Artikel
Size matters? Clinical development outside large research sites – the industry perspective [invited speaker]
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Autoren
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C. Baumgartner
- Bayer Austria Ges.m.b.H., Medical Department – Wien, Österreich
| Veröffentlicht: | 25. September 2014 |
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Gliederung
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Aim: The researching pharmaceutical industry needs clinically relevant and valid data, generated quickly and cost-efficiently in order to come to market first and be able to earn back money spent on research before patents expire. Besides having promising drug candidates and solid development plans, one of the most important steps is the site selection strategy. Traditionally, the majority of later phase clinical development is done in large university clinics because both expertise, interest in science and a large number of patients are concentrated there. Small peripheral hospitals or office-based practices are most often focused on primary care and triage to expert centers and thus easily overlooked.
The aim of this presentation is to analyze and discuss the impact of organizational size on study conduct and performance from an industry perspective.
Method: Based on recruitment performance in an industry setting, success factors are evaluated and corellated to organizational type and size.
Results: Size has the potential to influence all factors that are important in study setup and conduct. The number (and disease stage) of potential patients that visit the site, number of available staff and their backup as well as experience in the therapy area and GCP can be a direct result of being part of a large organization. Also, supporting, diagnostic and therapeutic facilities like radiology, pathology and pharmacies have to be taken into account especially for complex studies. However, size usually brings bureaucracy and complicated communication channels with it.
Conclusion: Bearing trial design in mind, it can be advisable for a Sponsor to have a healthy portfolio of sites included in feasibility assessments that includes both larger sites for sheer volume and smaller but dedicated sites in order to be successful. For sites, in order to stay competitive, it is imperative to know their own strengths and weaknesses and know which studies to accept and and even more so, which to decline.
