Clinical trials are specific research studies undertaken in order to test new treatments or methods to treat a medical condition
Clinical trials for cancer are research studies that are used for testing newly developed treatment methods for cancer patients. Once patients enroll for a clinical trial, they can be part of an experimental treatment prior to its official approval by the FDA (Food and Drug Administration). It must be noted that these clinical trials may not always be better than the standard treatment that is being used for curing cancer, and it is not deemed appropriate for every patient to enroll for clinical trials. For this reason, a complete evaluation should be done by the patient or his/her attending doctor to consider the circumstances of the patient. They must decide whether the standard treatment is adequate for the cure and whether the patient agrees to all the potential risks that may be posed by the experimental trial prior to enrollment. Many of these experimental clinical trials also prove to be highly beneficial for patients.
Who performs the trials?
One of the best starting points to find out which organization is licensed to conduct clinical trials is the National Cancer Institute, or the NCI online database. Other sources include cancer treatment centers, cancer patient organizations, various pharmaceutical companies and other websites which offer databases that can be searched online. A large number of websites do list trials that may not be listed by the NCI. Once the initial retrieval has been received, patients can initiate evaluation of the results in order to see whether or not the trial is suitable for their needs. One of the most basic criteria to observe is known as the trial phase. The following are the phases of a clinical trial:
Phase 1 trials: This only includes observing the safety data. The main goal of these trials is the establishment of the greatest dose that an individual can tolerate without the manifestation of any side effects and complications. It must be noted that, at this point, the benefits and risks of clinical trial are not established, and these phase 1 trials are restricted to a limited group of individuals who have not seen any positive effects with other treatment methods.
The phase 2 trials: These focus on the efficacy of the new, experimental trial by determining the effect that the new treatment has on the tumor or cancer. Similar to the phase 1 trials, these are only restricted to a small group of individuals. This is mainly because, at this point, the risks of the trial or experiment are not fully known or established.
Phase 3 trials: these trials focus on comparing the results of other patients that have taken the new experimental treatment with the results of those individuals who are undergoing the standard cancer treatments. The trial group is randomly assigned to either the control group which is subjected to the standard cancer treatment, or the treatment group, which is subjected to the new experimental treatment. After this, both groups are observed and monitored for any signs of side effects and to see which group shows better results. Only the treatments that have displayed some promising results in the first two phases are allowed to take part in the phase 3 trials. This group, therefore, is comprised of hundreds of people from all over the country, as well as the world.
There is a highly specific eligibility criterion for every single trial. This criterion lists a group of characteristics that all participants must possess in order to become part of the experimental trial. Some of the most important characteristics on the list include gender, age, stage and form of cancer, and various other characteristics specific to the trial. This eligibility criterion allows researchers to conduct the comparison of patient groups in order to establish some reliable results and outcomes.
What to watch out for:
Prior to enrolling for a clinical trial it is important for all potential participants to undergo an official informed consent procedure. In this procedure, the trial investigators are required to inform the participants about all the facts associated with the study. These include potential risks, all minor details and the possible benefits that the participants may acquire from the new treatments and tests. The participants have the choice to abandon the experimental study even after they have signed the consent form. There is an extensive section regarding all the protections and rights of participants of all sorts of clinical trials present on the NCI website.
There is another way of accessing the treatments or drugs that are being provided on clinical trials prior to their approval by the FDA, through the manufacturer of the drug. This is done by filling an application for compassionate use which is submitted directly to the manufacturer of the drug. These compassionate use programs are reserved for individuals who do not have access to effective cancer treatment and also cannot enroll for any clinical study because they do not meet some part of the eligibility criteria required for definite enrollment. There is no known database reserved for compassionate use programs as such, but the information regarding these programs can be acquired by contacting the manufacturers of the drugs.
NationalCancerInstitute.ClinicalTrials.Access at: www.cancer.gov/clinicaltrials
This section of Cancer.gov has information about the phase structure of clinical trials, the rights of participants, costs, and informed consent, but its main purpose is searching the National Cancer Institute (NCI) clinical trials database. Basic and advanced search forms are available, and the user selects various parameters from such menus as cancer type, stage, lo cation of trial, phase of trial, treatments methods, and so forth. While it is possible to narrow down the retrieval by selecting numerous parameters, this search interface does not allow keyword searching. The same data-base can be searched through ClinicalTrials.gov, which is the National Library of Medicine gateway to all of the National Institutes of Health trials,
including those in the NCI database.
Mulay, Marilyn. 2002. Making the Decision: The Cancer Patient’s Guide to Clinical Trials. Boston: Jones and Bartlett.
This book provides a practical approach to understanding the different aspects of clinical trials, from the patient’s perspective. The book reviews the process of drug development, the business of clinical research, and the structure of clinical trials. It also discusses the rights of patients, the care of the research subject, and financial considerations.
This article was originally published on 7/12/2014 and last revision and update of it was 9/14/2015.