Subject Numbers and Placebo Outcome Variability in Clinical Trials of New CNS Medications
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Derry Ridgway, MD Constella Group Arif Khan, MD Northwest Clinical Research Center, Bellevue, Washington; Duke University Medical Center, Durham, North Carolina Gavin Ridgway, BA Alhambra, California Mark A. Cierpial, PhD Constella Group, Research Triangle Park, North Carolina Charles G. Lineberry, PhD Constella Group, Research Triangle Park, North Carolina Key Words Placebo; Outcome variability; Funnel plot Correspondence Address Derry Ridgway, Constella Group (formerly Lineberry Research Associates), P.O. Box 14626, Research Triangle Park, North Carolina 27709 (e-mail: [email protected]). The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for a maximum of 1 contact hour or .1 continuing education units (CEUs). 286-000-07-407-H04. If you would like to receive a statement of credit, you must review the article, and complete the posttest and evaluation included on the DIA website. Participants must receive a passing score of 80% or better on the posttest in order to receive a statement of credit. To access the posttest and evaluation, please visit the DIA website at www.diahome.org, select Educational Offerings from the top menu bar, then select Continuing Education from the drop down menu, and the My Transcript link. This will take you to the My Transcript page where you will be prompted to sign-in using your DIA username and password. Once signed-in you may select the Subject Numbers and Placebo Outcome Variability in Clinical Trials of New CNS Medications link. You will be prompted to complete the posttest and evaluation. Upon successful completion of the posttest, you will be able to download your
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Subject Numbers and Placebo Outcome Variability in Clinical Trials of New CNS Medications Few investigations have compared placebo group outcomes across therapeutic areas. We examined placebo group outcomes from 171 clinical trials reported in the Food and Drug Administration (FDA) Summary Basis of Approvals describing 33 medications for six neurologic or neuropsychiatric conditions: migraine headache, advanced Parkinson’s disease, depression, postoperative (nondental) pain, postdental surgery pain, and schizophrenia. We used funnel plots to create a visual estimate of expected placebo outcome, to characterize the variability around the expected value, and to es-
tablish an empirically derived number of subjects to minimize the risk that sampling variability will lead to a placebo outcome that prevents a positive trial result for an effective drug. The results confirmed our hypothesis that in trials
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