NIHS Redefinition of Clinical Trials and Using the

NIHS Redefinition of Clinical Trials and Using the

NIHS Redefinition of Clinical Trials and Using the New Human Subjects Form Chris Sylvester, M.A. Senior Grant Administrator (AO) Grants and Contracts 617-414-2879 [email protected] NIHS NIHS REDEFINITION REDEFINITION OF OF CLINICAL CLINICAL TRIALS TRIALS A research study in which one or more human subjects are prospectively assigned (1) to one or more interventions (which may include placebo or other control) (2) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (3). 1) The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a Clinical Trial. 2) An "intervention" is defined as a manipulation of the subject or subjects environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. 3) A "health-related biomedical or behavioral outcome" is defined as the prespecified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects biomedical or behavioral status or quality of life. WHAT WHAT DOES DOES THE THE NIH NIH CONSIDER CONSIDER A A CLINICAL CLINICAL TRIAL? TRIAL? A research study in which one or more human subjects are prospectively assigned (1) to one or more interventions (which may include placebo or other control) (2) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (3).

Each of the Example 1: The three study components involves the of the recruitment NIHs Clinical of research Trial definition participants are with represented disease X. in It is Clinical the designedTrial to compare Questionnaire. the diagnostic If all ofperformance the below questions of approved aredevices answered A and YES, B, both human your of whichsubjects are used research in clinical is considered practice, toameasure Clinical Trial disease by the markers.

NIH: Device A will be used 1) Doesinthe half study of the involve patients; human device participants? B will be used in the other half. 2) Are the participants prospectively assigned to an intervention? 3) the study designed to evaluate effect of the intervention on the participants? ThisIsstudy is not considered a clinicalthe trial: 4) Is the thatinvolve will be evaluated a health-related,Yes, biomedical, or behavioral Does theeffect study human participants? the study involves human outcome? participants. Are the participants prospectively assigned to an intervention? No, in this context the diagnostic device would not be considered an intervention. The purpose of the study is to evaluate the diagnostic performance of two devices, but not to determine their effects on any health-related or behavioral outcomes.

WHAT WHAT DOES DOES THE THE NIH NIH CONSIDER CONSIDER A A CLINICAL CLINICAL TRIAL? TRIAL? A research study in which one or more human subjects are prospectively assigned (1) to one or more interventions (which may include placebo or other control) (2) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (3). Example 2: The study involves the recruitment of research participants suspected to have disease X. It is designed to compare the ability of approved devices A and B to diagnose the disease and inform the clinical management of disease X. Device A will be used in half of the patients; device B will be used in the other half. This study IS considered a clinical trial: Does the study involve human participants? Yes. Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, one of two diagnostic devices. Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the ability of the two approved devices to inform the clinical management of disease X. Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, diagnosis and clinical management of patients with disease X, is a health-related outcome. FORMS FORMS E E HUMAN HUMAN SUBJECTS SUBJECTS FORM: FORM: THE THE FOUR FOUR PATHS PATHS The SF424 Forms-E Grant Application now contains The PHS Human Subjects and Clinical Trials Information Form dedicated to capturing detailed information concerning human subjects research and clinical trials. All grant applications proposing studies involving human subjects or samples/data must fill out this form to some extent. The four

possible uses of The PHS Human Subjects and Clinical Trials Information Form are: 1) HUMAN DATA / SAMPLES 2) DELAYED ONSET STUDY Human Subjects Front Page If No to human subjects but still using human data / samples Requires Justification Human Subjects Front Page If study cannot be defined at time of application Can be either CT or non-CT Requires Unique Title Requires Justification 3) STUDY RECORD, NON-CT 4) STUDY RECORD, CT At least one No on CT questionnaire

Requires completion of sections 1 3 of Study Record Requires completion of Inclusion/ Enrollment Report All answers are Yes on CT questionnaire Requires completion of sections 1 4 (and section 5 if called for by RFA) as well as Inclusion/Enrollment Report FORMS FORMS E E HUMAN HUMAN SUBJECTS SUBJECTS FORM: FORM: THE THE FOUR FOUR PATHS PATHS 1) HUMAN DATA / SAMPLES 2) DELAYED ONSET STUDY 3) STUDY RECORD, NON-CT 4) STUDY RECORD, CT Example 1: The study, which can be described at the time of application, involves the recruitment of research participants with disease X. It is designed to compare the diagnostic performance of approved devices A and B, both of whichRECORD, are usedNON-CT in 3) 3) STUDY STUDY RECORD, NON-CT clinical practice, to measure disease markers. Device A will be used in half of the

patients; device B will be used in the other half. Example 2: The study, which cannot be described at the time of application, involves the recruitment of research participants suspected to have disease X. It is designed to compare the ability of approved devices A and B to diagnose disease ONSET and inform 2) DELAYED STUDY, 2)the DELAYED ONSET STUDY, CT CT the clinical management of disease X. Device A will be used in half of the patients; device B will be used in the other half. Example 3: The study involves the analysis of de-identified data gathered from subjects suspected to have disease X and who have been treated with approved 1) HUMAN DATA // SAMPLES HUMAN DATA SAMPLES devices A and B to diagnose the disease. It is designed to1)compare the diagnostic performance of approved devices A and B. Thank You for Your Time and Participation! Chris Sylvester, M.A. Senior Grant Administrator (AO) Grants and Contracts 617-414-2879 [email protected]

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