Leveraging digital technology to transform clinical trials and therapeutics - Stefanini

Leveraging Digital Technology To Transform Clinical Trials And Therapeutics

Digital technology has the potential to provide a patient-centric experience for clinical trials and therapeutics that can drive patient engagement and reach whilst streamlining costs and efforts.

Pharmaceutical and healthcare companies are increasingly embracing innovative and game-changing digital ecosystems to make healthcare and clinical trials more efficient, effective, and manageable. Covid-19 disrupted traditional models of patient care and clinical trials. It has accelerated the adoption and acceptance of digital tools and technology to help in the prevention, management, and treatment of medical conditions.

Connected digital services include the use of cloud services, artificial intelligence (AI) and automation, CRM, data lakes and analytics, sensors and wearables, and cyber security. Together these provide customised global solutions and services for health journeys. They transform clinical trials and therapeutics.

The use of technology can accelerate the pace of generating evidence through clinical trials and bring new therapeutics to market.

How does digital technology benefit clinical trials?

Digital technology benefits clinical trials by improving patient recruitment and retention, securing and automating data collection, and utilising real-time data analytics.

Driving patient recruitment and retention

Participant recruitment, engagement, and adherence are often major obstacles to the timely completion of clinical trials.

A fully digital clinical trial enables potential participants to access it regardless of their geographical location. It negates any difficulties getting to study sites such as for older adults with mobility problems. With greater population reach, study validity is improved.

New recruitment and adherence tools offer real-time remote monitoring. Applications, assessments, and electronic informed consent can be simply made and tracked online. Data can be captured by wearable devices and remote monitoring systems. Virtual clinical visits can lessen the time and travel burdens of clinical trials.

In addition, technology offers multiple opportunities for interactive patient management. It can motivate patients to stay on track with a clinical trial. AI can determine the optimum digital channel combinations to reach and harness potential study volunteer engagement. Simple app reminders on the participant’s phones reduce appointment no-shows. Personalised conversations and community support with peers and professionals via social media treat volunteers as individuals and partners.

Denis Reynders, Global Business Unit Leader at Stefanini Digital Health Services, says: “People are more and more connected together on a global basis, are able to share technologies, are able to share information through social media for example, and able to create groups where they can help each other. This is activating a group feeling and the collection and utilisation of clinical data and medical information through these social media groups and other repositories are actually provoking a group feeling, a global feeling which provides benefits to the mental and medical health of those patients.”

Secure and automated data collection

Digital clinical trial data can take many forms. For example, clinical and demographic data, physiological and activity data, and patient-reported outcomes.

Cloud-enabled technology plays a vital role in maintaining strong, scalable, and agile data management and compliance for clinical trials. Central hubs collect a wealth of data and allow for secure data collaboration. The use of data lakes automatically processes raw data from multiple sources. Vast real-world data is captured and stored using VR, sensors, and wearables that would otherwise be complex to obtain.

Biomarker data gained digitally may provide detailed physiological process information that informs diagnostics, dosing titration, and endpoints for clinical trials.

Utilising digital analytics

Digital analytics has marked opportunities to improve clinical trials.

Faster real-time data analysis can be achieved by embedding machine learning and artificial intelligence algorithms into research processes rather than relying on traditional human manual and fragmented methods.

This offers an advanced understanding of rich data that can be mapped and multi-faceted. It drives insights to make better drug and medical device development decisions that are science-led and data-powered. This helps improve the outcomes of clinical trials and get new drugs and therapies approved sooner.

Furthermore, these insights allow the early signs of a trial to be detected, any problems solved in real-time, and continuous monitoring of the data and not just when the trial is finished.

Electronic data analysis can be used to better match participants to studies and personalise the delivery of trial tools to maximise their effectiveness for each participant. It boosts the enrichment of the clinical development process and can impact trial timelines whilst helping to reduce costs.

Moving away from information silos to an interconnected research ecosystem will allow for fluid data generation, sharing, and analysis that will benefit clinical trials.

How does digital technology benefit digital therapeutics?

Digital therapeutics deliver software-generated interventions directly to patients to prevent, manage, or treat a medical disorder or disease. For example, AI-enabled apps can help manage patient health, and digital sensors and wearables capture extensive patient data.

Digital therapies provide information that can be used to improve personal healthcare. They are relatively inexpensive and can help to reduce healthcare costs. Also, they are more scalable and accessible than many traditional treatments. This is supported by increased patient acceptance of online therapeutics as more people have embraced online tools for their personal use too. 

Denis Reynders, Global Business Unit Leader at Stefanini Digital Health Services, continues: “The adoption of the technology evolution means that people don’t only use those technologies in their own private world, at home for example, but also they are accepting and using them in the healthcare arena, in clinical trials or active therapies that they are submitting or participating in with pharma companies, with healthcare companies or with specific hospitals.”

A patient-centric digital approach to clinical trials brings new therapeutics to market quicker and at lower costs

Digital ecosystems offer a patient-centric approach to clinical trials that optimises participant recruitment, engagement, and retention and the capturing of data and its analysis, and ultimately gets therapeutics to market quicker and at a lower cost.

They reduce or relinquish the need for on-site visits which in turn widens the potential participant pool and improves study validity. Technical tools can personalise and improve an interactive patient pathway.

Cloud-based data integration, AI, and wearables enable the real-time and automated capture of rich and extensive real-world data from remote settings. Advanced digital data analysis can help to quickly develop study designs to improve the patient experience. It can enable faster recruitment and better engagement and retention which results in less recruitment.

In summary, digital tools, automation, and machine intelligence create end-to-end digital workflows across clinical trial life cycles. These have transformative benefits that allow healthcare and pharmaceutical companies to realise their goals earlier and bring drugs to market sooner and cheaper.

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