Probability of Success: A Crucial Concept to Inform Decision Making in Pharmaceutical Research and Development

Richard L Lalonde¹, Carl C Peck^{2

3}

Affiliations

¹ Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
² Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA.
³ NDA Partners, a ProPharma Company, Rochelle, Virginia, USA.

Comment

Richard L Lalonde et al. Clin Pharmacol Ther. 2022 May.

. 2022 May;111(5):1001-1003.

doi: 10.1002/cpt.2513. Epub 2021 Dec 24.

Richard L Lalonde¹, Carl C Peck^{2

3}

¹ Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
² Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, California, USA.
³ NDA Partners, a ProPharma Company, Rochelle, Virginia, USA.

No abstract available

Comment on

A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials.
Hampson LV, Holzhauer B, Bornkamp B, Kahn J, Lange MR, Luo WL, Singh P, Ballerstedt S, Cioppa GD. Hampson LV, et al. Clin Pharmacol Ther. 2022 May;111(5):1050-1060. doi: 10.1002/cpt.2488. Epub 2021 Dec 13. Clin Pharmacol Ther. 2022. PMID: 34762298 Review.

1. Lovallo, D. & Kahneman, D. Delusions of success. How optimism undermines executives’ decisions. Harv. Bus. Rev. 81, 56-83 (2003).
1. Hampson, L.V. et al. A new comprehensive approach to assess the probability of success of development programs before pivotal trials. Clin. Pharmacol. Ther. 111, 1050-1060 (2022).
1. Kirby, S., Burke, J., Chuang-Stein, C. & Sin, C. Discounting phase 2 results when planning phase 3 clinical trials. Pharm. Stat. 11, 373-385 (2012).
1. O'Hagan, A., Stevens, J.W. & Campbell, M.J. Assurance in clinical trial design. Pharm. Stat. 4, 187-201 (2005).
1. Zierhut, M.L., Bycott, P., Gibbs, M.A., Smith, B.P. & Vicini, P. Ignorance is not bliss: statistical power is not probability of trial success. Clin. Pharmacol. Ther. 99, 356-359 (2016).