Economic benefits of investigational drug services at an academic institution

LaFleur, Joanne; Tyler, Linda S.; Sharma, Robin

doi:10.1093/ajhp/61.1.27

Cited by 29 publications

(36 citation statements)

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“…McDonagh 5 muestra un coste evitado de 2.881.113 $ en 2 años en 72 EC, considerando solo las dosis de medicamento activo, no las de placebo, a diferencia de nuestro estudio en el que hemos valorado ambos costes como tratamiento activo (medicación experimental y placebo). En nuestro caso, 2 de los 5 EC incluidos eran doble ciego, y se han contabilizado todas las dosis dispensadas (medicación activa y placebo), al igual que en el estudio realizado por Lafleur 6 . Esto se realizó así con base en que si el paciente no estuviese incluido en el ensayo sería tratado con medicación activa, cuyo coste sería asumido por el sistema sanitario.…”

Section: Discussionunclassified

Coste evitado en medicamentos de ensayos clínicos en cáncer de próstata

Calvin-Lamas

Portela-Pereira

Rabuñal-Alvarez

et al. 2015

Actas Urológicas Españolas

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Section: Discussionunclassified

Coste evitado en medicamentos de ensayos clínicos en cáncer de próstata

Calvin-Lamas

Portela-Pereira

Rabuñal-Alvarez

et al. 2015

Actas Urológicas Españolas

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“…In circumstances where the IND has yet to receive approval for its trialled indication, a value for cost avoidance was not assigned to patients in the IND arm to avoid over‐counting and error during analysis. This contrasts with the methodology in some prior studies where cost avoidance was assigned to the IND arm, as the foregone SOC was not provided by the hospital …”

Section: Methodsmentioning

confidence: 95%

“…Pharmaceutical cost avoidance occurs when sponsored clinical trials supply medicines which otherwise would have likely been provided, or subsidised, by the government . In Australia, provision of sponsored PBS‐listed agents in clinical trials contributes to pharmaceutical cost avoidance.…”

Section: Introductionmentioning

confidence: 99%

“…In Australia, provision of sponsored PBS‐listed agents in clinical trials contributes to pharmaceutical cost avoidance. In the oncology context, cost avoidance has resulted in significant savings for hospitals . Depending on individual circumstances, these savings notionally accrue to the state (in‐patient therapies) or federal (out‐patient therapies) government.…”

Section: Introductionmentioning

confidence: 99%

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Retrospective pharmaceutical financial benefits and cost avoidance analysis of clinical trial participation in the Australian haematology setting

Truong

Kwan

Nigro

et al. 2019

Internal Medicine Journal

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Background Clinical trial participants receiving investigational new drugs, which subsequently become approved by a medicines regulatory authority for its trialled indication, effectively gain free early access to efficacious treatment. Participants may also benefit from receiving approved, but unsubsidised medicines. These financial benefits of clinical trial participation have not previously been defined or quantified. Additionally, there are limited Australian pharmaceutical cost avoidance studies quantifying government savings through sponsored clinical trials. Aims To calculate pharmaceutical financial benefits and cost avoidance of clinical trial participation at a single Clinical Research Unit. Methods Recruiting clinical trials between 1 January 2006 and 31 December 2017 conducted at the Haematology Clinical Research Unit, Concord Repatriation General Hospital, Sydney were reviewed. Dispensing records were used to quantitate the pharmaceuticals dispensed to every participant. Financial calculations were based on Pharmaceutical Benefits Scheme (PBS) pricing, or from UpToDate for non‐PBS listed agents. Results Thirty‐six eligible clinical trials involving 245 participants accrued AU$3 971 357 in financial benefit from early access to subsequently approved investigational new drugs, AU$12 209 538 in financial benefit from accessing approved medications not PBS listed, and AU$6 728 576 in government cost avoidance. These findings totalled AU$22 909 471, 89% of which was derived in the past 5 years. Conclusion Pharmaceutical financial benefit is a previously unquantified aspect of clinical trial participation, its assigned value reflecting a measure of the quality and quantity of life delivered to patients. These data, albeit from a single discipline and institution, suggest that financial benefit represents a greater value than cost avoidance, and that its inclusion in cost‐analyses may better reflect the monetary benefits of accessing efficacious pharmaceutical agents through clinical trials.

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“…This places significant burden on the IDS to demonstrate its value, typically identified through an assessment of revenue generated from charges to investigators or study sponsors. While most IDSs charge fees for the services that they provide, this revenue is often insufficient to cover the full cost of maintaining the service [ 8 , 9 ]. Assessing the economic value of an IDS through an evaluation of cost avoidance can aid in mitigating this discrepancy.…”

Section: Introductionmentioning

confidence: 99%

Economic outcomes associated with an investigational drug service within a Veterans Affairs health care system

Brown

Tillman

Jacob

et al. 2019

Contemporary Clinical Trials Communications

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Background An investigational drug service (IDS) has a foundational role in ensuring the safe and efficient management of investigational drugs. The objective of this assessment is to determine economic value of an IDS within a Veterans Affairs health care system. Methods This assessment was a single-center retrospective record review. Study protocols managed by the IDS over a 2-year period were evaluated for cost avoidance, revenue, and waived revenue. Cost avoidance was defined as the cost savings generated when a research subject received sponsor-provided treatment in place of a therapy that would have been otherwise funded by the institution. Revenue from fees charged to investigators and waived revenue based on the standardized IDS fee schedule were also totaled. The total economic value to the institution accounted for the personnel costs of the IDS. Results Twenty-three investigational study protocols managed by the IDS resulted in economic outcomes. The total cost avoidance during the two-year period was $482,627.33. The total revenue and waived revenue associated with the IDS was $16,822 and $54,200, respectively. Oncology protocols had the highest contribution to the outcomes of cost avoidance and revenue and mental health protocols had the highest contribution for waived revenue. The overall economic value of the IDS to the institution was $393,649.33. Conclusions Over a two-year period, the IDS demonstrated a substantial economic value that was largely driven by cost avoidance. Revenue generation from fees charged to investigators and cost savings to the investigator through waived revenue also contributed economic benefits to the institution.

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Economic benefits of investigational drug services at an academic institution

Cited by 29 publications

References 0 publications

Coste evitado en medicamentos de ensayos clínicos en cáncer de próstata

Coste evitado en medicamentos de ensayos clínicos en cáncer de próstata

Retrospective pharmaceutical financial benefits and cost avoidance analysis of clinical trial participation in the Australian haematology setting

Economic outcomes associated with an investigational drug service within a Veterans Affairs health care system

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