Phases I, II, and III Clinical Trials
The Food and Drug Administration (FDA) oversees the administration of promising drugs and therapies in clinical trials. Before moving the drug process into human testing, many preclinical studies including successful animal studies must be performed. Once human testing begins, it is generally done in three consecutive phases called phase I, phase II, and phase III.
Phase I: A phase I clinical trial attempts to assess whether a new drug is safe for use by humans and determines the maximum dose that can be administered. These are the primary end points, or aims, of a phase I clinical trial, although researchers will, of course, be looking for indications that the experimental drug may shrink or stabilize cancer growth.
Phase II: Agents successfully completing phase I move on to phase II, which assesses whether the drug has positive effects against the cancer in question. Many potential drug therapies go no further than phase II because they show no real beneficial effect against the specific tumor being studied. Successful phase II candidates, however, move on to phase III clinical trials.
Phase III: Phase III clinical trials are designed to compare these new therapies to existing therapies. This comparison is the real test of a potential new drug. Patients with similar characteristics are assigned to receive the existing standard therapy or to receive the new therapy (this is called a “randomized clinical trial”). If the new agent shows similar or improved results as compared to existing therapy and an acceptable safety profile, it is often approved for general release by the FDA. There is even a phase IV process of study that has to do with after approval monitoring of the new drug for side effects as it makes its way into wider use.
Questions to Ask When Considering a Clinical Trial:
- What is being Studied?
- Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
- What are the possible interventions that I might receive during the trial?
- How will it be determined which interventions I receive (for example, by chance)?
- Who will know which intervention I receive during the trial? Will members of the research team know?
- How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
- What will I have to do?
- What tests and procedures are involved?
- How often will I have to visit the hospital or clinic?
- Will hospitalization be required?
- How long will the study last?
- Who will pay for my participation?
- Will I be reimbursed for other expenses?
- What type of longterm follow-up care is part of this trial?
- If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
- Will results of the study be provided to me?
- Who will oversee my medical are while I am in the trial?
- What are my options if i am injured during the stud
*Provided by clinicaltrials.gov
You can download the above list as a Word document.
Clinical Trials Search Services
The Lustgarten Foundation, in cooperation with EmergingMed, is pleased to offer a Clinical Trials Matching and Referral Service. The Service provides free and unlimited access to current, verified clinical trial information. A unique and key element of the Service is providing direct and ongoing telephone support throughout the clinical trial search process. 1-800-535-1867
The cancerTrials area of the National Institutes of Health (NIH) will help you understand clinical trials and the process of informed consent, as well as provide a list of studies.
Cancer Trials Support Unit
The Cancer Trials Support Unit (CTSU) is an NCI-funded program to facilitate participation by patients and physicians in Phase III NCI-sponsored cancer treatment trials.
TrialCheck is a user-friendly cancer clinical trial search engine created by the Coalition of Cancer Cooperative Groups.