Sertkaya et al. 2014 - Examination of Clinical Trial Costs and Barriers for Drug Development

Authors: Aylin Sertkaya, Anna Birkenbach, Ayesha Berlind, John Eyraud

Link to paper


This report contains discussion of barriers to clinical trials from the consulting firm Eastern Research Group Inc., based on the authors’ interactions with industry experts.

The barriers are grouped as follows:


High financial cost

High costs are downstream of all other barriers and come from the following sources:

The largest costs come from clinical procedures, site retention/monitoring, and administrative staff. The reason why these costs are increasing include the following:

Lengthy timelines

Having a trial that takes a long time will increase costs for obvious reasons. Timelines are long due to the following reasons:

Difficulties in recruiting and retaining participants

This is noted as one of the largest barriers. These difficulties include:

Increasing competition for qualified investigators and sites

This is also noted as one of the largest barriers. It is challenging to find qualified researchers able to enroll high-quality patients. Some clinical research organizations have sole access to staff/resources/investigators which they only provide to companies they are partnered with. It is also unprofitable for many sites to run trials.

Regulatory and administrative barriers

Drug sponsor-imposed barriers

Disconnect between clinical research and medical care

Barriers at academic institutions

Written by Douglas Yao on 09 January 2023