TXP Medical Co. Ltd. launches a recruiting support service for acute clinical trials based on real-time analysis of emergency patient information. ~New services triggered by "NEXT Stage ER” ~

TXP Medical Co. Ltd.  (headquarter: Bunkyo-ku Tokyo, CEO: Tomohiro Sonoo, hereinafter "TXP Medical") which develops the NEXT Stage ER (hereinafter referred to as NSER) series, a patient information recording and management system specialized for emergency departments, will begin offering a patient recruitment support service for acute phase clinical trials.

The first case is an acute care clinical trial commissioned by A2 Healthcare Corporation (Head office: Bunkyo-ku Tokyo, President: Tadashi Katori) and provided to Makita General Hospital (Address: Ota-ku Tokyo, Chairman: Yoshinori Arai).

With this service, we will contribute to the development of drug development in Japan by supporting acute phase clinical trials, which are said to be difficult to recruit patients, with a completely new method.

Since 2017, TXP Medical has been offering Next Stage ER, an emergency medicine platform that integrates fragmented medical data under its corporate mission of "saving lives with medical data" to the emergency medical field.

We are developing our business with the aim of saving more lives in the medical field by circulating data through the use of this product.

【Background】
Clinical trials for acute diseases are difficult to accumulate cases for the following three reasons, which often lead to prolongation of the clinical trial period, resulting in a longer period of time until the new drug is launched.

<Subject>

1. Strict time constraints on Inclusion Criteria (e.g., entry within hours of onset)

2. The characteristics of acute disease with unpredictable onset timing makes it difficult for clinical research coordinators (CRC) to intervene in a timely manner to support patient recruitment.

3. Unlike a standard clinical trial, no recruitment scheme is available to inform the patient community about participation in a clinical trial.

【Overview of New Services】
In the medical field of acute care hospitals, "NEXT Stage ER" realizes digitalization of information from the moment a request for patient admission from the emergency team is received by telephone.

The new service evaluates the suitability of patients for clinical trials based on patient profiles, symptoms, underlying diseases (history information), disease scoring, and information on medications used, which are entered into "NEXT Stage ER," and notifies users (physicians, nurses, hospital administrative staff) via pop-ups on the system screen. This allows users to identify potential trial patients early in the course of their normal work.

Furthermore, after the user confirms the pop-up, the details of the selection/exclusion criteria and the contact information of the investigator and clinical research coordinator (CRC) can be confirmed, enabling smooth implementation of the NEXT Action for the candidate patient.

As a result, this service prevents medical institutions from omitting the screening of patients for clinical trials and contributes to speeding up the accumulation of the number of cases in acute clinical trials.

【Examples of diseases for which this service can provide patient recruitment support】

• Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)

• Acute myocardial infarction

• COVID-19 (especially moderate to severe)

• Acute heart insufficiency

• Pneumonia / COPD acute exacerbation

• Physical injury : head injury, cerebral contusion, spinal cord injury, fracture

• Allergy: anaphylaxis

• ICU disease: sepsis, DIC, severe respiratory failure, ARDS, acute pancreatitis

• Asthma attack

【Yoshinori Arai, President, Makita General Hospital, Jinikai Foundation for Social Medicine】
In Japanese healthcare, there is only so much that can be done through patient intervention by healthcare professionals. Many healthcare professionals recognize that the development of new drugs in Japan is very important for improving the quality of healthcare. However, the reality is that it is difficult to balance the provision of medical care and clinical trial operations in a tight acute care setting.

We have high hopes that this initiative by TXP Medical may dramatically increase the speed of patient recruitment for acute clinical trials, resulting in more lives saved.

【Yukikazu Hayashi, General Manager, Business Development Division, A2 Healthcare, Inc.】
I know that many trials in the acute setting are having difficulty recruiting patients. However, we were faced with the dilemma that it would be difficult to make further requests in the very busy field of emergency medicine. Under such circumstances, I feel that the NSER system is a very valuable step in supporting patient recruitment. We feel that this is a hopeful initiative that will not only save time and trouble for those in the emergency room, but will also provide a means for those requesting and administering clinical trials to promote patient recruitment.

【Tomohiro Sonoo, CEO(doctor), TXP Medical Co. Ltd.】
I have been working in the field as an emergency physician for over 10 years and have experience as a field physician in multiple acute care clinical trials. I have experience as an acute care clinical trial site physician in several large hospitals, where multiple clinical trials and clinical research studies are often running in the busy clinical setting. We would like to create a powerful stone in the area of acute clinical trial recruitment in the absence of existing solutions.