Healthcare Statistics and Research:

Task one
Informational Document

Linda S. Gaul

Western Governors University

A1. Research Protocol

Provider’s participation in clinical trials as an investigator is critical in development and advancement in treating diseases with new medicines, devices or protocols. Advantages of participation include; professional development, recognition as a leader in the medical community, potential for increased compensation and personal satisfaction. It should be noted not ALL studies provide physician compensation. There is also an advantage to patients whose physician is also a clinical investigator, they can have confidence you will have the ability to consider any potential conflict between the study and their current treatment.
The existing clinical trials department provides the necessary support to physicians and participants. The team is responsible managing a trial, providing the required documentation to the trial sponsor and FDA. The team also meets operational and oversight requirements of participating in a clinical trial. The physician’s primary responsibility remains with the patient and the providing assessments and recommendations to care. Clinical trial may provide possible treatment options through either new drugs, or there may not be at their disposal, without the clinical trials. Often time’s additional care and tests are paid for through the study sponsor which means there is little cost burden to the participant. Since these tests are paid by the sponsor, this means revenue potential to the practice.

A2. Clinical Trial Phases

A research study could be in one of three different phases.
Phase I test the effects and dosage of a new drug on patients. This phase requires a smaller number of participants usually fewer than 100. This phase studies effects of therapy on