Hepi40129
Basic
Steps for Clinical Trials
The National Institutes of Health and the
private pharmaco-biotechnological industry provide funds continuously for clinical research.
To test new protocols, the sponsors of the treatment hire physicians and
other researchers, providing compensation on a per-patient basis. The medical care is often provided without charge to the
patient, or a small fee is charged to the participant of the study.
Pre-clinical Phase
The sponsor should
conduct extensive laboratory research in animal and human cells before to pass to evaluate the drug in humans (phase I). The
preclinical phase could take years and is done extensively testing animals. If the preclinical stage of testing is successful
and safe, the sponsor submits the Investigational New Drug application (IND) to the Food and Drug Administration (FDA), to
begin testing the drug in humans (Clinical phase).
Clinical Phase
The clinical testing
in human of experimental drugs is done in three phases, and involves increased number of people. After the drug has passed
successfully the three phases, the company requests the New Drug Approval (NDA) to the FDA for marketing the drug. Phase IV,
provides additional details about drug affectivity when compared with similar ones, and add information about unknown side
effects.
1. Phase I Study – Evaluates drug's safety in humans -
Phase I studies are done in a small number
of healthy volunteers of 20 to 100., primarily concerned with assessing the drug's safety. This initial phase of testing in
humans who are usually paid for participating in the study determine what happens to the drug in the human body--how it is
absorbed, metabolized, and excreted. It investigates side effects that occur as dosage levels are increased. Phase I testing typically takes several months, and about 70 percent of experimental drugs pass to phase
II of testing.
2. Phase II Study – Evaluates drug’s efficacy
Phase II evaluates it must be tested for efficacy,
once the drug has been shown to be safe. Most phase II studies are randomized trials and takes months to two years involving
several hundred patients. One group of randomized participants receive the experimental drug.
One or more control groups may receive a placebo, or/and standard treatment. The value of these studies increase if
they are double blinded (neither observer, nor patients know who receives the experimental drug). Phase I study comparative
information about safety and effectiveness of the new drug and 33 percent pass to phase III of testing.
3. Phase III Study- Evaluates drug’s effectiveness and adverse reactions
Phase III study evaluates the drug's effectiveness,
benefits, and the range of possible adverse reactions. These are randomized and double-blinded trials involving hundreds or
thousands of participants taking several years. If phase III study is successfully completed, FDA could approve the marketing
the drug after the company request. About 90 percent of drugs complete this phase of testing.
4. Phase IV Studies – Compare drug’s cost-effectiveness and add
additional information of adverse reactions
During late phase III, or phase IV studies,
pharmaceutical companies have several objectives:
1. To compare a drug with other drugs already in the market.
2. To determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.
3. To monitor a drug's long-term effectiveness and impact on a patient's quality of life.
Participant
Rights
The patient's rights and safety are protected
in two important ways.
1. The physicians awarded a research grant by a pharmaceutical company or the NIH must obtain approval
to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay
people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study
does not present an undue or unnecessary risk to the patient.
2. Any participant in a clinical trial in the United States is required to sign an "informed consent"
form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed
consent tells patients that they have a right to leave the study at any time.
Patients who may consider in participating
in a clinical research should talk about it with their physicians and get a second opinion. They also should have access and
understand the credentials and experience of the individuals and institution providing the treatment and study. The participant
should familiarize him/herself with the trial. Some questions to ask, but not limited are:
1. Description of other alternative treatments
2. Duration of the trial
3. Benefits and payments as a part of the trial
4. Name of sponsors and where is the trial being conducted
5. Descriptions of treatments will be used
6. Main purpose of the trial
7. Methods of monitoring the safety of the trial
8. Description of risks involved
9. Description of possible benefits
10. Option
to remain on the treatment after termination of the trial
11. Protocol in case of side effects or harms of the trial
References
· Information for investigators. http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm
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for information purposes only. Please refer to the references provided for updated information regarding to the topic.
