New Business Model for Clinical Research in the Netherlands

On January 30, 2010, the largest trial ever to be run in the Netherlands enrolled its last subject. With the first subject vaccinated less than a year ago on March 30, 2009, this has been quite an achievement. The trial, with the acronym CAPITA,¹ enrolled 84,500 senior citizens who were randomized over two arms, either receiving a 13 valent conjugate vaccine developed to prevent pneumococcal infections, or a placebo. Follow-up is for three years during which the seniors are being monitored for pneumonia. Coordination of this trial is in the hands of the Julius Center in Utrecht, headed by Marc Bonte, PhD, Professor of University Medical Center Utrecht (UMCU). The project marks the cooperation between the academic, the regular hospitals, and the vast majority of the Dutch General Practitioners.

One of the project’s sub-investigators and a true pioneer with respect to setting up vaccine studies, mainly in non-academic environments, is Reinier Veenhoven, PhD, pediatrician, and Medical Manager at the Linnaeus Institute, based at the Spaarne Ziekenhuis in Hoofddorp. Veenhoven has gained experience with successful partnering of public institutions (like the RIVM² and the NVI³) with the UMC and, together with Professor E.A.M. (Lieke) Sanders, PhD, of UMCU, has ventured on new ways to stimulate clinical research efforts performed at the non-academic Dutch hospitals.

In the Netherlands, 85 general hospitals and eight university medical centers (UMC’s) are operational. Since 2009, all personnel involved in clinical research at any UMC should have gained training and certification on GCP and local requirements following the BROK⁴ course. Similarly, 27 of the larger teaching hospitals, providing highly specialized medical care, have joined together to form an association of tertiary medical teaching hospitals, known as STZ.⁵ Based on their role and geographic location it is evident that clinicians and researchers at these STZ hospitals serve nearly half of the Dutch population. However, applied clinical research has not been on their Board’s mission statements that much and staff have no institutional requirements to be certified yet. It is in these STZ hospitals where Veenhoven sees a lot of potential for the future.

The Linnaeus Institute was formed in 2009, where two of the STZ hospitals (Spaarne Ziekenhuis and Kennemer Gasthuis in Haarlem) combined their education and research programs. The key achievements in 2010 were setting up a science bureau, hiring two full time staff members (a epidemiologist and a statistician), and gaining full support of the two hospital boards. Veenhoven unfolded the Institute’s plans for 2011 in an interview and during a presentation at the 2010 FIGON Medicines days in October 2010.

As before, the Institute plans to continue to lend support to local investigator-initiated trials, and focus on vaccine programs. On the other hand, further professionalizing internal structures such as financial trial and project management, scientific and statistical support, protocol development, local feasibility testing (a requirement for each single center in a multi-center trial in the Netherlands, applying for ethics review), training staff further on GCP and local requirements (perhaps by adopting a BROK-like approach), and improving research alliances with the UMCs, will turn the Institute into a kind of regional site management organization. The Institute is open to source or be a partner for multi-center studies with pharmaceutical and CRO businesses alike, although its educational goals should be considered. In such a model, input in the trial protocol would be highly preferred, as would possibilities to publish some of the outcomes by the residents participating in the Institute’s education. “We are part of a training hospital after all,” concludes Veenhoven.

Further information can be obtained from Veenhoven, at rveenhoven@spaarneziekenhuis.nl.

Abbreviations:
1. CAPITA is for "Community Acquired Pneumonia Immunization Trial," www.vaccinatieonderzoek.nl
2. NVI is for "Nederlands Vaccin Instituut," http://www.nvi-vaccin.nl/
3. RIVM is for ‘Rijksintitiuut voor Volksgezondheid en Milieuhygiene’, www.rivm.nl
4. BROK is for "Basiscursus Regelgeving & Organisatie Klinisch Onderzoekers," http://www.nfu.nl/index.php?id=147
5. STZ is for "vereniging Samenwerkende Topklinische opleidingsZiekenhuizen," http://www.stz-ziekenhuizen.nl

Edgar Smeets, PhD, CCRA, is a Freelance Clinical Research Consultant, based in the Netherlands, and has no financial, personal, or professional interests in the initiatives reported here.