The Importance of Monitoring in Clinical Trials in Japan

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In recent years, the problems of "drug lag" (the approval of therapeutic drugs developed overseas is significantly delayed), and the "drug loss" (the new drugs from overseas do not enter a particular region) have become evident in Japan. These problems are particularly conspicuous in pediatric drugs and rare disease drugs. The government and pharmaceutical industry are working to resolve these issues, but at the same time CROs conducting clinical trials also play an important role in ensuring these vital drugs can reach patients quickly.

In this article, we will introduce the importance of monitoring in rare disease trials and how CRAs contribute to the success of trials through understanding protocols and diseases as well as strengthening communication with physicians and investigator site teams.

About the Clinical Trial Environment in Japan

Japan is known for the high quality conduct of clinical trials, but at the same time, there are unique challenges in conducting clinical trials in this region. For example, due to differences in laws and policies, there may be regulations that vary from international guidelines. In addition, because of the small number of patients in rare disease trials, it can be difficult to find and enroll sufficient patients, which often becomes a challenge in the progress of these trials.

The Vital Role of CRAs

CRAs are the main hub of information exchange in the conduct of clinical trials. CRAs monitor the progress of clinical trials based on protocols and various study plans while ensuring the quality of data. Especially in small-scale trials such as rare disease and pediatric drugs, the importance of data obtained from a limited number of patients increases.

Understanding Protocol Compliance

CRAs receive detailed training before each clinical trial starts, and the most important keys to success is understanding the protocol precisely. In the case of rare diseases, there may be no standard treatment. Therefore, the protocol specifies in detail the method of administration of the investigational drug and the evaluation criteria. It is important for CRAs to be familiar with this protocol and work with on-site physicians and staff to reflect these nuances in the trial.

Close Communication with Physicians and Site Staff

It is essential for the success of a clinical trial that CRAs communicate closely with on-site physicians and site staff. Especially in clinical trials of rare disease and pediatric drugs, it is important that physicians and staff understand the purpose and protocol of the trial and comply with the study plan. CRAs strengthen communication with the site through ongoing monitoring throughout the trial. Additionally, by actively sharing information and exchanging opinions, a relationship of trust with on-site physicians and staff is built which significantly improves the progress of the trial and the quality of the data.

Our Efforts and Success Stories

It is clear that in all clinical trials, a key to success is for CRAs to have a deep understanding of the protocol and disease and to communicate closely with on-site physicians and staff. To achieve this, continuous training and information sharing are essential. In addition, it is expected that technological advances will improve the efficiency of clinical trial monitoring and data management.

We believe that one of the important foundations for successful trials is how we can maximize on-site physicians’ awareness and engagement about the significance of investigational drug development. As a partner that represents the Sponsor's enthusiasm and goals for the clinical trial, we value our relationships with physicians. Linical’s experience, including thorough knowledge of target diseases, investigational drug profiles, and optimal study design has led to a track record of success.

As a specific success story, in a recent clinical trial for a rare disease, we were able to gain understanding and cooperation for the clinical trial by having in-depth discussions with physicians about the characteristics of the investigational drug and the possibility of treatment. As a result, patient recruitment proceeded smoothly, high-quality data was collected, and the clinical trial was successfully completed. This drug has been approved without major findings following an inspection by the PMDA.

In fact, the sponsor has sent a comment of gratitude. "Thanks to the Linical CRAs who collected and proactively reported about the voice of the sites and patients which usually cannot be read through normal clinical data. Because of your report, we could feel the significance of this development and understand the perspective of sites and patients even though we had only few opportunities to visit the site."


The importance of rare disease clinical trials in Japan is expected to increase in the future. In this context, we will further strengthen our role as CRAs and continue to contribute to the success of clinical trials. Although digital tools and remote monitoring are becoming more common due to technological advances, the importance of person-to-person communication remains unchanged. CRAs facilitate efficient study conduct and ultimately the success of clinical trials by directly communicating with physicians and site staff and building trusted relationships.

Going forward, our mission is to continue to strive to improve the quality of clinical trials through professionalism and continuous learning, and to contribute to the development of safe and effective treatments for patients. The role of CROs is vital to advancing clinical development, and Linical is committed to further strengthening our efforts toward the success of clinical trials across the globe.

Tomoko Inomata
Senior Executive Officer, Linical

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