Clinical trials frequently asked questions
What is a clinical trial?
Clinical trials are research studies that search for answers concerning the safety and effectiveness of proposed new drugs, treatments and therapies. Clinical trials also search for innovative ways to improve existing treatments.
What are the benefits and risks involved in clinical trials?
Generally, the benefits include:
- Receiving new and innovative research treatments before they are available everywhere.
- Receiving state-of-the-art care.
- Improving your own health.
- Improving the health of your friends, family and community through your contributions to medical research.
The risks may include:
- Experiencing unpleasant or adverse side effects.
- Experiencing results that are not significant.
- Dedicating personal time to participating in the study.
Who can participate in a clinical trial?
Each clinical trial has its own unique guidelines concerning eligible participants, depending on the goals of the research. A potential participant must meet these guidelines before becoming involved in the study. The guidelines are based upon two criteria:
- Inclusion criteria are factors that qualify someone to participate.
- Exclusion criteria are factors that disqualify a person.
These criteria are based on factors such as age, gender, disease status, medical conditions and past treatment history. The qualification criterion should not be looked at as personal judgments, but more as a means of ensuring the safety and appropriateness of the study.
What happens during a clinical trial?
Although each clinical trial is different depending on the goals of the research, each one generally includes a team of doctors, nurses, social workers, and other health care professionals. The participant's health is checked and recorded at the beginning of the study, and also monitored throughout the course of treatment and after completion of the study.
What are the types of clinical trials?
- Treatment trials test new treatments, combinations of drugs, and approaches to surgery and various therapies.
- Prevention trials look for new ways of preventing diseases in healthy people as well as preventing a disease from returning.
- Screening trials study the most efficient ways of detecting certain diseases or health conditions.
- Quality of life trials determine ways of improving comfort and quality of life for individuals with chronic illnesses.
What are the phases of clinical trials?
- Phase 1 involves researchers testing a small group of people to determine safety, appropriate dosage levels, and side effects of the treatment.
- Phase 2 studies a larger group of people to determine the drug's effectiveness.
- Phase 3 uses an even larger group to confirm effectiveness, monitor side effects, and compile information that will lead to the safest usage.
- Phase 4 involves marketing studies and compilation of any additional information regarding benefits, risks and optimal use.
What is a protocol?
A protocol is a study design that plans out the basis of clinical trials. It can include who may participate, the testing schedule, procedures, medications, dosages and length of the study.
Who sponsors clinical trials?
Clinical trials are funded by grants or donations from numerous organizations or individuals including foundations, pharmaceutical companies, governmental agencies, physicians, universities and voluntary groups.
What are things to consider before participating?
It is very important for a potential participant to be as informed as possible about the study before becoming involved. A participant should feel comfortable asking questions and know his or her rights, many of which are described in informed consent. (Also see what to ask your researcher about your study.)
What is informed consent?
Informed consent is a process of education, starting before agreement to participate and continuing throughout the study, outlining the objectives of the research and what it entails. Informed consent also describes the potential risks involved with the study. Once the participant signs the participation document, it is not a contract and he or she may decide to leave the study at any time.
How is the participant's safety and privacy protected?
Ethical and legal codes that apply to practicing medicine also regulate clinical research studies. The studies follow a detailed protocol that outlines what exactly the research entails. By law, participants' names are kept confidential while reporting the studies' results at medical conferences and in scientific journals. An institutional review board (IRB) monitors risks and benefits throughout each study.
Where can I obtain further information regarding clinical studies at SJMO?
Susan Schultz, MSN, RN
Director, Clinical Research & Education
St. Joseph Mercy Oakland Research Office
44555 Woodward Ave #107
Pontiac, MI 48341 USA
Adapted from clinicaltrials.gov