Clinical Trial Basics
Four Types of Trials with Cancer Research
Clinical Trials are in-depth medical research studies conducted to understand whether promising approaches to cancer prevention, diagnosis and treatment are safe and effective.
Cancer research, in general, includes four types of trials:
- Treatment: research to test new approaches to treatment including new drugs, drug combinations, radiation and surgery
- Prevention: research to investigate methods to prevent the disease from occurring in people who have previously not had cancer; or prevent the cancer from recurring in patients who previously have been diagnosed with the disease
- Screening: research to find the optimum approach in detecting cancer before symptoms occur; includes imaging , laboratory and genetic testing
- Quality of Life: research to investigate means of improving cancer patients' and survivors' quality of life; areas explored include the management of fatigue, nausea, pain, weight loss and depression associated with cancer treatments
Clinical Trial Phases
Clinical trials progress through a series of stages meant to ensure safety of patient and effectiveness of treatment:
- Phase I: a drug or treatment is initially evaluated with a limited group (approximately 20-30) to determine its safety, optimal dose or treatment levels and identify side effects
- Phase II: the experiemental study's drug or treatment is tested for safety and effectiveness and usually involves a larger number of participants (approximately 100-300) compared to Phase I
- Phase III: the experimental study's drug or treatment is given (administered) to confirm findings of Phase II and to compare it to existing treatments. A greater amount of information is collected in order to determine the safety of the drug or treatment (typically involves 1,000-3,000 participants)
- Phase IV: after the drug or treatment gains FDA approval, the study enters the marketing stage. This study observes the drug or treatment over a lengthy time period and involves a significantly larger number of participants (thousands). The purpose is to evaluate side effects, risks and benefits of a drug; and is typically conducted by the drug maker
- Health care professionals play an active role in the patient’s health care
- Patients have access to new treatments before being widely introduced
- Patients receive top-level care at leading medical institutions
- Patients play a valuable role in medical research with the potential to help other patients facing similar health challenges
- There is the potential for unpleasant side effects, including headache, nausea, hair loss or skin irritation
- The treatment may not be effective or produce the desired result
- Participation in a trial may involve a greater time commitment than pursuing non-trial treatment
More Trial Information
- Participatory guidelines exist, and these are commonly known as “inclusion/exclusion criteria.”
- All U.S. clinical trials are approved and tracked by an institutional review board to ensure risks are as minimal as possible and are worth the benefits.
- Participants should be well-informed and understand as much as possible about the clinical trial and should feel comfortable asking questions. A few questions:
- Who is in the study?
- How do the potential side effects and benefits compare with my current treatment?
- How might this trial affect my daily life?
- Will hospitalization be required?
- Who will be in charge of my care?