This blog is a companion piece to an article recently published in our November issue of OBR green titled “Consolidations Come with Concerns as NCI Cooperative Groups Restructure.” Enjoy the blog and then dig a little deeper by reading the OBR green article here.
Prior to the recent consolidations, 10 Cooperative Groups had been sharing that allotment ($150M from the NCI). With roughly 100 phase 3 trials with 20,000 patients and 200 phase 2 trials with 4,000 patients, that works out to only $500K per trial. These Groups are instrumental in establishing standards of cancer patient care and methods for clinical research. Each year they produce over 200 peer-reviewed publications. So, how do the Cooperative Groups accomplish so much with so little?
One answer is that the overall Cooperative Group funding is actually around $360M. Thus, the NCI budget of roughly $150M is less than half of the overall funding. Notably, one-third of the overall funding comes from institutional cost sharing ($88M) and pro bono investigator time ($28M), according to a September 2010 analysis by Judith A. Hautala, PhD, of the Science and Technology Policy Institute (STPI).
Additionally, a quarter of annual cash expenditures come from non-NCI sources, in the form of industry support at $41M (11% of overall Cooperative Group funding), philanthropic support at $6M (1.5%), and other support from sources such as parent institutions and state funds at $9M (2.5%).
The STPI analysis found that the fixed cost to establish and operate a Cooperative Group trial was $1.5M. Infrastructure costs make up 50%-60% of the budget of most of the Groups, with budgets for infrastructure ranging from $15 to $30M. The largest portion of infrastructure costs is statistics and data management (30%-40%), followed by core services (14%-30%). Each phase 3 or phase 2 patient accrual has infrastructure costs of about $3K.
Note that infrastructure costs also include scientific leadership, and the cost of the time commitments of those involved are largely met through $27.5M in pro bono time. This time is either donated by investigators or covered by their home institutions.
Besides infrastructure, patient accrual is the other large piece of Cooperative Group budgets. The estimated real cost of patient accrual is $6K per patient, according to the STPI analysis. While the NCI reimbursement rate has increased from $2K to $5K for phase 2 trials, most phase 3 trials reimburse $2K per patient, though additional funding is available for some complex phase 3 trials. These reimbursement rates do not pay the real cost of patient accrual.
Patients enroll in Cooperative Group trials at cancer centers, academic medical centers, and community oncology practices. Accrual costs are reimbursed at these sites through institutional NIH U10 awards ($5M), Group U10 sub-awards ($12M), per case reimbursements ($52M), and community clinical oncology program accrual reimbursements ($19M). After accounting for these funding mechanisms, over 60% of accrual costs are met through institutional cost sharing ($88M).
Together, pro bono time and institutional cost sharing cover $118M in costs. Consequently, volunteer buy-in is a key component of the success of the Cooperative Groups. Investigator and institutional support account for much of the strength of the Groups. Now the Groups are merging, and concerns have arisen about how this altruistic structure will be affected by these mergers. Meanwhile, their budget from NCI has remained flat.
by Kathy Boltz, PhD
To further explore the challenges of sustaining the Groups as they merge and evolve, please go to the November issue of OBR green.
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