William Shannon, PhD, is an Associate Professor of Biostatistics at Washington University School of Medicine, since 1995; and Founder and President of BioRankings, a pharma IT firm, since January 2007. Dr. Shannon has over 20 years of applied biostatistical expertise in biomedical, pharmaceutical, and biotech research. He has 100 peer-reviewed publications in areas such as oncology, genetics, cardiology, pulmonology infectious disease, sleep medicine, health care delivery, statistics, and other areas. By making complex biostatistical ideas understandable, Dr. Shannon can help companies gain insight on the strengths and weaknesses of pre-clinical data and clinical trials that may impact a company's long term viability, and understanding of statistical data to protect investment. (This is me - Update Profile)
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
Meta-analysis of probiotics in atopic dermatitis
April 16, 2009
Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. | www.ncbi.nlm.nih.gov
The use of meta-analysis to evaluate probiotics in this condition is commendable. The abstract suggests that improvement may be real, but the evidence presented indicates that probiotics may be ineffective on careful reading. The abstract is lacking information needed to determine the quality of the meta-analysis and whether its results/suggestions should be considered in investment decisions.
New FDA effort takes aim at genomics: Inherent risk to investors
February 6, 2009
New FDA Effort to Take Aim at Genomics | www.genomeweb.com
The risk to an investor in genomic or personalized medicine is significant and a clear understanding of the low power and high risk of false-positives needs to be kept in mind. The establishment at the FDA of a senior scientist to oversee and coordinate genomic activities is necessary but not necessarily sufficient to insure that future genomic treatments are effective.
Eli Lilly's Personal Medicine Goal
November 27, 2008
Personal medicine is goal of Eli Lilly & Co. | www.azcentral.com
The Chairman of Eli Lilly announcing that personalized medicine (e.g., pharmacogenetics) is a major shift in strategy for big pharma could impact in a significant way the market share for new drugs and the amount of money for research needed to bring a targeted therapy to market. If this strategy is widely accepted the likely impact on small biotech firms will be a significant increase in their value and more acquisitions.
Dealing with publication bias using the 'file drawer' scenario.
October 28, 2008
Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com
In this meta-analysis, the authors looked at the number of studies, if any, per new drug application with the FDA that got published, at what time, and how much information they released. They concluded that there is strong evidence of publication bias in what the drug companies will make public, with only 76% of pivotal trials and 24% of non-pivotal trials making publication. We looked at how this publication bias can affect investors when making investment decisions about pharmaceutical companies, due to limited or incomplete public information.
Is Biodel's argument to drop the India data from analysis valid?
October 9, 2008
Biodel Releases Preliminary Phase III Clinical Trials for VIAject | www.fiercebiotech.com
Biodel’s September 8th announcement of the Phase III non-inferiority trial results for VIAject at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome left many investors wary of the legitimacy of the data that was presented. The study, which was originally conducted in the US, Germany, and India, did not include the data from the Type 1 study in India in its final results due to the company’s claims of data anomalies that question the validity of the data for determining non-inferiority. We analyzed the study design and subgroup analyses to understand the impact of eliminating the India subgroup on the final trial results.
| Study Group Name | No. Members |
|---|---|
| Biostatisticians | 381 |
| Biostatisticians (US) | 254 |
William Shannon has not participated in any GLG Live Meetings.