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[Column] To Become a Leader in Clinical TrialsHoward Lee's A Great Deal of Trouble
  • By Howard Lee Columnist
  • Published 2016.12.31 09:51
  • Updated 2017.02.20 16:55
  • comments 0

In early April, our hospital held an international symposium to celebrate the opening of GREATS, the Global Center of Excellence in Early Clinical Trials at Seoul National University Hospital. The name GREATS embodies the determination to advance as a "great" center in early clinical trials.

It has been years since South Korea joined the world's top ten markets in clinical trials. In the process, Seoul has become a city that conducts one of the most number of clinical trials in the world. Over a decade ago, when I flew to the United States to learn advanced knowledge in the clinical development of drugs including clinical trials, honestly, I had no idea that South Korea would grow so fast in this field. One of the factors that contributed to this growth is the increase in investment on research by the private sector including the pharmaceutical industry. But I would have to say that the leadership in the relevant field within the medical industry and the government, which put its trust in this leadership and constantly funded research, were the greatest contributors. In particular, the Ministry of Food and Drug Safety constantly worked to improve regulations, an effort worthy of praise.

For South Korea to truly become an international powerhouse in clinical trials based on the quantitative growth it has accomplished in the past, it is now time to seek a transition to qualitative growth. Our hospital made the decision to focus on early clinical trials, which mediate between translational research and the clinical stage, based on such awareness. In short, we believe we should shift direction from late clinical trials, which stress the efficiency of the operation, in other words, the how, to early clinical trials, which emphasize the scientific content, the what.

The decision-makers at international pharmaceutical companies we met to promote GREATS shared our awareness. Of course, some did ask us how quickly we could conclude the clinical trials. But all of them first showed interest in the scientific uniqueness and difference that our hospital's research team could bring to early clinical trials.

Given the recent changes in the global pharmaceutical industry, their reaction was anticipated. Many research functions that the pharmaceutical companies personally conducted have been put in the hands of outside specialists, such as contract research organizations (CRO). Therefore, pharmaceutical companies now focus more on integrating research results organized in document form and submitting them to regulatory authorities such as the U.S. Food and Drug Administration (FDA). There may be some exaggeration here, but this is why the criticism that "pharmaceutical companies are gradually transforming into document management companies" is convincing.

The business model of the pharmaceutical industry gradually resembles that of the publishing industry. Publishers determine which book will sell and commission the work to an external expert, who can provide contents that fit the publishing plan.

In this situation, naturally, a research team that can provide value added on a different level from the drug development portfolios presented by pharmaceutical companies has the advantage. When the capacity of translational research increases, differentiated value added can increase.

But it is unfortunate that the leaders in the domestic pharmaceutical industry still do not seem to properly detect such a trend. Of course, we should humbly accept the criticism that scientific differentiation had never sprouted properly in domestic medical institutions.
Still, there is a belief that South Korea will do fine. Even when I witnessed the foundation of clinical trials within the U.S. gradually crumble over the years, South Korea continued to display remarkable growth. South Korea clearly has something extraordinary. I am grateful that such a difference was detected in the clinical trial field, in which I serve.

leehwd@gmail.com

<© Korea Biomedical Review, All rights reserved.>

Howard Lee is a professor at Seoul National University School of Medicine, and a practicing family physician. He was also an assistant professor at University of Pittsburgh and Georgetown University School of Medicine.

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