Clinical Trials 2.0: The Impact of Digitisation
Healthcare Pharma

Clinical Trials 2.0: The Impact of Digitisation

By Rajarshi August 16, 2023 - 111 views

Digitised healthcare is a compelling proposition for industry stakeholders today, since it carries with it the promise of enhanced consumer benefits and operational efficiencies alike. There are several clinical trial innovations that digitisation has enabled in recent years, paving the way forward towards better data integration, virtual clinical trials, eClinical solutions and patient-centric trials.

Digital health technologies have shown their propensity towards boosting objective data collection in trials, scaling up patient access, and facilitating improvements in terms of clinical outcomes. Here’s taking a closer look at digitisation and its overall impact in this space.

Recruiting and Retaining Participants in Clinical Trials

Digitised healthcare technologies have a leading part to play in terms of participant retention and recruitment for clinical trials. Here are some aspects worth noting in this regard: 

  • Poor rates of recruitment for RCTs (randomised clinical trials) are a major challenge along with retaining participants. Digital tools like automated messaging, data mining and data integration solutions can solve these issues in the long run.
  • The patient retention rates may vary as per the population nature, intervention, comparator, condition, and outcome. 
  • Effects of poor recruitment include lower statistical abilities of trials and higher risks of type II errors. Others include wastage of researchers’ and patients’ time and money along with delays. 
  • Clinical trial innovations with technology can enable enrolment of subjects based on defined eligibility criteria. It will also help in pre-screening subjects and automating retention messaging. 
  • Integration of smaller subject pools across localised sites will be possible while avoiding bias in studies through data analytics. 
  • Protocol determination and accuracy can also be taken care of with technological advancements. 

Here’s taking a closer look at how technology impacts clinical trials in the current landscape. 

How does technology affect clinical trials? 

Here are a few pointers that illustrate the impact of technology on clinical trials.

  • Various digital tools can enable more patient-centric trials while enabling virtual clinical trials too. 
  • These include automated messaging, advertisements, data mining and analysis, data warehouses, applications, pop-up reminders, social media and automated eligibility screening. 
  • A system of accessible and secure electronic health records and better data integration may also help in this regard. 
  • Automated screening may be personalised as per various algorithms for predicting eligibility. These may include reasoning and logical models on a case-to-case basis and machine learning models. 
  • Mobile communication can enable easier patient recruitment and retention. eClinical solutions can also ensure greater reach in remote areas and for under-served communities. 
  • Social media can be tapped for better recruitment of participants across numerous groups. 
  • Electronic informed consent, clinical outcome assessment, and data capture technologies are also a boon for this purpose. 
  • Wearable devices and other sources can automate data capturing and tracking. Electronic health records and databases can be used to integrate and store data. 
  • Patient-centric trials can be enabled through mobile health applications, trackers, wearables and more. 
  • Remote tracking is one of the biggest clinical trial innovations today and enables site access and integration amongst research organisations, sites, and sponsors. Remote monitoring and virtual clinical trials lowers costs while making it easier for participants too.  
  • Virtual trials have hybrid components and leverage telemedicine and mobile devices that patients and sites can easily access. Decentralised trials overcome transportation, access, and logistics barriers. 
  • Real-world data gathering through wearables and other sources is possible, along with prompt analysis and pattern identification.

Now that the positive effects of technology on clinical trials are visible, let us take a closer look at the impact of digitalisation on healthcare. 

How does digitalisation affect healthcare? 

Digitalisation-driven healthcare or digitised healthcare, whichever way you choose to see it, will eventually be the future for the entire ecosystem. This is how digitalisation affects healthcare in multifarious ways: 

  • Better access to medical data and records- Data integration, storage, interoperability, and access is simplified through digitisation. 
  • Big Data and Analysis- Clinicians can swiftly gather big data while also collecting information from a bigger population. This will enable better meta-analysis and identification of risk factors. Preventive healthcare recommendations for patients will be easier to generate as a result. 
  • Easier Communication- Automated and quick messaging and communication enables better patient/participant recruitment and retention. It enables personalised patient journeys and enables better communication among healthcare workers. 
  • Electronic Health Records- Patient medical records can be securely stored with cutting-edge technological innovations. Referrals can be done quickly while centralised storage ensures easy access anytime for improved outcomes and care. 
  • Telemedicine- Telemedicine has made it possible for the industry to reach out to un/under-served communities and remote areas. Video conferencing and other tele-health solutions enable easier tracking and care solutions. 


1. How are cutting-edge technologies like AI and IoT contributing to the success of Clinical Trials 2.0?

IoT is already contributing towards better clinical trials through enabling easy monitoring and gathering of information that can be swiftly accessed in real-time. AI is also identifying and screening potential trial participants based on diverse criteria. Both technologies are reducing costs and timelines for patient recruitment and data gathering alike. They are also making clinical trials more accessible and user-friendly. 

2. Can you elaborate on the advantages of virtual and decentralised clinical trials in the context of digitisation?

Decentralised and virtual clinical trials are enabling easier access to participants across remote and under-served areas/sites. Remote data gathering and monitoring is one advantage along with combating logistical, transportation, and access hurdles. There is also the opportunity to access bigger and more diverse populations with these trial systems. These are some of the biggest advantages of virtual clinical trials. 

3. What challenges arise in adapting legacy systems to the demands of digitised clinical trial processes?

Legacy systems need to be adapted to digitised clinical trial processes in the current scenario. Some of the major challenges in this case include software and technological costs, awareness and education on new technological procedures, choosing suitable technologies, and technological literacy of participants. 

4. What role does real-world data integration play in driving insights and innovation within digitised clinical trials?

Real-world data integration plays a crucial role in enabling greater innovation and insights as far as digitised clinical trials are concerned. Wearables, remote tracking, and virtual clinical visits may enable more patient-focused trials. This will enhance patient engagement greatly while enabling higher accuracy in terms of insights on how medicines perform in actual settings and scenarios.

Clinical Trials 2.0
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Clinical Trials 2.0
Welcome to Clinical Trials 2.0, where revolutionary methodologies, AI-driven insights, and ethical advancements redefine medical research for humanity's benefit.
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