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June 17, 2021

Ensuring data authenticity, integrity, and confidentiality biggest barrier to using digital technologies in clinical trials: Poll

The life sciences industry witnessed a wave of digital transformation due to the COVID-19 pandemic, with many companies adopting decentralised clinical trials using digital health technologies.

Employing digital technologies in clinical trials, however, has presented new challenges including regulatory issues and reliability of data.

In a poll Verdict has conducted to assess the barriers to using digital technologies in clinical trials, a majority 32% of the respondents expressed that ensuring data authenticity, integrity, and confidentiality is the main barrier.

Accessibility was considered as a major barrier by 17% of the respondents, while designing protocols that employ digital technologies is a barrier according to 15%.

Collecting, analysing, and interpreting the data, and regulatory challenges and preparation of supporting materials for regulatory submission were voted as barriers by 13% of the respondents each.

Selection of appropriate technology was considered a barrier by 10% of the respondents.

Ensuring data authenticity, integrity, and confidentiality biggest barrier to using digital technologies in clinical trials

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The analysis is based on 123 responses received from the readers of Clinical Trials Arena, a Verdict network site, between 08 February and 18 May 2021.

Barriers to using digital technologies in clinical trials

The rapid adoption of digital health technologies in clinical trials during COVID-19 highlighted their role in the quick development of vaccines and drugs, while also transforming the way clinicians engage with patients.

The use of digital technologies in clinical trials faces several challenges including integration of data collected digitally from patients as well as data collected on-site. Data surveillance, integration and interoperability of the technologies is crucial in such cases.

The shift towards digital is also encouraging companies to use data from electronic health records (EHRs), claims, and genomic databases. Accessing this data, however, raises concerns over security and patients’ privacy requirements, which often vary between states and countries. Better data governance and ensuring patient consent of data may help address the issues.

The uncertainty regarding regulatory approval based on data collected using digital technologies is another challenge as regulatory requirements change from one country to another. Regulatory authorities and industry groups, however, are recognising the contribution of digital technologies in clinical trials and examining the ways in which they can be made mainstream.

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