Clinical trials are conducted to evaluate the efficacy and safety of medicines and medical devices, and are essential steps in developing effective new medicines and treatments. Janssen companies sponsor and support clinical trials in more than 40 countries, allowing for wide diversity among people who participate in this important research.
Information about Johnson & Johnson clinical trials includes:
- Ethical Guidelines
- Participating in a Clinical Trial
- Registration and Reporting
- Clinical Trials by Outside Investigators
Ethical Guidelines
Our Ethical Code for the Conduct of Research and Development provides standards of conduct and behavior for physicians, clinical research scientists and others who are responsible for medical aspects of research and development. Additionally, our operating companies are required to adhere to the core principles of the Declaration of Helsinki and the Belmont Report, which set clear guidelines for the ethical treatment of patients across all borders. Our products regulated as pharmaceuticals or devices must adhere to all relevant statutes as well as our policies for registering and reporting clinical studies.
Participating in a Clinical Trial
Participants in clinical trials may gain access to new research treatments before they are widely available, and can help others by contributing to medical research. Before candidates can enroll and participate in a clinical trial sponsored by one of our operating companies, clinical investigators must ensure that participants are fully informed of the potential benefits and risks of the medicine or device.
We have procedures in place to fully inform participants of potential benefits and risks, to protect the confidentiality of their private information and to protect vulnerable populations. We abide by the guidelines for Good Clinical Practice of the International Conference on Harmonization. To ensure that study participants know what to expect and can make an informed decision about whether to participate in a study, they must be given relevant information about the treatment option they are considering and what it could mean for them. They are also informed about available alternative therapeutic options.
Registration and Reporting
Our operating companies ensure the medical community has access to comprehensive information about our products by:
- Publicly announcing or registering clinical trials in accordance with journal and legal requirements
- Disclosing timelines for conducting and completing these studies
- Providing information about the potential risks as well as the benefits of participating in the study with those who are considering study participation
- Appropriately publishing the results of clinical trials
Clinical trials conducted around the world by our pharmaceutical and device companies are listed on the U.S. National Institute of Health’s (NIH) website and the EU Clinical Trials Register. We are committed to publishing data that are scientifically or medically important and to abiding by established codes of ethics, presenting truthful, complete and accurate information.
Clinical Trials by Outside Investigators
Johnson & Johnson companies also support clinical studies by outside investigators. These requests are carefully evaluated for their potential value. In conducting clinical investigations, outside investigators must comply with local regulations, adhere to our policies, and ensure participant safety is respected and protected.
For more information, please see the Johnson & Johnson Responsibility website.
For more information about pre-approval access to our investigational medicines via clinical trials, click here.
In 2014, Janssen signed the first-of-its-kind agreement with Yale School of Medicine’s Open Data Access Project.Find out more about this important partnership in our Research & Development section.