Clinical Research Function
The main function of a clinical research associate is to monitor clinical trials. The CRA may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a contract research organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. Clinical research associates also "assure the protection of the rights, safety and well being of human study subjects. Additionally, a CRA must "make certain that the scientific integrity of the data collected is protected and verified" and "assure that adverse events are correctly documented and reported.
Who should consider clinical trials?
Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.
Where are clinical trials conducted?
Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.
What are the potential risks that are involved in a clinical trial?
The risks involved in a clinical research trial may be unpleasant, serious, or life-threatening. It is because the treatment given in a clinical research trial is generally experimental. These studies may require more time and various details like dosage and side-effects than a standard normal treatment. The potential risks of any clinical research trial include:
The lack of authorization in the decision-making of the type of treatment received:
The treatment given may not be effective:
Increase in the frequency of visits to the doctor:
Insurance companies may not cover the costs of clinical trials:
Clinical research trainings are given to every professional involved in the trial. Clinical research courses are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.