Costs of randomised-controlled trials – a systematic review and empirical case series

Session: 

Short oral session 8: Priority setting for evidence production, synthesis and use

Date: 

Thursday 14 September 2017 - 16:00 to 17:30

Location: 

Meeting Room 1.44

All authors in correct order:

von Niederhäusern B1, Speich B2, Schur N3, Hemkens L2, Agarwal A4, Pauli-Magnus C1, Schwenkglenks M3, Briel M2
1 Department of Clinical Research, University and University Hospital Basel, Switzerland
2 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Switzerland
3 Institute of Pharmaceutical Medicine (ECPM), University of Basel, Switzerland
4 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada
Presenting author and contact person

Presenting author:

Belinda Von Niederhäusern

Contact person:

Belinda Von Niederhäusern
Abstract text
Background: High-quality evidence from randomised-controlled trials (RCTs) comes at high cost. In the resource-restrained academic setting, thoughtful allocation of financial resources for an RCT is a crucial task. However, empirical evidence on cost drivers of RCTs in different disciplines and settings is sparse.

Objectives: To: (1) systematically review the existing evidence on resource use and associated cost of RCTs; and, (2) to retrospectively determine the resource use and costs of completed RCTs in Switzerland and internationally.

Methods: First, we systematically searched the literature on empirical cost data of RCTs (MEDLINE/EMBASE/EconLit). Second, using a previously compiled and validated standardised list of direct and indirect cost items associated with all phases (planning, conduct, etc.) of RCTs, we retrospectively recorded the resource use of academic RCTs conducted within our network. We further contacted pharmaceutical companies for cost data on RCTs conducted in Switzerland. Resources included human resources and fixed-cost items, materials, or services. Costs were calculated using unit costs for fixed-cost items and the applicable salary rates for human resources. In addition, we received resource and cost data from 12 completed RCTs of the Swiss Group for Clinical Cancer Research (SAKK).

Results: The systematic review showed that detailed empirical data on resource use and costs of RCTs are not available. At the Summit we will present a detailed cost analysis including the main cost drivers of 17 academic RCTs predominantly conducted in Switzerland, stratified by disease area. No pharmaceutical company provided detailed cost data on their RCTs conducted in Switzerland.

Conclusions: To our knowledge this is the first study to empirically investigate the resource use and associated costs of RCTs. The results will identify suitable lever-points to reduce RCT costs, inform effective cost monitoring, and support efficient allocation of scarce resources in order to reduce waste in clinical research.