Understanding Clinical Trials
Clinical research involves using human volunteers to assess treatments to improve health. This involves new drugs and/or devices, and new ways of using known treatments. New drugs must undergo lengthy testing which often take years, before the drugs are approved by the FDA.
Without volunteers for research studies, we would not have the medicines we do today for treatment of chronic and acute diseases. Clinical studies optimize safe, effective and promising medical treatments.
Research today is a small step that has far-reaching implications not only for the present but for future generations. Research done today will contribute to the advancement of the world’s efforts to reduce the burden of life-threatening and disabling disease in the future.
Making an Informed Decision to Join a Clinical Trial
The patients are provided with a process of learning key facts about a trial before deciding if they would like to participate in a trial. This process is called informed consent.
The study doctor and the study coordinator reviews the informed consent (ICF) with the patient and any other appropriate family member/support person(s). The ICF provides the participant with information about the study in regards to the purpose, benefits, risks/benefits, what will happen during the study, the length of the study, the # of participants that are expected to participate, whom to contact for additional questions and/or in case of emergency, confidentiality/HIPAA, etc.
The ICF provides the patient with the necessary information to allow him/her to make an informed decision on whether to participate. After the ICF is signed, the investigator and study nurse follows the applicable protocol making sure all research procedures, etc are completed according to protocol. Each protocol is different and varies in what is necessary to be done.
Benefits to Joining a Clinical Trial
People get involved in clinical trials for multiple reasons. The main reason a patient may volunteer for a study is to obtain the benefit of a new medication that might not yet be approved for commercial use or for treatment for a disease in which there is no current, approved, good treatment available yet for that disease. Others may choose to participate because they may lack insurance or they simply want to help advance the science of medicine. Other reasons may be because the medical staff may.
How to Get Involved with a Clinical Trial
All clinical trials have specific criteria as to who may participate. Using strict inclusion and exclusion criteria is an important principle of medical research that helps to produce reliable results and to ensure the safety of the patient.
Factors that allow someone to participate in a trial are called “inclusion criteria” and factors that disallow someone to participate in the trial are called “exclusion criteria.”
These criteria can include the disease classification, other medical conditions, and previous treatments. Often there is numerous criteria that a patient must meet in order to participate in a study. It is the role of the research team to review and carefully follow all aspects of the protocol. Just because a patient may meet all the criteria for a specific protocol, may not mean that patient may be the best candidate for participation.
Areas of Study at St. Joseph’s/Candler
At the Center for Infusion Therapy at SJ/C we have studies in multiple therapeutic areas. The areas of these studies include:
- Ear, Nose and Throat (ENT)
- Gastrointestinal (GI)
- Infectious disease
- Internal medicine/family practice
The Clinical Trial Environment at St. Joseph’s/Candler
SJ/C provides the infrastructure to support all aspects of clinical research and has over 18 years of experience conducting clinical trials. All staff are trained on applicable regulations and guidelines to conduct research.
Not all facilities and physicians can participate in research – they must demonstrate their ability and knowledge of research, prior experience as a researcher, and their capability in regards to facility/equipment, etc.
Patients who are approached with participating in a trial need to make sure the office/physician has the staff necessary to properly conduct the study (in regards to time/personnel/experience).
In summary, the Center for Clinical Research provides the infrastructure to:
- Support physicians in their pursuit of research opportunities, aiding in new knowledge, growth of professional credentials, expertise and satisfaction.
- Provide alternative therapies for patients in community.
- Promote SJ/C as a leader in healthcare.
- Allow access to medical care that patients my not normally have.
- Enhance medical care/higher technological advances.
- Obtain access to new therapies for treating illness without patients having to leave the geographic area and allowing a continuum of care for patients.
- Aids in bringing multiple drugs to market.