Designed with patients, for patients.

TransCelerate’s Clinical Research Access & Information Exchange Initiative aims to help the industry better inform patients by facilitating improved touchpoints with information about clinical research and specific clinical trial opportunities.

TransCelerate’s solutions are designed through collaboration with multiple stakeholders across the ecosystem. Specifically, we have led a series of iterative design workshops to co-create our Clinical Trial Registry of the Future concept in partnership with patients. We have and will continue to obtain and incorporate important perspectives from patients, clinical trial sites, healthcare providers, and government agencies.

Learn how you can further contribute to:

  • Enabling patient-focused enhancements to government-owned clinical trial registries
  • Improving patients’ options for contact with investigative sites
  • Improving information exchange with patients before, during and after clinical trial participation

What we’ve come to learn and appreciate through this process is that the Registry of the Future will only be as valuable to patients as the data it contains is informative and useful. Today, registries receive submissions with incomplete data fields, dense jargon, internal inconsistencies and other issues of data quality. As a result, the National Institute of Health, which maintains ClinicalTrials.gov expressed concerns over data quality to TransCelerate, as this could be a barrier for patients accessing meaningful information on ClinicalTrials.gov. This led us to create the Clinical Trial Registration Tool that individual sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries.

We are seeking comment from additional industry stakeholders to affirm that the Clinical Trial Registration Tool could help improve clinical trial registration data, specifically for the “Brief Title” and the “Brief Summary” fields. The public comment period will run through November 22, 2019. Please select the dropdown for the Public Comment Period.

Public Comment Period: Clinical Trial Registration Tool

Clinical Trial Registration Tool:

What do you think? Join the conversation and submit your comments!

Submit Feedback

 

Clinical Trial Registration Tool Demonstration Video:
Narrated video describes the purpose of the Clinical Trial Registration Tool and how to use it.

Clinical Trial Registration Tool:

Title

Description

The Clinical Trial Registration Tool is a tool individual clinical trial sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries.  Download to take a closer look at how you may be able to leverage the Clinical Trial Registration Tool and then provide your feedback by clicking the “Submit Feedback” button above.

Educational Materials for the Clinical Trial Registry of the Future

Clinical Trial Registry of the Future Videos

What is the Clinical Trial Registry of the Future?

Narrated video describes the purpose of the Clinical Trial Registry of the Future concept and the principles of its design.

Searching for Clinical Trials

Narrated video highlights new ways patients might search for and narrow down clinical trial options, as demonstrated in the Clinical Trial Registry of the Future concept.

Evaluating a Clinical Trial

Narrated video highlights information and features proposed in the Clinical Trial Registry of the Future concept aimed at providing patients a more robust experience when evaluating or considering a clinical trial.

Other Clinical Trial Registry of the Future Materials

Title

Description

Proposal illustrates the challenges patients, their family members and healthcare professionals face when interacting and understanding the vast clinical research information available through government-sponsored registries, and provides a perspective, illustrative proof of concept, and call to action to advance multi-stakeholder collaboration on potential improvements to clinical trial registries.

eBook illustrates the step-by-step user experience and functions featured on each screen in the Clinical Trial Registry of the Future proof of concept.

Educational Materials for Site Contact & Information Exchange

Title

Description

Paper offers guidance on a practical first step toward closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings.

Graphic showcases patient reported data around the process of searching for clinical trials and what information they are expecting prior, during and after participating in a clinical trial.

Infographic highlights potential communication opportunities to provide the information patients are looking for along the clinical trial continuum.

This paper reviews data collected by TransCelerate around information exchange in clinical trials, including insights from patients, sponsors, sites and healthcare professionals, and provides potential opportunities to improve participants’ experience with clinical trials through greater transparency.

Overview presentation that summarizes the template objectives, considerations for use, methodology of development, and feedback received from patients, sites, and IRBs.

Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he/she has enrolled in a clinical study.

Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he/she has completed participation in a clinical study.

Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after the full clinical study is completed and results of the study are available.

General Principles to Prepare and Distribute Layperson Summaries

 

Implementation Guide Supplemental Tools

Title

Description

Provides general principles helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation (EU CTR) No 536/2014.

Intended to provide general principles to help sponsors prepare lay summaries in a manner that reduces the risk that the summaries could be perceived as promotional, which would raise regulatory concerns.

Provides guidance to consider when developing an educational slide set on the overview of layperson summaries, potential content for the layperson summary, and investigator involvement.

Provides a sample Thank You Letter to thank participants for taking part in the study and provides information on how, when, and where the results and/or layperson summaries will be made available to participants.

Provides guidance when discussing the results of the study with the participants and answering study participants’ questions in a non-promotional manner.

Provides a sample letter which may be used to communicate with investigators and site personnel about the plans of providing layperson summaries.

Provides a sample communication deck which describes the vision and overview of the layperson summary program.