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Genentech pursues a comprehensive clinical trial program across all therapeutic areas to advance research and development and create data that the US Food and Drug Administration and other regulatory bodies around the world may review.

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Advancing Inclusive Research: Full Position Statement

At Roche and Genentech, we believe that improving health outcomes for all patients is core to our mission, and we are committed to being industry leaders in delivering improved health outcomes for all.

In the increasingly diverse world around us, the time is now for research and clinical development to ensure greater inclusion of patients across racial and ethnic groups in support of optimizing health outcomes for all patients worldwide.

Because disease outcomes and drug responses can vary across populations, research must include patients who are racially, ethnically, and gender representative of those who experience disease. We are deeply committed to addressing barriers to clinical trial participation, diversifying genetic data for scientific discovery, and increasing access to innovative diagnostic and therapeutic solutions, by advancing inclusive research.

By building trusted partnerships with patients, providers and across the healthcare ecosystem, we can collectively combine scientific advances, new technologies and real-world data to drive scientific innovation and create new standards for inclusive research.

As we strive to deliver more patient benefit, we are passionately addressing healthcare disparities in order to deliver even more personalized healthcare solutions for all patients.

Clinical trial information by therapeutic area

Use the links below to visit ClinicalTrials.gov and review details for active trials across all Genentech therapeutic areas.

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Information and Support About Genentech-Sponsored Trials

Phone: (888) 662-6728
Hours: Monday - Friday, 5am - 5pm PT

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Clinical Trial Approach and Design

Clinical trials serve as the foundation for evidence-based medicine by addressing specific clinical questions that may lead to improvements in current clinical practice.

Select a topic to learn more about study design, how protocols are developed, and the process of conducting a trial.

Investigating the efficacy and safety of an agent or combination of agents through clinical trials involves multiple phases, beginning with smaller Phase I trials and culminating in larger, randomized Phase III trials. Phase IV trials may also be conducted to gather additional information.1-3

Trials phases in the United States are defined as follows2-4:

  • Phase I: Initial trial of a drug in humans for dosing, safety, and early efficacy information (20-80 patients*).
  • Phase II: Subsequent trial of a drug's safety and efficacy in a particular disease setting (100-300 patients*).
  • Phase III: Larger trial comparing a drug with best available therapy to confirm efficacy and safety; often used for drug approval (100-3000 patients*).
  • Phase IV: Trial conducted after US Food and Drug Administration (FDA) approval to gain additional information about the drug's risks and benefits. Phase IV studies may range in study size, from a few hundred to a few thousand patients.

*Patient numbers cited here apply to clinical trials in general.

When designing a clinical trial, investigators define a number of parameters in order to generate meaningful results. These parameters include5:

  • Patient population to be studied
  • Therapies to be investigated
  • Endpoints
  • How the trial will be conducted (eg, randomized vs non-randomized)

When determining the patient population to be studied, investigators should include patients who are likely to respond from the intervention being tested.5 The population should also be selected such that the results of the trial can be generalized to patients in clinical practice. The more diverse the patient population, the more generalizable the results may be to the wider patient population.6

In order to study a patient population of the appropriate disease state and level of diversity, investigators define criteria that determine if a patient is eligible for a trial.6

Inclusion and exclusion criteria can include patient characteristics (eg, age) as well as disease- and treatment-specific characteristics (eg, number and type of prior therapies).6

Efficacy and safety in clinical trials are measured by means of predetermined endpoints, or outcomes, that the trial is designed to evaluate. These may include clinical endpoints, as well as surrogate endpoints, which are expected to predict for a clinical outcome.5

The primary endpoint is the key measure from which clinical benefit is assessed. The primary endpoint selected by the investigators impacts the number of patients needed for the trial and must be determined before the trial is initiated.7 Secondary endpoints are other outcomes that provide additional and potentially valuable information about the investigational treatment(s). The trial protocol should pre-specify secondary endpoints to increase the likelihood that statistical analysis of those endpoints will be valid.5

Determining the primary endpoint requires consideration of several factors:

  • What is the most clinically meaningful measure of benefit that could guide treatment decision-making in this disease and patient population?
  • Can the trial be conducted in a reasonable timeframe?
    • Some endpoints require longer follow-up than others, lengthening the time required to complete the trial and obtain meaningful results.8

  • Can a sufficient number of patients be recruited to complete the trial?
    • Some endpoints necessitate larger trials in order to demonstrate statistically significant differences between arms, potentially creating difficulties in recruitment.8

When the trial population, treatment, and endpoints have been identified and defined, the trial design is not yet complete. In Phase III and some Phase II trials, the patient population may be randomized and stratified. The gold standard in clinical research is a scientifically rigorous, randomized, and well-controlled trial.

    • Learn about clinical studies. ClinicalTrials.gov website. Accessed November 4, 2021. https://clinicaltrials.gov/ct2/about-studies/learn

      Learn about clinical studies. ClinicalTrials.gov website. Accessed November 4, 2021. https://clinicaltrials.gov/ct2/about-studies/learn

    • The FDA's drug review process: ensuring drugs are safe and effective. US Food and Drug Administration website. Accessed November 4, 2021. https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

      The FDA's drug review process: ensuring drugs are safe and effective. US Food and Drug Administration website. Accessed November 4, 2021. https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

    • ClinicalTrials.gov protocol registration data element definitions for interventional and observational studies. ClinicalTrials.gov website. Accessed November 4, 2021. https://prsinfo.clinicaltrials.gov/definitions.html

      ClinicalTrials.gov protocol registration data element definitions for interventional and observational studies. ClinicalTrials.gov website. Accessed November 4, 2021. https://prsinfo.clinicaltrials.gov/definitions.html

    • Zhang X, Zhang Y, Ye X, Guo X, Zhang T, He J. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry. BMJ Open. 2016;6(11):e010643. doi:10.1136/bmjopen-2015-010643.

      Zhang X, Zhang Y, Ye X, Guo X, Zhang T, He J. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry. BMJ Open. 2016;6(11):e010643. doi:10.1136/bmjopen-2015-010643.

    • Chin R, Lee BY. Principles and Practice of Clinical Trial Medicine. Academic Press; 2008.

      Chin R, Lee BY. Principles and Practice of Clinical Trial Medicine. Academic Press; 2008.

    • National Cancer Institute. Cancer Clinical Trials: The In-Depth Program. National Cancer Institute; 2001.

      National Cancer Institute. Cancer Clinical Trials: The In-Depth Program. National Cancer Institute; 2001.

    • Stanley K. Design of randomized controlled trials. Circulation. 2007;115(9):1164-1169.

      Stanley K. Design of randomized controlled trials. Circulation. 2007;115(9):1164-1169.

    • Lebwohl D, Kay A, Berg W, Baladi JF, Zheng J. Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development. Cancer J. 2009;15(5):386-394.

      Lebwohl D, Kay A, Berg W, Baladi JF, Zheng J. Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development. Cancer J. 2009;15(5):386-394.