How Clinical Trials Are Performed
click to view the processA clinical trial requires patient participation, sponsorship from a research institution or drug manufacturer, in addition to the research administrators who operate and control the study. Because of the large impact that a given clinical trial can have on a patient's health, the process of how a clinical trial is performed must be systematic from start to finish.
Each trial has a specific, predetermined objective, and guidelines for the trial are written to achieve that objective. Collection and analysis of the data is used to determine if a specific treatment yields clinically significant results to warrant approval for public use.
A clinical trial for mesothelioma is similar to trials for other cancers and diseases. A trial can last for weeks, months or years, depending on the goal and whether the drug or treatment needs additional testing to reach the market. Many drugs require more than one trial to determine their efficacy.
Mesothelioma clinical trials require extensive planning, funding and stringent execution. Because of strict federal and industry guidelines, clinical trials must be conducted in safe, regulated facilities. For information about mesothelioma clinical trials, cancer centers and treatment options, fill out the form to request a free informational packet from the Mesothelioma Center.
Planning a Clinical Trial
The concept for a new mesothelioma clinical trial normally originates when researchers determine that a new mesothelioma treatment holds promising results for the rare cancer. A researcher poses certain assumptions and hypotheses to test. Upon determining the viability of the clinical trial, the researcher then establishes a specific plan that dictates how things will be done, what the goals and objectives are, how it will be paid for and who will be involved. This plan is known as a protocol. A formal document is created and managed by a person called the principal investigator or protocol chair.
A protocol answers specific questions about why a clinical study is being performed.
Who Pays To Run a Trial?
Government agencies or pharmaceutical companies typically absorb the majority of the costs.- How many participants are needed?
- Who is eligible?
- What medical tests will be provided?
- What resources are needed?
One important role of a principal investigator is determining who will participate in the clinical trial. Beyond the shared commonality of being a mesothelioma patient, specific mesothelioma patients may be tested in particular segments. For example, one test segment could be pleural mesothelioma patients who failed to show improvement in previous chemotherapy treatments.
In a clinical trial for Alimta, a drug that treats mesothelioma patients, participant criteria ranged from patients who have not received any treatments to patients who have undergone a variety of previous treatments. These qualifications are determined by goals listed in the protocol, which guide the investigator through the trial.
View active mesothelioma clinical trials.
Performing Trials in Phases
Clinical trials are divided into phases, each defined by the treatment's degree of safety and the population quantity involved in testing. Many clinical trials will entail four phases throughout the lifetime of the drug's study.
When Phase I or Phase II of a clinical trial is completed, researchers must review the collected data and make choices about the next step. There are usually two options available – move to the next phase of the trial or stop testing the drug because it is dangerous or ineffective. Upon successful completion of the first three phases, the drug or treatment may be submitted for final approval to the U.S. Food and Drug Administration (FDA).
The extent of the FDA's power throughout the clinical trial process is exemplified by its ability to end a clinical trial at any point if it is perceived as too dangerous to continue.
Phase I
Phase I trial typically involves a small test sample of people, usually between 20 and 80 participants. At this stage, researchers strive to identify if treatment is safe for humans as well as what the correct dosage of the treatment or drug may be. They also aim to identify side effects.
Phase II
This stage involves a larger sample of participants, usually between 100 and 300 people, and the goal is to measure accurately the drug's effectiveness. Researchers want to determine whether the drug works as intended, and if so to what degree.
For example, one drug (MORAb-009) in Phase II is being tested at Duke Cancer Institute to determine if the standard treatment of pemetrexed and Cisplatin works better for pleural mesothelioma patients when provided with the experimental drug. This type of treatment is known as "standard of care plus," which indicates that a new solution, the 'plus,' is being combined with the standard treatment of care that is currently available.
Phase III:
If the drug accomplishes its Phase II benchmarks, it moves on to Phase III. Here the drug is compared against current treatment options already in the marketplace. Researches typically involve 1,000 participants, though they can use as many as 3,000.
Such large-scale testing provides significant context for the drug's effectiveness in comparison to the standard treatment options. Examples of mesothelioma drugs that have passed this phase include Cisplatin, Gemcitabine and Alimta.
Phase IV
Phase IV involves further testing of effectiveness, usually after the FDA has already approved it for standard use. At this stage of a clinical trial, several hundred to thousands of people may participate. This phase involves the in-depth testing of a treatment to determine its optimal use and additional risks and benefits.
Reporting Conclusions
The FDA reviews the results of the study to verify that the clinical trial was performed within proper guidelines and that the outcome is statistically and clinically significant to warrant approval. By this point the sponsors of the trial will have already published the results in scientific or medical journals for peer review.
The peer review process allows other researchers, practitioners, institutions or companies to analyze the study for sound reasoning and accurate processes. If the clinical trial involved a drug or treatment that could have widespread implications, then it is likely research publications will spread quickly from academia to more traditional news sources.
If you have been diagnosed with mesothelioma and are considering participating in a clinical trial, contact the Mesothelioma Center's Doctor Match Program at (800)549-0544 to find specialized doctors in your area who may be hosting research studies.
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