Good examples

KTA-Prim wants to increase clinical research in primary care

Eva Hellström Lindberg

Malin Frank is a specialist in general medicine and school physician in Stockholm. One day a week, she works as a clinical investigator at KTA-Prim, a reception center where she meets volunteer primary care study participants who want to test the future's treatments. The reception is one of three units within the Karolinska Trial Alliance, a clinical research center specializing in clinical studies commissioned by the academy, health care and life science industry.

A stone's throw from the main entrance at Sabbatsberg Hospital is KTA-Prim, a center for clinical studies in primary care and outpatient care. The aim is to increase clinical research without burdening routine health care.

It is morning and relatively quiet at reception center. It is not always like this. Here, about twenty clinical trials are conducted each year and thousands of volunteers pass through to participate in the studies. Earlier this year, for example, a large screening study for atrial fibrillation, which included 7,000 patients, was completed. Studies may also include future medical devices, new treatments for depression or diabetes, or testing of new medicines for the cardiovascular system or chronic obstructive pulmonary disease.

– Primary care is under a lot of pressure, and it is hard to find the time to do research. We can help because KTA-Prim is a county council actor who carries out primary care studies on behalf of researchers, clinics, and small and large companies from the life science sector, says Malin Frank.

She is a specialist in general medicine and has been working as a school physician in Stockholm for two years. However, one day a week she is at KTA-Prim where she is employed as an investigator. She meets with the patients who will participate in clinical studies that are being planned or underway.

One of her tasks is to ensure that participants meet certain criteria. She also conducts surveys continuously in accordance with a study protocol, follows test responses and ensures that patients are taken care of within the framework of the regulations that surround the studies.

– I started here in 2015 alongside my work at a health center. It was a whole new world for me. Here I can be part of a trial team, it is exciting and I enjoy it. It is fun to meet all the amazing study participants, but also to have the opportunity to deepen my understanding, to keep up with the development of knowledge and to monitor new treatments and what is going on in different areas, says Malin Frank.

Facilitates clinical studies

KTA-Prim provides the infrastructure required for clinical studies and there is a trial team consisting of investigators, experienced research nurses, study coordinators, study administrators and lab managers.

Just over a year ago, Terése Sörslätt began working in the clinic. She is a nurse and has been working with Phase I clinical trials for many years. She is now a project leader at KTA-Prim.

– When I went to University, I chose between the nursing program and the law program. Working with clinical studies came to suit my mind very well, as I work a lot with regulations and can also work patient-centered.

KTA wants to help companies as well as primary care and research staff to conduct and participate in clinical studies. A support unit offers help and expertise.

– Our largest client is the life science industry, but we have a relatively high proportion of academic research. It is quite difficult to start a study and it requires high level of competence. Here we can be helpful with different parts, from setting up a study or assisting with knowledge on applications, to take care of the whole study and carry it out ourselves, says Terése Sörslätt.

A clinical trial initiative may come from different directions; the life science industry or academic researchers, but also from university hospitals. Each year, KTA-Prim receives about 60 feasibilities. It is not only actors Swedish actors that can contact KTA-Prim.

– We receive feasibilities from all over the world, such as England and Portugal. Phase III studies require a large amount of patients to make relevant conclusions and then we can assist with study participants from our unit. We have a database of over 10,000 patients registered, which is a great and valuable source for research. We also participate in global studies where we can be one of several testing centers in the world.

The studies performed at KTA-Prim are in Phase II to IV, and the idea is that the clients can choose and mix services according to their specific needs, or choose a complete solution from start to finish..

– When we have reached an agreement, the study will be set up and we will cooperate with primary care to recruit appropriate patients. We start with a screening process in which we interview patients to find the ones best suited for each study, says Terése Sörslätt.

Grateful patients

District physician Malin Frank sees several benefits of being a specialist in general medicine and working as a clinical investigator. The study patients participating in the studies are typical "primary care patients" and are treated as if they were at a regular healthcare center.

– I get to use my general medicine knowledge even as an investigator and it allows me to capture things that can be outside of the study. Recently, I met a study participant and when I was listening to the lungs, I discovered a suspected basal cell carcinoma on the back, a malignant skin tumor. I contacted the patient's regular doctor who could refer the patient to specialist care.

Other examinations and lab tests may also show deviations beyond the clinical study and need to be taken care of by other healthcare providers.

– Many of our study participants are very grateful and happy to be part of our studies. They are well investigated and taken care of and get a relatively high amount of time in the meeting with us, says Malin Frank.

The clinical research in Sweden is of high quality, say both Malin Frank och Terése Sörslätt.

– With the help of the regulatory framework that covers clinical trials, we are always striving to improve processes, both to get the most secure data and to maintain very high safety for patients, says Terése Sörslätt.

Although the quality of clinical studies in Sweden is high, it is important to continue to streamline work so that Sweden will maintain its position as a strong research nation in the future.

– It is therefore important to review whether we can help smaller units that conduct clinical research to merge into larger units. By streamlining processes, especially when it comes to recruiting patients to the studies and to allow more primary care patients to participate in clinical trials, we can save a lot of time and energy

Terése Sörslätt would also like more time to be spent on informing patients about the possibilities and conditions for participation in clinical studies.

– Many patients are not aware that there is an opportunity to participate in clinical studies and be involved in testing and evaluating a new treatment. Many people appreciate coming to us. They get a continuous contact and a sense of being seen.