Clinical Trials Networks
Massive Network for Clinical Trials (MNCT)
The number of clinical trials conducted in Japan has been decreasing in the past years. The decrease is partly attributable to a lack of investigational sites and trained clinical research staff.
To address this problem, JMACCT developed the Massive Network for Clinical Trials (MNCT), a nation-wide network of hospitals and clinics, and provides support for establishing the necessary infrastructure for performing high-quality clinical trials.
Currently, over 1,600 highly motivated medical institutions, which vary in size and medical specialties, are registered with MNCT.
JMACCT provides MNCT members with a variety of services including the following:
- Support for the participation in JMACCT-funded investigator-initiated clinical trials.
- Distribution of information on study site recruitment for industry-sponsored clinical trials.
- Provision of clinical trial-related information through newsletter service.
- Support for the participation in regional clinical trials networks funded through the MHLW’s Project for Research on Establishment of Regional Clinical Trials Networks. (A medical institution must be a member of MNCT to be included in a regional clinical trials network.)
Regional Clinical Trial Networks
The clinical sites registered with the MNCT have been developing regional clinical trials networks in the areas where they are located.
Since 2004, JMACCT has provided funding for 22 of such community-based clinical trials networks under the MHLW’s Project for Research on Establishment of Regional Clinical Trials Networks with the purpose of putting the necessary infrastructure in place and establishing an appropriate framework to improve clinical trial capabilities in Japan.
Apart from providing funding, JMACCT’s support also includes dissemination of regional networks’ activities among the networks. We also promote the use of networks to pharmaceutical companies by organizing forums for medical institutions and industry sponsors to exchange their views. Through these services, we will continue to help medical institutions to have more opportunities to participate in industry-sponsored clinical trials and contribute their expertise to the development of innovative drugs and devices.
Activities of Regional Clinical Trials Networks
The clinical sites and investigators within a regional clinical trials network collaborate and function as if they were a single institution. This results in a reduced burden on trial sponsors and more efficient and smoother conduct of clinical trials.
The efforts of the regional clinical trials networks to streamline clinical trial processes and enhance the networks’ clinical trial capabilities include the following:
- Use of uniform SOPs and forms
Each clinical trial network has uniform SOPs and forms that are used by its members.
- Provision of a single contact point
The management office of each network serves as a one-stop contact point for study sponsors.
- Management of cooperative Institutional Review Board (IRB)
To ensure the ethical and scientific conduct of clinical trials, the networks have cooperative IRBs in place for the institutions that do not have their own IRB.
- Establishment of a support system for emergency
The networks have necessary arrangements among their members for securing the safety of trial participants in case of emergency, such as the occurrence of unexpected adverse events.
- Educational support in clinical trial methodology
Training opportunities are offered to network members on a regular basis.
- Distribution of clinical trials information
Some networks provide trial information for potential trial participants on their websites. Open lectures are also offered to the public to raise awareness about the importance of clinical trials and to encourage participation in these trials.
Service to Industry through Clinical Trials Networks
Through the use of MNCT and regional clinical trials networks within MNCT, JMACCT offers complimentary site selection support that is mutually beneficial to both industry and medical institutions in the networks.
For companies sponsoring clinical trials, it can be difficult to locate medical institutions that are not already on their list of potential study sites. On the other hand, many medical institutions, especially small-size sites, are having difficulties in obtaining clinical trials from industry sponsors because they have not yet established a working relationship with the person responsible for selecting study sites. Therefore, as part of our effort to improve clinical trial efficiency in the nation, we serve as liaison between potential study sites in MNCT and sponsors in the site selection process and help the sponsors find the right sites as well as provide the network members with more opportunities to participate in industry-sponsored clinical trials.
The site selection process can be difficult and time-consuming, which can prolong the time it takes to get a new drug onto the market. Our services assist in improving this process and ultimately contribute to reducing drug development times in Japan that are currently much longer than in the US and EU.
Benefits of the serviceJMACCT’s site selection support intends to be beneficial to both industry sponsors and medical institutions.
With this service, the sponsors will be able to:
- Locate potential study sites for their study at no charge.
- Obtain a rough estimate of availability of eligible patients at the network sites.
- Gain information about clinical sites in MNCT that may meet their needs for a clinical trial in the future.
- Have opportunities to participate in industry-sponsored clinical trials.
- Promote themselves to industry sponsors (even if they are not selected) by answering survey questionnaires, so they may be considered for a future trial.
- Identify what is needed to improve their sites by examining survey questions.
How it works
After signing a confidentiality agreement with a study sponsor looking for investigational sites, we prepare a site selection questionnaire in close consultation with them. This allows the sponsor to decide what and how much information about their study they want to distribute in the network. The survey is designed to ensure the questions are clearly understood and answered properly so that the sponsor can find the right study sites that meet the selection criteria for their study.
Once we have finalized the questionnaire, we notify medical institutions within MNCT of the upcoming clinical trial via an e-mail newsletter. This notice may be e-mailed to all members or only to those chosen by the sponsor. In response, interested sites then answer the Online Site Selection Questionnaire on our website to apply for the study. A site survey usually takes about two weeks and the results are forwarded to the sponsor by e-mail within one day of the closing date. The sponsor then shortlists applicants based on the results and, if necessary, asks them additional questions to make sure the sites fully meet their criteria.
The sponsor visits shortlisted sites before making their final selection. JMACCT staff accompanies site assessment visits, if requested by the sponsor, in order to ensure smooth communication between the site and the sponsor. Study details are discussed between the sponsor and the selected study sites before they sign a clinical trial contract.
To facilitate smooth conduct of the study, JMACCT follows study progress and provides necessary support to the sites.