At Genentech, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA). In rare circumstances, we may provide patients with access to unapproved or investigational medicines outside the clinical trials process.
The Trial Information Support Line (TISL) handles all incoming trial inquiries from patients, caretakers and HCPs in the US. The TISL team provides responses for trial information, trial status, inclusion/exclusion, site referrals/warm transfers, Potential Investigators and Pre-Approval Access inquiries (Expanded Access Programs and Compassionate Use).
Genentech's clinical trial information can be found on our Clinical Trial Information page or contact the Trial Information Support Line at Genentech (888) 662-6728), Monday - Friday, 5am - 5pm PST.
Clinical trials are research studies that are designed to determine if a medicine is safe and effective for patients. The FDA and medical experts agree that the best way for patients to obtain access to medicines before they are approved in the United States is through participation in a clinical trial.
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study.
FDA guidance, sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Call our US Compassionate Use Information Line at (844) 287-3783 (CU-REQUEST) to provide preliminary information and discuss the potential options and/or general questions, including eligibility for any ongoing clinical trials. Further information can be found on https://www.gene.com/patients/clinical-trial-information
EAPs allow a limited group of patients, who meet specific criteria, to have access to a specific investigational medicine. Expanded access programs are studies managed by the company and follow a specific protocol, which is developed in consultation with the FDA. Further information can be found on https://www.gene.com/patients/clinical-trial-information
If you are questions about coverage or insurance, please call our Patient Resource Center at (877) 436-8683.
To learn more Genentech’s financial support for patients, visit www.gene.com/patients/financial-support
Genentech's clinical trial information can be found at https://www.gene.com/patients/clinical-trial-information or contact the Trial Information Support Line at Genentech (888) 662-6728), Monday - Friday, 5am - 5pm PST.
Information on our clinical trials may be found on our website, www.gene.com, and on the National Institute of Health (NIH) website, www.clinicaltrials.gov. The study name, study number, sponsor (Genentech), or the product and disease state may be entered in the search field of the home page to access available clinical trials.
Information on inclusion/exclusion criteria can be found on www.clinicaltrials.gov. Please review any clinical trial information with your healthcare provider. You can also contact us directly to have one of our nurses review a trial with you.
Contact the Trial Information Support Line at Genentech (888) 662-6728), Monday - Friday, 5am - 5pm PST.
For more information about Clinical Trials in your country, please contact your local Roche affiliate located on https://www.roche.com/about/business/roche_worldwide.htm
For results on a completed study, please visit https://www.clinicaltrials.gov/ct2/help/how-find/find-study-results or contact our Medical Communications department for further information at (800-821-8590), Monday - Friday, 5am - 5pm PST.
To find out more about the Genentech pipeline, please visit www.gene.com/medical-professionals/pipeline