Data processing: financial – business practice – management – or co – Automated electrical financial or business practice or... – Health care management
Reexamination Certificate
2009-08-21
2010-11-23
Morgan, Robert W (Department: 3626)
Data processing: financial, business practice, management, or co
Automated electrical financial or business practice or...
Health care management
C705S001100, C705S003000
Reexamination Certificate
active
07840419
ABSTRACT:
A method and system for performing a clinical trial having a reduced placebo effect is disclosed. The method includes randomizing study participants into three or more treatment groups and performing a first phase of testing on the groups. In a typical embodiment, the first phase of testing includes administering an active treatment to a first group, and administering a placebo to a second group and to a third group. Responders and non-responders are determined for each group. A second phase of testing is then performed. The second phase of testing includes administering the placebo to non-responders in the first group, administering the active treatment to non-responders in the second group, and administering the placebo to non-responders in the third group. The data from the first phase of testing and from the second phase of testing is pooled and analyzed to determine response rates to active treatment and placebo.
REFERENCES:
patent: 5898586 (1999-04-01), Jeatran et al.
patent: 6041788 (2000-03-01), Shen
patent: 6450954 (2002-09-01), Selker
patent: 2002/0143563 (2002-10-01), Hufford et al.
patent: WO 01/32017 (2001-05-01), None
“Effect of Hypericum Perforatum (St. John's Wort) in Major Depressive Disorder—A Randomized Controlled Trial;” Journal of the American Medical Association; vol. 287, No. 14; Apr. 2002; pp. 1807-1814.
Bech et al.; “The Hamilton Depression Scale, Evaluation of Objectivity Using Logistic Models;” Acta Psychiat. Scand. (1981) 63; 1981; pp. 290-299.
Campbell et al.; “A Primer on Regression Artifacts;” The Guilford Press; New York; 1999; entire book.
Chassan; “Intensive Design: Statistics and the Single Case;” Research Designs and Methods in Psychiatry; Chapter 11; Jan. 1992; pp. 173-183.
Chmura Kraemer et al.; “Methodology in Psychiatric Research;” Archives of General Psychiatry; vol. 44; Dec. 1987; pp. 1100-1106.
Cutter et al.; “Development of a Multiple Sclerosis Functional Composite as a Clinical Trial Outcome Measure;” Brain, vol. 122; 1999; pp. 871-882.
DeBrota et al.; “Same Rater Versus Different Raters in Depression Clinical Trials;” 42ndAnnual NCDUE Meeting; Boca Ratan, FL; Jun. 10, 2000; 1 sheet.
Demitrack et al; “The Problem of Measurement Error in Multisite Clinical Trials;” Psychopharmacology Bulletin 34 (1); 1998; pp. 19-24.
Diener et al.; “Cyclandelate in the Prophylaxis of Migrane: A Randomized Parallel, Double-Blink Study in Comparison with a Placebo and Propranolol;” Cephalalgia; 1996; pp. 16:441-447.
Dunger-Baldauf, et al.; “Designs with Randomization Following Initial Study Treatment;” Wiley Enclopedia of Clinical Trials, copyright 2007; pp. 1-7.
Dunger-Baldauf, et al.; “Re-Treatment Studies: Design and Analysis;” Drug Information Journal, vol. 40; 2006; pp. 209-217.
Faries et al.: “The Double-Blink Variable Placebo Lead-in Period: Results From Two Antidepressant Clinical Trials;” Journal of Clinical Psychopharmacology; vol. 21, No. 6; Jul. 1999; pp. 561-568.
Faries et al.; “The Responsiveness of the Hamilton Depression Rating Scale;” Journal of Psychiatric Research; vol. 34, Jan. 2000; pp. 3-10.
Fava et al.; “The Problem of the Placebo Response in Clinical Trials for Psychiatric Disorders: Culprits, Possible Remedies, and a Novel Study Design Approach;” Psychotherapy and Psychosomatics; May/Jun. 2003; pp. 72: 15-127.
Fava et al.; “How to Write a Study Protocol: A Primer for the Clinician;” Research Designs and Methods in Psychiatry; Ch. 20, Jan. 1992; pp. 297-305.
Fava et al.; “Major Depressive Subtypes and Treatment Response;”1997 Society of Biological Psychiatry; vol. 42; Jan. 1997; pp. 568-576.
Fava; “Traditional and Alternative Research Designs and Methods in Clinical Pediatric Psychopharmacology;” Journal of the American Academy of Child Adolescent Psychiatry; vol. 34, No. 10; Oct. 1996; pp. 1292-1303.
