( r thelong-lasting benefit to the patie...)Myriad Genetics Presents Mathematical Comparison of Disease,Modification Trial Designs at Alzheimer's ConferenceCurrent,Flurizan Phase 3 Study Design May Demonstrate Disease Modification,Health

r the long-lasting benefit to the patient is maintained, demonstrating disease modification, or if the patient drops back to the level of patients on placebo for the duration of the study. In a staggered start design, one group of patients receives the active study drug for the entire study period, while a second group initially receives placebo and then later is given the active drug. If the second group fails to "catch up" in the level of performance of the first group, this is taken to be evidence for a disease modifying effect of the drug. Unfortunately, these designs are difficult to implement and have rarely been used in clinical trials as they are complicated by very long study durations, leading to high dropout rates that introduce biased results, as well as presenting ethical concerns unacceptable to patients and their families.

A team of biostatisticians and mathematicians at Myriad, led by Suzanne Hendrix, Ph.D., Sasha Gutin, Ph.D., and Scott Horton, has proposed an alternative strategy designated the "Natural History Staggered Start" analysis, that compares the slopes of decline of drug treated patients with those of patients receiving placebo and corrects for the severity of disease at baseline. The mathematical analysis presented at the Alzheimer's Association AD Prevention Conference demonstrates that this trial analysis methodology is mathematically equivalent to the "Staggered Start" and "Randomized Withdrawal" designs and provides the same level of evidence of a disease-modifying drug effect in a clinical trial that is not subject to the above-mentioned complications, bias and ethical challenges of the previous designs.

"We are excited about this persuasive mathematical comparison of clinical trial designs," said Adrian Hobden, PhD, President of Myriad Pharmaceuticals, Inc. "We believe that this mathematical proof, coupled with the Flurizan trial design may strengthen the Company's position with the FDA in favor of a disease modificat
'"/>

Page: 1 2 3 4 5
Related medicine technology :

1. Myriad Genetics Presents Tumor Origin Technology at AACR
2. Myriad Genetics Presents Azixas Mode of Action at AACR
3. Response Genetics Announces Publication of a Phase III Clinical Trial Demonstrating That Low Levels of ERCC-1 Help to Predict Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer
4. Genetics Journal Thimerosal/Autism Study the Best Science Drug Company Money Can Buy
5. Targeted Genetics Reports Inflammatory Arthritis Clinical Data at European Rheumatology Conference
6. ZymoGenetics Reports Results From Atacicept Phase 1b Clinical Trial in B-Cell Chronic Lymphocytic Leukemia
7. Seattle Genetics Highlights Data on its Proprietary Antibody-Drug Conjugate Technology at AACR
8. Aeolus Pharmaceuticals AEOL 10150 Highlighted in Nature Genetics Publication
9. Expression Genetics, Inc. Announces Successful Completion of Phase I Trial of Gene-Based IL-12 for Treatment of Ovarian Cancer
10. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
11. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference