The COVID-19 pandemic has had an impact on clinical trials around the world with the research and medical industry having to adapt to the ongoing challenges. Adopting virtual and decentralised clinical trial models has been one way clinical trials have been able to continue, with the help of telehealth services and advancements in technology.  

The main goal of virtual/decentralised clinical trials is to enable clinical trial staff and participants to continue to have some form of interaction with one another, as well as offering real time availability of continuous data which allows for more efficient monitoring of participants and earlier detection of any issues that may arise. 

Virtual Clinical Trials in Asia 

Asia has large, state-of-the-art clinical trial sites which are run by skilled investigators, consistently meet participant enrolment goals and generate high-quality data. With transparency in the regulatory authority environment improving, Asia is fast becoming the preferred destination for clinical trials. 

Here is what the current clinical trial landscape looks like in Asia: 

  • Virtual clinical trials in India expands the reach of clinical trials and provides access to a diverse patient population. 
  • China is working to improve their regulatory process, leading to a reduction in start-up times. 
  • Countries including Thailand, China, Vietnam and Singapore have introduced or expanded their Universal Health Coverage, and private insurance coverage has also increased. 
  • Japan, China and Singapore are leading the way in stem cell therapy thanks to market-friendly government regulations and extensive funding. 
  • Japan’s conditional marketing approval option for regenerative medication allows companies to sell medication earlier on in the clinical research process which expands their revenue cycle. 

Important Considerations for Asian Virtual Clinical Trials 

  • Cross-cultural sensitivities: In Asia, patients are reliant on the guidance and advice given by their doctors. Participants of a virtual clinical trial may be less willing or trusting of their clinical trial physicians who they barely know. It may take time to earn their trust. 
  • Regulatory requirements: There needs to be a clear understanding of each region’s regulations. Addressing any regulatory issues early on in the clinical trial ensures that there’s a clear understanding of which virtual   capabilities are going to be incorporated into the clinical trial. (Some countries are more open than others to some virtual aspects). 

Virtual Clinical Trials in Australia  

Australia has made decades worth of progress in platforms which have delivered online care during the COVID-19 pandemic. Between March 2020 and April 2021, over 56 million telehealth services were delivered to 13.6 million patients. The 2021-2022 Federal Budget invested a further $204.6 million into telehealth, bringing the total to $3.6 billion. 

Australia is regarded as a global centre of excellence for health and medical research. This, as well as an expanding technology sector makes it an ideal place to establish a world-class digital health industry which delivers health interventions and high-quality data which benefit the global patient population. 

The Australian National Health and Medical Research Council (NHMRC) have released the COVID-19: Guidance on Clinical Trials for Institutions, HRECs, Researchers and Sponsors guidelines which state that utilising digital strategies to continue clinical trials during the COVID-19 pandemic is acceptable and encouraged whenever approved. 

Approvals needed for amendments to clinical trials include: 

  • Virtual visits 
  • Using telehealth and providing medical education via digital means 
  • Electronic consent for participants 
  • Changing trial site to a location outside of a hospital or clinic 
  • Any other changes that do not have an impact on participants' safety or well-being and are intended to safeguard the health of participants, the clinical trial staff, and the community 

These amendments outlined by the NHMRC allow for technology and the medical and research industry to collaborate and create innovative ways to use technology in clinical trials, as long as it’s safe for participants and eases the burden of having to participate in clinical trials during the pandemic. 

While the shift towards virtual clinical trials is largely due to the ongoing COVID-19 pandemic, it is clear that some of the changes are here to stay for good. This is especially evident with the recent changes to the regulations around Software as a Medical Device in Australia put in place by the Therapeutic Goods Administration (TGA). 

Digital health technologies have proven to have a measurable and safe impact on the well-being of patients and healthcare consumers. These technological advances continue to deliver greater healthcare outcomes for all.