Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Session 4: Costs of Cooperative Group Clinical Trials
Session 4: Costs of Cooperative Group Clinical Trials
Pages 75-90
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From page 75... ...
Lurie Comprehensive Cancer Center, provided a cost analysis of cooperative groups. He reiterated that there has been a decline in NCI funding for the cooperative groups, and he noted that because of NCI funding limitations, cooperative groups usually receive 30 to 50 percent less than the total grant money asked for on their applications.
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From page 76... ...
Dr. Benson pointed out, as other speakers had, that lack of reimbursement for the standard-of-care costs of patients in clinical trials leads to another major cost that cooperative groups have to bear.
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From page 77... ...
Marcy Waldinger, chief administrative officer at the University of Michigan Comprehensive Cancer Center, showed how the costs of a clinical trial can be determined and used to negotiate better
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From page 78... ...
To help assess clinical trial costs more accurately, the University of Michigan developed an "effort tracker" that provides real-time reporting of research support staff costs. Data managers, research nurses, regulatory staff, and staff involved in specimen processing spend about five minutes each day logging how they are spending their time for various clinical trials.
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From page 79... ...
The University of Michigan Comprehensive Cancer Center saw an increase in its clinical trials budgets when it changed personnel three years ago to hire staff who were experienced in clinical trials finance and negotiation. Another helpful tool that is increasingly being used to assess clinical trial costs, according to Ms.
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From page 80... ...
App = application, CDA = confidential disclosure agreement, Co-Is = Co-investigators, Figure 3new broadside CTO = Clinical Trials Office, CTRAC = Clinical/Translational Resource Allocation Committee, DRDA = Division of Research Development and Administration, Hem/Onc = Hemotology/Oncology, IRB = institutional review board, IT = information technology, Mgr = manager, MTA = materials transfer agreements, PAF = proposal approval form, PI = principal investigator, PRC = protocol review committee, syncing = synchronization. SOURCE: Waldinger presentation (July 2, 2008)
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From page 81... ...
"We have quite a lot of circumstances in all of our cancer centers where physicians are doing work that nurses could do and nurses are doing work that data managers should be doing," she noted. Clinical trials could also be more efficient if the forms required by industry sponsors were simplified and standardized, she suggested.
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From page 82... ...
The supposed lack of therapeutic intent of clinical trials prevents insurance reimbursements and underlies the lengthy consent forms and IRB reviews, he said, yet most patients opt to participate in clinical trials and most physicians place them in those trials because they hope it will benefit them. "There is an extensive body of ethical literature that says that patients, through their doctors, are somehow misinformed or do not understand because there is no therapeutic intent in much of what we do, certainly in the Phase I area," he said (Glannon, 2006; Henderson et al., 2007; Joffe et al., 2001)
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From page 83... ...
A final issue Dr. Markman raised is the new federal law that requires all clinical trials, including industry trials, to be registered on a publicly accessible site.30 The law also mandates timely reporting of study results, but it is not clear how this will be implemented and who will have responsibility for reporting data from multi-center trials or from industrysponsored trials.
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From page 84... ...
Recognizing the need for this elderly population to have access to cutting-edge treatments, Medicare made a national coverage determination that took effect in 2001, which mandated that CMS cover the routine clinical care costs of its beneficiaries who participate in clinical trials, assuming that benefit categories for those costs already were established. Non-covered items and services include the specific technology being investigated, completion of case report forms, and any other services provided free of charge to other participants in the trial (CMS, 2008a)
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From page 85... ...
Andrea Denicoff, a nurse consultant in the clinical investigations branch of CTEP in the NCI, said that traditionally only about 13 percent of people enrolled in clinical trials have been aged 65 and older. A little more than three-quarters of Medicare-eligible participants are using Medicare to cover their clinical trial costs in the pilot project, Dr.
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From page 86... ...
He provided the private insurance company's perspective on covering the costs linked to clinical trials. He began his talk by noting that, historically, insurance companies were reluctant to cover experimental treatments, because they were trying to prevent coverage of quackery.
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From page 87... ...
Newcomer said, and it is difficult to define what should be covered within the clinical trial space. Particularly problematic is scope creep, whereby an insurance company will cover an experimental drug offered within a trial and then be expected to also cover it when the same drug is used to treat patients outside of the trial before the drug is approved for the specific indication being tested.
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From page 88... ...
Newcomer expressed skepticism about clinical trials that use people with few health complications to test experimental treatment, because these people do not represent what is seen in the "real world." He also questioned what he called the "tyranny of the randomized controlled trial." The randomized, controlled trial is considered the gold standard, but given the problems with sufficient patient accrual -- which are caused, in part, by patients not willing to be put into a control arm of a study -- Dr. Newcomer suggested using well-run observational studies instead.
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From page 89... ...
New Jersey has a state law, for example, that mandates coverage for participation in any clinical trial that occurs within the state. "We know we are paying for a lot of one- and two-person trials that never gain any knowledge and are a waste of resources," Dr.
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