How IIS Are Improving Outcomes in Heart Patients

Our CRO focuses on industry-driven and investigator initiated studies.

While industry-driven trials are initiated by the pharmaceutical, medical devices or eHealth industry, investigator initiated studies (IIS) are developed by an independent investigator.

Also known as investigator initiated trials (IIT), these clinical studies are extremely valuable for a varied research landscape since they are oriented to find a scientific answer to a question relevant in daily practice.

Having conducted over 200 investigator initiated studies in cardiology, we can proudly say we’ve become your trusted expert.

Talking To Our Expert Investigators

We reached out to some of our favourite investigators to discuss the importance of this interesting type of research, the common obstacles and latest developments.

Elvin Kedhi

In our first interview in this series, we’re talking to Prof. dr. Elvin Kedhi MD, PhD (interventional cardiologist), Erasmus Academical Hospital, Brussels, Belgium.

He’s been working with Diagram since 2011 and is the Principal Investigator of the current COMBINE-INTERVENE trial, the follow-up of the successful COMBINE (OCT–FFR) trial.

Researching Interventional Cardiology

My focus changes over time, but it’s always about the unanswered question in daily clinical practice.

Prof. dr. Kedhi started his career in interventional cardiology in Rotterdam, the Netherlands, after which he spent six years in Zwolle before moving to Belgium, two years ago.

Diagram and Prof. dr. Kedhi started their collaboration in 2011, when Prof. dr. Kedhi was working in Rotterdam. They continued working together ever since, conducting an impressive total of seven cardiology trials over the last decade.

When asked about his research focus, Prof. dr. Kedhi shares: “My focus changes over time, but it’s always about the unanswered question in daily clinical practice.

It started in the years 2007/2008, when stent thrombosis was a problem with drug-eluting stents so we worked on new second generation stents with very nice results.

From there, we moved into duration of dual antiplatelet therapyafter myocardial infarction, after acute coronary syndromes, with the DAPT STEMI trial and COMBO trial. We also did the Absorb DM Benelux and then the COMBINE (OCT–FFR) trial.”

Prof. dr. Kedhi continued his research into FFR-guided revascularisation with the TCW trial and RFR guided versus angiography guided CABG revascularization with the RFR-CABG trial, both ongoing.

In addition, he’s working on a program with combined FFR and OCT assessment to PCI revascularization strategy based on FFR alone in subjects with multivessel disease in the COMBINE-INTERVENE trial.

Doing Investigator Initiated Studies To Find Scientific Answers

Investigator initiated trials are trials that answer questions that are relevant in our daily practice.

We’re interested to learn the how and why of Prof. dr. Kedhi’s research topics.

Prof. dr. Kedhi shares: “To quote Professor Felix Zijlstra: when you debate over a topic where different cardiologists have a different opinion, and the dynamics are not clear, then that’s the topic to do a trial.

So, investigator initiated trials are not trials that have a commercial impact, but are trials that are there to answer questions that are relevant in our daily practice. These are purely oriented to a scientific answer.”

He concludes: “And sometimes it’s difficult to get them funded, because there is no direct commercial end towards these trials.”

Overcoming Challenges

Having the funding is super important, it’s step one of the trial.

So we wonder, is funding the biggest challenge for IIS?

“It is of course one of the biggest challenges,” Prof. dr. Kedhi says. He explains that there are a lot of people involved organising a trial, like nurses, different centres, statisticians, the CRO. You need funding to cover the salaries of all those the people.  

“Having the funding is super important, it’s step one of the trial,” he says.  

Prof. dr. Kedhi continues: “And credit to Diagram, that is able to manage with the limited budgets these trials have. To illustrate, when I started, these trials were one centre trials, then multi centre within one country, then European level trials and the last trial we’re doing is going across four continents and 60 centres.”

Finding Support For IIS

Doing a trial has become very complex nowadays. For a doctor who has his daily work, it’s simply impossible to do.

A second common challenge young investigators face, is being supported from a professional organisation.

To clarify this point, Prof. dr. Kedhi explains: “Doing a trial has become very complex nowadays: you’re going to need a database, a program coordinator, people who will tell you what the rules of doing a trial are. You need to have good clinical practice, papers etc. And you’re going to need a data clinical event committee. Then you’ll need to do all approvals from ethical committees. You’re going to have to do data safety monitoring.

All this, for a doctor who has his daily work, it’s simply impossible to do.

And that’s exactly where I think Diagram comes in, by facilitating all this to investigators. I believe Diagram does this very well, guiding you through this complex process.”

Developments In Investigator Initiated Studies

Research is still aimed to answer the same basic question: how can we serve the patient better?

Having conducted IITs for over a decade, we’re curious to hear about shifts that happened in the clinical research landscape.

Prof. dr. Kedhi shares: “In the time that the drug-eluting stents were coming out, there was a lot of research to be done with these stents. We had first drug-eluted stents, then second generation and after that many trials comparing new types of devices. Extensive analysis had to be done for these trials and some research organisations would employ up to 60 people to accommodate this need.”

He explains that today things are different: “We’re seeing that whatever had to be done on stent-level, has been done. There are very few stent-trials going on around the world. This tendency is here to stay.”

According to Prof. dr. Kedhi, interventional cardiology now needs structural trials. These trials are different from the stent-trials, in that they require much less patients.

Yet, despite this shift, research is still aimed to answer the same basic question: how can we serve the patient better?

Prof. dr. Kedhi: “As an interventional cardiologist, this means researching strategies and treatments that are currently being used: ischemia, short/long DAPT, new medication that reduces your risk profile, going into prevention etc.

All these are very interesting topics, and there is definitely room for it,” Prof. dr. Kedhi concludes.

Looking into the future

When asked what we can expect from Prof. dr. Kedhi in the near future, he mentions: “That’s a very tough question to answer. Five years from now, first of all I want to see a healthy planet and a peaceful planet.

And if we are still part of this planet in five years, then I’d like to have all these trials finished and published. And hopefully have new ideas generated from already done work and working on new trials again.”

Working with Diagram Research

The team at Diagram is a compact but very efficient, responsive team with a personal approach.

To conclude our interview, we ask Prof. dr. Kedhi about his partnership with Diagram. What’s the best part?

Prof. dr. Kedhi happily obliges: “First of all, Diagram was founded from very prominent cardiologists in the 90s to give tailored answers to the investigators. And to my knowledge, they’re the only CRO that focuses itself to serve the doctors who are doing the trials.

Secondly, it’s a compact but very efficient, responsive team with a personal approach: you need something, you simply pick up the phone or send an email and you get an answer within 24hrs. This is for me one of the most important aspects.”

He continues: “Another important aspect is the flexibility you have as an investigator. Sometimes when you do a trial and you don’t need the full package of services that Diagram has to offer, you can pick and choose.

Finally, last but not least, the fact that I keep working with Diagram proves that the quality of the work delivered is also good.” 

Prof. dr. Kedhi wraps up the interview with one final remark: “I’ve worked with other CROs, but there’s something special about this one. It’s about being this Northern Dutch centre, it expresses the Northern Dutch mentality: to the point, quick, efficient, by the rules and trying to be as accommodating as possible to the client. And that’s what makes them special.

So, I’d like to thank the team of Diagram for their excellent work, our partnership and for our friendship that has grown throughout all the years of working together.”

Diagram Research

– Improving outcomes in heart patients, one heart at a time –

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