Clinical trials are research studies that evaluate new medical approaches and increase scientific understanding of a wide variety of diseases. As a participant in a clinical trial, you will be welcomed by a professional, caring staff who will guide you through the trial process and provide continued support throughout the entire study. In most cases, you will be seen more frequently during a trial than through similar standard of care treatment. It is the goal of our research department to deliver quality care resulting in a positive experience for each trial participant here at Digestive Health Partners, PA.
Why Clinical Trials Are Important
Advances in medical care stem from new concepts and approaches developed through research. Physicians may conduct clinical trials to accomplish a variety of goals depending on what they are investigating. The different types of clinical trials are:
- Treatment: Testing new drugs, medical procedures or devices.
- Prevention: Seeking better ways to prevent diseases through medicine, vaccines, vitamin or mineral supplements, or lifestyle modifications.
- Screening: Finding new ways to test for the presence of a disease or condition where early identification may be important to treatment.
- Quality of Life: Exploring ways to improve the quality of life for those chronically ill.
There are also different phases (and sub-phases) of clinical trials (Phase I, II, III, IV, V, and 1A, 1B, etc.). The earliest trial phase is Phase I advancing to the latter stages of studies, i.e. Phase IV & V. The Phase IV/V trials generally have more documented study data regarding the investigational drug/device.
Participation in a Clinical Study
Participation in a clinical study involves careful screening of all potential candidates. This includes a list of “inclusion” criteria as well as “exclusion” criteria. Inclusion criteria include specific parameters that MUST be met before participation in the study, such as age range accepted, gender, specific diagnosis, and/or other medical conditions, etc. Exclusion criteria are conditions/exceptions to the trial parameters, such as concomitant illness or medications, etc. that are disallowed. This review is used to find the most qualified candidates for the study and to ensure safety for all subjects enrolled in the study. This also contributes to the validity of the data collected. Depending on the trial, most will include nominal compensation for time and travel during the course of the study visits.
Benefits to You
Involvement in a clinical trial is strictly voluntary, but those who elect to participate can experience benefits. Some of these could include:
- Access to promising medications, medical devices, or treatment approaches before availability to the general public.
- Close attention and monitoring of your health care.
- Free or subsidized health care for the duration of the trial.
- Medical care rendered by exceptionally qualified and interested providers.
Informed Consent Form
The majority of clinical trials require the signing an Informed Consent Form. The purpose of the Informed Consent Form is to outline both the risks and benefits of the trial, the expectations for both the subject and site, as well as a thorough discussion of the trial parameters. This is also an opportunity for any potential subject to ask questions and have them answered to their satisfaction. This is an on-going process but allows for any potential candidate to have enough information regarding the trial to make an informed decision about whether to participate or not. No trial procedures are conducted prior to the signing of this form. Once the subject agrees to participate, this form is signed by both parties with a copy provided to the patient.