Source: http://www.google.com/patents/US7983936?dq=6,202,008
Timestamp: 2016-08-24 13:45:46
Document Index: 1206934

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'Application No. 18']

Patent US7983936 - System and method for reducing the placebo effect in controlled clinical trials - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA 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...http://www.google.com/patents/US7983936?utm_source=gb-gplus-sharePatent US7983936 - System and method for reducing the placebo effect in controlled clinical trialsAdvanced Patent SearchPublication numberUS7983936 B1Publication typeGrantApplication numberUS 12/909,075Publication dateJul 19, 2011Filing dateOct 21, 2010Priority dateMar 31, 2003Fee statusPaidAlso published asUS7647235, US7840419, US8145504, US8145505, US8219419Publication number12909075, 909075, US 7983936 B1, US 7983936B1, US-B1-7983936, US7983936 B1, US7983936B1InventorsMaurizio Fava, David SchoenfeldOriginal AssigneeThe General Hospital CorporationExport CitationBiBTeX, EndNote, RefManPatent Citations (7), Non-Patent Citations (93), Referenced by (2), Classifications (14), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetSystem and method for reducing the placebo effect in controlled clinical trials
As is known in the medical field, the term “clinical drug treatment study” or “clinical drug trial” (or more simply a “clinical trial”), refers to the testing done on humans to determine the value of a given drug treatment. A clinical drug trial is referred to as a “controlled drug trial” when the effect of a drug treatment is measured against a comparison treatment or treatments administered over the same time period and under similar conditions. In the most typical form of controlled clinical trial, the comparison treatment is provided by supplying a placebo to test study participants in place of the actual treatment (placebo-controlled clinical trial).
As is also known, the term “blinding” in a clinical drug trial refers to the concealment of treatment assignment in order to prevent influencing the behavior, observation or reporting of the person receiving the treatments or of the person administering the treatment. In a double blind, clinical drug trial, both the persons receiving the treatment and the persons administering the treatment are unaware of which study participants are receiving which treatments.
As is also known, the term “randomization” in a clinical drug trial refers to the random assignment to treatment, so that a random sequence determines whether a given subject is assigned to active treatment(s) or placebo. Randomization is an important aspect of a clinical trial in that it eliminates possible biases in treatment assignment.
The purpose of a randomized, double-blind, placebo-controlled trial is to compare the efficacy of a specific treatment or treatments with that of placebo for study participants identified according to a priori criteria and assigned by chance to a given treatment group. The conventional design of such a trial involves the parallel comparison of one or more treatments with placebo, with sample sizes considered adequate to detect a therapeutic signal, given the expected placebo response rates in that specific population. As the term is commonly used, “placebo response” represents an apparent improvement in the clinical condition of study participants randomly assigned to the placebo treatment, (e.g., a pre-post treatment change within the placebo group). It is not uncommon for clinical trials to yield uninterpretable results, due in part to the placebo response. It has been suggested that addressing the placebo response issue is one of the most important challenges facing the future of industry-sponsored psychopharmacologic drug development.
The technique of the present invention utilizes two phases of treatment. The first phase involves a so-called “unbalanced randomization” between a placebo treatment group/arm and one or more active treatment(s) group(s)/arm(s). In such an unbalanced randomization, a greater number of study participants are randomly placed in a treatment group/arm where they will receive a placebo treatment rather than an active treatment. Thus, more study participants are said to be “randomized to placebo” than are “randomized to active treatment(s)” hence the term “unbalanced.”
At the end of the first phase, so-called “responders” (i.e. those study participants who are given the active treatment and who respond to the active treatment as well as those study participants who are given the placebo and respond to the placebo) and non-responders (i.e. those study participants who are given the active treatment and who do not respond to the treatment as well as those study participants who are given the placebo and who do not respond to the placebo) are identified. For the purpose of the related analytical plan, only the data from the first phase of the study will be considered for the responders. However, responders to active treatment in the first phase may go on to continue the assigned double-blind treatment or may go on to open continuation treatment or may simply stop treatment.
