Adaptive Learning of Drug Quality and Optimization of Patient Recruitment for Clinical Trials with Dropouts
Published Online:24 Mar 2021https://doi.org/10.1287/msom.2020.0936
References
- (2016) Response-adaptive designs for clinical trials: Simultaneous learning from multiple patients. Eur. J. Oper. Res. 248(2):619–633.Crossref, Google Scholar
- (2020) An approximation approach for response-adaptive clinical trial design. INFORMS J. Comput. https://doi.org/10.1287/ijoc.2020.0969.Google Scholar
- (2009) Missing outcomes in randomized trials: Addressing the dilemma. Open Medicine 3(2):51–53.Google Scholar
- (2001) A Guide to Patient Recruitment (CenterWatch, Boston, MA).Google Scholar
- (1985) Bayes solution to dynamic inventory models under unknown demand distribution. Management Sci. 31(9):1150–1160.Link, Google Scholar
- (2004) Pre-ipo operational and financial decisions. Management Sci. 50(7):935–948.Link, Google Scholar
- (1994) Bayesian Theory (John Wiley & Sons, Hoboken, NJ).Google Scholar
- (2004) Bayesian Statistics and the Efficiency and Ethics of Clinical Trials. Statist. Sci. 19(1):175–187.Crossref, Google Scholar
- (2007) A learning approach for interactive marketing to a customer segment. Oper. Res. 55(6):1120–1135.Link, Google Scholar
- CBO (2006) A CBO Study: R&D in the Pharmaceutical Industry (Congressional Budget Office, Washington, DC).Google Scholar
- (2005) An adaptive sampling algorithm for solving Markov decision processes. Oper. Res. 53(1):126–139.Link, Google Scholar
- (2017) A Bayesian decision theoretic model of sequential experimentation with delayed response. J. Royal Statist. Soc. B 79(5):1439–1462.Crossref, Google Scholar
- (1994) A periodic review, production planning model with uncertain capacity and uncertain demand optimality of extended myopic policies. Management Sci. 40(3):320–332.Link, Google Scholar
- Cognizant (2015) Patients recruitment forecast in clinical trials. Cognizant 20-20 Insights. https://www.cognizant.com/whitepapers/patients-recruitment-forecast-in-clinical-trials-codex1382.pdfGoogle Scholar
- (1997) Optimal management of an R&D budget. J. Econom. Dynamics Control 21(2-3):575–602.Crossref, Google Scholar
- Editors (2003) Clinical monitoring: Answers to questions about good clinical practice. Applied Clin Trials. https://www.appliedclinicaltrialsonline.com/view/clinical-monitoring-answers-questions-about-good-clinical-practice.Google Scholar
- FDA (2019) Adaptive designs for clinical trials of drugs and biologics guidance for industry. Accessed January 1, 2020. https://www.fda.gov/media/78495/download.Google Scholar
- (2002) Guidelines for the design of clinical trials with longitudinal outcomes. Control Clinical Trials 23(3):257–273.Crossref, Google Scholar
- (1994) Lot sizing in assembly systems with random component yields. IIE Trans. 26(2):19–24.Crossref, Google Scholar
- (2007) Valuing R&D projects in a portfolio: Evidence from the pharmaceutical industry. Management Sci. 50(9):1452–1466.Link, Google Scholar
- (2011) Multi-Armed Bandit Allocation Indices (John Wiley & Sons, Hoboken, NJ).Crossref, Google Scholar
- (2014) Clinical development success rates for investigational drugs. Nature Biotechnol. 32(1):40–51.Crossref, Google Scholar
- IFPMA (2015) The Pharmaceutical Industry and Global Health: Facts and Figures (International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland). Accessed June 24, 2019, https://www.ifpma.org/resource-centre/facts-figures-2015/.Google Scholar
- IOM (2012) Public Engagement and Clinical Trials: New Models and Disruptive Technologies (Institute of Medicine, The National Academies Press, Washington, DC).Google Scholar
