Site stops “expensive” CRO monitoring with in-house system

16-Nov-2010 - Last updated on 16-Nov-2010 at 11:53 GMT

An academic clinical research centre that claims CROs markedly increase costs and reduce trial monitoring to box ticking, statements disputed by ACRO, has described its adoption of an in-house system.

In a research paper the clinical centre links outsourcing of trial monitoring to high costs and a shift from an informed discussion and guidance style of monitoring to a tick box checking process by less experienced staff. In response the site stopped using contract research organisations (CRO) for monitoring.

However, John Lewis, vice president, public affairs at Association of Clinical Research Organizations (ACRO), told Outsourcing-Pharma the centre “makes several assertions about CROs without providing any evidence to back its claims”. Furthermore, other research contrasts with views expressed by the clinical centre.

Creating an in-house system

Moving trial monitoring in-house necessitated the adoption of a new system. This process is described in a research paper by employees at the Kenya Medical Research Institute (KEMRI)-Wellcome centre who helped implement inexpensive and practical in-house monitoring.

The system adopted by KEMRI-Wellcome gives clinical staff trial monitoring training. Once trained the clinical trial employees monitor studies of which they are independent.

Having used this system for two years the research centre reports it has: raised standards across all trials by creating a platform for sharing best practices; increased the profile of trial staff; and been well received by investigators, sponsors and trial staff teams.

KEMRI-Wellcome has a pool of 20 monitors cum coordinators who have become the key implementers of good clinical practice (GCP) at the site. Using the pool of monitors KEMRI-Wellcome has managed to allocate at least two trained employees to each study.

Expanding the system

Now, the system is being scaled-up to incorporate many sites. Scale-up is progressing in partnership with the East African Consortium for Clinical Research, the World-Wide Anti-Malarial Resistance Network and the Global Health Clinical Trials Programme.

By collaborating KEMRI-Wellcome is aiming to establish reciprocal monitoring schemes in South-East Asia and East Africa. These schemes will share a comprehensive evaluation process to help establish the benefits, cost-effectiveness and limitations of the monitoring process.

The case for CROs

In response to the research paper Lewis cited a 2005 analysis by the Tufts Center for the Study of Drug Development. This analysis “concluded that outsourcing of clinical trials led to a 30 day gain in time to approval submission versus in-sourcing, at less expense and at no difference in quality”, said Lewis.

Also, the reach of CROs offers advantages. Lewis said that, unlike academic organisations, CROs can “monitor multi-site, multi-regional studies while maintaining consistency and quality”.

Finally, Lewis questions the in-house system implemented by the research centre. Lewis said: “High-quality monitoring may be performed by in-sourced or outsourced monitors but the program of in-house monitoring presented in this paper seems susceptible to questions of independence and objectivity.”