HAMILTON, N.J., June 2 /PRNewswire/ -- MedAvante, Inc., the leader in centralized evaluation of central nervous system (CNS) disorders, announced today it was launching its CQC Continuous Quality Control Service for trials assessing Alzheimer's Disease. Its CQC Services are already in use for trials of other central nervous system disorders including depression, anxiety and schizophrenia in the United States, Europe, Asia, Latin America and South Africa.
The number of Americans with Alzheimer's Disease exceeds 5 million, and the Pharmaceutical Research and Manufacturers of America estimates there are 27 medications in development for Alzheimer's, with more than 200 trials recruiting patients. In Alzheimer's trials, like other CNS trials, patients are evaluated using rating scales that must be administered and interpreted by professionals. It is critical that such evaluations be accurate and consistent from the beginning of a study until the end to preserve the validity of the trial.
"In Alzheimer's Disease trials, which tend to be larger and longer than other trials, the quality of the data is only as good as the quality of the ratings and the raters who are responsible for measuring the degree of cognitive impairment exhibited by study participants. By using CQC, we can assure Alzheimer's Disease trial sponsors that regardless of rater turnover or the length of the study the results of a trial will reflect the activity of a drug, not bias or subtle errors caused by inconsistent ratings or less experienced raters," said Paul Gilbert, Chief Executive Officer of MedAvante. "Researchers have made great strides in understanding Alzheimer's Disease, which could triple by 2050, but translating those gains into treatments will require well-executed clinical trials."
Such an approach can impact the overall outcomes of studies. By reducing inter-rater variability, results are more consistent, making it easier to identify whether a drug is having an effect.
"When experimental therapies for Alzheimer's Disease fail in clinical trials, or there are mixed or inconclusive results, one of the questions that naturally comes up is whether the intervention simply doesn't work or whether the methodology used for assessing patients could have been flawed," said Pierre Tariot, Director, Memory Disorders Center Banner Alzheimer's Institute, Research Professor of Psychiatry, University of Arizona College of Medicine and MedAvante Alzheimer's Advisory Board co-chair, "It is a potentially critical issue in making go-no go decisions in the development process, and of particular concern in the Alzheimer's field, since the need for new, effective treatments is so acute and the development process so fraught with peril."
The CQC process, developed in collaboration with an advisory board of leading academics, includes several components designed to maintain the highest quality of those evaluations over the years of an Alzheimer's Disease trial. First, the participating raters are extensively trained to administer with the same standardized approach the key rating scales used in Alzheimer's studies, including the ADAS-Cog, ADCS-ADL, MMSE, CDR, and ADCS-CGIC. Second, after the training they are then evaluated and qualified as ready to begin the trial. During the trial, each rater's assessments are continually monitored by a centralized cohort of expert trainers to ensure consistency and provide additional training if indicated. MedAvante's Monthly Clinical Trial Dashboard Report to the sponsor provides continual detailed updates on the quality and reliability of the assessments during the trial to permit remediation if needed.
MedAvante is the premier global provider of centralized expert psychiatric rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. Our flagship service, Remote Centralized Ratings are real-time assessments, either by telephone or videoconference, of subjects in global drug trials. Centralizing the assessors and blinding them to study protocols, results in a level of standardization, calibration and objectivity that is not achievable with a decentralized group of study raters participating from unconnected investigative sites. In addition to Centralized Ratings, the company provides Continuous Quality Control CQC, a monitoring service in which expert calibrated trainers review site based study interviews via audio and video. MedAvante's solutions help sponsors achieve increased drug effect and reduced trial failure rates, enabling them to bring better drugs to market faster. MedAvante operates facilities in Hamilton, NJ; Madison, WI; and Moscow, Russia.
|SOURCE MedAvante, Inc.|
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