It is becoming increasingly important for individual researchers or research institutes to conduct research after proposing research topics. This is because the results of the study are reflected in clinical treatment guidelines or incentivize the development of new drugs and medical devices. In the case of research related to infectious diseases, such as Covid-19, it can become the basis for establishing public health policies

It has a different meaning from the Sponsor-Initiated Trial (SIT) conducted by pharmaceutical companies and medical equipment makers to commercialize their products. That explains why major domestic hospitals, including Samsung Medical Center, Severance Hospital, Asan Medical Center, and Seoul National University Bundang Hospital, are operating an Academic Research Organization (ARO) to support clinicians’ academic research.

Recently, a private ARO has also taken the first step. LSK Global PS, a contract research organization (CRO), established the Academic Research Service (ARS) in March, and recruited Kim Sun-woo, an ARO expert, as its managing director. Kim has been supporting academic and private research in medical and pharmaceutical fields over the past three decades, serving as head of the Biomedical Information Center of Samsung Medical Center and senior research at the Medical Statistics Research Center.

Korea Biomedical Review recently met with Managing Director Kim to hear about why ARO service is necessary, major research projects supported by LSK Global PS, and future plans.

Kim Sun-woo, managing editor leading the Academic Research Service headquarters at LSK Global PS explains ARO service during a recent interview with Korea Biomedical Review.
Kim Sun-woo, managing editor leading the Academic Research Service headquarters at LSK Global PS explains ARO service during a recent interview with Korea Biomedical Review.

Question: ARO is still an unfamiliar concept in Korea. There is a CRO that supports the design and performance of clinical trials. Why a separate ARO service is needed?

Answer: Sponsor-initiated trials (SITs) evaluate the efficacy and safety of products after their approval or marketing by clients, and thus are conducted according to a somewhat formalized process in terms of research purpose, evaluation variables, and study proceedings.

In contrast, academic research turns medical curiosity or ideas initiated by researchers or clinical trials into a research question and gradually develops them into a form of research. Each search needs a customized design, and when there is an ARO that can support it throughout the full cycle, research can be conducted more successfully.

Q: Supplier’s know-how seems to be important for customized service. Is there any support case that you remember?

A: I remember a researcher-led clinical trial, which compared treatments for young breast cancer patients while working at Samsung Medical Center. Because the proportion of young breast cancer patients in the West is lower than in Korea, pharmaceutical companies are also less interested in the treatment of young breast cancer patients. Against this backdrop, a young researcher consistently studied treatments for young breast cancer patients and presented its results at the American Society of Clinical Oncology (ASCO). This research has attracted the attention of global pharmaceutical companies and led to research sponsorship. It was also published in the world-renowned journal, JAMA Oncology.

In another example, an observational study was conducted to confirm whether the congestion in the emergency room was related to the infection rate in the emergency room. Although it was predictable as common sense, we needed to confirm it with real data, so we divided the emergency room area according to the degree of congestion and confirmed the infection rate in divided areas. At the time, the level of emergency rooms remained poor, and it was the study that sought an answer to the question of whether the infection rate in the emergency room will decrease if the level of emergency rooms in Korea improves to those of the advanced countries?

Q: What could be the know-how in providing ARO service?

A: When we receive requests for academic research, we ask two questions. One is about the research’s motive or purpose. The other is about the research’s clinical value. In other words, we ask what are the researcher’s expected results assuming the study ends successfully.

Researchers often tend to begin research with value expectations, but they can get nothing in this way. Therefore, we keep asking questions so that they can answer the research purposes or expected results concretely. These processes result in a clear answer, based on which we specify the research purpose and expected results through careful consideration and discussion.

Q: The ARS headquarters were established in March. How many academic studies have you received?

A: We have received 13 projects – nine researcher-led clinical trials, one big data-based research, and three observational studies. Three of these projects were revision works after submitting theses. There was a study on anesthesia and pain submitted to the British Journal of Anaesthesia and was asked for a correction. We also helped the paper pass immediately by modifying it at the ARS headquarters.

Q: What are your plans?

A: As the demand for researchers diversifies and their expectations rise, ARO also requires advanced expertise. LSK Global PS has accumulated experiences and capabilities entrusted with many sponsor-initiated trials. ARS headquarters also have a professional workforce who have accumulated experience at university hospitals By connecting our professional functions as a CRO with ARS headquarters, we can provide high-quality service and make efficient progress, based on which we intend to establish academic leadership in the future.

 

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