- (2003) In search of innovative techniques to evaluate pharmaceutical R&D projects. Technovation 23:291–296.Crossref, Google Scholar
- (2000) Group Sequential Methods with Applications to Clinical Trials (CRC Press, Boca Raton, Florida).Google Scholar
- (2015) An approximate dynamic programming algorithm for monotone value functions. Oper. Res. 63(6):1489–1511.Link, Google Scholar
- (2014) Production capacity investment with data updates. IIE Trans. 46(7):664–682.Crossref, Google Scholar
- (2000) Real-options valuation for a biotechnology company. Financial Anal. J. 56(3):76–84.Crossref, Google Scholar
- (2005) A practical comparison of group-sequential and adaptive designs. J. Biopharmacology Statist. 15(4):719–738.Crossref, Google Scholar
- (2017) Clinical trials for new drug development: Optimal investment and application. Manufacturing Service Oper. Management 19(13):437–452.Link, Google Scholar
- (1999) Stalking information: Bayesian inventory management with unobserved lost sales. Management Sci. 45(3):346–363.Link, Google Scholar
- (1971) Optimal management of an R&D project. Management Sci. 17(11):679–697.Link, Google Scholar
- (1986) The value of waiting to invest. Quart. J. Econom. 17(4):707–728.Crossref, Google Scholar
- National Institutes of Health (2016) Strattera trials (U.S. National Library of Medicine, Bethesda, MD). Accessed July 1, 2016, www.clinicaltrials.gov.Google Scholar
- NRC (2010) The Prevention & Treatment of Missing Data in Clinical Trials (National Academies Press, Washington, DC).Google Scholar
- (2001) Interim monitoring of group sequential trials using spending functions for the type i and type ii error probabilities. Drug Inform. J. 35:1113–1121.Crossref, Google Scholar
- (1987) The complexity of Markov decision processes. Math. Oper. Res. 12(3):441–450.Link, Google Scholar
- (1995) A periodic review inventory model with markovian supply availability. Internat. J. Production Econom. 42(2):131–136.Crossref, Google Scholar
- (2014) Optimal Bayesian sequential sampling rules for the economic evaluation of health technologies. J. Royal Statist. Soc. Ser. A 177:419–438.Crossref, Google Scholar
- PhRMA (2015) Pharmaceutical Industry Profile (Pharmaceutical Research & Manufacturers of America, Washington, D.C.). Accessed June 24, 2019, http://phrma-docs.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf.Google Scholar
- (1993) Investments of uncertain cost. J. Financial Econom. 34(1):511–530.Crossref, Google Scholar
- (1983) Clinical Trials: A Practical Approach (John Wiley & Sons, Hoboken, NJ).Google Scholar
- (2011) Approximate Dynamic Programming: Solving the Curses of Dimensionality (John Wiley & Sons, Hoboken, New Jersey).Crossref, Google Scholar
- (2018) Trial termination and drug misclassification in sequential adaptive clinical trials. Service Sci. 10(3):354–377.Link, Google Scholar
- (2004) Patent and R&D as real options. Econom. Notes 33(1):23–54.Crossref, Google Scholar
- (2015) Recruitment challenges in clinical research including cancer patients and caregivers. Trials 16(428):1–9.Google Scholar
- Tufts (2010) Outlook 2010. Technical report, Tufts Center for the Study of Drug Development, Boston.Google Scholar
- (1996) Periodic review production models with variable capacity, random yield, and uncertain demand. Management Sci. 42(1):130–137.Link, Google Scholar
- (2017) A Bayesian adaptive design for clinical trials in rare diseases. Comput. Statist. Data Anal. 113:136–153.Crossref, Google Scholar
- (1980) Sample sizes for long-term medical trial with time-dependent dropout and event rates. Control Clinical Trials 1(2):111–124.Crossref, Google Scholar

