The clinical side of research is dependent on volunteers with the condition that the new medication, device, or procedure is aimed to help. Almost all medications have gone through many stages of research before they were ready for the market. In phase one trials, researchers are typically trying to determine if a treatment is safe and often includes healthy participants. Phase two studies are aimed to discover if the treatment actually works and to determine correct dosages. Phase three studies monitor patients long-term to screen for side effects. (see chart) CenterWatch – a Boston-based publisher of clinical trials information – estimates that one out of 30 volunteers will experience a serious side effect and one in 10,000 will die during clinical trails. Even so, volunteers chose to participate in trials for a variety of reasons that include:
- Being a part of advancing medical science,
- Obtaining the latest medical care or education, and
- Gaining access to highly sought after physicians and specialists.
- Patients often receive an honorarium (money) for their participation in a trial.
Participating in a clinical trial should not be taken lightly. The study’s success depends on its participants. Consequently, the screening for studies is stringent, and subsequent results may be for only a small subset of people with the illness. If you do not do your part to ensure that you are right for the study, by being absolutely truthful when answering all medical questions, then you and/or the results will suffer. Do not enter into a trial that is not right for your condition and situation. Examine the study guidelines and always consult your doctor before entering into a trial. During a clinical trial you may have to take medication, may need laboratory and diagnostic tests, you will have to visit the required health care facility/provider, and/or you may even have to change your diet and exercise habits. The following additional information may aid you in this process.
What questions should I ask before the trial?
- How many other volunteers are involved in this study?
- Could I possibly end up with a placebo (inactive substance) during this trial?
- Have any other trials been performed on this drug/procedure? What were the results?
- How long will the trial last?
- How many visits to the clinic/hospital will I have to make? And how long will each visit be?
- What are the risks to my health?
- Is there a cost to participate?
- What are the trial goals?
- What type of tests will I need?
- Where can I get the trial results? When?
- Do I have to complete the trial?
What are the benefits of joining a trial?
- Knowledge that you are helping advance medical science
- Laboratory services at no cost
- Medical care from specialists who might otherwise be unavailable to you
- You can often get free access to the medication
What is the downside of participating in a clinical trial?
- You will have to devote time to the procedures, tests, and clinic visits
- The treatment might not work
- If using a medication, you may experience side effects
- If a placebo is involved in the trial, you may receive no medication, also
- Be sure to read the consent form thoroughly for any other potential risks
How can I join a clinical trial?
The most common way for a person to be included in a study is to be referred by a physician. Companies, universities, or other researches facilitating trials contact local clinicians for patient referrals. Your doctor may already have information on trials directly related to your condition or could find out for you. Sometimes there will be advertisements in newspapers for research studies. From time to time, the GI Society receives information on clinical trials and will notify members via The Inside Tract® newsletter and online.