Fiore et al.; “The Effectiveness of the Nicotine Patch for Smoking Cessation: A Meta-analysis;” 9 pages as printed in the Journal of the American Medical Association; Jun. 22, 1994; pp. 1940-1947.
Gibbons et al.; “Exactly What Does the Hamilton Depression Rating Scale Measure?;” Journal of Psychiatric Research; vol. 27, No. 3; Jan. 1993; pp. 259-273.
Hooper et al.; “Do Clinical Trials Reflect Drug Potential: A Review of 5 FDA Evaluations of New Antidepressants;” 39thAnnual NCDUE Meeting; Boca Raton, FL; Jun. 11-14, 1998; Poster No. 182, 1 sheet.
Hróbjartsson et al.; “Is the Placebo Powerless? Update of a Systematic Review With 52 New Randomized Trials Comparing Placebo With No Treatment;” Journal of Internal Medicine; vol. 256; Jan. 2004; pp. 91-100.
Jorenby et al.; “A Controlled Trial of Sustained-Release Bupropion, A Nicotine Patch, or Both for Smoking Cessation;” New England Journal of Medicine; vol. 340, No. 9; Jan. 1999; pp. 685-691.
Kellner; “The Development of Sensitive Scales for Research in Therapeutics;” Research Designs and Methods in Psychiatry; Jan. 1992; pp. 213-222.
Kobak et al.; “Computerized Assessment of Depression and Anxiety Over the Telephone Using Interactive Voice Repsonse;” MD Computing; vol. 16; May 1999; pp. 64-68.
Koch et al.; “Methodological Advances and Plans for Improving Regulatory Success for Confirmatory Studies;” Statistics in Medicine, vol. 17; 1998; pp. 1675-1690.
Laird; “Estimating Rates of Change in Clinical Studies;” Research Designs and Methods in Psychiatry; Chapter 12; Jan. 1992; pp. 185-193.
Lin; “An Issue of Statistical Analysis in Controlled Multi-Centre Studies: How Shall We Weight the Centres?;” Statistics in Medicine, vol. 18; 1999; pp. 365-373.
Myers et al.; Information, Compliance and Side-Effects: A Study of Patients on Antidepressant Medication; British Journal of Clinical Pharmacology; vol. 17(1); Jan. 1984; pp. 21-25.
NDA; Center for Drug Evaluation and Research, Application No. 18-936/S-036; Food and Drug Administration; 1988.
Niaura et al.; “Multicenter Trial of Fluoxetine as an Adjunct to Behavioral Smoking Cessation Treatment;” Journal of Consulting and Clinical Psychology; vol. 70, No. 4; Feb. 2002; pp. 887-896.
O'Sullivan et al.; “Sensitivity of the Six-Item Hamilton Depression Rating Scale;” American College of Rheumatology Psychiatric Scandinavian; vol. 95; Jan. 1997; pp. 379-384.
Otto et al.; “Assay Sensitifity, Failed Clinical Trials, and the Conduct of Science;” 9 pages as printed in Psychotherapy Psychosomatics; Jan. 2002; vol. 71; pp. 241-243.
Peselow et al.; “Melancholic/Endogenous Depression and Response to Somatic Treatment and Placebo;” American Journal of Psychiatry; vol. 149, No. 10; Oct. 1992; pp. 1324-1334.
Quitkin et al.; “Are There Differences Between Women's and Men's Antidepressant Responses?:” American Journal of Psychiatry; vol. 159, No. 11; Nov. 2002; pp. 1848-1854.
Quitkin et al.; “Identification of True Drug Response to Antidepressants;” Archives of General Psychiatry; vol. 41; Aug. 1984; pp. 782-786.
Quitkin; “Methodology of Measuring the Efficacy of Antidepressants;” Psychopharmacology (Berl); vol. 106; Jan. 1992; pp. S87-S89.
Rao et al.: “Linear Statistical Inference and its Applications;” New York: Wiley; 1952, p. 50.
Reginster et al,; “Long-Term Errects of Glucosamine Sulphate on Osteoarthritis Progression: A Randomised, Placebe-Controlled Clinical Trial;” The Lancet, vol. 357, Issue 9252; Jan. 27, 2001; pp. 251-256.
Robinson et al.; “Concerns About clinical Drug Trials;” Journal of Clinical Psychopharmacology; Dec. 2000; vol. 20, No. 6; pp. 593-596.
Rush; et al.; “The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and Self-Report (IDS-SR) Ratings of Depressing Symptoms;” International Journal
Fava Maurizio
Schoenfeld David
Daly, Crowley & Mofford & Durkee, LLP
Morgan Robert W
Squires Eliza
The General Hospital Corporation
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