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Answer:
The term you're looking for is "sponsorship" or "sponsor-provided drug." In a clinical trial or research study, when a pharmaceutical or biotech company not only produces the drug being tested but also supplies it to the investigators for use in the study, it is referred to as the company is the "sponsor" of the trial. The sponsor is responsible for funding, organizing, and overseeing the clinical trial, including providing the investigational drug or treatment. This ensures consistency and quality control in the production and administration of the drug throughout the study
Explanation:
In the context of clinical trials or research studies, there is a term called "sponsorship" that refers to the organization or entity that takes the lead in conducting and overseeing the study. When a pharmaceutical or biotech company sponsors a clinical trial, it means that the company not only develops and manufactures the investigational drug (the drug being tested) but also provides it to the investigators who are conducting the study.
Here's a breakdown:
1) Clinical Trial Sponsorship: The sponsor is the organization or entity that initiates and takes overall responsibility for the clinical trial. This can be a pharmaceutical company, a biotechnology company, an academic institution, or other research organizations.
2) Production of the Investigational Drug: The sponsoring company is responsible for developing and manufacturing the investigational drug. This drug is often an experimental or new medication that is being tested for its safety and effectiveness.
3) Supplying the Investigational Drug to Investigators: In addition to producing the drug, the sponsoring company supplies the investigational drug to the investigators who are conducting the study. Investigators are typically healthcare professionals or researchers involved in the actual administration of the drug to study participants.
4) Quality Control and Consistency: By providing the investigational drug to investigators, the sponsor ensures that there is consistency and quality control in the drug's production and administration throughout the study. This is important for maintaining the integrity of the clinical trial results.
5) Overall Responsibility for the Trial: The sponsor is responsible for various aspects of the clinical trial, including protocol development, regulatory submissions, monitoring the trial's progress, ensuring participant safety, and analyzing the study results.
In summary, when a company sponsors a clinical trial, it means that they not only develop and produce the investigational drug but also take a leading role in overseeing and supporting the entire study, including the supply of the drug to investigators. This ensures that the trial is conducted in a controlled and standardized manner.
Final answer:
An investigational drug is supplied by the company producing it to investigators for clinical study purposes. It is essential in the IND process, which includes preclinical studies and clinical trials as per FDA requirements. Post-approval, the drug is monitored for safety and efficacy through pharmacovigilance.
Explanation:
The term investigational drug refers to a new pharmaceutical that is being tested and has not yet been approved for market release. The company responsible for this drug not only produces it but also supplies it to the investigators conducting the clinical study.
These investigations form part of the Investigational New Drug Applications (INDs) process, which is essential for obtaining approval from the Food and Drug Administration (FDA). Before a drug can enter the clinical investigation phase, non-clinical laboratory studies must be conducted to assess the safety and effectiveness of the drug.
Once a drug enters clinical trials, it undergoes several phases, and the involvement of placebos might be crucial to the trial design. Upon successful completion of clinical trials and eventual FDA approval, the drug enters the market; however, it remains under scrutiny through pharmacovigilance activities to monitor long-term safety and efficacy, particularly in various subgroups of patients.
Responsibilities and guidelines for trial sponsors and investigators are outlined in 21 CFR 312 Subpart D and the FDA's Guideline for the Monitoring of Clinical Investigations. These documents provide a framework for conducting and monitoring clinical trials and ensuring the adherence to the established protocols.
