Page 5 - HFA Dateline 2019-2020 Special Issue

protocol. Factors are based on characteristics such as age, this trial compare with those of my current treatment?
gender, the type and stage of a disease, previous treatment X What tests and procedures are involved?
history, and other medical conditions.
X Who will pay for my participation and will I be
Where? reimbursed for other expenses?

Studies take place in hospitals, universities, doctors’ offices X What type of long-term follow-up care is part of this
and community clinics, depending on who is conducting the trial?
study.
X If I benefit from the intervention, will I be allowed to
Length? continue receiving it after the trial ends?

The length varies, depending on what is being studied. X Will results of the study be provided to me?
Protections? X Who will oversee my medical care while I am

Informed consent is a process used by researchers to participating in the trial?
provide potential and enrolled participants with information X What happens if I am injured during the study? S
about a clinical study. It protects participants and provides
enough information for a person to understand the risks of,
potential benefits of, and alternatives to the study. (See page The Five Phases of a Clinical Trial:
55 for more information on informed consent.) The Five Phases of a Clinical Trial:
• Early Phase 1 (Formerly listed as “Phase 0”):
Institutional Review Boards
Each federally-supported or -conducted clinical study and Exploratory study involving very limited human
each study of a drug, biological product or medical device exposure to the drug, with no therapeutic or
regulated by FDA must be reviewed, approved and monitored diagnostic goals. Examples would include screening
by an institutional review board (IRB). An IRB is made up of studies and microdose studies.
doctors, researchers and members of the community, who • Phase 1: Studies that are usually conducted with
make sure the study is ethical and the rights and welfare of healthy volunteers and that emphasize safety. The
participants are protected. goal is to find out what the drug’s most frequent and
serious adverse events are and, often, how the drug is
Relationship to Usual Health Care metabolized and excreted.
While enrolled in a clinical study, participants continue to see
their usual health care providers who work with the research • Phase 2: Studies that gather preliminary data on
team to make sure the study will not conflict with other effectiveness, as in whether the drug works in people
medications or treatments. who have a certain disease or condition. For example,
participants receiving the drug may be compared to
Interested in Participating? similar participants receiving a different treatment,
Ask These Questions: usually an inactive substance, called a placebo, or a
different drug. Safety continues to be evaluated and
Know as much as possible about the study and feel short-term adverse events are studied.
comfortable asking the research team questions about the
study, the related procedures and any expenses. • Phase 3: Studies that gather more information
about safety and effectiveness by studying different
X What is being studied and for how long will it last? populations and different dosages, and by using the
X Why do researchers believe the intervention being tested drug in combination with other drugs.
might be effective?
• Phase 4: Studies occurring after FDA has approved
X What will I have to do and is hospitalization required? a drug for marketing. These include post-market
requirement and commitment studies that are
X Who will know which intervention I receive during the
trial? Will I know? Will members of the research team required of, or agreed to by, the study sponsor. These
know? studies gather additional information about a drug’s
safety, efficacy, or optimal use.
X How do the possible risks, side effects and benefits of

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