Recruitment remains a key challenge in clinical trial conduct. With the clinical trial protocols becoming more complex with stringent inclusion and exclusion criteria, it makes it more difficult to enrol and retain participants in clinical trials through traditional recruitment strategies. Decentralise clinical trials on the other hand have redefined successful recruitment, facilitating better subject engagement and more accessibility into conduct of clinical trials remotely and as a hybrid model. The clinical trial industry is evolving from the traditional set-up and 3H is geared in providing patient-centric services through decentralised clinical trials.

3H as a premier service provider for clinical trial and research company in Japan and in Asian countries, specialises in the conduct of decentralised clinical trials. We have a  proven track record in providing specialist services for timely and high quality recruitment across Japan and in neighbouring Asian countries. 3H executes home nursing support and mobile healthcare services which is more patient centric compared to the traditional clinical trial model.

The Switch to Decentralised Clinical Trials which promoted Virtual Clinical Trial Conduct

Pfizer set the trend in 2011 to conduct the first ever randomised clinical trial virtually under an investigational new drug application. This study used electronic tools to help participants to participate in the clinical trial remotely, without having to physically visit the clinical trial site. The thoughtful protocol modifications helped Pfizer to ship the investigational study drug to subject homes. The data was collected using web-based technology and there were no in-clinic visits. This was the first step towards bringing in de-centralised clinical trials into a reality. The positive impact it created in reducing the subject burden was immense. The subjects had more flexibility for trial participation and saved up on their travel time. This trial by Pfizer was a great learning experience while validating on new technology. Thus, the concept of using centralised investigators became a reality and the trial helped to understand the subject mindset of taking part in decentralised clinical trials.

The Benefits of Conducting Decentralised Clinical Trials

Decentralised clinical trials work on the concept in providing a patient-centric approach to conducting clinical trials. The present pandemic has accelerated the need to conduct clinical trials virtually for many reasons and the future lies in switching to decentralised clinical trial conduct:

·      Flexibility: The traditional clinical trial operations involve, subjects visiting the study site to complete the visit. This generally disrupts the daily activities of subjects and represents only the local population. The benefits of conducting a decentralised clinical trial is that, it is patient-centric giving a better leverage of using virtual tools to conduct visits remotely and monitor data. It gives more flexibility, reducing subject travel and saves subject time. This is an essential factor with millennials who prefer convenience, fast service and like to engage with technology.

·      Better patient recruitment and retention: Decentralised clinical trials help in improving participant recruitment and retention. While on a clinical trial, the subject experience needs to be understood and catered for. It is observed that patient attrition is high when subjects perceive a significant patient burden with increased onsite visits. Telehealth and use of smart wearable devices can help to reduce subject burden through remote monitoring. Also decentralised clinical trials decrease geographic barriers and help to include diverse populations which maybe under-represented in traditional clinical trials.

·      Better Communication: Decentralised clinical trials help with real time communication, which helps better subject engagement. The use of ePRO tools help report outcomes as soon as they occur helping with improved data collection. It helps clinicians to reach out to subjects faster and in a timely manner.

3H’s role in running decentralised clinical trials across Japan and Asia

3H is actively helping pharmaceutical companies to conduct virtual and hybrid models of clinical trials across Japan and in Asia. 3H supports substantial clinical trial cost reduction by incorporating the latest technology, facilitating subject recruitment and speedy launch of clinical trials in the Asian region. Recruitment of subjects is facilitated through online campaigns. 3H specialises in using the right platform which is ideal for each country. The relevant clinical advertising, supporting and retention tools are used by incorporating the cultural background of each country. Many clinical trials across Japan are conducted by 3H as decentralised or virtually which has helped to enrol subjects from interior areas as well which was untouched most of the time.

Feel free to get in touch with us for DCT based Clinical Trial start-up facilitation.