Analysis Group experts and biostatistics thought leaders from leading universities and research institutions have applied biostatistical methods to clinical trial data in the context of life-sciences research and legal disputes involving intellectual property, drug safety, product liability, securities fraud, false claims and kickbacks allegations, and in white collar investigations.
Our work has included:
- Utilizing counterfactual models, such as the inverse probability of censoring weighted (IPCW) method and rank-preserving structural failure time (RPSFT) model, to adjust for selective crossover and informative censoring issues in clinical trials.
- Developing the matching-adjusted indirect comparison (MAIC) method to facilitate indirect comparisons across clinical trials when head-to-head clinical trials are not available.
- Analyzing clinical trials data with respect to efficacy and safety to address questions regarding the drug’s patent and the potential making and selling of a generic form prior to the patent’s expiration.
- Conducting ad hoc analyses of clinical trials data to address emergent drug safety issues and to analyze secondary endpoints, such as quality-of-life measures, in the trials.
Selected Examples of Our Work
- Cella D, Pickard AS, Duh MS, Guerin A, Mishagina N, Antràs L, Neary MP, McCann L, Hodge R, Sternberg CN. Health-Related Quality of Life in Patients with Advanced Renal Cell Carcinoma Receiving Pazopanib or Placebo in a Randomised Phase III trial. Eur J Cancer. 2012 Feb;48(3):311–323.
- Signorovitch JE, Wu EQ, Yu AP, Gerrits CM, Kantor E, Bao Y, Gupta SR, Mulani PM. Comparative Effectiveness Without Head-to-Head Trials: A Method for Matching-Adjusted Indirect Comparisons Applied to Psoriasis Treatment with Adalimumab or Etanercept. PharmacoEconomics. 2010;28(10):935–945.
- Chen L, Antras L, Duh MS, Neary M, O'Brien ME. Symptom Assessment in Relapsed Small Cell Lung Cancer: Cross-Validation of the Patient Symptom Assessment in Lung Cancer Instrument. J Thorac Oncol. 2008 Oct;3(10):1137–1145.
- Duh MS, Walker AM, Lindmark B, Laties AM. Association Between Intraocular Pressure and Budesonide Inhalation Therapy in Asthmatic Patients. Ann Allergy Asthma Immunol. 2000 Nov; 85(5):356–361.
- Featured Expert Lee-Jen Wei Professor of Biostatistics, Harvard School of Public Health
- Related Focus Area Drug Safety Litigation
An Effective Way to Quantify the Safety Profile of a Drug or Device When Background Toxicity Rates Are LowFDLI Update, January/February 2011
- Featured Expert Eric Q. Wu Managing Principal, Boston, Paris, Brussels, London, Chaoyang, Beijing
- Forum The Missing Data Challenge: Using Clinical Trials Results
- Featured Expert Daniel O. Scharfstein Affiliate
- Featured Expert Mei Sheng Duh Managing Principal, Boston
Bone Care International v. Roxane Labs, et al.