The world is transitioning into the information age in healthcare and modern digital health technologies have a lot to offer in optimising clinical trial conduct. The advent of wearable medical devices has enabled collection of multi-dimensional subject data. This has enabled de-centralisation of clinical trial conduct. 3H has been agile to adopt the latest information and digital technology in clinical trial conduct. It has helped in providing better-quality service, data quality and flexibility to clinical trial subjects.

Use of digital health technology is beneficial as it accelerates, streamlines, and optimises clinical trial conduct. A shift from conventional, traditional methods to digitalisation makes clinical trials youth friendly.

This gives potential pharmaceutical sponsors the ability to market their drugs within the timeline and greatly reduces the cost associated. Till recently, the health sector has remained isolated from using digital technology, however, the pandemic has greatly accelerated the use of technology making room for virtual and hybrid clinical trial models. Use of digital health technology is beneficial as it accelerates, streamlines, and optimises clinical trial conduct. A shift from conventional, traditional methods to digitalisation makes clinical trials youth friendly. Careful consideration should however be given to improve the subject-physician interaction and give confidence to the subjects that they are well looked after while participating in clinical trials.

Digital Health Technology to Improve Diagnosis in Clinical Trial Subjects: Use of smart technology and wearables is popular today. Smart phones are able to check the vital signs of individuals, helping to be in control of one’s health. Smart phones also have the capacity to receive primary health data to integrate additional sensors. 3H actively uses smart wearables to monitor patient vitals. The bulk ECG monitoring equipment has been replaced with smart sensors for monitoring heart rate. This gives the flexibility to monitor subject vitals more easily and more frequently. The subject medical information can be stored in a cloud setting and even be sent real time for physician evaluation. Thus, the use of digital health technology has helped in improving diagnosis of subjects more frequently even from a remote setting. This has helped in reducing life threatening conditions like strokes.

The wearable devices have helped in generating a huge amount of health-related data and these biosensors have made de-centralised clinical trial conduct a reality.

3H’s Digital Health Technology as a Decision Tool for Disease Management: A great advantage of using digital health technology is that it can improve health outcomes by improving self-care and patient engagement. Modern technology has given a chance to improve evidence-based medicine and personalised medical care. The communication gap has been reduced and subjects have many ways to reach out for support services and their physicians. The flagship website of 3H, Seikatsu-Kojo WEB (https://www.seikatsu-kojo.jp/) hosts information on clinical trials held in Japan. It is a great platform for clinical trial subjects to interact and has great tips and information on nutrition, rare disease management and lifestyle improvement methods.

Recently, 3H also implemented an adverse-drug reaction management supporting tool which helps in early detection and treatment of adverse drug reactions, including immune related adverse events. This tool termed as Fukusapo App is based on the 3H P-Guardian system. The clinical trial subjects have the opportunity of being in self control through the use of 3H’s electronic patient diaries. The electronic diary sends alerts when the normal range is exceeded, encouraging clinical trial subjects to contact the institution when there is suspicion of an adverse drug reaction.

Decision support health systems such as these allow disease management for clinical trial subjects from their homes. It empowers subjects to optimise their health conditions and is user-friendly, triggering subjects to reach out when there are alerts indicated in their apps or other electronic health systems.

Better Recruitment with Digital Health Technology: Recruitment is a critical and very challenging component in clinical trial conduct. Today, there is a potential to harness modern technology for subject recruitment. Social media platforms and digital technology has helped in reaching out to potential subjects. Awareness about clinical trials can be spread through digital media and this helps to enhance enrolment in conventional as well as clinical trials conducted for rare diseases.

Modern technology has been imbibed and informed consenting is now done electronically, which cuts off wastage of print material. It brings in better engagement and clarity for conventional paper-based consenting which is filled with heavy technical jargon. Electronic consenting brings in innovative strategies which improves interaction through interactive videos and subject quizzes for better understanding.

Clinical Study Endpoints with Digital Health Technology: New insight into risk-benefit assessments can be made using digital health technologies. Primary endpoints can be collected and assessed easily. The endpoints can be picked up easily and worsening of activity measured. Continuous data collection using biosensors ensures that end point data can be collected effectively.

In conclusion, digital health technologies have helped in revolutionizing healthcare delivery and facilitated decentralisation of clinical trial conduct. The health outcomes of people have improved with digital apps and bio sensors giving individuals more self-control to review their own health data. Frequent patient monitoring and direct access for physicians to evaluate the medical data has helped in personalising clinical trial conduct. 3H has collaborated with DCT tech giants to improve the clinical trial experience for subjects and pharmaceutical sponsors benefit through timely recruitment, improved retention and a great cost reduction with improved subject care. 3H as the leader in clinical trial conduct in Japan is well-prepared to facilitate smooth conduct of clinical trials on your behalf.

To learn more about how we can support your study, kindly reach us at imran@3h-ms.co.jp