Protocol Registration, Study Results Disclosure on Upswing
JERSEY CITY, NJ, Nov. 25, 2019 – The number of clinical trials an organization reports directly correlates to its level of automation, according to TrialScope’s 2019 Global Clinical Trial Disclosure & Transparency Benchmark Survey. As sponsors look toward the coming year, their biggest disclosure focus is plain-language summaries, followed by the new EU Portal, clinical trial results, data sharing and patient engagement/centricity.
When it comes to tracking global disclosure and related requirements, the number of clinical trials an organization reports can predict its level of automation.
Key findings of the biennial industry survey include:
- The lack of trial disclosure policies is common among organizations that report fewer than 10 trials over the past 12 months, with 81 percent having no formal trial disclosure policies.
- Over half of organizations reporting between 11-50 trials over the past 12 months rely on commercial solutions to tracking global clinical trial disclosure.
- Across the board, the level of automation is directly related to the number of trials reported over the past 12 months. Organizations reporting more than 50 trials are about two times more likely than smaller organizations to have automated processes of any kind.
- Sponsors are likely to outsource up to half of their clinical trial disclosure work
Comparing the results of this year’s survey with those of TrialScope’s 2015 and 2017 surveys reveals the following trends:
- Protocol registration commitments, down in 2017, returned to 2015 levels this year. In 2015, about 30 percent of respondents had disclosure policies reflecting legal requirements and commitments; in 2015 and 2019, over 40 percent of respondents had such policies in place.
- The scope of results disclosure commitments, which remained constant from 2015 to 2017, showed an additional 10 percent of respondents in 2019 committing to more voluntary results disclosure.
- As the below graph indicates, results disclosure automation has, for the most part, seen an upward climb since 2017.
The 2019 results are based on responses representing a cross-section of the clinical trial industry, including sponsors, contract research organizations (CROs) and consulting service providers. TrialScope Chief Strategy Officer Thomas Wicks shared survey highlights at the recent EXTRA: TrialScope Transparency Experience event.
While transparency overall is on an upswing, most respondents predict their organization will spend the same on disclosure in 2020. Increasing their commitment to transparency, 42 percent expect to spend more than they did this year. See the full survey report here.
Join us Dec. 12 at 11 a.m. ET for a webinar that will dive into the survey results, analyze industry benchmarks and offer industry predictions for the coming year. Register online for this free webinar.
For more information on TrialScope, the global leader in clinical trial transparency and disclosure compliance solutions, visit TrialScope.com.
TrialScope is the global leader in clinical trial disclosure and transparency management technology, supporting 16 of the top 20 industry clinical trial sponsors worldwide. TrialScope provides proven solutions that optimize the efficiency of disclosure activities, maximize trial data transparency, and foster more informed, engaged patients through open research sharing. To learn more about TrialScope, visit TrialScope.com.