A clinical trial is a research study in human volunteers that is carefully designed and monitored for safety to answer specific questions about investigational drugs or devices. A properly conducted and controlled research study will determine safety and effectiveness of the drug, device, or treatment modality under investigation. Carefully conducted clinical trials are the fastest and safest way to find treatments that work to improve health.
Patients benefit from participating in Clinical Trials:
- Access to cutting edge technologies that are otherwise not available.
- Increased and closely monitored patient care by healthcare provider and supporting study team.
- Additional tests and study-related medical care (study-related care is generally free to patient volunteers).
- An opportunity to be part of new medical discoveries and technology.
Clinical trials are available to qualified volunteers.
Clinical research is an extension of the services provided by Mercy Hospital to the community of Miami. The clinical trials conducted through the Mercy Research Institute are available to anyone who meets the required medical criteria.
All clinical trials have guidelines addressing who can qualify for participation in a clinical study, called inclusion/exclusion criteria. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable data on safety and efficacy. The factors that allow someone to participate in a clinical trial are the "inclusion criteria" and those that disallow someone from participating are the "exclusion criteria".
These criteria are based on factors such as age, gender, the type and stage of a disease, medical history treatment history and other medical conditions. All participants must qualify for the study.
Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants based on medically and scientifically reviewed data in order to keep patient volunteers safe. The eligibility criteria help ensure that researchers will be able to answer the questions about the investigational product.