What Clinical Research Involves
The use of new drugs/devices to diagnose, treat, and prevent disease
The use of currently FDA-Approved drugs/devices for new indications
What is Clinical Research?
Why It Matters
To give patients the opportunity to find new treatment options
Medications/vaccines that keep us healthy were all tested on real patients (ex: Tylenol, Penicillin, Insulin)
Frequently Asked Questions
Every clinical trial must be approved and monitored throughout the duration of the study by an Institutional Review Board (IRB), as required by FDA regulation, to ensure minimal risk to participants. The IRB also ensures the benefits of the clinical study outweigh any risks. Once IRB approval is received, the clinical trial investigators (physicians) must follow the study protocol and design.
The protocol describes how the clinical trial will be conducted; including the study objective(s), procedures, and organization of the clinical study. The protocol also ensures the safety of study participants and data integrity. Participants will be fully informed of the protocol procedures and study treatment prior to signing consent for clinical trial participation.
The main benefits of a clinical trial are that participants gain access to innovative treatment options years before it may be available to the public. Participants may also have additional access to information regarding their health status and health risks. Additionally, participants make an extremely valuable contribution to research.
A clinical trial may require more time and medical attention than standard care. Participation in a clinical trial may include frequent physician visits, phone calls, bloodwork, ECGs, imaging and additional treatments. Although new clinical study treatment may help some participants, it might not help or have the same effect on others. The treatment may cause serious side effects and/or reactions.
A placebo is a pill or other substance that has no therapeutic effect. If a placebo is part of the clinical trial, the participants will be fully informed prior to obtaining consent and administration. Although placebo is not an option for all clinical studies, participants are only considered for such a trial when it is safe and medically appropriate.
A potential participant must meet the description (inclusion/exclusion criteria) of the clinical trial and/or observational study. Criteria may include age, gender, ethnicity, type and stage of disease, or other characteristics. Clinical studies may exclude participants with serious medical conditions such as cancer, serious heart disease, autoimmune diseases and more.
A participant can withdraw for any given reason and at any time. The physician may ask to continue monitoring the participant for the duration of the study period after withdrawing treatment to assess any long-term effects of the study treatment received.
Clinical research is the study of health and disease in our society. Physicians use clinical research to investigate new investigational products (medications and devices) in the prevention, diagnosis and treatment of illness. Clinical trials give human participants the opportunity to explore new treatments options. Often, new treatments may be more effective and/or have less harmful adverse effects than the standard treatment options.
The principal investigator (PI) is responsible for the preparation, conduct, and administration of the clinical trial. The PI has the most important responsibility as they are involved with and aware of all the study procedures at their site. The sub-investigators and research nurses assist the PI with screening patients and the study procedures throughout the study. The data manager collects and documents all data pertaining to each study subject. It is extremely important for study personnel to ensure the subject is aware of all aspects of the study protocol so that the patient remains compliant and does not report false information.