Page 4 - HFA Dateline 2019-2020 Special Issue
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Clinical Studies:




                        How Do They Work?





                               What Is a Clinical Study?


                               Research using human volunteers or “participants”
                                      intended to add to medical knowledge.




        Two types:

        Clinical Trials                                           Who Conducts?
        Participants receive specific interventions according to the   INVESTIGATOR
        research plan or protocol created by the investigators, which   Study is led by a principal investigator, often a medical
        may include medical products, such as drugs or devices    doctor.
        procedures or changes to participants’ behavior.
                                                                  RESEARCH TEAM
           X May compare a new medical approach to a standard one   Team may include doctors, nurses, social workers and
             that is already available or to a placebo that contains no   other health care professionals.
             active ingredients or no intervention.
                                                                  SPONSOR
           X  May compare two already-available interventions to
             each other.                                          Studies can be sponsored or funded by pharmaceutical
                                                                  companies, academic medical centers, voluntary
           X  Investigators determine safety and efficacy by      groups and other organizations, in addition to federal
             measuring certain outcomes in the participants. When   agencies such as the National Institutes of Health, the
             a new product or approach is studied, it is not usually   U.S. Department of Defense and the U.S. Department of
             known whether it will be helpful, harmful or no different   Veterans Affairs. Doctors, other health care providers
             than available alternatives.                         and other individuals can also sponsor clinical research.
           Some people who are not eligible to participate in a clinical trial may be able to get
           experimental drugs or devices outside of a clinical trial.   Who Participates?
        Observational Studies                                     Participants who have the  illnesses or conditions that

        Investigators assess health outcomes in groups of participants   will be studied or participants. Some studies are limited
                                                                  to a predetermined group of people.
        who receive interventions, but participants are not assigned to
        specific interventions by the investigator as they would be in a   Who’s Eligible?
        clinical trial.
                                                                  The factors that allow someone to participate in a
           Intervention Examples:                                 clinical study are called inclusion criteria, and the factors
             X  Given medical products such as drugs or devices or   that disqualify someone from participating are called
               procedures as part of their routine medical care.   exclusion criteria, and both criteria are listed in the study

             X  Observing a group of older adults to learn more about
               the effects of different lifestyles on cardiac health.








        4    HEMOPHILIA FEDERATION OF AMERICA < www.hemophiliafed.org
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