The transformative use of digital innovation in drug development

Introduction

Clinical development use of digital tools has increased dramatically in recent years improving data capture and streamlining processes, but also greatly enhancing patients’ experience and participation in clinical development. Emerging biopharmas (EBPs) and biotech companies can now harness the potential of digital innovation (henceforth known as digital) to drive drug discovery and increase clinical trial efficiency. COVID-19 accelerated the adoption of digital in decentralized clinical trials (DCTs) and highlighted the full potential it can achieve in driving better patient and site engagement while accelerating clinical development. This blog explores the benefits of digitization, ways to overcome challenges it poses and the future that it brings.

Digitization transforms patient engagement and enhances trial process

With the COVID-19 pandemic, the DCT model transformed patient engagement, becoming the new normal for clinical trials. With patients increasingly utilizing digital tools, DCTs have removed geographical barriers and streamlined communication between patients and investigators with the easy flow of relevant and contextual information.

Here are some ways that digital devices and digitization have increased patient engagement:

Complementing visits to sites and tele-visits are conducted by site personnel through mobile phones and other devices to engage patients at their homes
Connected devices, such as sensors, wearables, Blood Pressure Monitors, Continuous Glucose Monitors, Imaging, Spirometry, etc. are used to collect biometric measures while the digital platform eCOA (Electronic Clinical Outcome Assessment) collects qualitative data, both giving rise to real-time assessment of patients’ health
The digital platform for electronic consent (eConsent) helps patients understand trial requirements and enables them to consent their participation electronically
Other benefits include bringing lab diagnostics to the homes of patients, more efficiently tracking and shipping clinical supplies, and better coordination of home nurse visits

Digital transformation goes deeper than patient engagement. It also accelerates clinical development timelines by utilizing data to find the right investigator sites, identifies patient populations for trial marketing, and recruits patients for trials. It expedites data and information collection to enhance decision-making for successful regulatory submissions.

IQVIA has leveraged digital across the full continuum of clinical development for the EBP market, providing an integrated and interoperable decentralized trial clinical platform, using data and analytics to accelerate site activation by identifying the right sites, and introducing digital products such as eCOA, eConsent and connected devices to help EBPs and biotech companies engage sites and patients better.

The use of Artificial Intelligence and Machine Learning (AI/ML)

Clinical data is often siloed and fragmented but having standardized clinical data can help to extract meaningful insights. To achieve this, IQVIA offers the IQVIA Connected Intelligence™, offering clinical data and analytics that gathers, standardizes, and harmonizes disparate clinical data. Pre-built AI/ML models within the platform help deliver predictive and prescriptive insights for sites, patients, and for sponsors to achieve clinical trial efficiency.

There are many ways that AI/ML can be used in patient selection and engagement, and clinical data collection. For example, it is widely used during the pandemic to identify patients from a diversity and inclusion standpoint for an accurate representation of patients participating in clinical trials.

Patient engagement patterns generated by AI/ML can help to ensure that the right engagement mechanisms are leveraged to maintain active patient participation in trials. AI/ML also encourages proactive data collection by spotting gaps in patient data and ensures that sites use the right engagement tools to collect accurate data.

Overcoming challenges of digital adoption

As with any opportunity, there lie challenges. Regulatory guidance and getting the right stakeholder support are key challenges faced by EBP and biotech companies when deciding on a digital adoption.

The increase in digital adoption has brought about regulatory concerns around patient safety and secure data sharing between patient and investigators. China has imposed strict data privacy laws for the use of AI/ML when targeting and engaging patients, such as the Personal Information Protection Law (PIPL) and Personal Data Security Specification (PDSS). EBPs and biotech companies in Asia Pacific need to examine regulations in the areas of data privacy, data residency, data stewardship before embarking on digital adoption.

Companies can navigate the myriad of regulations with the help of an experienced Contact Research Organization (CRO) such as IQVIA that monitors regulatory developments closely. IQVIA comprises a rich collection of processes, technology, and people with deep clinical expertise, which sets up a good regulatory infrastructure for companies adopting digital and helps drive compliance in a holistic manner.

At the same time, education, training, and support are needed to help stakeholders understand the benefits of digital adoption and ensure a smooth transition process. At IQVIA, a support infrastructure for both sites and patients has been put in place to help people navigate their issues using digital tools.

Summary

Patients ultimately benefit from the digitization of clinical trials as it accelerates the drug development process. As the industry moves ahead, digitization continues to bring about more opportunities beyond patient recruitment and engagement. Trial designs are being enhanced with strategies like adaptive trials where digital twins can be created to monitor trial progress in real time by using real-time and real-world data.

However, digital adoption by EBPs and biotech companies in Asia Pacific has been slow due to regulatory concerns in the region. Therefore, it is best for these companies to engage a CRO, such as IQVIA, that knows best practices across different countries and has good global regulatory understanding, operations support and technology to support digital activities of sites, patients, and sponsors, to accelerate their digital adoption.

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For more information on new approaches and trends in the biotech landscape, do listen to our mini four-episode podcast series, Through the Biotech Lens: Molecule to Market, for Emerging Biopharma where industry stalwarts give an insightful perspective on biomarker selection, innovative trial designs, decentralized trials and the value of digital to advance patient centricity.

IQVIA Biotech employs a flexible and adaptable approach to align with each customer’s needs. The process begins with the initial alignment meeting where we listen to our customer and have an open conversation in order to outline the approach and discuss the most efficient way to perform the study. This helps clarify the scope of the trial, allowing for the development of a sound strategy and to ensure the work is achieved in a timely, efficient manner. Our goal is to help our customers get their life-saving therapeutics to commercialization as efficiently and cost-effectively as possible so that patients can receive the treatments they need.