Defying worries that the continued Covid-19 pandemic could discourage clinical trials, researchers are increasingly testing drugs in more trials than ever worldwide.
Statistics show that the number of newly registered clinical trials led by pharmaceutical companies increased 14.3 percent on-year to 5,068 in 2020.
Korea hit a record-high number of clinical studies last year as well, ranking sixth in the world. This was possible because of active collaboration among the private sector, the public sector, and research labs, enhanced R&D capability for new drugs, and the government’s support for quick implementations of clinical trials.
Korea’s ranking in the number of multinational clinical trials also went up to 10th in 2020 from 12th in 2019.
With the rapid growth of clinical trials, a medical team’s role within a pharmaceutical company – bridging between an R&D department and a business department – is becoming increasingly important.
Despite the pandemic situation, Boehringer Ingelheim is conducting various early-stage clinical trials of major pipelines in Korea.
The company is also aggressively building real-world evidence (RWE), which has become a hot topic in the pharmaceutical industry.
Korea Biomedical Review has met with Shin So-young, Head of Medical at Boehringer Ingelheim Korea, to hear about the medical team's role, various R&D activities, and her operating philosophy.
Question: The recent registrations of clinical trials showed that your company was conducting early-stage clinical trials in Korea. Can you explain what they are?
Answer: Boehringer Ingelheim focuses on diseases with high unmet needs, and our trials are ongoing to treat various diseases, including nonalcoholic steatohepatitis, schizophrenia, psoriasis, inflammatory bowel disease, and solid cancer. About 70 percent of trials in Korea are either phase 1 or phase 2.
The Covid-19 pandemic last year made the headquarters modify strategies for clinical trials. For example, the company made the operating system more flexible if a phase 1 study could not progress in a certain country due to the pandemic. The company picked Korea to be included in phase 1 trials unconditionally to confirm the appropriate dose.
The latest R&D trend shows that drugmakers conduct trials and develop new drugs based on in-house expertise and external partnerships.
Boehringer Ingelheim Korea has the initiative to invite world-renowned scholars of specific diseases and health experts with extensive research experience as advisors and discuss early clinical development strategies.
Recently, the company selected a Korean expert as an advisor. This means that the headquarters recognize the excellence of the Korean healthcare environment and Korean researchers’ experience and expertise.
Q: It was unusual for the company to present large-scale local real-world study data.
A: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is on a project to update ICH guidelines for real-world evidence (RWE).
In a randomized controlled clinical trial (RCT), researchers conduct the study only on patients with pre-set inclusion/exclusion criteria. However, in real clinical settings, the patient group using the drug is much broader, and it is very important to check the safety and effectiveness in these patients.
The importance of RWE is growing all around the world.
RWE is important to solve scientific questions about authorized drugs. In Korea, data from the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) are used a lot, so there is a lot of data that can be developed for RWE.
Q: Can you introduce RWE that Boehringer Ingelheim Korea has built so far?
A: Boehringer Ingelheim Korea has conducted several studies based on data from the HIRA and the NHIS, and one of them is the EMPRISE global trial for diabetes treatment.
EMPRISE is a global trial where Korea participated as one of the representative countries in Asia.
The study evaluated the safety and effectiveness of Boehringer Ingelheim’s treatment based on the database of 28,000 diabetic patients from the U.S., Europe, Korea, Taiwan, and Japan, and healthcare utilization data.
The results showed that the cardiovascular outcome from the previous EMPA-REG OUTCOME study was confirmed in RWD.
Diabetes associations in Europe and the U.S. are continuing to present related data.
The EMPRISE study is drawing particular attention because it can confirm how the vast database can show which drugs are effective and clinically meaningful in actual patient care.
One local RWE study analyzed Korean data from 2002 to 2016 in patients with chronic obstructive pulmonary disease (COPD) to evaluate how different the incidence of pneumonia depends on the initial treatment, the time until the third treatment, and the status of healthcare utilization.
In oncology, the company conducted a study to assess whether the treatment period, disease progression rate, and objective treatment response rate become different depending on which primary and second-line therapies are used in patients with non-small cell lung cancer (NSCLC).
Similar studies were carried out in other countries, but the Korean RWE study included data of 700 patients, a large group. In addition, the study's abstract was recently presented at the meeting of the American Society of Clinical Oncology (ASCO).
Q: Covid-19 is an unavoidable challenge. How did the pandemic change the company?
A: In the initial stage of the pandemic, job cuts have been an issue worldwide. However, our CEO at the head office promised employees that the company would not dismiss a single worker because of Covid-19 in an e-mail. He could send this message because the company was family-owned and has a culture that puts employees first.
The crisis management team in Korea also put the safety of the company, employees, families, and clients first. Following the government’s guidelines, the team strictly monitored the situation, had discussions, and took action to change work and behavior. For example, when there was a shortage of masks at the beginning of the outbreak, Boehringer Ingelheim Korea quickly decided to sign a contract with a mask supplier. As a result, the company has provided masks and hand sanitizers for employees every month until June. Also, the company activated working from home, greatly changing the way people work.
I don’t worry much about employees’ work efficiency or results because many seem accustomed to working from home and using digital tools to work in a non-face-to-face environment. Still, we need “human touch.” I think we should consciously make small but constant efforts to feel the “team spirit” in each other’s thoughts, trust, and attention.
Q: How did the company cope with external contacts with clients? Employees who used to have many connections with doctors must have felt it difficult to do their work.
A: Due to the pandemic, meeting a client has become limited. But it was also an opportunity to understand what the client’s values and priorities are. Every employee must have felt the change, but the Medical Team and Angels Team were relatively less affected. This is because doctors recognized the value of the information we deliver and the activities we create.
Of course, the meetings with doctors are not 100 percent the same as in the past, and we use various digital tools. But the Medical Team has a more flexible change to meet physicians, which will make the role of the Medical Team more important.