Investigator Initiated Studies
Investigator initiated clinical studies play an important role in answering important medical and scientific questions regarding Genentech’s medicines and related diseases. Consistent with the company’s overall research and development strategies, these studies can enhance the understanding of Genentech’s medicines, how improve patient care and spark new ideas for further disease-related research aimed at creating improved medicines for people who need them.
Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researcher (e.g. individual investigator, institution, collaborative study group, cooperative group) who, as the sponsor, is responsible for the conduct and management of the study as defined by all applicable laws and regulations.
We support investigator initiated studies, including:
- Clinical studies of approved and investigational uses of Genentech medicines, including medicines approved by the FDA or still in development (interventional studies phase I to IV)
- Clinical observational studies, real world evidence (non-interventional studies)
The following are not considered investigator initiated studies:
- Non-clinical studies – requests for these can be submitted here
- Access to investigational medicines through compassionate use or expanded access. For more information, please see here.
Studies that align with the company defined areas of strategic interest will be evaluated. If your proposal is approved, Genentech may support Investigator Initiated Studies by supplying medicines, funding, material and/or information, as allowed under local laws and regulations, and provided that the sponsor/investigator fulfills (or agrees to) the following requirements:
- Have the scientific, technical and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc)
- Have expert statistical support
- Submit a scientifically well-designed and well-written study proposal
- Deliver to agreed timelines
- Be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final study report and manuscripts etc)
- Deliver a written report of the final study results to Genentech
- Publish the study in a scientific journal
- Agree to safety reporting to health authorities and to Genentech
- Agree to provide study updates to Genentech
Researchers are invited to submit their concept proposal via the IIS submission portal (link below). Submissions will be reviewed collectively by the Roche Review Committee. Genentech will inform the requester about the outcome and, should Genentech be interested in the submission, the investigator will be contacted by Genentech and invited to submit further details and a final protocol on the IIS portal to be considered for full approval.
Proposals will be reviewed based on scientific merit and alignment with corporate research and development plans. All funding requests will be assessed to ensure that they do not exceed local fair market value. In addition, funding request for expenses not associated with the conduct of the study is strictly prohibited.
Genentech requires that the following documents are in place before the support can be initiated:
- Fully executed IIS agreement between the sponsor and Roche
- Fully executed IIS safety data exchange agreement between the sponsor and Roche
- EC/IRB and/or Health Authority Approval