When faced with a decision about participating in a clinical trial,
the most important thing you can do is educate yourself about what
exactly they are, how they are conducted, and how they affect the
patients participating in the trial. This section was developed for just
that reason, enabling you to learn more about clinical trials so that
you can make an informed decision.
What is the origin of each trial?
A clinical trial is really born in the laboratory and developed by
researchers who are studying various ways of treating certain cancers. A
plan for each trial (called a protocol) is created when this research
indicates promising procedures, treatments and medications. Trials are
separated into phases, with Phase I trials focusing on safety and
subsequent phases (II and III) testing effectiveness.
What is a protocol?
A protocol refers to the plan of a particular trial. The protocol
explains what the study will do, how it will be conducted, and outlines
the necessity of each part of the study. To that end, a typical protocol
might include: the purpose of the study, the number of people involved,
eligibility, the medications that patients will take, the tests they
will be given and how often information will be gathered. The success of
clinical trials is dependent upon highly structured guidelines. It is,
therefore, of paramount importance that all patients are treated
identically no matter where they participate. To that end, every doctor
and research center that takes part in the trial uses the same protocol.
Who sponsors clinical trials?
Clinical trials are sponsored by a number of organizations.
Regardless of who the sponsor is, the goal is always the same: to find
better ways to prevent, detect or treat cancer. The National Cancer
Institute (NCI) is responsible for sponsoring a large number of trials
at any given time. Actual sites and investigators vary and include:
- The Community Clinical Oncology Program (CCOP).
This program, of which TCOP is a member, links physicians with
researchers at cancer centers all across the United States. CCOP
allows participation in clinical trials in its local and surrounding
communities, so neither physicians nor patients have to travel far
- Cooperative Clinical Trials Program
This is an NCI-supported network consisting of several Cooperative
Groups. The Network's collective goal is to define important
unanswered questions in cancer research and conduct the necessary
trials to answer these questions at many sites around the country.
The program brings together groups of researchers, cancer centers,
and community physicians throughout the nation. The Cooperative
Groups enroll about 20,000 new patients in treatment trials each
year and help establish state-of-the-art cancer therapies.
- Guide to Cooperative Group Web Sites
This Network provides a wide variety of information and resources
including a searchable database list of NCI's clinical trials.
- Cancer Centers Program
These research-oriented institutions work closely with the NCI to
collectively bring cancer research, outreach and education to the
public and the medical community. Recognized for their scientific
excellence, about 60 of these facilities are located throughout the
Individual physicians may sponsor clinical trials themselves using
participating cancer centers and medical institutions to perform the
- Pharmaceutical Companies
The U.S. Food and Drug Administration (FDA) only allows the sale of
a product after it has been proven safe and effective in clinical
trials. Therefore, drug companies, as well as medical equipment
manufacturers, will often finance and sponsor clinical trials with
the goal of demonstrating that their products are safe and
What happens after a clinical trial is completed?
To ensure accuracy of findings, clinical trials consist of several
phases and can take several years to complete, even though a particular
patient’s participation may not last the entire duration of the trial.
Upon completion of a trial, a number of things may happen. After a Phase
I or Phase II trial is completed, researchers will examine all the data
collected and make the decision to either move on to the next level of
the trial with the treatment, or stop testing the treatment because it
is not safe or effective. After a Phase III trial is completed,
researchers must determine if the results have medical importance.
Generally, results of trials are published in medical journals and
can be accessed by the public either though treatment nurses or via the
PubMed database of medical publications. After a treatment of medication
is proven safe and effective through a clinical trial, it may become
standard practice, allowing the development of better ways of
preventing, treating, detecting or diagnosing cancer and continuing a
process that is progressive and ongoing.