CONNECT seminar: investigator-initiated clinical trials

How can researchers have successful collaborations with industry in clinical studies? This was a central question at a recent CONNECT seminar.

“Investigator-initiated clinical studies – from idea to start” was the topic of the second meeting in the series Clinical Trials, arranged by CONNECT Working Group 2 via Zoom, on 24 October 2022.

The meeting attracted 100 participants from all over Norway - a new record for a CONNECT digital seminar and demonstrating the high level of interest in the topic.

Åsmund Flobak, oncologist at St. Olavs Hospital, opened the meeting by introducing the topic:

“Our focus is on: How do hospitals collaborate with industry? What does the industry think versus how the hospitals and public institutions think? And how do researchers navigate this landscape?”

View the meeting here:

From idea to results

The first speaker was Bjørn Henning Grønberg, Professor at the Institute for Clinical and Molecular Medicine at NTNU and oncologist at the Cancer Clinic at St. Olavs Hospital. He talked about how to take an idea for a clinical study all the way to publication of results.

Grønberg emphasised that the organisation of studies has become more complex, with multi-centre studies that span different countries, which makes the studies more challenging to run.

“So, how do you define a concept? Of course, there needs to be a knowledge gap, but in reality, you also have to be pragmatic. How many patients can you recruit? How many collaboration partners can you find? Any study with a degree of innovation will require access to new drugs and it is extremely difficult to get public funding to cover these costs in a large, randomized study. Lastly, you need to have financing to cover the running costs of the study.”

Grønberg also stressed the importance of securing a degree of consensus with your colleagues and having a good dialogue with industry. He advised colleagues to attend congresses, build network and get the attention of decision-makers in the pharmaceutical companies.

Working with industry

Anne Hansen Ree, oncologist, Akershus University Hospital and Professor at the University of Oslo, and Ali Areffard, Disease Area Head Immuno-Oncology, Bristol Myers Squibb Norway, shared their experiences from their long-term collaboration in the second part of the meeting.

The collaboration began when Ree sent a request to Areffard at Bristol Myers Squibb (BMS) about initiating a clinical study on metastatic microsatellite-stable colorectal cancer, a disease with poor prognosis.

“It is important before you send a request to a pharma company to have a solid academic understanding. We need this to understand the concept and have a good dialogue internally. We want to promote the Norwegian research environments in a global context. As you gain more knowledge, you can facilitate a good scientific discussion,” Areffard commented.

At that point in time, BMS was curious to see why this patient group didn’t respond to immune checkpoint-inhibitor drugs and decided to support Ree’s study.

“You need a bit of serendipity. It was new to me to collaborate directly with the pharmaceutical industry, but it has been a delight. We talk continuously with one another, and it is great to have someone locally in Norway to discuss with. It has been one of the success factors,” Ree complemented.

Areffard and Ree also repeated the importance of networking between hospitals and industry, as well as the importance of having a concept worthy of publication.

Nordic collaboration

Marianne Brodtkorb, oncologist and cancer researcher at the Department for Cancer Treatment and the Institute for Cancer Research, Oslo University Hospital, and Janne Beheim, Medical GSK Norway (as moderator) discussed the MERLIN project in the third part of the meeting. MERLIN is a phase II study on follicular lymphoma that will run at 13 sites in the Nordics starting 2023.

“The idea came from my long clinical experience with the disease and being a part of a research-intensive milieu at the Radium Hospital. I identified this patient group with a bad prognosis. There is now increased awareness of this sub-group with follicular lymphoma that becomes chemo-resistant and needs new treatments. New forms of innovative immunotherapies are of interest for this group,” Brodtkorb explained.

Brodtkorb talked about how they have established a strong relationship with industry by inviting companies to pipeline meetings.

“We try to promote our research activities, resources, competencies, and infrastructure. Even if Norway is expensive, we have a long tradition of delivering what we promise, including good quality data and patients that are positive to participate in trials. We also have a well-established Nordic collaboration,” Brodtkorb continued.

Pharma’s best advice

The last part of the meeting was a panel discussion with four representatives from the pharmaceutical industry, namely: Eli Bergli, Medical Head Oncology, Novartis; Ali Areffard, Disease Area Head Immuno-Oncology, Bristol Myers Squibb Norway; Anne Bee Hegge, Medical Director, Roche Norway and Catrine Notland, Pfizer. They shed a light on how the industry views investigator-initiated trials.

“Research collaboration between industry and clinicians is important and necessary. When you have a proposal for a research project, it is important we have common scientific goals and interests. The studies shed light on different challenges and cover different medical needs, which we as a pharma company don’t have the opportunity to do. It is an important job being done, especially for the patients,” Bergli said.

“I want to highlight how to get competency and build network. You can participate in ongoing academic or industry-sponsored studies. We had several Nordic sites participating in the same study. They built competency, did their own research, delivered great results and had quick patient inclusion. A few years later, they applied for their own academic study in the Nordics, led from Norway. They had shown great track record, presented an innovative idea and this was good timing for the research interest in the company,” Notland explained.

“A good example of research collaboration can be real world evidence studies, where there is a large knowledge gap to understand how to design next-generation studies, and identify which patients have the greatest needs. Here there are many opportunities to start a dialogue with the industry, since this is what we do on a large, global scale,” Areffard said.

“Two of the studies mentioned here are supported by Roche and we see internally that they are answering clinical questions that are relevant, not just for Norway, but also for the Nordics and globally. There has also been a lot of local enthusiasm to get these studies up and running – with a clear strategy to talk to our headquarters. I also think it is very motivating when Norway is seen as a country for clinical studies,” Hegge added.

The meeting was then rounded off with an audience Q&A, where the attendees could pose questions directly to the pharma representatives.

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