Your browser doesn't support javascript.
Investigational medicinal products, related costs and hospital pharmacy services for investigator-initiated trials: A mixed-methods study.
Taji Heravi, Ala; Henn, Anne; Deuster, Stefanie; McLennan, Stuart; Gloy, Viktoria; Mitter, Vera Ruth; Briel, Matthias.
  • Taji Heravi A; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Henn A; Swiss Tropical and Public Health Institute, Basel, Switzerland.
  • Deuster S; Hospital Pharmacy, University Hospital Basel, Switzerland.
  • McLennan S; Hospital Pharmacy, University Hospital Basel, Switzerland.
  • Gloy V; Institute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.
  • Mitter VR; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Briel M; Department of Gynaecology, University Hospital Bern, University of Bern, Bern, Switzerland.
PLoS One ; 17(3): e0264427, 2022.
Article in English | MEDLINE | ID: covidwho-1731598
ABSTRACT

BACKGROUND:

Conducting high quality investigator-initiated trials (IITs) is challenging and costly. The costs of investigational medicinal products (IMPs) in IITs and the role of hospital pharmacies in the planning of IITs are unclear. We conducted a mixed-methods study to compare planned and actual costs of IMPs in Swiss IITs, to examine potential reasons for differences, and to gather stakeholder views about hospital services for IITs.

METHODS:

We included all IITs with IMP services from the Basel hospital pharmacy invoiced between January 2014 and June 2020 (n = 24). We documented trial and IMP characteristics including planned and actual IMP costs. Our working definition for a substantial cost difference was that the actual IMP costs were more than 10% higher than the planned IMP costs in a trial. We conducted semi-structured interviews with investigators, clinical trials unit and hospital pharmacy staff, and qualitatively analyzed transcribed interviews.

RESULTS:

For 13 IITs we observed no differences between planned and actual costs of IMPs (median, 11'000 US$; interquartile range [IQR], 8'882-16'302 US$), but for 11 IITs we found cost increases from a median of 11'000 US$ (IQR, 8'922-36'166 US$) to a median over 28'000 US$ (IQR, 13'004-49'777 US$). All multicenter trials and 10 of 11 IITs with patients experienced substantial cost differences. From the interviews we identified four main themes 1) Patient recruitment and organizational problems were identified as main reasons for cost differences, 2) higher actual IMP costs were bearable for most investigators, 3) IMP services for IITs were not a priority for the hospital pharmacy, and 4) closer collaboration between clinical trial unit and hospital pharmacy staff, and sufficient staff for IITs at the hospital pharmacy could improve IMP services.

CONCLUSIONS:

Multicenter IITs enrolling patients are particularly at risk for higher IMP costs than planned. These trials are more difficult to plan and logistically challenging, which leads to delays and expiring IMP shelf-lives. IMP services of hospital pharmacies are important for IITs in Switzerland, but need to be further developed.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pharmacies / Pharmacy Service, Hospital Type of study: Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0264427

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Pharmacies / Pharmacy Service, Hospital Type of study: Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0264427