Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.
The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities. Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete. Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data. Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc. Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials.
Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:. A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.
The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports. This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.
A Phase I trial takes several months to complete. About 70 percent of experimental drugs pass this initial phase of testing. Phase II studies determine the effectiveness of an experimental drug on a particular disease or condition in approximately to volunteers. This phase may last from several months to two years. A secondary objective for a Phase II trial is to ascertain therapeutic dose level and dosing frequency. Most Phase II studies are randomized, which means that subjects are assigned randomly by chance not by choice to receive either the experimental drug, a standard treatment or a placebo harmless, inactive substance.
Those who receive the standard treatment or placebo are called a control group. Randomized Phase II studies are often double-blind, which means that both subject and physician don't know which treatment is being used. Blinding prevents any unscientific influence on the study results that could be caused by knowledge of the treatment. In a single-blind study, only the subject is unaware of the treatment used.
Though the phases and design of clinical trials may be different for certain diseases and specialized medicines, such as cancer drugs or gene therapies, here is a general overview of each phase of a clinical trial for most medications:. During Phase 1 studies, researchers generally test a new drug candidate in healthy volunteers healthy people. In most cases, 20 to 80 healthy volunteers participate in Phase 1.
The primary purpose of a Phase 1 study is to evaluate the safety of a new drug candidate before it proceeds to further clinical studies. In addition to safety, researchers can answer other questions in a Phase 1 trial related to how much drug is measured in the blood after administration, how the drug works in the body and the side effects associated with increased dosage. In Phase 2 studies, researchers administer the drug to a larger group of patients typically up to a few hundred with the disease or condition for which the drug is being developed to initially assess its effectiveness and to further study its safety.
A key focus of Phase 2 studies is determining the optimal dose or doses of a drug candidate, in order to determine how best to administer the drug to maximize possible benefits, while minimizing risks. For diseases affecting many patients, Phase 3 studies typically involve to 3, participants from patient populations for which the medicine is eventually intended to be used.
Participants are assigned to receive either the medication being evaluated or a control group that receives either the current standard of care treatment or a placebo a substance that has no therapeutic effect. Researchers design Phase 3 studies — among other things — to demonstrate whether or not a drug candidate offers a treatment benefit to a specific population provide more detailed safety data, and serve as the basis for product labeling.
When one or more Phase 3 trials are completed, the researchers examine the results and decide whether the drug has demonstrated effectiveness and an acceptable safety profile in treating a disease. If so, the company can submit a New Drug Application NDA , which contains all of the data and information gathered at every stage of the process through the results of the Phase 3 clinical trial s , as well as other information required by the applicable regulatory authority.
The NDA is submitted to the FDA or analogous applications may be submitted to other regulatory agencies outside the US for consideration for marketing approval.
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