The Study
o What is the purpose of the particular study?
o Do you have enough data to prove that the medication being tested is effective?
o Who is sponsoring the study?
o Who has reviewed and approved the study?
o What are the qualifications and experience of the investigator and other study staff?
o How are the study results and safety of participants being monitored?
o What is the duration of the study?
o How will the results of the study be shared?
Possible Risks and Benefits
o What are the possible short-term benefits?
o What are the possible long-term benefits?
o What are the short-term risks/side effects?
o What are the possible long-term risks?
o What other treatment options are available in the market?
o How do the possible risks and benefits of the trial drug compare with those of the drug already available?
Participation
o What kinds of treatment, medical tests does the subject have to undergo during the study?
o How often will they receive the treatments, tests, or procedures?
o Will treatments or tests be painful? If so, how can the pain be controlled?
o How do the tests in the study compare with what people might receive outside the study?
o Will participants be able to take their regular medications while in the clinical trial?
o Where will the participants receive their medical care? Will they be hospitalized? If so, for how long?
o Who will be in charge of the subjects’ care? Will they be able to see their own doctors?
o How long will participants need to stay in the study? Will there be follow-up visits after the study?
Personal Issues
o How could being in the study affect the subjects’ daily lives?
o What support is available for subjects and their families?
o Can potential subjects talk with people already enrolled in the study?
Cost Issues
o Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
o Will the subjects be paid for participating in the trials?
o What is health insurance likely to cover?
Raghu is an experienced trainer in the field of Clinical Research, with good experience in the conducting Clinical Trials.
Author: Raghav V
Article Source: EzineArticles.com