Clinical Trials
Clinical Trials are research studies which are designed to test safety and efficacy of new approaches to cancer management. Some clinical trials evaluate new procedures for diagnosis, staging and monitoring of cancer, others investigate novel surgical techniques or radiation strategies. A large proportion of clinical trials in oncology are designed to study new anti-cancer drugs or their combinations.
In this section we will provide a brief discussion of clinical trials and Internet Links to Clinical Trials information sites and “Clinical Trial Matching Services".
What is involved in moving a new medication “from bench to bedside”?
The road from “bench to bedside” is long and tedious. In the lab, discovery of a new drug might begin with a brilliant hypothesis or an unexpected result of an unrelated experiment. However the process starts, it usually takes years of experiments on cancer cells in test tubes and, later, in animals, to confirm that a new substance has promise. This initial part of the work is called pre-clinical studies .
Even the best and most carefully planned pre-clinical studies can not guarantee that an emerging drug will be as effective and safe in humans as it was in animals. After all, humans and mice differ in so many ways. The next step is to test the novel compound in Clinical Trials. Clinical trials have 4 phases.
Phase I Trials
The first priority of Phase I trials is to make sure the new drug is safe. These trials usually involve a small number of people who do not have effective standard options available. The first group of participants receives a low dose of the drug and is watched closely. If there are no serious problems, the next group receives a larger dose and the process is repeated until either the highest planned dose is reached or further dose increase leads to unacceptable side effects. Phase I trials are not designed to test efficiency of new drugs; however, you have to remember that all the “old”, standard anti-cancer agents were initially tested in Phase I trials. These trials give us access to a wide variety of novel anti-cancer agents and approaches; some of these approaches might eventually become the new gold standard. Currently, there are two Phase I Trial groups in San Antonio.
Phase II Trials
Phase II trials are determining whether new drugs or drug combinations are effective. These trials use the drug doses identified in Phase I Trials on a larger groups of people, usually 25 to 50 participants.
Phase III Trials
In Phase III trials novel medications or new combinations of the old medications are compared to the standard, approved drug regimens. If they are proven more effective and/or less toxic, request is made to FDA for approval.
Phase IV Trials
Even after multiple trials and FDA approval some questions about efficacy and long-term toxicity of the routinely used drugs can remain. These questions are addressed in Phase IV Trials.
Information on Clinical Trials
National Cancer Institute
http://www.cancer.gov/clinicaltrials
American Cancer Society
http://www.cancer.org/docroot/ETO/
Cancer and Leukemia Group B (CALGB)
http://www.calgb.org/Public/clinical_trials/clinical_trials.php
Coalition of Cancer Cooperative Groups
http://www.cancertrialshelp.org/Icare_content/icMainContent.aspx
CenterWatch Clinical Trial Listing Service
http://www.centerwatch.com/
American Cancer Society Clinical Trial Matchmaking Service
http://www.cancer.org/docroot/ETO/content/Clinical_Trials_Matching_Service.asp