
- Applied Clinical Trials-11-01-2019
- Volume 28
- Issue 11
2020: The Industry’s Future Awaits
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
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
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.
Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at
Articles in this issue
almost 6 years ago
Applied Clinical Trials, November 2019 Issue (PDF)almost 6 years ago
Establishing Early Phase Capabilities in Malaysiaalmost 6 years ago
How ICH E6 (R2) Offers Wins with Risk-Based Study Executionalmost 6 years ago
News Notesalmost 6 years ago
The Challenges in Fulfilling the Promise of Precision Oncologyalmost 6 years ago
Sponsors Struggle with Trial Disclosure, Patient Privacy Requirementsalmost 6 years ago
The ‘Quest’ For an Effective Partner in Pharma And Biotechalmost 6 years ago
China: A New Era of Drug Development and Innovationalmost 6 years ago
Who’s Going to Be Disrupted by Shifts in European Health Strategy?Newsletter
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