Patients may have various motivations for participating in a clinical research program:
In the United States, conducting a clinical study necessitates obtaining approvals from both the FDA (Food and Drug Administration) and the IRB (Institutional Review Board). These essential green lights are mandatory prerequisites for commencing a clinical trial and are bestowed in adherence to the pertinent legal framework. Only upon securing these approvals can the initiation of a clinical trial proceed in accordance with regulatory standards.
The document overseeing the execution of clinical trials and detailing all activities within the trial is known as a research protocol. This document encompasses information about the study's objectives, criteria for patient inclusion, the schedule and types of procedures, drug dosages, the study duration, and methods for reporting.
A research doctor is a seasoned and highly qualified physician specializing in a specific therapeutic area. They are required to possess in-depth scientific knowledge and relevant clinical experience. Clinical research doctors undergo specialized training in the field of clinical trials. The research physician is entrusted with the responsibility of overseeing the clinical trial. In instances where a clinical trial involves a team of specialists, a chief trial physician, also known as the Principal Investigator, is appointed to manage the entire course of the trial.
Clinical trial sponsors are typically pharmaceutical companies or government agencies. These sponsoring organizations formulate the strategy and provide financial support for clinical research. In cases where sponsors lack adequate internal resources to organize clinical trials, they often opt to outsource the execution of these trials to specialized private research companies.
Before embarking on each study, the patient invests a significant amount of time with the research doctor, delving into the study's purpose, stages, required examinations, clinic visit frequency, at-home responsibilities, and potential risks. The patient is thoroughly acquainted with the study drug, and the research doctors actively encourage questions to ensure a comprehensive understanding of all aspects of study participation.
A crucial document, the "Informed Consent," is provided to the patient, outlining the aforementioned details in-depth. This document can be taken away for further consideration or consultation with friends, family, or their family doctor, if needed. The signing of the "Informed Consent" occurs only when the patient feels adequately informed to decide on study participation.
Even post-signing, if the patient has a change of heart regarding study involvement, they possess the liberty to withdraw at any time without repercussions. Research physicians advocate for in-person visits to ARENSIA research clinics, enabling patients to gather extensive information before committing to clinical trial participation.
Every drug therapy, whether available in pharmacies or undergoing research, carries inherent risks. In the realm of clinical practice, a perennial question surfaces: what poses a greater risk - administering medicine to the patient or leaving them untreated?
Each drug approved for sale, and consequently found in pharmacies, is accompanied by instructions outlining its side effects, revealing the risks associated with its use. These side effects, cataloged in the instructions for any drug, emanate from observations derived from clinical studies, rooted in the statistical data of thousands of participating patients.
As clinical trials progress to the patient testing phase, the risks of using the drug are already discerned and deemed negligible/acceptable. These may include, for instance, drowsiness, constipation, or discomfort at the injection site, based on the experiences garnered from prior clinical trials involving the corresponding molecule. Before a patient opts to partake in the clinical trial, the medical team provides a detailed explanation of these risks or discomforts.
Clinical trials are meticulously designed to ensure continuous supervision of the patient by the research doctors, who are reachable at any time for direct communication regarding any adverse events. The studies incorporate a battery of examinations to promptly detect any changes in the participant's health. In the event of adverse events, immediate medical attention is extended to the participant, delivered by the research team with the involvement of other specialists as deemed necessary.
Certain studies necessitate only outpatient visits, while others entail inpatient stays. The research doctors will duly apprise the study participants of any requirement for hospitalization.
The confidentiality of the patients' data engaged in the study will be rigorously maintained, with access to personal information granted solely to the research doctors and regulatory authorities, in strict compliance with national and international laws. All study-related data will be identified only by patients' initials and year of birth. Consequently, the information shared by the research doctor with the Sponsor, such as test results, will solely include the results, collection date and time, initials, and year of birth of the participant.
