Behind every great medical device, there’s a great clinical trial. MTI editor Dave Gray spoke to Colette Donaghy, clinical operations manager, Venn Life Sciences, to find out what goes into making a device trial successful.
Venn Life Sciences is an integrated Drug Development and Clinical Research Organisation with offices in Dublin, Belfast, France, Germany, and The Netherlands. Clinical operations manager Colette Donaghy is responsible for the planning, delivery, and execution of the group’s clinical trials.
With significant experience in the medical device arena, Venn faces the usual challenges posed by the wider medtech market. Donaghy believes that the UK & Ireland uptake of new drug innovations still lags behind the rest of Europe.
“We have a very good healthcare system, and improved access to new medicines and innovations help enhance patient care. But the long process of getting these new products readily available can mean that companies will choose to test their products in other countries where this is not an issue.
Yet despite these challenges, Donaghy says that Venn continues to attract innovators from around the globe. In fact, the group recently collaborated in a clinical trial in cardiology which turned out to be one of the largest investigator-lead studies in disease of the left main artery being conducted anywhere in the world.
The project began when Venn’s COO was approached by one of two lead investigators, Professor Robert-jan van Geuns at the Erasmus University in the Netherlands. Both he and Professor Keith Oldroyd who is based in the Golden Jubilee Hospital in Glasgow realised at a very early stage that they needed help to conduct this large-scale investigator initiated study.
The study involved a comparison of two drug-eluting stents; the newer of the stents uses a different coating that allows the drug to dissolve differently in the patients’ heart. Additionally, the newer stent reduces the length of time that patients must take blood thinners to reduce the risk of foreign body reactions. Typically, stents of this type would require the patient to take blood thinners for 12 months – which increases the risk of bleeding events and complications from any further surgeries that may be required during that time. The new stents reduce that time down to just four months.
Donaghy explains: “This study was not being run by large pharma or a large medtech company. This was the responsibility of the two interventional cardiologists above who wanted to look at this particular use of the newer stent in a real-world environment.”
The sponsor of the trial is the Golden Jubilee National Hospital, National Waiting Times Centre Board in Glasgow.
The first challenge was the administrative task of setting up the study in different countries. To do that requires knowledge of the regulatory pathways in each country.
Venn has experts around the world capable of undertaking this kind of work.
Donaghy says that this specialist knowledge is invaluable when trying to conduct trials on an international scale. “In each country we had to go through the relevant ethical review bodies, who looked at the study, checked that they were happy for it to be conducted, and that there would be no negative impact for the patient.”
The other challenge for the client was setting up contracts. Venn needed to set up a contract with each institution, and in some cases with each investigator. The group uses a corporate legal adviser, which is essential in securing an agreement which protects both Venn, and the client.
“There’s a lot to do when setting up an international clinical trial. Each country needs to be set up individually and the sites trained in the study processes. And if that’s going to be happening in different countries, then you need people who can speak the language.” Venn has sites in Russia, Poland, Germany, France, the Netherlands and the UK.
The trial is ongoing, and Donaghy says that there is significant interest from clinicians in the eventual findings and the primary outcomes at 24 months.
“This study will be followed up for the next five years. We will monitor major adverse coronary events and they’ll be classed into categories – e.g. bleeding, thrombosis, stent replacement, etc. We will monitor this over a period of five years, allowing us to look back and see why those things happened.
“Currently the client is highly satisfied that we delivered the trial within the timelines that we were given, and that we managed to get full recruitment. This is one of the largest investigator-lead studies in this area that is being conducted anywhere in the world.”
If you'd like to talk to Venn about IIS studies visit www.vennlifesciences.com or meet the team at Med In Ireland.
