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Nordic clinical trials on the agenda

This year’s Outsourcing in Clinical Trials Nordics conference covered a range of current topics in the clinical and medical device trial industry.

At the beginning of September this year, CEOs, Chief Medical Officers and Clinical Directors met in Copenhagen to discuss current matters within outsourcing in clinical trials. The Outsourcing in Clinical Trials Nordics (OCT Nordics) is an annual event that has been established as a clinical outsourcing-specific event, developed for companies of any size based in the Nordic countries. As the region is placing more and more emphasis on healthcare innovation and growth, clinical trials are starting to play an important role in helping deliver this on demand. The OCT Nordics conferences have been arranged to offer a focused agenda, where companies can discuss, learn and improve region-specific strategies that are vital to the clinical and medical device trial industry. The aim is to deliver cutting edge information directly from the industry decision makers.

Outsourcing within the Nordics

The OCT Nordics features presentations, interactive roundtables and panel discussions, as well as networking opportunities with industry peers. Like previous years’ events the 2015 conference brought up the current challenges within clinical outsourcing and medical device-related issues; budgeting and contracting, improved vendor communication strategies and patient recruitment. This year the event had a focus to offer a stronger presence from both the pharmaceutical and medical device industries.

“We brought in a longer stream for medical device companies this year, so attendance for them was definitely worthwhile. We also included a wider range of discussion about outsourcing trials within the Nordics. To cover this we had a presentation from a Nordic site in Sweden, and also a discussion about the Single Point of Entry service available for free in Denmark, which can promise a rapid consultation service for small biotechs looking to get into clinical trials for the first time,” says Andrew Taylor from Arena International, Program Director for the OCT Nordics event.

The right outsourcing model

The conference is now in its 3rd year and this year’s event appears to have been a great success, according to Andrew Taylor.

“We had over 200 attending delegates across the two days, talking about a range of key outsourcing issues. We brought together some of the Nordic top pharmaceutical companies with smaller biotech’s, medical device companies and a range of CROs, talking about issues ranging from risk-based monitoring to a talk from an academic site’s perspective. The standout presentation appeared to be Eric Leire’s discussion on selecting the right outsourcing model for your company.”

Dr. Eric Leire is the CEO of DanDrit Biotech A/S. The company develops a dendritic cell-based immunotherapy for the treatment of advanced colorectal cancer. Leire gave a presentation to smaller sponsor companies about weighing up the advantages of technical outsourcing, reviewing umbrella partnership models such as data management services and safety endpoints and how to establish ways for biotechs to find the right outsourcing models for their needs. Some other speakers featured during the conference were Christoffer von Sehested, Director of Clinical Operations at Veloxis Pharmaceuticals, talking about challenges when producing an all-encompassing sponsor-CRO contract for the benefit of the clinical trial; Nabil Al-Tawil, Medical Director for Karolinska Trial Alliance (KTA), presented how sites such as the Karolinska Trial Alliance are prevailing as sites for early phase studies; Mark Flynn, Director of Research & Applications at Cochlear Nordic, talked about running clinical trials overseas with your medical device outsourcing partner while ensuring patient safety.
Other topics for this year’s event included CRO selection techniques, alternative outsourcing models and a look at new trialing sites available for both pharmaceutical and medical device candidates. Other discussions involved getting academic research into medical devices and helping companies transition to clinical trials. The new EU regulation 536 and its impact was also discussed. The new clinical trials legislation, which was adopted on April 16 2014, has been set up to ensure that the rules for conducting clinical trials are identical throughout the EU. The regulations will become fully active next year and will increase the speed of trial set-ups, and at the same time outline the necessary changes companies will need to implement in their application process.

A key topic was how the Nordics can be leading the way in making clinical trial data-sharing a reality. How will this become a reality?

“This was covered within the Single Point of Entry talk, by discussing how a unified, Nordic pharma/med-device industry could be a great way of progressing the Nordics industry as whole, helping it compete as a site of clinical trials on the worldwide stage against countries like the USA, UK and Germany.”

The Single Point of Entry talk was led by Kristian Teglkamp, Special Advisor for Pharma at the Clinical Trials Office in Denmark. The country is currently facing a reduction in clinical trial activity. In 2010 Denmark had only 140 industry initiated clinical trials at the country’s hospital sites, a decline from 230 trials in 2006. As in many other countries, the pharmaceutical industry has moved trials to low-cost emerging economies. Competitiveness in industry-sponsored clinical research depends on speed, quality and cost. Denmark has been seen as a region that generates high quality data. Therefore, an improved ability to attract future trials could be achieved if speed can be enhanced by taking advantage of the ample national, as well as regional, registries, as Kristian Teglkamp pointed out in an article on[GA1]  Clinical Trials Arena. To secure the progress of clinical trials, an idea of a single point of entry for Danish clinical studies was born. All five Danish regions have now launched a simple and efficient point of entry for the industry to enter into agreements about clinical trials. Each region has established a coordinating center of excellence, making feasibility and patient-recruitment fast and effective.

During his presentation at the OCT Nordics event, Kristian Teglkamp talked about the Single Point of Entry Unit as a source of information for all smaller biotechs looking to outsource within Denmark, as well as single point of entry’s potential formation in other locations in the Nordics, such as Sweden.