A flow diagram of the presently disclosed method is depicted in FIG. 2. The rectangular shaped elements are herein denoted “processing blocks” and the diamond shaped elements, are herein denoted “decision blocks.” It should be appreciated that all, some or none of the functions provided in each of the processing and decision blocks may be carried out by humans or may be carried out by processors. Thus in one embodiment, the “processing blocks” represent computer software instructions or groups of instructions and the “decision blocks” represent computer software instructions, or groups of instructions which affect the execution of the computer software instructions represented by the processing blocks. It should be noted that the flow diagram of FIG. 2 represents one embodiment of the design and variations in such a flow diagram which generally follow the process outlined above and are considered to be within the scope of the present invention.
Turning now to FIG. 2, processing begins in processing block 32 in which, after an initial screening visit, eligible study participants are randomly allocated to one of three possible treatment groups: drug alone (DP), placebo then drug (PD) and placebo then placebo (PP). The allocation is done in an unbalanced ratio. One possibility is using a 2:3:3 ratio (DP:PD:PP) in blocks of 8 to maintain the 2:3:3 ratio between groups. However, in general, the ratio could be 1-2a,a,a for a choice of “a” (in units of percent %) to maximize power (see examples discussed below in conjunction with FIGS. 3 and 4).
The second phase of the study begins in processing block 46. Since those study participants in the second phase have already failed to respond to placebo in the first phase (i.e. they have already “failed placebo,”) their placebo response will be reduced.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS5898586Nov 4, 1994Apr 27, 1999Eli Lilly And CompanyMethod for administering clinical trail materialUS5991731Feb 1, 1999Nov 23, 1999University Of FloridaMethod and system for interactive prescription and distribution of prescriptions in conducting clinical studiesUS6041788Jan 4, 1999Mar 28, 2000Shen; LijiMethod of evaluating drug effect in a multiple dose clinical trialUS6450954Nov 1, 1999Sep 17, 2002New England Medical Center Hospitals, Inc.Method of randomizing patients in a clinical trialUS7647235Jan 12, 2010The General Hospital CorporationSystem and method for reducing the placebo effect in controlled clinical trialsUS20020143563Apr 2, 2001Oct 3, 2002Hufford Michael R.System for clinical trial subject complianceWO2001032071A2Oct 31, 2000May 10, 2001New England Medical Center Hospitals, Inc.Method of randomizing patients in a clinical trialNon-Patent CitationsReference1"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. 1807-1814.2"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. 1807-1814.3Altman et al.; "Statistics notes How to randomize", BMJ, vol. 319, Sep. 11, 1999, 703-704.4Bech et al.; "The Hamilton Depression Scale, Evaluation of Objectivity Using Logistic Models;" Acta Psychiat. Scand. (1981) 63; 1981; pp. 290-299.5Beller et al.; "Randomisation in clinical trials", MJA, vol. 177, Nov. 18, 2002, 565-567.6Brown, Jr.; "The Crossover Experiment for Clinical Trials;" Publication of Stanford University Medical Center, Stanford, CA; Biometrics 36; Mar. 1980; pp. 69-79.7Campbell et al.; "A Primer on Regression Artifacts;" The Guilford Press; New York; 1999; entire book.8Carriere; "Crossover Designs for Clinical