An article published in 2015 by Ken Getz, Associate Professor at the Tufts University, and a director at the Tufts Center for the study of Drug Development, shows the statistics of average delays (per indications) in patient recruitment for clinical trials.
Although not surprising, the results indicate a big difference between the planned period for recruitment and its actual length. Those delays, which in average are doubling the recruitment period, create a negative financial impact on the overall cost of the study.
It is not only the huge costs which are associated with such long delays. Professionals in the business of clinical trials knows how much delays impact all stake holders involved in the study:
- Sponsors/CROs need to consider staff allocation, business predictions, share price and loss of opportunities.
- Investors become concerned about their investments and might be less generous with future funding.
- Investigators lose the momentum and shift their attention to other activities, including competitive studies
- Vendors expectations are changed and change orders are submitted.
It is clear that patient recruitment is a significant process that needs a plan, expertize and budget, in order to best serve the success of the entire study. Budget allocated to achieve recruitment goals is budget well spent that in the bottom line, has a positive impact on the overall expenses of the R&D program.