Johnson & Johnson is currently making clinical trial data for pharmaceutical, medical device, and consumer products available.

Johnson & Johnson has adopted a policy that fosters sharing clinical trial data, including both recently completed as well as older trials. Before any trial is listed as available, Johnson & Johnson confirms the location of the data and the electronic format, as well as any agreements with collaboration partners to ensure each trial listed can be shared.

Trials listed for sharing on this site have been confirmed to meet the below criteria. The YODA Project and Johnson & Johnson continuously add to this list, as additional trials are identified that meet the below criteria. In cases where clinical trials do not meet the below criteria, the disclosure of these study data is at the sole discretion of the Data Partner. If there is any question about the availability of a trial not currently included in the trial list, please submit an inquiry.

Pharmaceutical Data

Researchers may submit requests for full CSRs and/or de-identified participant-level data for pharmaceutical Phase II-IV clinical trials for which:

• Janssen Pharmaceutical Companies of Johnson & Johnson is the market authorization holder;
• The product and relevant indication studied have been approved by regulators in the US and EU; and
• The study has been completed for 18 months.

OPTICS Trial Bundle

OPTICS (Open Translational Science in Schizophrenia) was a project designed to provide a forum for true translational science based on Janssen clinical trials and other publicly available data from related observational studies and trials in schizophrenia. The goal was to demonstrate the value of an open-science approach for fostering collaborations leading to insights about the disease and therapeutic safety and efficacy.

OPTICS Statement from Janssen

The Open Translational Science in Schizophrenia (OPTICS) Project was launched by Janssen Research & Development, LLC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with a group of leading research organizations including the National Institutes of Health, Yale University School of Medicine, Rutgers University, and the Harvard T.H. Chan School of Public Health. The aim of the project was to create a forum for collaborative analysis of Janssen’s schizophrenia clinical trial data along with publicly available schizophrenia data from the NIH. The ultimate goal was to create new open science models for conducting research.

The OPTICS Project was one part of a larger effort at Janssen and other Johnson & Johnson research companies to share clinical trial data to enhance public health and advance science and medicine. To that end, all intellectual property generated by the OPTICS Project was dedicated to the public and free for all to use.

For more information please visit the OPTICS website and the NIH Database of Genotypes and Phenotypes (dbGaP) website. The OPTICS Project has concluded, with available results. The OPTICS data available through the YODA Project included 17 paliperidone clinical trials conducted by Janssen.

Medical Device Data

Researchers may submit requests for full CSRs and/or de-identified participant-level data for “applicable” (as defined under FDAAA) medical device trials for which:

• A member company of the Johnson & Johnson Medical Devices Companies is the market authorization holder;
• The product and relevant indication studied have been approved by regulators in the US and EU in 2014 or later;
• The study was initiated in 2007 or later; and
• The study has been completed for 18 months.

Consumer Data

Researchers may submit requests for full CSRs and/or de-identified participant-level data for interventional clinical studies in humans of consumer products that are regulated as medicinals or devices for which:

• A member company of Johnson & Johnson Consumer Inc. is the market authorization holder;
• The product and relevant indication studied have been initially authorized or cleared by the US FDA and EMA or by a health authority anywhere in the world if US FDA and EMA authorization or clearance are not required or sought to allow marketing in that region from 2014 going forward; and
• The study has been completed for 18 months.