Trials;" Statistics in Medicine; vol. 13; Apr. 1993; pp. 1063-1069.9Chassan; "Intensive Design: Statistics and the Single Case;" Research Designs and Methods in Psychiatry; Chapter 11; Jan. 1992; pp. 173-183.10Chmura Kraemer et al.; "Methodology in Psychiatric Research;" Archives of General Psychiatry; vol. 44; Dec. 1987; pp. 1100-1106.11Cutter et al.; "Development of a Multiple Sclerosis Functional Composite as a Clinical Trial Outcome Measure;" Brain, vol. 122; 1999; pp. 871-882.12DeBrota et al.; "Same Rater Versus Different Raters in Depression Clinical Trials;" 42nd Annual NCDUE Meeting; Boca Raton, FL; Jun. 10, 2000; 1 sheet.13Demitrack et al; "The Problem of Measurement Error in Multisite Clinical Trials;" Psychopharmacology Bulletin 34 (1); 1998; pp. 19-24.14Diener et al.; "Cyclandelate in the Prophylaxis of Migraine: A Randomized Parallel, Double-Blind Study in Comparison with a Placebo and Propranolol;" Cephalalgia; 1996; pp. 16:441-447.15Doody et al.; "Open-Label, Multicenter, Phase 3 Extension Study of the Safety and Efficacy of Donepezil in Patients With Alzheimer Disease", Arch Neurol/vol. 58, Mar. 2001, pp. 427-433.16Dunger-Baldauf, et al.; "Designs with Randomization Following Initial Study Treatment;" Wiley Enclopedia of Clinical Trials, copyright 2007; pp. 1-7.17Dunger-Baldauf, et al.; "Re-Treatment Studies: Design and Analysis;" Drug Information Journal, vol. 40; 2006; pp. 209-217.18Ellenberg; "Randomization Designs in Comparative Clinical Trials", The New England Journal of Medicine, vol. 310, No. 21, May 24, 1984, 1404-1408.19Faraone et al.; "The Drug-Placebo Response Curve: A New Method for Assessing Drug Effects in Clinical Trials", Journal of Clinical Psychopharmacology: Dec. 2000-vol. 20-Issue 6-pp. 673-679.20Faraone et al.; "The Drug-Placebo Response Curve: A New Method for Assessing Drug Effects in Clinical Trials", Journal of Clinical Psychopharmacology: Dec. 2000—vol. 20—Issue 6—pp. 673-679.21Faries et al.: "The Double-Blind Variable Placebo Lead-in Period: Results From Two Antidepressant Clinical Trials;" Journal of Clinical Psychopharmacology; vol. 21, No. 6; Dec. 2001; pp. 561-568.22Faries et al.; "The Responsiveness of the Hamilton Depression Rating Scale;" Journal of Psychiatric Research; vol. 34, Jan. 2000; pp. 3-10.23Farlow et al.; "A 52-Week Study of the Efficacy of Rivastigmine in Patients with Mild to Moderately Sever Alzheimer's Disease;" European Neurology; vol. 4, Nov. 2000; pp. 236-241.24Fava et al.; "How to Write a Study Protocol: A Primer for the Clinician;" Research Designs and Methods in Psychiatry; Ch. 20, Jan. 1992; pp. 297-305.25Fava et al.; "Major Depressive Subtypes and Treatment Response;"1997 Society of Biological Psychiatry; vol. 42; Jan. 1997; pp. 568-576.26Fava 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. 72:15-127.27Fava; "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. 1292-1303.28Fiore 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. 1940-1947.29Gibbons et al.; "Exactly What Does the Hamilton Depression Rating Scale Measure?;" Journal of Psychiatric Research; vol. 27, No. 3; Jan. 1993; pp. 259-273.30Grandi; "The Sequential Parallel Comparison Model: A Revolution in the Design of Clinical Trials", Affective Disorders Program, Department of Psychology, University of Bologna, Bologna, Italy, Psychotherapy and Psychosomatics 2003; 72:113-114.31Hart; "The mysterious placebo effect", Modern Drug Discovery, Jul./Aug. 1999, 2 (4) 30-40, 7 pages.32Hills et al.; "The Two-Period Cross-Over Clinical