Companies and Markets: "Innovative Clinical Trial Design and Management - Trends, success stories and impact upon research and development budgets" market report available now.LONDON -- Companies and Markets announces the addition of "Innovative Clinical Trial Design and Management - Trends, success stories and impact upon research and development budgets" market research report to its portfolio (http://www.companiesandmarkets.com/link.asp?id=304804B8H44869) The costs associated with developing drugs have risen dramatically over the past decade and fewer drugs are obtaining regulatory approval. The pharmaceutical industry is continually con·tin·u·al adj. 1. Recurring regularly or frequently: the continual need to pay the mortgage. 2. exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs. These innovative clinical trial designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy. 'Innovative Clinical Trial Design and Management' is a new report that explores the major types of adaptive design and their role in dose finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. , assesses the logistical lo·gis·tic also lo·gis·ti·cal adj. 1. Of or relating to symbolic logic. 2. Of or relating to logistics. [Medieval Latin logisticus, of calculation implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. . Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of the potential cost and time savings that innovative trial designs can offer throughout the clinical development process. Key Findings * Major pharmaceutical companies are implementing adaptive trials to improve dose-finding in the Phase 2 setting. The use of adaptive clinical trials will increase across the industry over the next 2-3 years. * Adaptive clinical trial designs are more effective than traditional designs in cases where there is uncertainty surrounding sur·round tr.v. sur·round·ed, sur·round·ing, sur·rounds 1. To extend on all sides of simultaneously; encircle. 2. To enclose or confine on all sides so as to bar escape or outside communication. n. the dose, effect size and variability, clinical endpoint In a research trial, a clinical endpoint refers to a disease, symptom, or sign that constitutes one of the target outcomes of the trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the or patient populations. * The planning and execution of adaptive designs is more complex than the traditional approach. Successful implementations require teams of statisticians Statisticians or people who made notable contributions to the theories of statistics, or related aspects of probability, or machine learning: A to E
* Predictive biomarkers have been found to require detailed prospective analysis far earlier in the clinical development process, and with the same clarity as traditional drug approvals. Post-hoc correlations were previously thought to be good enough for identifying the biomarkers used to predict the patients most likely to respond well to a new treatment. * Regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities are supportive of adaptive trials, particularly in the Phase 2 setting. However, there are concerns over the confidentiality of data and companies have been asked to demonstrate that the parties involved in running the study will remain unaware of ongoing adaptations. Published Date: 01/05/2008 Number of Pages: 170 The report provides a highly detailed and comprehensive 170 pages of analysis covering the clinical trials market. |
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