Biopharmaceuticals and Conventional Drugs: Clinical Success Rates

Bienz-Tadmor, Brigitta; DiCerbo, Patricia A.; Tadmor, Gilead; Lasagna, Louis

doi:10.1038/nbt0592-521

Cited by 28 publications

(7 citation statements)

References 3 publications

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“…The historical literature focusing specifically on the quantification of drug development risks is fairly robust 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 . The aforementioned research on drug development costs includes estimates of drug development risks.…”

Section: Introductionmentioning

confidence: 99%

Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs

DiMasi

Feldman

Seckler

et al. 2010

Clin Pharmacol Ther

734

490

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This study utilizes both public and private data sources to estimate clinical phase transition and clinical approval probabilities for drugs in the development pipelines of the 50 largest pharmaceutical firms (by sales). The study examined the development histories of these investigational compounds from the time point at which they first entered clinical testing (1993-2004) through June 2009. The clinical approval success rate in the United States was 16% for self-originated drugs (originating from the pharmaceutical company itself) during both the 1993-1998 and the 1999-2004 subperiods. For all compounds (including licensed-in and licensed-out drugs in addition to self-originated drugs), the clinical approval success rate for the entire study period was 19%. The estimated clinical approval success rates and phase transition probabilities differed significantly by therapeutic class. The estimated clinical approval success rate for self-originated compounds over the entire study period was 32% for large molecules and 13% for small molecules. The estimated transition probabilities were also higher for all clinical phases with respect to large molecules.

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Section: Introductionmentioning

confidence: 99%

Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs

DiMasi

Feldman

Seckler

et al. 2010

Clin Pharmacol Ther

734

490

View full text Add to dashboard Cite

show abstract

“…A variety of innovative approaches to cancer drug development are being simultaneously explored by companies, including focusing on new targets within validated pathways and new pathways, design of novel drug formats, and improved clinical study design and protocols that may expedite the process. Development of new drugs, however, is lengthy, is very expensive, and has substantial technical risks 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 . To foster a better understanding of the technical risks specifically associated with development of new cancer drugs, we examined the biopharmaceutical industry pipeline of cancer drugs that entered clinical study from 1993 to 2004 and estimated clinical phase transition rates and overall clinical approval rates.…”

mentioning

confidence: 99%

“…Development of new drugs, however, is lengthy, is very expensive, and has substantial technical risks. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] To foster a better understanding of the technical risks specifically associated with development of new cancer drugs, we examined the biopharmaceutical industry pipeline of cancer drugs that entered clinical study from 1993 to 2004 and estimated clinical phase transition rates and overall clinical approval rates. We analyzed these data to determine success rates for cancer drugs in general, and examined factors such as the composition of matter, the type of cancer investigated, and successive indications pursued clinically overall and conditional on the success or failure of the lead indication.We collected data relevant to the clinical development and approval of cancer drugs that first entered studies during 1993 to 2004 from the public domain and the archives of the Tufts Center for the Study of Drug Development.…”

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confidence: 99%

Clinical Approval Success Rates for Investigational Cancer Drugs

DiMasi

Reichert

Feldman

et al. 2013

Clin Pharmacol Ther

178

118

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We examined development risks for new cancer drugs. For the full study period, the estimated clinical approval success rate for cancer compounds was 13.4% (9.9% for the first half of the study period, 19.8% for the second half). Small molecules had a somewhat higher clinical approval success rate than did large molecules (14.3 vs. 11.5%). Compounds studied solely in hematologic indications had markedly higher estimated clinical approval success rates than did compounds studied only in solid tumor indications (36.0 vs. 9.8%). The first, second, and third cancer indications pursued had estimated clinical approval success rates of 9.0, 8.2, and 6.9%, respectively. Success rates of second and third indications were found to be highly dependent on the success or failure of the first indication pursued (54.9 and 42.4%, respectively, for second and third indications if the first indication is a success, but 2.5 and 1.8%, respectively, if the first indication is a failure).

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“…1,[8][9][10][11][12][13][14] Several studies have also examined clinical success rates for biotechnology-derived drugs. [15][16][17] Statistical modeling can be helpful in analyzing success rates for recent periods because many of the compounds will still be in active testing at the time of the analysis. Tufts CSDD has also conducted a number of studies that use this approach to predict final success rates for groups of compounds for which the ultimate fate of some of the compounds in the data set is not known.…”

mentioning

confidence: 99%