Trial;" British Journal of Clinical Pharmacology; Jul. 1979; pp. 7-20.33Hofman, et al.., Prospective Randomized Trial to Evaluate Two Delayed Granulocyte Colony Stimulating Factor Administration Schedules After High-Dose Cytarabine Therapy in Adult Patients With Acute Lymphoblastic Leukemia , Ann Hemotol 81; Oct. 17, 2002, pp. 570-574.34Holbrook et al.; "Innovation and placebos in research: a new design of clinical trial", The Lancet, vol. 362, Dec. 20/27, 2003, pp. 2036-2037.35Hooper et al.; "Do Clinical Trials Reflect Drug Potential: A Review of 5 FDA Evaluations of New Antidepressants;" 39th Annual NCDUE Meeting; Boca Raton, FL; Jun. 11-14, 1998; Poster No. 182, 1 sheet.36Hrobjartsson 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 2004; 256:91-100.37Hr�bjartsson 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. 91-100.38Hrobjartsson et al; "Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with no Treatment", The New England Journal of Medicine, vol. 344, No. 21, May 24, 2001, pp. 1594-1603.39Image File Wrapper for U.S. Appl. No. 10/814,852, filed Mar. 31, 2004 and downloaded on Oct. 19, 2010; Part 1 of 4; 350 pages.40Image File Wrapper for U.S. Appl. No. 10/814,852, filed Mar. 31, 2004 and downloaded on Oct. 19, 2010; Part 2 of 4; 350 pages.41Image File Wrapper for U.S. Appl. No. 10/814,852, filed Mar. 31, 2004 and downloaded on Oct. 19, 2010; Part 3 of 4; 300 pages.42Image File Wrapper for U.S. Appl. No. 10/814,852, filed Mar. 31, 2004 and downloaded on Oct. 19, 2010; Part 4 of 4; 161 pages.43Image File Wrapper for U.S. Appl. No. 12/545,562, filed Aug. 21, 2009 and downloaded on Oct. 19, 2010; Part 1 of 5; 225 pages.44Image File Wrapper for U.S. Appl. No. 12/545,562, filed Aug. 21, 2009 and downloaded on Oct. 19, 2010; Part 2 of 5; 125 pages.45Image File Wrapper for U.S. Appl. No. 12/545,562, filed Aug. 21, 2009 and downloaded on Oct. 19, 2010; Part 3 of 5; 350 pages.46Image File Wrapper for U.S. Appl. No. 12/545,562, filed Aug. 21, 2009 and downloaded on Oct. 19, 2010; Part 4 of 5; 325 pages.47Image File Wrapper for U.S. Appl. No. 12/545,562, filed Aug. 21, 2009 and downloaded on Oct. 19, 2010; Part 5 of 5; 330 pages.48Jorenby 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. 685-691.49Kellner; "The Development of Sensitive Scales for Research in Therapeutics;" Research Designs and Methods in Psychiatry; Jan. 1992; pp. 213-222.50Klein et al.; "Improving Clinical Trials" American Society of Clinical Psychopharmacology Recommendations, Arch Gen Psychiatry/vol. 59, Mar. 2002, pp. 272-278.51Kobak et al.; "Computerized Assessment of Depression and Anxiety Over the Telephone Using Interactive Voice Response;" MD Computing; vol. 16; May 1999; pp. 64-68.52Koch et al.; "A Two-Period Crossover Design for the Comparison of Two Active Treatments and Placebo", Statistics in Medicine, vol. 8, 487-504 (1989).53Koch et al.; "Methodological Advances and Plans for Improving Regulatory Success for Confirmatory Studies;" Statistics in Medicine, vol. 17; 1998; pp. 1675-1690.54Kraemer, Ph.D., et al., How Do Risk Factors Work Together? Mediators, Moderators, and Independent Overlapping and Proxy Risk Factors, American Journal of Psychiatry, Jun. 2001, pp. 848-856.55Kraemer, Ph.D., et al., Mediators and Moderators of Treatment Effects in Randomized Clinical Trials, Arch Gen Psychiatry, vol. 59, Oct. 2002, pp. 877-883.56Kravitz, et al., Evidence-Based Medicine, Heterogeneity of Treatment Effects, and the Trouble with Averages, University of California, The Milbank Quarterly, vol. 