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Transparency of Clinical Trial Data

Clinical Trials

Clinical Trials

Donna Williams, Discovery
Donna Williams, Discovery
Clinical Trial Data Transparency

At Janssen, we believe transparency of clinical trial data advances science and medicine and is in the best interest of the patients who use our pharmaceutical products and providers who prescribe them. As such, we support the overall principles of greater clinical trial data transparency, including registration and disclosure of clinical trial results in external registries, publication of results in peer-reviewed journals, sharing of clinical study reports (CSRs), participant level data, and making available plain language summaries (PLS) from clinical trials, as outlined below.

Registration and Disclosure of Clinical Trial Results

Janssen publicly discloses information about its clinical trials in external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register.

Disclosure includes:

  • Registering pharmaceutical clinical trials conducted in patients (Phase 1b through Phase 4) on external registries in accordance with specified requirements
  • Upon receiving regulatory approval, disclosing clinical trial results of investigational studies in accordance with specific format and timeframe of local laws and regulations
     
Publication of Clinical Trials Results in Peer-Reviewed Journals

We seek to publish, in peer-reviewed journals, results from all company-sponsored pharmaceutical Phase 2 through 4 clinical trials and Phase 1 trials in patients. Studies that terminate early (prior to pre-specified study end date) are included in our commitment to publish, provided they yield scientifically or medically important results.

We also seek to publish pharmaceutical research of scientific or medical importance from discontinued clinical research programs, prospective observational studies including registries, analyses from subscribed databases, and health economics and outcomes research programs.

Sharing of CSRs and Participant Level Data

We appreciate and acknowledge that study participants (patients, investigators and sites) who agree to participate in our clinical trials are critical partners in advancing medical knowledge. We are dedicated to protecting the commitments we have made with them, including patient privacy.

  • Clinical study reports (CSRs) are formal reports that provide comprehensive description of the design, methods and results of clinical trials
  • Participant level data are those data collected on each study participant at each visit or study contact. Analyzable participant level data are in databases that allow analysis by computer programs and statistical tests
  • We have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for CSRs and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. For more information on this process or to make a request, please visit The Yoda Project
     
Making Plain Language Summaries available

As partners in research, Janssen believes the people who participated in our clinical trials should have the option to access information about the study findings to which they contributed.

A Plain Language Summary (PLS), is a summary of the key results of a clinical trial, written in a non-technical manner that is understandable to the general reader. Plain Language Summaries share the study outcomes, acknowledge the important contribution of the people who participated in the trial and help participants understand more about the research they have contributed to.

PLS in English (and local languages) will be shared publicly as required by local law for Janssen-sponsored interventional trials in accordance with local regulatory requirements.

Where not required by law, PLS will be made available to study participants for Phase 2 and 3 interventional studies conducted with drug products that have not received marketing authorization in any country.