Trial Results Summaries
We are the leading global provider of plain language clinical trial results summaries. Let us show you why.
Our award-winning program will help your organization provide plain language trial results summaries efficiently, with exceptional care and quality. CISCRP can assist your organization in preparing for and complying with European Union Clinical Trials Regulation (EU CTR) trial results requirements and the expected FDA requirements to follow.
The Problem
At the end of a clinical trial, a high percentage of volunteers receive no information about what was learned from their participation.
Study volunteers want to know that their participation matters and that it made a difference. But sadly, at the end of a clinical trial, a high percentage of volunteers receive no information about what was learned from their participation. And years later, when the results are finally published in highly technical medical journals, study volunteers and their families have great difficulty understanding the study results and their implications.
CISCRP’s 2021 Perceptions & Insights Study found that both clinical trial participants, and those considering participation, view access to their clinical trial results as a top priority.2
The CISCRP 2021 study found that 85% of respondents who had participated in a clinical trial reported that it is “somewhat important” or “very important” to receive a summary of the results of the clinical trial. However, the majority (61%) reported that they did not receive any reports or updates on the results of their trial once they completed their participation. 39% reported they never even heard back from a research professional after the trial had ended.
61%
of participants did not receive any reports on the results of their trial
CISCRP's Solution
Communicating complex clinical trial results in plain, easy-to-read and understand, balanced and non-promotional language is a critically important but an ambitious responsibility. CISCRP brings nearly 15 years of expertise and experience preparing thousands of plain language trial results summaries to each of our engagements.
Our large and growing health communications team is made up of exceptional project managers, medical writers, editors, and graphic designers trained in health literacy best practices. In addition, our team is intimately familiar with the clinical research process and we routinely and actively gather input from a review panel comprised of a diverse community of patients, the public, and health care professionals.
CISCRP’s internationally-recognized solution produces the highest quality content that is well-organized, easy to navigate, visually appealing, and compliant with global regulatory requirements. And CISCRP’s trial results summaries include all required elements for layperson summaries identified in Annex V of the 2014 European Union (EU) Clinical Trials Regulation, which is necessary for a summary to be published in the EU database.
Program Setup
Let CISCRP help you set up and implement your organization’s trial results summary program.
- Highly specialized, extensive expertise and experience to help you build, launch and grow your organization’s commitment to provide plain language trial results summaries to your study volunteers
- Operationalize our insights from thousands of projects with sponsors across all therapeutic areas, phases, and study types
- Knowledge and experience developing all the necessary templates, operating procedures, guidelines, training, and tools
- Getz. The Monitor. September 2008: 17-21.
- 2019 CISCRP P&I Study, n=12,451
- Getz et al. 2012. Expert Rev. Clin. Pharmacol. 5(2): 149-156
- Informa Connect, Clinical Trials Europe Conference Award, 2014.
