Prioritising for a data-driven 2023

Last year was another challenging one for the pharmaceutical industry. On top of residual pandemic-related challenges and supply chain issues, the ever-adapting regulatory environment has continued to set new standards and enforce new requirements. This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023.

EU Clinical Trial Information System

In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. The transition to the new registration system has begun in earnest now. From February 2023 all new clinical trials applications must be submitted via the new portal. However, a good many companies are not yet well set up for this, leaving work still to do.

The aim with the EU developments is to harmonise and streamline processes across the diverse region, making it a less daunting location for conducting clinical trials. Persistent anomalies between countries continue to trigger enquiries however, and this year all kinds of companies will be trying to figure out how to navigate the new requirements and overcome any residual complexity. This area also screams for further integration with related overall (master) data, such as related (active) substance, organisational info, and other product-related information that is shared with the regulator.

Time to review data governance

Supply chain issues, driven by the pandemic, continue to present problems for the pharmaceutical industry situation that was exacerbated during the winter, with demand at an all-time high. Even though the worst of the recent crisis appears to be over, there is now an extended mandate – certainly in Europe – to monitor and manage any shortages of medicinal products and medical devices. Action is being taken at an industry level, and by EU member states.

The onus is on the industry now, to capture and provide the right data during major events and public health emergencies. This may require formal data mapping – to identify where the relevant data sits within a company, and who can provide it. Given that efficiency and accuracy of these insights are critical when public health is at stake, it is essential that the industry is prepared. Forward-thinking companies will see this as an opportunity to review existing data governance, determining where the relevant data sits within their organisations, for instance, and how it might be provided to the European Medicines Agency (EMA) most efficiently.

The increased speed of regulatory processes seen during the pandemic has set a precedent, and the only way to maintain that pace over the longer term is to modernise. ISO IDMP standards remain pivotal to the expanding and transforming role of data – so that it becomes a lever for improvement.

But this requires more proactive data governance, if companies are to truly harvest the power of their data. This is a challenge companies must navigate this year alongside other internal and external pressures – alleviating the increasingly critical but hugely labour-intensive burden of data management. Overall, the pre-condition of setting up suitable data governance is becoming clearer all the time. Although, as they are, data and systems may facilitate an exchange, it is not a given that this would happen in a reliable way without the right controls.

Building on data standardisation in clinical trials and beyond

Necessity being the mother of invention, much faster regulatory processes materialised during the pandemic – from rapid access to scientific advice and rolling reviews, to accelerated assessments and other possibilities under compassionate-use programmes. Improvements were also seen in the drug development process itself.

Ultimately, the pandemic forced out-of-the-box thinking and helped identify weaknesses in existing systems. We have seen old norms being challenged in clinical trials as a result of issues that peaked in the pandemic, including those linked to subject recruitment. These challenges have helped inspire alternative approaches to clinical trials design – including decentralised trials, faster data sharing, and increased collaboration across parties.

Clinical innovation: using digital solutions to deliver the next wave of medicines

Having an agreed model for the data that multiple stakeholders and collaborators can work with is potentially transformational in many ways. The European project on substances (the EU-SRS database), which went live on 24 January, illustrates the possible here. Using the same data model, software and scientific standards per substance class enables increased exchange with the US Food and Drug Administration (FDA), World Health Organization (WHO) and other regulators. In the event of a future pandemic, we would soon see the practical benefits of that improved exchange.

It is also encouraging to witness the efforts being undertaken to allow for a harmonised adoption of the ISO IDMP standards and their guidance, for example in the context of the UNICOM project, the CTADHL Transatlantic efforts, and the Pistoia IDMP Ontology project.

The overriding challenge for this industry now will be to hold onto some of the lessons of the last two to three years and use them as a springboard to reduce the time to deliver the latest advances to patients.

No time to waste for companies to embrace data-driven approaches

As escalating cost and resourcing pressures threaten safe access to healthcare for all, the drive for new care models is strong. Data lies at the heart of many of the proposed solutions. These include increasingly sophisticated patient self-care propositions (using devices for condition monitoring and management), and selective first-line care provision by high-street pharmacies.

The unifying enabler is good quality, standards-based data that everyone can trust.

Specifically, we can expect clinical trial innovation to continue apace; defined next steps toward IDMP implementation in the EU and US (beyond the immediate DADI-based Marketing Authorization submissions process); as well as further clarifications on electronic Product Information (ePI) and serialisation.

However, companies that wait for regulators to take the lead on data strategy and/or process innovation before moving forward are taking too great a risk.

While fine details may need to be determined in the data requirements for data-driven marketing authorisation applications, or clinical trial administration, there is no viable excuse for delaying transformation. Those companies that have managed to keep pace with the changes can expect to start reaping some of the rewards of their efforts over the coming year. Others still have work to do, but as new waves of digital transformation promise new efficiency, process burdens should start to reduce and improved patient experiences will gradually become a reality.