“Patients may try to sell their medical information (unless physicians and researchers share them).”
So warned Chee Dong-hyun, president of the Korea National Enterprise for Clinical Trials (KoNECT), a non-profit organization funded by the government to promote the nation’s clinical trials capabilities.
She raised such concern through a keynote speech at a conference on “Transformation of Clinical Trials through Data-driven Approaches,” organized by the Korean Society of Medical Informatics, at Chonbuk National University Hospital in Jeonju, North Jeolla Province, on Thursday.
Chee introduced the latest trends in new drug development and clinical studies around the world and major countries’ policies regarding clinical trials, to emphasize the need for a change in Korea’s system for local clinical trials.
With the paradigm of novel drug development rapidly changing, researchers are trying to obtain more detailed information from clinical tests, she said.
When not only pharmaceuticals but physicians and the government gauge over time, costs, and risk of failure in new drug development, advanced countries, including the U.S. and European nations, are making various efforts to address the issue, Chee noted.
She emphasized that the government, academia, and the industry are setting up a consortium to develop new biomarkers, innovative clinical designs, standardized clinical trial data, and to prepare for the use of biomedical information in those countries.
“The U.S. and Europe have formed the clinical trial support process in top-down methods since the early 2000s and mid-2000s. In there, the industry is included to accelerate new drug development,” Chee said. “In Korea, however, there are not many networks formed to support clinical trials as much as they did.”
According to Chee, the newest trend in clinical research is to pursue patient-centered tests and share data to save time and costs.
“I want to ask how much efforts Korean researchers have made to share data. They should be ‘hungry’ for more data to collaborate. If they think they have enough data, collaboration is almost impossible,” she said.
Chee criticized the narrow mindset of patients or physicians which made them shunned from sharing data.
“Some local hospitals and researchers regard patients’ medical information as their own. That is the problem. Even within a single hospital, people don’t share data,” she said. “Unless researchers and hospitals share data, patients could try to sell their data in the future. In the U.S., some businesses do that already.”
If patients trade their information, the cost for clinical trials will rise and make new drug development more challenging, Chee warned. “This is not a desirable scenario, both to patients and researchers,” she added.
The conference focused on “Real-World Data,” considered as a new medical paradigm, and the main theme was “Real-World Data to Optimize Clinical Trials.”
More than 700 scholars and industry officials participated in the conference. The event offered various symposiums including deep learning-based medical image analysis, real-world data use and new drug development, clinical trials using big data, standard data models, nursing informatics, and medical information certification.
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