Clinical Research Access & Information Exchange Solutions
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 is that the Registry of the Future will only be as valuable if it contains useful information for patients. Registries receive submissions with incomplete data fields, dense jargon, and internal inconsistencies. 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 information on ClinicalTrials.gov.
In response, TransCelerate convened patient advisory boards and conducted a global online survey (N=1070) to determine patient preferences when searching for clinical trials for participation. The results of the global survey and an analysis of current ClinicalTrials.gov entries in regard to their patient friendliness can be found in a peer-reviewed journal article. The results were used to create the Clinical Trial Registration Tool that allows individual sponsors to proactively evaluate the quality of the clinical trial registration data, specifically for the “Brief Title” and the “Brief Summary” fields, that they submit to government-owned registries.
The Clinical Trial Registration Tool and “Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields” journal article are now available! Click the “Clinical Trial Registration Tool and Global Patient Preference Information” folder below to access the assets.
Clinical Trial Registration Tool and Global Patient Preference Information
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 and Global Patient Preference Information:
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.
The paper describes the results of a global survey on the information preferences of patients when looking for a trial to participate in. It also provides an analysis of current ClinicalTrials.gov entries in regard to their patient friendliness and their adherence to guidelines. The paper concludes that sponsors should make ClinicalTrials.gov entries more user friendly to facilitate patient access to clinical studies.
Educational Materials for the Clinical Trial Registry of the Future
Clinical Trial Registry of the Future:
What do you think? Join the conversation and submit your comments!
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
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.
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.
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.
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
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 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.