82, No. 4, 2004, pp. 661-687.57Laird; "Estimating Rates of Change in Clinical Studies;" Research Designs and Methods in Psychiatry; Chapter 12; Jan. 1992; pp. 185-193.58Laughren; "The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective", Eur Psychiatry 2001; 16: 418-23.59Leber et al.; "Threats to the Validity of Clinical Trials Employing Enrichment Strategies for Sample Selection;" Elsevier Science Inc.; Controlled Clinical Trials; vol. 19, Issue 2 Apr. 1998; pp. 178-187.60Lin; "An Issue of Statistical Analysis in Controlled Multi-Centre Studies: How Shall We Weight the Centres?;" Statistics in Medicine, vol. 18; 1999; pp. 365-373.61Myers 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. 21-25.62NDA; Center for Drug Evaluation and Research, Application No. 18-936/S-036; Food and Drug Administration; 1988.63Niaura 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. 887-896.64Nordenberg; "The Healing Power of Placebos", The Body, FDA Consumer, Jan./Feb. 2000, 6 pages.65Noseworthy et al.; "The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial" American Academy of Neurology, 1994; 44; 16-20.66O'Sullivan et al.; "Sensitivity of the Six-Item Hamilton Depression Rating Scale;" American College of Rheumatology Psychiatric Scandinavian; vol. 95; Jan. 1997; pp. 379-384.67Otto et al.; "Assay Sensitivity, Failed Clinical Trials, and the Conduct of Science;" 9 pages as printed in Psychotherapy Psychosomatics; Jan. 2002; vol. 71; pp. 241-243.68Peselow et al.; "Melancholic/Endogenous Depression and Response to Somatic Treatment and Placebo;" American Journal of Psychiatry; vol. 149, No. 10; Oct. 1992; pp. 1324-1334.69Quitkin et al.; "Are There Differences Between Women's and Men's Antidepressant Responses?:" American Journal of Psychiatry; vol. 159, No. 11; Nov. 2002; pp. 1848-1854.70Quitkin et al.; "Identification of True Drug Response to Antidepressants;" Archives of General Psychiatry; vol. 41; Aug. 1984; pp. 782-786.71Quitkin; "Methodology of Measuring the Efficacy of Antidepressants;" Psychopharmacology (Berl); vol. 106; Jan. 1992; pp. S87-S89.72Rao et al.: "Linear Statistical Inference and its Applications;" New York: Wiley; 1952, p. 50.73Raskind et al; "Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension;" American Academy of Neurology; Jun. 2000; pp. 2260-2269.74Reginster et al.; "Long-Term Effects of Glucosamine Sulphate on Osteoarthritis Progression: A Randomised, Placebo-Controlled Clinical Trial;" The Lancet, vol. 357, Issue 9252; Jan. 27, 2001; pp. 251-256.75Robinson et al.; "Concerns About clinical Drug Trials;" Journal of Clinical Psychopharmacology; Dec. 2000; vol. 20, No. 6; pp. 593-596.76Rosner et al; "Randomized Discontinuation Design: Application to Cytostatic Antineoplastic Agents;" Journal of Clinical Oncology; vol. 20, No. 22; Nov. 15, 2002; pp. 4478-4484.77Rush et al.; "The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and Self-Report (IDS-SR) Ratings of Depressing Symptoms;" International Journal of Methods in Psychiatric Research; vol. 9, No. 2; Jan. 2000; pp. 49-59.78Schatzbert et al.; "Use of Placebo Control Groups in Evaluating Efficacy of Treatment of Unipolar Major Depression;" 2000 Society of Biological Psychiatry; Jan. 2000; vol. 47; pp. 736-744.79Shelton et al.; "Effectiveness of St. John's Wort in Major Depression-A Randomized Controlled Trial;" Journal of the American Medical Association; vol. 285, No. 15; Apr. 2001; pp. 1978-1986.80Shelton et al.; "Effectiveness of St. John's Wort in Major Depression—A