Supporting clinical trial patients at home is getting popular choice today in Japan following this pandemic. The need for decentralized clinical trials in Japan has increased, as measures have been implemented to prevent the re-emergence of the outbreak and streamline the systems used to run clinical trials. Unless mandatory, clinical trial patients are served in their respective homes than visiting the facility. This helps to keep the subjects safe and provides the subjects with more flexibility. Home health clinical trial support has become an essential to conduct such decentralized clinical trials in Japan. 3H is at the forefront in running such decentralized clinical trials in Japan. 3H is the leader in facilitating decentralized clinical trials for many reasons:

·     3H has expert knowledge and resources to facilitate Home Health Care Support which is essential for conducting decentralized clinical trials

·     A robust subject database to facilitate online recruitment of subjects to clinical trials

·     A dedicated IOT department with experienced staff who can handle the activity of all forms of medical devices and its logistics

·     An extensive knowledge of the medical practices in Japan and the region together with a close working experiences with PMDA, Ministry of Health and Welfare for Home Healthcare Support

The Benefits of Decentralized Clinical Trials: Conducting decentralized clinical trials help to improve clinical trial subject retention rates and has added flexibility to clinical trial subjects by reducing their burden of frequently visiting clinical trial sites. 3H supports a range of facilities to smoothly conduct all protocol related procedures from subject blood draw, to checking vital signs and the administration of investigational product. As a modern medical research company, 3H uses advanced technology and well-trained staff to facilitate pharmaceutical giants to conduct their clinical trials according to GCP. This helps sponsors to complete the clinical trials of their choice within the stipulated timelines and budget.

Home nursing clinical trial support in Japan is advancing and it is proving to be a flexible, proactive and highly responsive care for clinical trial subjects. 3H facilitates e-recruitment. Currently there are 950000 PHPs nationwide who want to be part of clinical trials and 3H has a clinical trial portal helping to build awareness in oncology and rare diseases too about upcoming clinical trials. Home nursing is facilitated through a team of experienced Nurses and medical institutions familiar with the concept of de-centralised clinical trials. Remote visits are made possible through telemedicine and e-source documentation. In addition, the vitals of subjects are monitored through smart devices and wearables and sent directly to clinicians for review which 3H facilitates too.

High quality support services by 3H home nursing team to support decentralized clinical trials: 3H home nursing team has all it takes to provide high quality, patient-centric care for clinical trial subjects. We understand that catering to clinical trial subjects according to the protocol can be demanding, and that is why we ensure that we have the right specialist research nurses to do the job. 3H follows a strict protocol to select the most competent nurses for the job. The nurses who are assigned duties are interviewed and screened to evaluate their qualifications and experience. Then 3H trains the selected nurses under a study manager prior to starting the routine of home clinical trial care. 3H has experts in the field of home nursing to impart knowledge to these newly joined nurses. Protocol training too would be done to the nurses delegated to a certain study protocol. In addition, the nurses will be trained on any additional material provided by sponsors. The trained nurses are issued a certificate of training completion.

During home-based study visits, the assigned research nurse collects the specific patient data for that study. Vital signs, patient questionnaires and other relevant assessments are performed. The nurse would carry study specific worksheets to record the data which would serve as source documentation. The source documents would be shared with the relevant principal investigator and the clinical trial site.

Home Healthcare Support Management for Decentralized Trials by 3H: The success of clinical trials depends on timely recruitment, high retention rates and data integrity. It is foremost that the rights, safety and well-being of subjects are preserved. This essence of clinical trial principles must translate to both on-site and de-centralised clinical trials. This is the reason why 3H hires competent and well-trained staff for home nursing clinical trial management.

Having a trained nurse visit the study subject gives confidence to subjects too on the conduct of de-centralized clinical trials. Home visits reduce the travel time by patients to sites. It is a great solution for patients with chronic conditions where mobility is restricted. Frequent travel by such patients can result in recruitment difficulties as well a high drop out rate. However, a well organized home nursing clinical trial management like 3H can improve clinical trial subject experience and reduce the dropout rate bringing success to de-centralised clinical trial conduct.

The success of any clinical research depends on the amount of study data collected from clinical trial subjects. The objectives of a study protocol are only met when there is sufficient data collected. This makes it particularly important to retain all recruited patients in the clinical trial. Premature discontinuation of subjects can adversely affect study data collection and lead to study delays. This can ultimately lead to investigational products reaching the consumer market late. 3H ensures that these decentralized clinical trials are conducted on time with a high retention rate. This helps study sponsors to obtain their market authorization approval on time.

In Summary

De-centralised clinical trials are a hot topic area in Japan. The Covid-19 pandemic has accelerated its growth and individuals now has shown their interest to be part of de-centralised clinical trials. For the successful conduct of de-centralised clinical trials, home healthcare support and home nursing clinical trial support is essential. These initiatives make it less demanding for patients and the caregivers, while improving the retention rates and giving more flexibility. De-centralised clinical trials are the future of clinical trial conduct in Japan. It is the best way to improve patient compliance and offers a more patient-centric experience. With specialist research nurses and experienced clinicians managing the patients, it gives better service to subjects. 3H thus offers the best of care in conducting de-centralised clinical trials while keeping the operational costs affordable to pharmaceutical sponsors.

To learn more about how we may help you with DCT for your study, kindly reach us at imran@3h-ms.co.jp