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Transformation of clinical trials through digitization – impact on the sponsor

01 Feb 2023

Reducing the cost of research, reaching a more diverse patient population, monitoring patient safety promptly, and bringing new and novel data sources into trials have been the primary goals of going digital for all clinical operations teams that strive to achieve operational excellence. The pandemic only accelerated the adoption of a digital-first approach to achieve the above goals.

A recent survey, by DT Consulting – an Indegene company, on the digital maturity of clinical operations in the global pharmaceutical industry revealed that while most senior leaders from sponsor organizations say that their organization has a clearly defined vision and strategy for digital transformation in clinical trials, only 30% of the companies have allocated budget to support clinical trial sites with digital technologies. Nevertheless, it is encouraging to see from the survey results that the organizations that do not have a clear vision and strategy are working towards defining it.

In my previous two blogs, I reflected on the likely impact of a digital-first approach to running clinical trials on patients and research sites. This final blog of the series reflects on the transformation these new digital approaches are bringing to how a sponsor can run and engage with clinical trials.

Digitalization of clinical trials is a key priority for the pharma industry.

New technologies are already enabling a shift toward decentralized and virtual trials to improve patient experiences and the overall clinical journey. By supporting both patients and investigators, digital tools have the potential to significantly reduce the rate of clinical trial failure and lower drug development times and costs, bringing new, improved, and potentially cheaper drugs to the market faster.

Most organizations are taking the hybrid approach

For sponsors, most clinical trials will not be entirely virtual, as they will use one or more decentralized elements suitable for their study. However, based on the record number of ~1,300 trials¹ that were initiated with a decentralized component in 2022 (a remarkable 50% growth when compared with 2020), it is evident that decentralized trials (DCT) are a part of many life sciences companies’ larger R&D portfolio. Many life sciences companies have begun to take a hybrid approach to clinical trials and they implement digital technologies for each study based on the design and the feasibility of decentralization for a given therapeutic area.

For instance, post-pandemic Electronic Data Capture (EDC) was the earliest to be widely adopted to expedite the process of data entry and query resolution of Case Report Forms (CRF) at local sites. This was followed by a series of solutions to capture data and manage the medical research process from the sponsor, site, and patient perspective. Below are a few of the solutions which are currently being used during clinical trials.

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Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient-Reported Outcomes (ePRO) to capture data directly from patients (and others involved in research such as a caregiver or doctor) and often also support consent/reconsent.

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Interactive Response Technology (IRT) systems that randomize patients and ensure drug is distributed to the right patient at the right place and at the right time.

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Clinical Trial Management Systems (CTMS) to plan, manage and track the clinical study.

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Electronic Trial Master Files (eTMF) and Electronic Investigator Site Files (eISF) to digitally capture, manage, share, and store essential documents and content from a clinical trial.

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Digital payment solutions to streamline the payment to study participants.

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Digital solutions to enable Risk-Based Quality Management (RBQM) for oversight and regulatory compliance

Key advantages of decentralized clinical trials (DCT) are:

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As DCTs are more focussed on patients, they offer several benefits to them such as flexibility with site visits, increased access to clinical trials, and better engagement with research sites and physicians

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Significant improvements in patient enrolment and engagement in clinical trials is the key benefit of DCT to sponsors. This is followed by near real-time capture of patient insights with improved data accuracy which determines the quality of clinical study outcomes

Sponsors need to build a framework that is flexible to accommodate new digital capabilities

Given all the advantages and the solutions that are being adopted, there is no doubt that, clinical trials are one of the functions that have greatly benefited from digitization. Digitizing clinical trials has increased the adoption of telemedicine and various scheduling tools which helps patients actively participate in trials remotely from the convenience of their home or by visiting nearly local micro-sites. In addition, tools such as wearables, sensors, health monitoring devices, and apps enable new ways to capture data and effectively monitor patients’ health and engagement throughout the study.

Also, the move to cloud has resulted in both operational and clinical data being available in real-time. Potential issues can be identified much earlier in the trial and changes can be made to the study as required, by applying modern analytical tools and methodologies to this data. For instance, sponsors can leverage Real-World Evidence (RWE) to design studies, identify and target study sites and the right cohort of patients, thereby improving trial efficiencies. This information can also be presented on sophisticated dashboards with appropriate built-in alerts enabling sponsors to adopt a risk-based approach to run clinical trials.

To achieve these outcomes, it is critical for sponsors to develop digital capabilities, because once a study is decentralized, there will be many opportunities to capture various types of insights arising from continuous data collection and accordingly use them in the study. This also necessitates sponsors to develop an enterprise blueprint to develop DCT infrastructure so that they can easily add solutions in the future based on the extent of digitization required for specific clinical trial studies.

Decentralizing clinical trials requires a huge mindset change

While the adoption of digital technologies will continue to increase, the complex ecosystem also presents many challenges to sponsors. Some of the challenges that sponsors need to address are:

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Choose between a single platform comprising most or all the solutions vs implement different best-in-class solutions in each area

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Execute a single strategy across all programs and studies thus driving efficiency of contracting/training, vs different approaches for each study

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Understand the acceptance and impact of solutions when they are used by sites and patients

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Understand the risks involved in adopting new technologies, especially those related to regulatory and data privacy requirements at a regional level

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Sustainability of the DCT throughout the course of study on data collection and analysis, and patient experience, especially when new solutions are added

Favourable regulatory outlook and fit for purpose technology will support the scale and pace of decentralization needed

Traditionally the relationship between clinical trials and the real world was mostly one-way. Drugs were developed using a tried and tested methodology and commercialized post regulatory approval. More recently, attitudes have changed and analytical power has increased - both deeper and more complex data sets, and new tools that can analyze the data sets are now available. In parallel, the regulators including the FDA have been accepting the greater use of RWE derived from Real World Data (RWD). As a result, RWD is being used to supplement the data collected during clinical trials and inform protocols and study designs. A parallel development is the use of large RWD sources (for example Electronic Hospital Records) to identify the right target hospitals for specific patient populations.

The road ahead

Given the substantial process improvements and technological advancements sponsors garner with digitization, there is an increasing interest in the value that can be gained beyond this. Talking with our customers, Indegene has seen some common themes emerge on where they believe technology can help them run clinical trials more efficiently. The most common topics discussed are centred on how can sponsors recruit patients more quickly, including the identification/selection of appropriate sites. Services such as hyper-targeted campaigns, personalized virtual interactions, Central Registered Nurse (RN) concierge, home health care, and logistics support, will continue to assist sponsors to optimally digitize clinical trials and improve patient engagement during the entire study.

Whether sponsors decentralize clinical trials for experimental use cases or to shift operating models, factors that drive successful DCTs remains the same - Patient centricity, an array of digital health technologies, data collection and analytics and the leadership’s intent to improve the efficiency of clinical trials to enable safe, effective, and affordable therapies to patients faster.

We would be keen to discuss and understand your thoughts on how you are seeing the industry evolving!

References

https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/

Author

Ram Yeleswarapu