Randomized Controlled Trial;" Journal of the American Medical Association; vol. 285, No. 15; Apr. 2001; pp. 1978-1986.81Shiffman et al.; "A Randomized Controlled Trial of Maintenance Interferon Therapy for Patients with Chronic Hepatitis C Virus and Persistent Viremia;" Gastroenterology; Nov. 1999; vol. 117, No. 5; pp. 1164-1172.82Shun et al.; "Statistical Consideration of the Strategy for Demonstrating Clinical Evidence of Effectiveness-One Larger vs. Two Smaller Pivotal Studies;" Statistics of Medicine; 2005; pp. 24: 1639-1651.83Shun et al.; "Statistical Consideration of the Strategy for Demonstrating Clinical Evidence of Effectiveness—One Larger vs. Two Smaller Pivotal Studies;" Statistics of Medicine; 2005; pp. 24: 1639-1651.84Simpson et al.; "Two Dosages of Imipramine in Hospitalized Endogenous and Neurotic Depressives;" Archives of General Psychiatry; vol. 33; Sep. 1976; pp. 1093-1103.85Stevens et al.; "A Randomized Trial of Itraconazole in Allergic Bronchopulmonary Aspergillosis;" The New England Journal of Medicine; Mar. 16, 2000; pp. 756-881.86Streiner; "Placebo-controlled trials: when are they needed?" Schizophrenia Research 35 (1999), 201-210.87Talbot; "The Placebo Prescription", New York Times Magazine, Jan. 9, 2000, 10 pages.88Temple; "Special Study Designs: Early Escape, Enrichment, Studies in Non-Responders;" Communications in Statistics-Theory and Method; vol. 23, Issue 2; 1994; pp. 499-531.89Trivedi et al.; "Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?;" American College of Neuropsychopharmacology 1994; vol. 11, No. 1; Mar. 1994; pp. 33-43.90Uhlenhuth et al.; "Intensive Design in Evaluating Anxiolytic Agents;" Psychopharmacology; vol. 52; Jan. 1977; pp. 79-85.91Walsh et al.; "Placebo Response in Studies of Major Depression: Variable, Substantial, and Growing;" Journal of the American Medical Association; vol. 287, No. 14; Apr. 10, 2002; pp. 1840-1847.92William J. Carpenter, Jr., M.D., From Clinical Trial to Prescription, Arch Gen Psychiatry, vol. 59, Mar. 2002, pp. 282-285.93Zelen; "A New Design for Randomized Clinical Trials", The New England Journal of Medicine, vol. 300, No. 22, May 31, 1979, pp. 1242-1245.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8145505Mar 27, 2012The General Hospital CorporationSystem and method for reducing the placebo effect in controlled clinical trialsUS8219419Feb 23, 2012Jul 10, 2012The General Hospital CorporationSystem and method for reducing the placebo effect in controlled clinical trialsClassifications U.S. Classification705/2, 705/3, 705/1.1International ClassificationA61B5/00, G06Q10/00, G06F19/00, G06Q50/00Cooperative ClassificationG06Q50/24, G06Q50/22, G06F19/366, G06F19/363European ClassificationG06F19/36C, G06Q50/24, G06Q50/22Legal EventsDateCodeEventDescriptionOct 26, 2010ASAssignmentOwner name: THE GENERAL HOSPITAL CORPORATION, MASSACHUSETTSFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:FAVA, MAURIZIO;SCHOENFELD, DAVID;SIGNING DATES FROM 20040724 TO 20040804;REEL/FRAME:025193/0590Dec 20, 2011CCCertificate of correctionAug 17, 2012ASAssignmentOwner name: CLINICAL TRIAL SOLUTIONS LLC, FLORIDAFree format text: LICENSE;ASSIGNOR:THE GENERAL HOSPITAL CORPORATION;REEL/FRAME:028803/0035Effective date: 20080826Dec 31, 2012SULPSurcharge for late paymentJan 14, 2014ASAssignmentOwner name: RCT LOGIC, LLC, FLORIDAFree format text: CHANGE OF NAME;ASSIGNOR:CLINICAL TRIAL SOLUTIONS LLC;REEL/FRAME:032006/0001Effective date: 20100427Jan 19, 2015FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services