The4 phases of clinical trials are:
A. Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
B. Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
C. Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
D. Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment benefits, and optimal use.
A typical clinical trial protocol include:
A. the goal of the study, the benefits of the study & who is eligible to take part in the trial & who is not
B. protections against risks to participants
C. details about tests, procedures, and treatments
D. how long the trial is expected to last & what information will be gathered
What are the ethical requirements for informed consent?
A. Codes of research ethics, regulations, and laws (limited exceptions) require informed consent from the research participant or her legally authorized representative (and documentation): ICH-GCP, Declaration of Helsinki, US Federal Regulations (Common Rule (45CFR46) and FDA (21CFR50)), & National, state, institutional requirements.
B. Respect for autonomy — an individual's capacity & right to define his/her own goals & make choices consistent with those goals.
C. "Informed consent is rooted in the fundamental recognition…that adults are entitled to accept or reject health care interventions on the basis of their own personal values and in furtherance of their own personal goals" Presidents Commission for the study of ethical problems…1982.
D. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided…[when] informed consent are satisfied — The Belmont Report.
What rights do human subjects have according to the National Institute of Justice in the United States?
A. voluntary, informed consent, respect for persons: treated as autonomous agents
B. right to end participation in research at any time, right to safeguard integrity
C. benefits should outweigh cost, protection from physical, mental and emotional harm
D. access to information regarding research, protection of privacy and well-being
Which of the following statements about the goals of clinical research are correct?
A. The goal of clinical research is to generate useful knowledge about human health & disease.
B. Clinical research results in compelling societal health benefits – development of therapies, diagnostic & preventive strategies, improvement in quality of life, & understanding of health & disease.
Clinical research provides evidence which clinicians use to know how to safely & effectively treat, prevent, or diagnose diseases or promote health.
D. A small number of participants are asked to participate in the research; benefit to participants is not the purpose (although it does occur); participants are the means to developing useful knowledge; & are thus at risk of exploitation.
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