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Monitoring Participants in a Virtual Clinical Trial

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Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
KR -  Seoul
CN -  Taipei City
TH -  Bangkok
NZ -  New Zealand

North America

US -  Boston

GLOBAL

English

Monitoring is a crucial element of any clinical trial, with The National Statement on Ethical Conduct in Human Research 2007 (updated in 2018) stating that Sponsors, Investigators, institutions and Human Research Ethics Committees (HRECs) have a responsibility to monitor clinical trials. 

With the rising popularity of Virtual Clinical Trials comes the more frequent practice of Remote Patient Monitoring (RPM). Remote Patient Monitoring (RPM) is a method of healthcare delivery which uses the latest information technology to collect participant data outside of the traditional healthcare settings. 

RPM has been rapidly adopted by Contract Research Organisations (CROs), Sponsors and clinical trial sites for the many benefits it provides, especially for being patient-centric and for the convenience of having the data at your fingertips. 

Remote Patient Monitoring uses different devices and a virtual interaction centre to monitor participants behavior, medical status and the efficacy of the Investigational Product. 

Remote Patient Monitoring (RPM) offers the following benefits

  • Passive reporting: Participants and the clinical trial staff being in contact virtually allows responses and feedback to be recorded right away. Entering this data straight away reduces any loss of data or memory loss. The data is raw and unbiased and is sent directly to the centralised database. 
  • Lower costs: Clinical trial Sponsors and Investigators benefit from a reduced number of in-person participant visits and reduced staff requirements. 
  • Big data: Clinical trial Investigators have easy access to an increased amount of data from integrated medical devices and mobile applications.   The clinical trial process is more efficient with data being received in real time. 
  • Tracking: Virtual Clinical Trials enables the tracking of every participant's data including their clinical visits, medical data, cost per subject, etc. on a real-time basis. 
  • Technology: The requirements of a Virtual Clinical Trial have been converted into a cloud-based solution. These solutions and technological advancements allow for multi-device configurability (including smartphones), which makes it incredibly convenient for participants, Investigators and Contract Research Organisations (CROs) to interact with one another from anywhere and at any time. 
  • Resolving issues faster: The trial data is constantly monitored which means that issues like missing data or skipped study tasks can be picked up on in real-time and the study team can reach out to participants and help them resolve any issues. In an on-site clinical trial, missing data can sometimes go unnoticed until it's too late to be resolved. 
  • Faster Adverse Event detection: Adverse Events are detected faster with Remote Patient Monitoring as participants have 24/7 access to the clinical trial team and can report any symptoms straight away.  

Remote Patient Monitoring Tools 

The tools that make Remote Patient Monitoring possible include: 

  • Electronic Informed Consent (eConsent): A digital consent process which clinical trial participants complete before their enrolment in the clinical trial. It keeps participants engaged while it also tracks the progress and conducts assessments to verify participant understanding during the consenting process. Detailed analytics, remote access, and real-time alerts simplifies the process for both participants and the clinical trial staff. 
  • Wearables: Wearables make it easy for a participant’s behaviours and medical data to be tracked in real-time. The most common wearables used in Virtual Clinical Trials are ActiGraphs (worn on the hand or ankle), FitBits, the Apple Watch and Garmin watches. 
  • Virtual Clinical Trial software: There are lots of different software options which make the success of Virtual Clinical Trials possible. 

ObvioHealth, for example, provide an easy-to-read participant dashboard where the clinical trial staff can track recruitment, enrollment, compliance and study progress whenever they want. Issues like protocol deviations and adverse events are discovered as they occur, allowing for investigators and Sponsors to react to the situation in real-time. 

It’s easy to see why this cost-effective and time-saving model is getting more popular, especially when travel is more restrictive due to factors such as the COVID-19 pandemic. The advancement of technology and the popularity of devices like smartwatches and smartphones makes the transition from on-site to virtual even easier as some participants will already own the necessary devices to take part in a Virtual Clinical Trial and feel comfortable enough to use them. 

Remote Patient Monitoring combines real-world data and transmission in real-time to provide clinical trial staff with improved insights about the efficacy of an Investigational Product, product compliance and participant behaviours.