Will Clinical Trial Activity in Nordic Region Increase?
The Nordic area is incredibly popular for clinical trials, with several thousand occurring at any one time. However the biotech and pharmaceutical industry is undergoing a huge period of change, with many organisations looking to expand geographically.
According to a number of studies over the last 18 months, while clinical trial activity in the Nordic region remains strong, it is levelling off. This must be halted if the area is to maintain its reputation as a hub for clinical sciences. A reduction in clinical trial activity would also see a drop in pharma and biotech jobs and facilities as well as a general slowdown in the region's knowledge.
Challenges and recommendations
In A Study of Clinical Trials in a Nordic Arena by Norden – Nordic Innovation Centre, published in late 2010, it was suggested that the limited patient numbers in each Nordic country is a major challenge contributing to the decline of clinical trails in the region. However, the authors Ida Iren Eriksen and Kirsti Kierulf proposed that "if they join resources, the region will become more attractive and easier to operate in for institutions that wish to conduct clinical trials". The pair were referring to the Nordic region as the specific countries of Norway, Sweden, Denmark, Finland and Iceland.
This view was echoed by Clinical Trials in the Nordic Region - challenges and opportunities by LIF-Uddannelse which said that action must be taken by future and current shareholders to maintain the area's, and the organisation's specifically, reputation as a provider of "high quality clinical trial".
However, combining resources throws up additional problems itself. In order for all five countries to have harmonised clinical trials they must ensure that application and government approval processes are unified, that the industry has a unit that manages data and websites. The pair also advised that the governments and pharmaceutical firms need to do more to explore collaborations. In addition to this there would need to be increased access to databases containing relevant information on trial centres, contact details, and ongoing and completed clinical trials so that the public could be encouraged to take part.
Unifying processes could be a long and arduous process, while contract negotiations would also have the potential to be hindered if the system did not work efficiently, potentially slowing down employment, patient recruitment and trial speed. This in turn could have a damaging impact on the cost of conducting clinical trials so work needs to be done to ensure the entire process operates smoothly.
Similarly, having a harmonised and easily accessible database across the Nordic region increases the risk of security breaches and data losses, something which could damage the good reputation the area's industry currently has. However, it would be essential for the speed of trials and sharing of resulting knowledge.
It is clear some work has begun to increase the number of clinical trials in Norway, Sweden, Denmark, Finland and Iceland. According to Outsourcing Pharma, the Helix Research Centre launched a clinical research and good clinical practice training programme in order to boost drug research and development (R&D) in the Nordic region.
Helix chairman, Dr. Venkateswar Rao told the source: "We felt inspired by Nordic government policies and the efforts of government and non-government associations, clinicians and researchers, to promote R&D initiatives in this region." He echoed similar claims that the Nordic countries provide the most suitable destination for global clinical trials, with high quality and accuracy, and claiming that there is already a significant outpouring of support and demand for the training.
Dr. Rao explained that the industry had been under some pressure as a result of the global financial crisis but insisted that things are likely to pick up and return to normality. "[There is] no recession for dreadful diseases," he added.
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