should be about 50 days until 2020. Here are two stats pulled out of 2017 regarding the drug development enterprise for 2020. It is estimated that the majority (72%) of clinical trials will be run by CROs in 2020, and the internal rate of return (IRR) on pharma R&D is predicted to be at 0% in 2020. Since CROs don’t run clinical trials out of the graciousness of their hearts, there looks to be a bit of unsustainability in the market. What future awaits the industry remains to be seen; here are some more uplifting tidbits around innovation that could help change this bleak prospect.
Exhibit A. Veeva Systems’ 2019 Unified Clinical Operations Survey: Annual CRO Report came out at the end of October with these highlights. CROs are initiating change to simplify information exchange with study partners, which they expect to yield significant benefits, including reduction in manual processes (77%), streamlined collaboration (65%), improved study quality (64%), and faster study execution (64%). In addition, the survey found site contracting and budgeting the most cited and fastest growing issue during the study start-up process, with 70% saying it is their top challenge, up 11 percentage points since 2018 and among the primary drivers for change.
Exhibit B. I will be attending KNect 365’s Clinical Trials Europe event this month. Speakers provided their own predictions for the future of clinical trials here, and I look forward to learning more about the relationship between CROs and sponsors. As stated by Patricia Moenaert, director, portfolio sourcing and relationship management (PSRM) at Celgene, “Sourcing/outsourcing will be supported by more automated systems by 2020 and sponsors will mainly do oversight and less micromanagement since both CROs and sponsors will join the same most common technology. This will allow sponsors to be more efficient in resourcing internally and avoid duplication of task by both CRO and sponsor. Non-core activities will be delegated to CROs who are becoming the experts, while science will stay core at the sponsor.”
Exhibit C. It’s becoming increasingly disingenuous for industry to point fingers at FDA as the block to furthering innovation in drug development. While agency guidances are paramount to following regulatory intent, even when the guidances literally tell industry they can get away from archaic practices, something keeps the CROs and sponsors entrenched. Former FDA Commissioner Scott Gottlieb had been direct in his comments during his tenure around sponsors and CROs that resist change, noting that there needs to be a more concerted effort by leadership across the entire community to lead that change. He did acknowledge that drugmakers need additional contact or reassurance from FDA, that if they are implementing change, they’re going down the right path. But he believes that FDA’s processes are transparent, and often go through a notice and comment period, either rule-making or guidance. And with recent CDER and CBER restructures and a push for the necessary digital transformation, the regulatory future for innovation is bright.
The December issue of Applied Clinical Trials will highlight Regulatory Updates and include articles around FDA pilots, regulatory information systems, and updated information around China, the EU, and more.