Clinical Trial Update from CROWN Congress

The clinical trials industry continues to evolve, as novel concepts arose at the 7^th annual CROWN Congress. During this conference, there was discussion on CRO acquisition and consolidation, growing interest in the use of Blockchain technology in clinical trials, and new patient engagement methodologies. ExL’s 9^th Proactive GCP Compliance conference is occurring from March 19-21 in Philadelphia.

Industry Trends: Consolidation in the CRO Industry

David Windley, Managing Director at Jeffries, discussed how the CRO industry is starting to stabilize and consolidate. Specifically, bookings growth (or new study contracts) volatility has decreased over the last decade and has rebounded in 2017. For example, in aggregate, Year on Year (YoY) bookings rose from 4% in 2015 to 14% in 2017. A recent increase in biopharmaceutical funding and available cash for R&D investments may have contributed towards increased CRO study bookings. Accordingly, from an investment standpoint, CRO stock price performance has followed the biopharmaceutical sector without being exposed to the same market risks as the biopharmaceutical industry.

Because of increasing stability and bookings growth, and lowering profitability in the mid-sized CRO arena, the CRO industry is starting to consolidate. Examples include QuintilesIMS acquiring TKL Research's Clinical Trials Division, INC merging with InVentiv, ERT acquiring ExcoInTouch, and PPD acquiring Evidera, creating several large CRO options for the biopharmaceutical industry to choose from. However, this consolidation is also creating a gap between large and small CROs. Despite consolidation, the biopharmaceutical industry tends to feel more positively towards acquisitions between larger CRO enterprises compared to smaller ones, as they realize scale and consistency in clinical operations. Additionally, CRO operational results reflect positively on outsourcing, as demonstrated by increasing NDA and NME approval rates (increasing from ~40% in 2000 to more than 80% in 2017). Albeit YoY study bookings growth from 2010-2016 was volatile, growth rates are expected to stabilize, and become more predictable from 2017-2021, as the CRO industry matures.

Technology Innovation: Blockchain Application Concepts Gain Momentum

Munther Baara, Head of New Clinical Paradigm at Pfizer, and Maria Palombini, Director of Communities and Initiatives Development at IEEE Standards Association, discussed how Blockchain will transform the biopharmaceutical industry. Palombini explained that Blockchain is a process that is decentralized, transparent, verifiable, secure and private, and is a young and rapidly evolving technology, where transactions are created by participants in the system. Blockchain is still in the very early stages of its evolution and will likely change, however, there is a lot of potential towards applying Blockchain in clinical trials including clinical supply chain, smart contracts for eConsenting, and patient recruitment and enrollment. Dany DeGrave, Senior Director of Innovation Programs & External Networks at Sanofi believes Blockchain can contribute towards smart GMP, GCP, and GCLP, enhance manual recording of clinical data, and empowering personnel (including patients) to own their data.

The Search for Patient Engagement Continues

Patient engagement is starting to move towards educating patients on clinical trial opportunities, according to Kevin Hudziak, Consultant and Innovation Lead of Clinical Innovation and Optimization at Eli Lilly. Hudziak described clinical trial challenges including the need for faster enrollment, broadening patient bases, and recruiting patients in a new digital world. Specifically, patients are leveraging the Internet to become more empowered, as 46% of patients hear about clinical trials over the Internet. However, many patients are lost through this process, as study websites come and go. Lily created Lilly Trial Guide to not only capture patients for specific studies, but also continue engagement by redirecting them to a listing of all Lily clinical trials. To elaborate, if a patient does not meet study criteria, they are redirected to a main page, where they can search for other Lily studies. In addition, the website acts as a trove of information for patients to raise awareness about clinical trial participation.

Cassandra Smith, Associate Director of Investigator & Patient Engagement at Janssen, believes patient engagement is about properly informing and consenting patients via investigator and patient engagement. This can be done through better ICF templates; in other words, simplifying ICF language and improving design to reduce complexity and enhance comprehension. Janssen studied patient comprehension levels by conducting scientific studies with patients. In those studies, Janssen leveraged eye tracking technology, emotional dials, comprehension surveys and emojis to evaluate consent form comprehension and affection levels. By re-designing and simplifying consent forms, Janssen discovered that patients spent more time reading consents, and comprehension levels increased; patients’ lowest scores rose from 32% (with a 6-minute reading time) to 54% (with a 13-minute reading time).

Summary

Financial and fundamental evidence suggest that the CRO industry is stabilizing, which is creating opportunities for consolidation. However, this consolidation is leaving a gap between large and small CROs. While Blockchain is a new technological process, the biopharmaceutical industry is thinking of how this process can benefit clinical trials, and thought leaders believe strongly in the future potential of Blockchain applications. Patient engagement continues to evolve to meet new patient demands including evangelizing the concept of clinical trials to patients, maintaining patient communities, and enhancing clinical trial understanding through better consent form design.

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.