Nancy A Nixon1, Omar F Khan1, Hasiba Imam2, Patricia A Tang1, Jose Monzon1, Haocheng Li3,4, Gavin Sun5, Doreen Ezeife1, Sunil Parimi6, Scot Dowden3,4, Vincent C Tam3,4. 1. Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada. 2. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 3. Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 4. Department of Community Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 5. Department of Clinical Pharmacology and Toxicology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. 6. British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
Abstract
BACKGROUND: Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timeline and attrition rate of different drug classes for common cancer disease sites. METHODS: Drugs entering clinical trials for breast, colorectal, and non-small cell lung cancer were identified using a pharmaceutical business intelligence database. Data regarding drug characteristics, clinical trials, and approval dates were obtained from the database, clinical trial registries, PubMed, and regulatory Web sites. RESULTS: A total of 411 drugs met the inclusion criteria for breast cancer, 246 drugs met the inclusion criteria for colorectal cancer, and 315 drugs met the inclusion criteria for non-small cell lung cancer. Attrition rates were 83.9% for breast cancer, 87.0% for colorectal cancer, and 92.0% for non-small cell lung cancer drugs. In the case of non-small cell lung cancer, there was a trend toward higher attrition rates for targeted monoclonal antibodies compared with other agents. No tumor site-specific differences were noted with regard to cytotoxic chemotherapy, immunomodulatory, or small molecule kinase inhibitor drugs. Drugs classified as "others" in breast cancer had lower attrition rates, primarily due to the higher success of hormonal medications. Mean drug development times were 8.9 years for breast cancer, 6.7 years for colorectal cancer, and 6.6 years for non-small cell lung cancer. CONCLUSIONS: Overall oncologic drug attrition rates remain high, and drugs are more likely to fail in later-stage clinical trials. The refinement of early-phase trial design may permit the selection of drugs that are more likely to succeed in the phase 3 setting. Cancer 2017;123:4672-4679.
BACKGROUND: Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timeline and attrition rate of different drug classes for common cancer disease sites. METHODS: Drugs entering clinical trials for breast, colorectal, and non-small cell lung cancer were identified using a pharmaceutical business intelligence database. Data regarding drug characteristics, clinical trials, and approval dates were obtained from the database, clinical trial registries, PubMed, and regulatory Web sites. RESULTS: A total of 411 drugs met the inclusion criteria for breast cancer, 246 drugs met the inclusion criteria for colorectal cancer, and 315 drugs met the inclusion criteria for non-small cell lung cancer. Attrition rates were 83.9% for breast cancer, 87.0% for colorectal cancer, and 92.0% for non-small cell lung cancer drugs. In the case of non-small cell lung cancer, there was a trend toward higher attrition rates for targeted monoclonal antibodies compared with other agents. No tumor site-specific differences were noted with regard to cytotoxic chemotherapy, immunomodulatory, or small molecule kinase inhibitor drugs. Drugs classified as "others" in breast cancer had lower attrition rates, primarily due to the higher success of hormonal medications. Mean drug development times were 8.9 years for breast cancer, 6.7 years for colorectal cancer, and 6.6 years for non-small cell lung cancer. CONCLUSIONS: Overall oncologic drug attrition rates remain high, and drugs are more likely to fail in later-stage clinical trials. The refinement of early-phase trial design may permit the selection of drugs that are more likely to succeed in the phase 3 setting. Cancer 2017;123:4672-4679.
Authors: Yasamin A Jodat; Min G Kang; Kiavash Kiaee; Gyeong J Kim; Angel F H Martinez; Aliza Rosenkranz; Hojae Bae; Su R Shin Journal: Curr Pharm Des Date: 2018 Impact factor: 3.116
Authors: Ariana D Suarez-Martinez; Marc Sole-Gras; Samantha S Dykes; Zachary R Wakefield; Kevin Bauer; Dima Majbour; Angela Bundy; Christine Pampo; Matthew E Burow; Dietmar W Siemann; Yong Huang; Walter Lee Murfee Journal: Tissue Eng Part A Date: 2020-11-18 Impact factor: 4.080