PURPOSE: Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. METHODS: We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. RESULTS: Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). CONCLUSION: The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
PURPOSE: Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. METHODS: We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. RESULTS: Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). CONCLUSION: The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
Authors: Mehmet Sitki Copur; Ryan Ramaekers; Mithat Gönen; Mary Gulzow; Rebecca Hadenfeldt; Courtney Fuller; Jenifer Scott; Sarah Einspahr; Heather Benzel; Mary Mickey; Max Norvell; Douglas Clark; Dron Gauchan; Dax Kurbegov; Mehmet Sitki Copur; Ryan Ramaekers; Mithat Gönen; Mary Gulzow; Rebecca Hadenfeldt; Courtney Fuller; Jenifer Scott; Sarah Einspahr; Heather Benzel; Mary Mickey; Max Norvell; Douglas Clark; Dron Gauchan; Dax Kurbegov Journal: J Oncol Pract Date: 2015-08-11 Impact factor: 3.840
Authors: Simon J Craddock Lee; Caitlin C Murphy; David E Gerber; Ann M Geiger; Ethan Halm; Rasmi G Nair; John V Cox; Jasmin A Tiro; Celette S Skinner Journal: Med Care Date: 2021-05-01 Impact factor: 3.178
Authors: Daniel Hind; Barnaby C Reeves; Sarah Bathers; Christopher Bray; Andrea Corkhill; Christopher Hayward; Lynda Harper; Vicky Napp; John Norrie; Chris Speed; Liz Tremain; Nicola Keat; Mike Bradburn Journal: Trials Date: 2017-05-02 Impact factor: 2.279
Authors: E Liniker; M Harrison; J M J Weaver; N Agrawal; A Chhabra; V Kingshott; S Bailey; T G G Eisen; P G Corrie Journal: Br J Cancer Date: 2013-09-24 Impact factor: 7.640