Clinical Trials FAQ
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Clinical trials keep researchers at the forefront of discovery and assure that patients have access to the newest and most effective medical treatments available.
FAQ: Frequently Asked Questions about Clinical Trials at Stanford and Volunteering
- How does one participate in a Clinical Trial at Stanford?
- What Is a Clinical Trial?
- What is a protocol?
- What is an Institutional Review Board (IRB)?
- Who serves on Stanford's IRB?
- Who participates in a Clinical Trial?
- Why participate in a clinical trial?
- Are clinical trials safe?
- Where is information available on clinical trials?
- What Does It Mean: Phase One, Phase Two, Phase Three Clinical Trials?
How does one participate in a Clinical Trial at Stanford?
- Read this patient FAQ
- Search our page of research trials at Stanford , or browse the sites of individual departments
- Search national databases http://www.clinicaltrials.gov
- Ask your doctor - he/she may know of new trials relating to your condition
A clinical trial is a carefully designed investigation to measure the effectiveness of a medical treatment on a group of patients. The medical treatment under investigation could be a pharmaceutical product (drug), medical device, or biotechnology therapy. All products tested in clinical trials are approved by the Food and Drug Administration (FDA).
A clinical trial is conducted under the close supervision of a physician investigator. It is a carefully proscribed, step by step process that assures trial subjects receive careful medical attention.
The protocol is the trial method. It has been studied and approved by an oversight committee called the institutional review board (IRB).
What is an Institutional Review Board (IRB)?
An Institutional Review Board (often abbreviated as "IRB") is a committee or panel comprised of medical and non-medical members who study and properly consider all clinical protocols involving human subjects. The IRB assesses:
- the risks to the subjects,
- the anticipated benefits to the subjects and others,
- the importance of the knowledge that may reasonably be expected to result, and
- the informed consent process to be employed.
Stanford University's IRB is called "Administrative Panels on Human Subjects in Medical Research." Stanford has three such panels, each of which meets 11 times a year. Panel A, for example, has 10 voting members: six faculty physicians, a nurse, a pharmacist; a minister, and a graduate student. There are 8 alternate voting members. Non-voting members include 4 administrators, one staff member, and a legal counsel.
The purpose of the Administrative Panels on Human Subjects in Medical Research (IRB) is to assure the University's compliance with federal regulations of research activities. The Panels review all proposals involving the use of human subjects in medical research. They assess current policies and their implementation and may recommend new policies within the Panels' province.
Stanford University and the IRB are guided by the ethical principles regarding all research that involves humans as subjects regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship). The involvement of human subjects in research is not permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from each human subject of Biomedical and Behavioral Research.
Who participates in a Clinical Trial?
Participants are adult and/or pediatric subjects, who may be healthy or with disease, depending on the study. Trial subjects volunteer for a clinical study and sign an informed consent form. Subjects have the option to withdraw at any point. In some clinical trials, patients may be reimbursed for their participation.
Why participate in a clinical trial?
Subjects might volunteer for a clinical trial to receive a promising new therapy before it is generally available to the public. Others may want to help scientific advancement. Another benefit is that medical treatments in a clinical trial are routinely made available at no charge to the patient, family, or insurance company.
Patients considering participating in a clinical trial should discuss it with their physician and/or medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a private company or the National Institutes of Health must obtain approval from an Institutional Review Board before conducting the study. The review board, usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that a patient's rights are protected, and that the study does not present undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Where is information available on clinical trials?
There is a more extensive FAQ on clinical trials on the ClinicalTrials.gov site.
Bulletin boards and notices in doctors' offices, newspapers and radio stations regularly provide brief descriptions and contact information for clinical trials. Searching the Internet for information about a disease or condition will yield news on where and what clinical research activity is ongoing. If you don't find the information you are looking for regarding clinical studies at Stanford University Medical Center, you can contact SPCTRM at (650) 498-7425 (49-TRIAL).
What Does It Mean: Phase One, Phase Two, Phase Three Clinical Trials?
When a drug or other product has undergone successful preclinical testing, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to initiate testing of the treatment in humans. This is called an Investigational New Drug application (IND). Receiving FDA-approval, the company will initiate a Phase One clinical study.
Drug Development & Approval Process |
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It takes 15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved. |
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| Years | Test Population | Purpose | Success Rate | |
| Preclinical Testing | 6.5 | Laboratory & animal studies | Assess safety & biological activity | 5,000 compounds evaluated |
| File Investigational New Drug (IND) at FDA | ||||
| Phase I | 1.5 | 20 to 80 healthy volunteers | Determine safety & dosage | 5 enter clinical trials |
| Phase II | 2 | 100 to 300 patient volunteers | Evaluate effectiveness, look for side effects | |
| Phase III | 3.5 | 1,000 to 3,000 patient volunteers | Confirm effectiveness, monitor adverse reactions from long-term use | |
| File New Drug Application (NDA) at FDA | ||||
| FDA | 1.5 | Review Process/approval | 1 approved | |
| Total years to this point: 15 | ||||
| Phase IV | Additional Post marketing testing required by FDA | |||
| Source: Pharmaceutical Research and Manufacturers of America | ||||
A Phase One Study is the earliest use of an FDA-approved pharmaceutical in people. Phase I studies require specialized monitoring and lab facilities as well as a skilled investigative group to ensure safety of the product and to perform the sophisticated data analyses needed. A Phase I study usually involves a small number of healthy patients, perhaps 20 or more, and also investigates side effects that may occur as dosage levels are increased.
A Phase Two study enrolls a carefully screened group of patients into detailed protocols to study a product's clinical efficacy. This testing phase may last up to two years, and involve several hundred patients. Many Phase II studies are randomized trials , in which one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are blinded , so neither the patient nor the physician knows who is receiving the experimental drug. In this manner, the study can yield comparative information about the relative safety of the new drug and its effectiveness.
A Phase Three study usually involves multiple sites and greater numbers of patients (perhaps several thousand). Patients are carefully screened to meet stringent protocol requirements, and studies are usually randomized, blinded, and last several years. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. This expanded safety and efficacy database is the last stage before a company can request FDA approval for marketing the drug.
Once the FDA has granted a New Drug Approval (NDA) to market the drug, a post approval Late Phase Three and/or Phase Four study might continue assessment of the drug or device's performance in actual clinical use, without the strict criteria employed in earlier phase trials. The company may also want to compare a drug with other drugs already available, and monitor a drug's long-term effects and impact on quality of life. Statistical information about the costs of treating illness, compared to alternate therapies, and the measurements of outcomes are derived from large-scale databases.
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