Testing new possibilities
But better treatment cannot come about without research. To apply a new treatment to patients, the safety and effectiveness of new methods should be proven on scientific grounds. To decide whether they can be applied to humans, preclinical toxicity and effectiveness tests should be conducted.
However, due to differences among species, these outcomes cannot be the basis for approved usage on humans. In the end, a human needs to be part of a safety and effectiveness test. This is the clinical test.
There are negative perceptions about clinical trials. Nazi Germany and Japan conducted cruel experiments in the name of science during World War II. The 1964 Declaration of Helsinki set standards for “good clinical practice” that prioritizes the safety, rights and welfare of research participants and produces reliable data based on the most scientific methodologies. It is only fair that researchers do their best to protect the safety of participants in clinical trials.
The United States, Europe and Japan are key countries in the medical industry, leading the development of new drugs. Naturally, they conduct the most clinical trials. In order to properly assess new drugs, advanced medical environments, facilities, equipment, treatment guidelines and technologies are necessary. Most countries developing new drugs conduct clinical trials within the country. But they are faced with problems as the cost of clinical trials goes up and the process for recruiting patient volunteers takes longer.
Global pharmaceutical companies are looking outside the three key countries. Until the early 2000s, Korea had little interest in clinical trials, and there was little infrastructure to conduct clinical trials in accordance with international standards. But thanks to state-sponsored assistance for clinical trial infrastructure and joint efforts by industries, the government and academia, Korea has attained surprising development in a short period of time. The development and improvement of clinical trials is significant in several respects.
First, more high-quality research results contribute to the development of new drugs that help the treatment of patients. Here, high-quality research results do not mean that the tested drugs are effective and safe. It means that the test accurately evaluates the effectiveness and safety of the drug.
Second, the recruitment period has been reduced and overall development period minimized while safe and effective drugs are developed at the same time. When the development period for a new drug drags on, that translates to additional cost. The cost is included in the development cost, reflected in the drug price. In the end, there will be more burden on patients. Therefore, researchers work hard to reduce the development period as much as possible.
But it is not just about the cost. There are patients waiting for effective treatments for incurable cancers and rare diseases. To them, a shorter development period can mean saving a life. For some patients in desperate situations, participating in a clinical trial is be the only hope. There are many cases where patients suffering from terminal cancer participate in clinical trials for a new drug and get cured.
Clinical trials are certainly necessary, and they are simply impossible without the participation of test subjects. But there are concerns as a clinical trial is inherently uncertain. Therefore, respect and protection of individuals voluntarily participating in a trial should be prioritized over justifications like medical development or social benefit.
We should never allow situations where test participants get involved for money or are treated unfairly and have their rights infringed. Related laws, international standards and a monitoring system have already been established. But the point is how well we comply with them. No matter how strict regulations become, it is hard to change people’s minds or attitude.
Researchers need to ask themselves whether they are doing their best to protect patients and conduct tests to produce reliable outcomes. Only then can people’s distrust of clinical trials be cleared and we can accomplish the goal of improving national health through the development of better treatments.
Translation by the Korea JoongAng Daily staff.
JoongAng Ilbo, Oct. 27, page 33
*The author is a professor at the Yonsei University College of Medicine and president of the University-Industry Foundation at the Yonsei University Health System.