About the process

Considerations regarding the sharing of clinical data

Janssen supports the disclosure of clinical trial data. We believe increased transparency is in the best interest of medical research and that sharing of clinical trial data must be done responsibly, with the interests of patients in mind and for the advancement of public health.  We appreciate and acknowledge that 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. As such, Janssen is committed to ensuring that the terms of the informed consent with which a patient agreed to enroll in a study are honored and that we share data in a way which will maintain patient confidentiality. This may limit the ability to share data in some instances.

There may be additional circumstances that prevent the sharing of data in some instances. Some factors that may lead to a request not being approved include, but are not limited to:

  • Whether the studies have been published or accepted for publication.
  • Whether the research or approved indication has been terminated.
  • Whether we have the authority to provide the data. For example, we may not have the authority because the medicine has been obtained by an external partner under a contract that does not permit the disclosure that is sought.
  • Whether it is feasible to ensure the privacy and confidentiality of research participants. For example, studies of rare diseases may have too few participants to prevent re-identification of individuals.
  • Whether there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies or the resources (costs) required to retrieve data and documents from repositories and redact personally identifiable information from relevant documents.

Requests for Clinical Study Report (CSR) synopses 

Janssen discloses on public registry websites (e.g., ClinicalTrials.gov) company-sponsored clinical trials results in accordance with specific format and timeframe of applicable laws and regulations. Individuals wanting to access more complete summaries, in the form of a CSR synopsis, may request to do so through this site.

Individuals should provide as much information as possible in the form about the CSR synopsis being requested. In many cases, it would be helpful to have the specific trial or dataset (e.g., Clinical Study ID # from ClinicalTrials.govname or description of particular trial). It may be necessary for Janssen to contact requestors via the email address provided to ask clarifying questions. Once identified, the reports will be redacted to remove any confidential information or private information that could permit re-identification of participants or investigators prior to being shared with the requestor.

Requests for complete CSRs or participant level data

To inquire about the availability of CSRs or participant level data through this site, external researchers must complete an online request and provide information about the studies or data required. Researchers can identify studies by searching registers such as ClinicalTrials.gov and literature databases such as Medline. Consistent with good scientific practice, researchers will be required to submit a research plan and to commit to transparency in the publication of their work. 

Request and evaluation process

Researchers may submit requests for complete CSRs and/or participant level data for trials for which:

  • Janssen is the market authorization holder,
  • The product and relevant indication studied has either been approved by regulators in the US and EU or terminated from development, and/or
  • The study has been completed for 18 months

Termination refers to an investigational medicine that is no longer being developed by Janssen for any indication (terminated during development) or termination of an indication for an approved medicine.

The research proposal will be reviewed by an independent external panel of scientific and medical experts. The independent panel will evaluate the research plan for completeness and scientific validity. It may be necessary for the independent panel to contact requestors via the email address provided to ask clarifying questions or obtain further information. Information about the requestor as well as the proposal will be made public.

What information will be required to make a request?

Following submission of the request, researchers will be asked to provide a research proposal. Upon approval of the request, researchers will need to sign a data use agreement and possibly other documentation, as required, prior to receiving access to the data.

Access to data

Participant-level data: Upon approval of a research request, researchers will be granted access to participant-level study data that are devoid of personally identifiable information. Data will be made available via a secure data sharing platform and be subject to a data use agreement. All analysis of participant-level data will take place within the secure platform.

Full CSR: Upon approval of a research request, redacted study reports will be provided directly to the researcher via secure data exchange. Reports will be redacted to remove any confidential information or private information that could permit re-identification of participants or investigators prior to being shared with the requestor.

If the request is not approved, the external panel will contact the requestor with the rationale for not approving the request.

To submit a request, click here to access the online form.

Definitions

CSR: A formal report that provides a comprehensive description of the design, methods and results of a clinical trial. A CSR can be short (“abbreviated”) or several thousand pages long.

CSR synopsisA brief overview summarizing the study plan and results, including numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc.

Participant Level Data: Individual study participant data collected on each study subject at each visit or study contact. Participant level analyzable data are in databases that allow analysis by computer programs and statistical tests.