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Clinical Trials
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Understanding Clinical Research: From Promise to Practice
Where Do the Ideas for Trials Come From?
The ideas for clinical trials often originate in the laboratory. Researchers develop a
clinical protocol (the action plan) for a trial after laboratory studies indicate the
promise of a new drug or procedure. Initial trials in people focus on feasibility and
safety. As researchers gain further experience, later trials then seek to determine
whether the new approach benefits people and whether it has advantages over standard
approaches currently in use.
Who Sponsors Clinical Trials?
Clinical trials are sponsored by organizations or individuals who are seeking to discover
better interventions to improve health care. It is the responsibility of the sponsor to
see to it that a clinical trial is conducted in a scientifically sound and ethical manner
in accordance with all laws and regulations.
The interventions being studied can be a new drug or device for treating or preventing
disease, or a new diagnostic method for detecting or diagnosing a disease early.
Pharmaceutical companies or companies that manufacture diagnostics devices, like X-ray
equipment, sponsor trials of their products, in the hope of demonstrating that their
products are safe and effective for their intended use. Once this is done, the Food and
Drug Administration (FDA) will permit companies to sell the drug or device and advertise
it for the intended use. In this way clinical trials serve the very important function of
helping to assure that the drugs and devices offered to people for their standard care
are, in fact, safe and effective for these purposes. The National Cancer Institute
sponsors a large number of clinical trials in the areas of prevention, diagnosis and
detection, and treatment. Finally, individual physician-investigators at cancer centers
and other health-care institutions can sponsor clinical trials themselves.
More about Clinical Trials Sponsored by the NCI.
The NCI has a number of programs designed to make clinical trials widely available in the
United States. Thousands of investigators at over a thousand sites participate in various
aspects of NCI's clinical trials programs. These include the following:
Cancer Centers
Program. More than 45 research-oriented institutions have been designated as NCI
Comprehensive or Clinical Cancer Center for their scientific excellence. Located
throughout the country, they play an important role in cancer research, in delivery of the
highest quality cancer care, and in outreach and education of both the general public and
health-care professionals. The centers are key partners in the NCI's efforts to bring the
benefits of clinical research directly to you. When an institution meets the rigorous
competitive standards of an NCI Cancer Center, it is awarded a Cancer Center Support
Grant, which allows the center to coordinate multidisciplinary approaches to research
questions, to gain access to cutting-edge technologies, and to take rapid advantage of new
research opportunities.
The Cooperative
Clinical Trials Program. This program knits together groups of academic investigators,
cancer centers, and community physicians into an NCI- supported network of national scope.
The network consists of a number of consortia (cooperative groups) that seek to define the
key unanswered questions in cancer and then conduct high-quality clinical trials to answer
them. This kind of cooperation makes it possible to have central administration and data
collection for trials taking place at a large number of sites all over the country. In the
area of cancer treatment, the cooperative groups place approximately 20,000 new patients
on clinical trials each year. These are principally the large Phase III randomized trials
that help establish the state of the art for cancer therapy. In addition, the groups
cordinate and perform large trials in cancer prevention.
The Community Clinical Oncology Program (CCOP). This program makes clinical trials
available in a large number of local communities in the United States by linking community
physicians with researchers in cancer centers. Local hospitals thoughout the country
affiliate with a cancer center or a cooperative group. This enables doctors to offer
people participation in clinical trials more easily, without having to travel long
distances or leave their usual caregivers. Several of these programs focus on encouraging
minority populations to participate in trials.
Evaluating the Results of Clinical Trials
When a clinical trial is completed, the researchers analyze the data. IF the new strategy
has proven promising and feasible in early (Phase I) studies, it moves to the next phase
of investigation. If the strategy has proven safe and effective in a definitive Phase III
trial, the next step is to get the word out to the medical community and to the general
public. Usually a trial's results are first reported in a medical journal to bring the new
approach to the attention of doctors and researchers. Most journals have in place a
process of peer review, in which experts critique the report before it is published, to
make sure that the analysis and conclusions are sound. Particularly important results are
likely to be featured by the print or electronic media, and widely discussed at scientific
meetings and by patient advocacy groups. Once an intervention is proven safe and effective
in a clinical trial, it may become the new standard of practice. In this way the
development of better interventions for prevention, for treatment, or for detection and
diagnosis is an ongoing, continuous process that builds progressively on itself to
improve the quality of cancer care and prevention available to us all.
Source: National Cancer Institute
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