Clinical Trials

Questions to be answered before stating a clinical trial

The Study·         What is the purpose of the particular study?

·         Do you have enough data to prove that the medication being tested is effective?

·         Who is sponsoring the study?

·         Who has reviewed and approved the study?

·         What are the qualifications and experience of the investigator and other study staff?

·         How are the study results and safety of participants being monitored?

·         What is the duration of the study?

·         How will the results of the study be shared?

Possible Risks and Benefits

·         What are the possible short-term benefits?

·         What are the possible long-term benefits?

·         What are the short-term risks/side effects?

·         What are the possible long-term risks?

·         What other treatment options are available in the market?

·         How do the possible risks and benefits of the trial drug compare with those of the drug already available?

Participation

·         What kinds of treatment, medical tests does the subject have to undergo during the study?

·          How often will they receive the treatments, tests, or procedures?

·         Will treatments or tests be painful? If so, how can the pain be controlled?

·         How do the tests in the study compare with what people might receive outside the study?

·         Will participants be able to take their regular medications while in the clinical trial?

·         Where will the participants receive their medical care? Will they be hospitalized? If so, for how long?

·         Who will be in charge of the subjects’ care? Will they be able to see their own doctors?

·         How long will participants need to stay in the study? Will there be follow-up visits after the study?

Personal Issues

·         How could being in the study affect the subjects’ daily lives?

·         What support is available for subjects and their families?

·         Can potential subjects talk with people already enrolled in the study?

Cost Issues

·         Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?

·         Will the subjects be paid for participating in the trials?

·         What is health insurance likely to cover?

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