CROee supported Phase Ⅲ global clinical study for chronic lower back pain and osteoarthritis, achieving the target number of cases in Japan.

CROee, Inc (Headquarters: Toshima-ku, Tokyo President: Sho Ando) contributed to the achievement of enrollment goals for a phase 3 global study sponsored by Pfizer Inc. (Headquarters: Tokyo, President: Akihisa Harada) by providing patients with clinical trial information through overviews and study advertisements etc. on the clinical trial site “Seikatsu-Kojo WEB”.

As global studies* are increasing amongst clinical trials, recruitment of patient is becoming an issue. Recently, rather than studies where the target number of subjects is set for each participating country, there is an increasing number of competitive studies where an overall target number is determined for the study and the study ends when the total subject number amongst the countries reach the target. Therefore, if patient recruitment is delayed and the number of cases cannot be secured sufficiently in a country before the study ends, the process for drug approval in that country will be greatly affected. In order to solve such problems, PROs (Patient Recruitment Organization) that specialize in the recruitment of patient are used by pharmaceutical companies in Europe and the United States. However, there are few reliable PROs in Japan, and it is still not considered a standard compared to Europe and the United States.

To tackle this issue, Pfizer implemented the patient recruitment services of CROee into this competitive study. By using the clinical trial information site “Seikatsu Koujyou WEB” and clinical trial advertisements, and by working with medical facilities, CROee provided information on this trial to patients suffering from chronic lower back pain and osteoarthritis. In the chronic lower back pain trial, despite having only one year of enrollment period left, CROee managed to recruit more than 30% of the total subjects in Japan.

Drug development is one of the important industries in Japan, as seen with the Ministry of Health, Labor and Welfare’s initiative “Comprehensive Strategy for Strengthening the Pharmaceutical Industry ~ Drug Discovery Looking to Global Expansion ~” last year.
CROee will continue to contribute to Japan’s medical field by providing appropriate clinical trial information to patients and supporting the development of new drugs.

※Global study：Clinical trials that medical institutions in multiple countries and regions participate in and simultaneously conduct so that new medicines can be used by patients worldwide quickly. It is mainly subject to Phase III clinical trials.

■Comments from Sho Ando, President of CROee
Where competitive studies is becoming the standard for global studies, patient recruitment is an important factor for enhancing the international competitiveness of Japan in new drug development. We will continue to contribute to the development of new drugs in Japan through providing appropriate information to patients so that shortage of patient will not create drug development lag.

■Comments from Tatsuya Murakami, General Manager, Clinical Operation and Quality, Pfizer
Japan is an important base for drug development, but there is an issue of lack of access to clinical trial information and thus low recognition. With the growing importance of patient-oriented efforts (Patient Centricity) in clinical trials, we are making effort to inform patients, such as by providing information about study sites on our website and results of clinical trials to trial participants. By providing appropriate information and cooperating with CROee, we could carry out clinical trials as planned. We will continue to make effort to provide new treatment options to Japanese patients in the future.

■About CROee：The realization of a society where everyone can be themselves.
In order to improve the clinical development speed in Japan, we started a business specialized in patient recruitment. Drug development takes longer, and higher costs compared to Europe and the United States. One of the causes is a shortage of patients. In response to this issue, patient recruitment activity is conducted at every phase of the trial. From preparation of recruitment plans to follow up of patients after the completion of clinical trials, we support more than 10,000 cases of randomizations annually. For details, please visit our website https://www.croeeglobal.com/

【For inquiries regarding this】
CROee, Inc
URL：www.croeeglobal.com/
TEL： 03-5953-2108　FAX：03-5952-1887　Mail：imran@croee.com