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Revolutionizing Clinical Trials with DATAcc's New Resources

In a significant leap towards modernizing clinical trials, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) has unveiled an important suite of resources. These tools are designed specifically to assist clinical trial sponsors and developers of digital health technologies in illustrating the advantages of digital endpoints in clinical research.

The Need for Digital Endpoints

Recent studies highlight the financial advantages associated with digital endpoints, revealing they can reduce costs in Phase 3 studies by nearly $48 million, manifesting a return on investment that ranges from four to seven times. Nonetheless, the utilization of digital endpoints has not been without its hurdles; experts frequently encounter difficulties in advocating for their acceptance, compelling leadership support, and showcasing their value to potential partners. Until now, the absence of standardized methods for assessing and presenting the impact of these digital measures made it nearly impossible to substantiate their advantages.

New Tools for Clinical Trials

The newly launched resources from DATAcc aim to bridge that gap, enabling stakeholders to leverage relevant data in building a compelling business case for the broader integration of digital endpoints within clinical trials:

1. Digital Endpoints Value Framework: This framework outlines the value propositions of digital endpoints throughout various stages of the trial process, assisting users in understanding their roles during different phases of development.

2. Digital Endpoints ROI Calculator: Designed for pharmaceutical companies, biotechnology firms, and digital health technology stakeholders, this calculator aids in making informed, data-driven decisions regarding the implementation of digital endpoints. Furthermore, it assists users in articulating the measurable benefits to key decision-makers, providing them with tangible data to support their proposals.

3. Digital Endpoints Business Case Template: This structured template helps align the business case surrounding digital endpoints with organizational goals and portfolio objectives, ensuring that strategic decisions are backed by solid data.

4. Case Study Catalog: Featuring real-life examples from eight diverse organizations that successfully utilized digital endpoints, this catalog illustrates the measurable benefits realized in their clinical trials.

Expert Insights

Prominent voices in the field have emphasized the transformative potential of these new tools.

Elena Izmailova, Chief Scientific Officer at Koneksa, reflected on the untapped opportunities provided by digital measures, stating, “Digital measures provide untapped opportunities and insights into people's symptoms and experiences, advancing our understanding of many diseases.