Clinical Trials: Are They a Good Buy?

Bennett, Charles L.; Adams, Jared; Knox, Kirstin S.; Kelahan, Andrew M.; Silver, Samuel; Bailes, Joseph S.

doi:10.1200/jco.2001.19.23.4330

Cited by 30 publications

(15 citation statements)

References 6 publications

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“…The resultisthateitherphysiciansarenotpaidforstudy-related overtimeorafinanciallossduetoexpensiveresourcesconsumption can lead to compensation by reducing physicians' jobs. Therefore, PIs and their health care institution should havetheright,andeventheobligation,intimesofrationed medicinetorejectinsufficientlysponsoredclinicaltrials,since their task is to provide health care and not to subsidize the In contrast to incremental costs between standard medicalcareandclinicaltrials [19][20][21],whichmightbeofinterest for health insurances and politicians and can only be calculated specifically for each study concept, this paper focuses onauniversalmodeloftheactualstudy-relatedcostsandits cost-coveringreimbursementfromtheproviders'perspective. Thedecisiondiagram( fig.1)encouragesafairandadequate budgetnegotiationofstudybudgetswithsponsors [13].Manager competence for research [11] with in-depth knowledge ofcalculatingresearch-relatedcostsisbecomingincreasingly importantforresearchers.Butcostcalculationsespeciallyfor clinicalstudiesrequirebyfarmorethanjustpersonnelcosts andmaterialexpenses [11,22].…”

Section: Discussionmentioning

confidence: 99%

Making or Losing Money with Participation in Clinical Trials: A Decision Analysis

Jacobs¹

2009

Onkologie

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Background: There is increasing demand and qualitydriven pressure from professional organizations for physicians and health care providers to increase participation in clinical studies. But this can have a severe financial impact on the institution, so costs should be identified and calculated in advance. Method: In a diagram, the decisionmaking process to participate in clinical trials based on economic and budget impact is reviewed and analyzed in detail. Results: This flow chart describes how costeffective participation in clinical trials is determined. Since its implementation, all trials in our institution have been cost covering. Conclusions: All service and care required within the studies must be distinguished as either medically necessary or study related. Costs for the first category have to be covered by the health care system, but in case of the second category by the study sponsor. The institution’s own costs for studyrelated services should be known and deducted from the study income to determine the actual study gains. Subsidizing studies from tight clinic budgets is difficult in times of rationed medicine and should be avoided. Noncostcovering clinical studies should be renegotiated with the sponsor until cost effectiveness is reached. Otherwise, a rejection of study participation for financial reasons should be seriously considered. The design of costcovering clinical trials supports better recruitment for studies.

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Section: Discussionmentioning

confidence: 99%

Making or Losing Money with Participation in Clinical Trials: A Decision Analysis

Jacobs¹

2009

Onkologie

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“…Cost-EffectiveClinicalTrials 379 cal to the analyses [2]. Our study of 70 cancer patients enrolledinphaseIIclinicaltrialsfoundthat,in1996,chargesfor participants on cancer-related clinical trials were no greater than charges for participants incurred outside of the clinical trialsetting.Theseestimateswerecomparablewiththosereported from other single-site studies [3,4].…”

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confidence: 98%

Upping Recruitment in Clinical Trials: Are the Costs Worth It?

McKoy

Samaras²,

Bennett³

2009

Onkologie

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“…In 2001, Bennett et al (7) found that some states had already been experimenting with mandates that insurers who did business within their borders cover routine care costs in oncology trials. In 2003, McBride (8) reported an increase in state cancer trial coverage mandates.…”

Section: From the Editorsmentioning

confidence: 99%

State Payer Mandates to Cover Care in US Oncology Trials: Do Science and Ethics Matter?

Taylor¹

2010

JNCI Journal of the National Cancer Institute

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ResultsTwenty-six states mandated coverage. Four states (15%) required scientific peer review for all studies. For 20 states (80%), an approved investigational new drug qualified as scientific review. In 10 states (38%), institutional review board (IRB) approval could replace scientific review. Twenty-four states (92%) permitted trials without academic medical connection. All states covered privately insured patients; seven (27%) included government and Medicaid patients. Fourteen states (54%) covered phase I to phase IV trials. Sixteen states (62%) covered treatment trials only; one (4%) covered prevention, detection, treatment, and palliation. Thirteen states (50%) covered research-related injuries. Only seven states (27%) required IRB approval. Three states (12%) required commensurate risks and benefits; 23 (88%) had no standard. Eight states (31%) required clinical equipoise with standard care; eight (31%) had no standard; and remaining states (46%) had unique standards. Two states (8%) addressed publication or registries. ConclusionsMost states did not demand independent scientific review, IRB review, or basic ethical features of high-quality trials; provided partial coverage; omitted prevention, detection, and palliation research; and omitted mandated coverage for research-related injuries. Few required evaluation, independence in publication, or posting trial results. Further research on the impact of diverse state choices would improve policy making.

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Clinical Trials: Are They a Good Buy?

Cited by 30 publications

References 6 publications

Making or Losing Money with Participation in Clinical Trials: A Decision Analysis

Making or Losing Money with Participation in Clinical Trials: A Decision Analysis

Upping Recruitment in Clinical Trials: Are the Costs Worth It?

State Payer Mandates to Cover Care in US Oncology Trials: Do Science and Ethics Matter?

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