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Ciao from an Important Clinical Trials Conference

by Imogen Cheese

Milan, a city of culture, renowned for its amazing gastronomy and shopping… and for two days in May, the home of the 9th annual Outsourcing in Clinical Trials Europe Conference. Rather than talk food or fashion, we would be talking clinical trials and the challenges involved in finding the right vendor and maintaining a mutually beneficial long term relationship with vendors.

Milano Convention Centre sits quite a way outside the city center. Whilst somewhat sunburnt and unassuming on the outside, inside the venue was a mass of color and activity. Over 60 exhibitors filled the bustling main hall, eager to impart their unique support to the delegates attending this annual event.

This is by no means unique, and it fits the format for most industry gatherings. Select a desirable venue and attract the right number of vendors, and the dialogue is soon to follow. What stood apart for me at this conference was that mixed in amongst the standard and yet vital sessions that covered how to move forward effectively with the various technology solutions proposed by the speaker(s) were some gems of talks and really interesting interactive panel discussions.

Dr. Martine Dehlinger-Kremer of Synteract gave an excellent and very emotive talk that outlined a real shift in mindset within pediatric studies where we need to shift away from thinking we should protect children from research to instead thinking about protecting children through research. She expressed her opinion that pediatric trial success is completely dependent on patient centricity. Within her talk she shared the details of some innovative consulting groups made up of experienced juvenile volunteers such as the International Children’s Advisory Network (iCAN) and the European Young Persons’ Advisory Group Network (eYPAGnet). These organizations offer the facility to consult directly with the target audience of pediatric studies – the children. 

It’s a solution that is not just efficient and beneficial to all involved, it also has a remarkable knock on effect to the industry that we will no doubt feel for many years to come. This solution of inclusion and dialogue with these highly knowledgeable and influential patients means you are actually encouraging and growing the next generation of researchers and innovators simply through talking to them when at their most vulnerable.

There was a fascinating lightning round followed by a discussion panel looking at oversight models and how you can best communicate and manage risk with your vendors in line with the resources available. Denise Lee, Allergy Therapeutics, Veronique Freund, Sanofi, and Annelies Legters, Kiadis Pharma shared their experiences. Was it preferable to have one main vendor for all studies (and if so it was better that this was a preferred partner rather than sole partner role) or multiple vendors with no direct loyalty involved but greater flexibility within each organization to choose?

It was clear across the room of delegates voting and asking questions that the majority of the audience work to the second model – multiple vendors. Yet through the process of the session that panel reached a consensus that if managed well, one main vendor – or a select few preferred vendors — leads to better long term relationships. There may well be faults and both tolerance and compromise are required with this option… a bit like marriage… it takes time and equal commitment from both sides.

This was an active interactive discussion that caused talk to spill over into lunchtime, especially after the closing remark included something that all clients should consider: It is easy to blame the vendor, but what should always be considered is the costs that came from our own decisions. We are partly responsible for the success and failure of a study.

I found this fascinating, especially because at Imperial we very much work to the partnership model. We work in close collaboration with our clients and we place great emphasis on honesty and advising clients even if they don’t always want to hear of the hurdles and challenges ahead. The only way that a partnership between sponsor or CRO and vendor can be effective is by removing the shiny object from the equation. Promises should be made from knowledge and experience, not plucked from thin air or conceived to impress, blindside, or lure whilst knowing full well they aren’t deliverable. Trust, just as a patient places on their medical professional, should be established in vendor relationships.

Certainly there are challenges and changes that face all in this industry. There were some incredible statistics shared by Jose Manuel Ordonez of Roche, such as:

  • Biopharmaceutical companies spend $100 billion per year on the clinical development of drugs
  • 50 percent of Phase 3 trials are failures
  • 45 percent of Phase 3 trials have the wrong dose

These facts show it’s clear we have a long way to go in the industry. Selecting the right vendor to work with, to challenge us if our thinking is wrong, and to work in partnership with us when we reach crisis point, is imperative.

So much of our time and energy is busy juggling our own increasing workload, so it was interesting the number of times over the two days that speakers advised upon the importance of not just finding the right vendor, but having the right people in their own company, each assigned with their own clear roles and responsibilities.

Another talk that very much stood out and clearly could have had almost double the time to cover the complexities and questions that it created was a topic that seems to take up enormous amounts of time for every company we speak with – the EU General Data Protection Regulation (GDPR). Esther Daemen of Fluidda gave a clear and thankfully simple talk on the challenges relating to the rollout of GDPR and how vendors could best align, use standard formats, and implement GDPR effectively and efficiently.

The success of events like this rely upon talks just like the ones mentioned. Talks that stand out cause conversation outside of the event. Make people reassess and evaluate their own systems and procedures. And talks that have the audience fully engaged throughout.

I was even luckier that in addition to Esther Daemen being a brilliant speaker, she also was brilliant company as we navigated with great amusement the Milan tube map to find ourselves a restaurant that evening outside Milan Cathedral.

Milan gave me a very enjoyable two days. Shopping was sadly curtailed to a bottle of Limoncello in the duty free shop as I departed. More importantly, however, Milan OCT gave me a number of fantastic new acquaintances in the industry as well as hope that however challenging this industry can be, there are people and companies out there that not only want to, but have found effective ways to navigate to success.

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