Purpose of phase 1 clinical trials

Before HGP was formulated, clinical trials for new experimental drugs only have a small chance to benefit a person because they were often on a last-ditch effort. However, the excellent option to extend life is to participate in the phase 1 clinical trial. In order to determine if an experimental drug or treatment is safe, there is a need to undergo phase 1 clinical trials. After testing the treatment in the laboratory or on animals, it will enter a phase one lab to conduct tests on humans.

It involves only a small number of people to check if a treatment or drug is safe. This will also determine the best dose and how it must be given. This is the first study to be tested on humans and so it carries the greatest risks. Those enrolled in the study are monitored closely wherein blood and urine are collected regularly.

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You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered. A summary of key laws and policies requiring clinical trial registration is provided in the table below:.

Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Saved Studies. Related Pages Login to ClinicalTrials.

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.