By Francine Lane & Thomas Wicks
This article originally appeared in Applied Clinical Trials.
With 2018 not far behind us, we turn our attention to the coming year. On a daily basis, TrialScope’s collective fingers are on the pulse of clinical trial disclosure and transparency. Over the past decade and more, we have seen a heightened awareness of – and focus on – the compliance of clinical trial sponsors. And so we offer a laundry list of 2019 predictions for the pharmaceutical industry:
Patient-centricity will be an ongoing theme in the clinical trials industry:
- Sponsors will make significant investments in patient-friendly clinical trial websites to support active patient-engagement programs.
- Patients, caregivers and advocates will be more vocal regarding their expectations of making clinical trial information more accessible and understandable.
Industry watchdogs will keep sponsors on their toes:
- Sponsors will be forced to respond to new and expanded disclosure tracking sites ranking trial sponsors by compliance metrics. These were formed in 2018:
FDAAA Trials Tracker
EU Trials Tracker
Governmental regulatory agencies will aim for greater consistency and stricter enforcement:
- The Food and Drug Administration (FDA) is poised to assess civil monetary penalties and publish public notices for violating requirements relating to ClinicalTrials.gov; draft guidance has been issued.
- Sponsors will be scrambling to test and prepare for the new EU portal, scheduled to launch in 2020, which will be the single entry point for submitting clinical trial information in the EU.
- Because International Committee of Medical Journal Editors (ICMJE) requirements to publish a data sharing plan cannot be fulfilled by all registries (EudraCT, for example), we will see more consolidation around CTGOV as the registry of choice.
- While big pharma will continue to be under the microscope, so to speak, greater attention will be placed on smaller biopharmaceutical and device organizations as well as academia for non-compliance.
- Likewise, regulators and registries will be under greater pressure to monitor compliance.
Medical devices will be under greater scrutiny:
- Device companies will need to pay attention to the new Eudamed device regulations and database in 2019 to prepare for 2020.
- In the U.S., devices also are drawing more attention. This year, the FDA released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.
“Data sharing” will become a new industry mantra:
- Sponsors will encounter challenges navigating the various data-sharing requirements in Europe, Canada and the U.S. (FDA Pilot).
- The “data-sharing economy” of clinical trials will continue to grow, as sponsors look for new ways to efficiently leverage existing data for the benefit of patient recruitment and retention, research transparency and innovation, and trial disclosure compliance.
We’ll go out on a limb here and say that 2019 could be the “Year of Clinical Trial Transparency.” Patient centricity, patient experience and health literacy are buzzwords that are rapidly becoming the new reality. Data sharing is already gaining ground in Europe’s scientific community; it remains to be seen whether it will secure a strong foothold in the pharmaceutical industry as well.
About the authors
Francine Lane is the Vice President of Global Transparency at TrialScope and chair of the DIA Clinical Trial Disclosure Community. She is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally. Francine also dedicates her time building relationships with external stakeholders to help align their goals and expectations, as well as help identify more consistent ways sponsors can meet industry standards.
As Chief Strategy Officer, Thomas Wicks is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.