Clinical trials
Clinical trials are essential to determine whether new drugs or diagnostics are safe and effective when used to diagnose or treat people.
Clinical trials support the search for new solutions
Clinical trials are an integral part of the drug and diagnostics discovery and development process. Before a new medicine or diagnostic test can be made available, evidence of its safety and effectiveness must be provided by well-designed, well-controlled, and carefully monitored clinical studies in patients consenting to participate. Carefully conducted clinical trials are performed to provide answers to questions such as:
Does a treatment work?
Does it work better than other treatments?
Does it have side effects?
Clinical trials also provide important information on the cost-effectiveness of existing treatments, the clinical value of a diagnostic test, and how a treatment improves quality of life.
We conduct each trial according to a comprehensive plan or protocol. The plan outlines the types of patients who can enter the trial, the schedule of tests and procedures, drugs and dosages, necessary follow-up, and the length of the study.
It also describes the results (endpoints) that will be measured and the type of information to collect. We then share this information with regulatory authorities to obtain marketing approval and with payers to obtain reimbursement.
Clinical trials are conducted in phases. Each phase is designed to answer certain questions while taking steps necessary to safeguard the participants.
Every new treatment is usually tested in three phases of clinical trials before regulatory agencies consider it safe and effective. Trials are also conducted according to Good Clinical Practice (GCP) guidelines that regulators require to protect patient safety.
ForPatients and Roche-sponsored clinical trials
ForPatients is an informational resource for patients, their relatives, caregivers or doctors looking for information in clear and simple language about clinical trials or diseases where Roche is doing research or supporting research conducted by others.
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Frequently asked questions on clinical trials
We answer the most frequently asked questions on clinical trials.
Our commitment to clinical study transparency
How Roche is committed to sharing clinical study information with patients, physicians and researchers.
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Our statement on advancing inclusive research in clinical trials
Roche believes 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.
Our research and clinical development ensures more comprehensive inclusion of all patient profiles 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. Roche is 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 ever more personalized healthcare solutions for all patients.