Europe tackles digital terminals in drug development

The hope is to build a formal framework for the use of digital health technology in clinical trials in Europe and beyond.

As digital technology continues to increasingly pervade the world of healthcare, the attention of the clinical trial community is now turning with new intensity to the adoption of digital endpoints in drug development. . The European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe’s leading association for the pharmaceutical industry, recently set up a specific working group to explore and assess the current European landscape affecting the speed of adoption of metrics derived from digital health technology (DHT).

It is a vast field which widens. This includes, but is not limited to, endpoints and methodologies based on digital technologies in drug development. The range extends from sensors such as ingestible and implantable to mobile health tools such as wearable devices that patients wear to measure certain health-related parameters or for remote monitoring of patients. It can provide measures of pharmacodynamics, efficacy and safety. And it has applications in a wide range of therapeutic areas, including hematology, immunology, neuroscience, respiratory, cardiovascular, oncology and ophthalmology.

Certain guidelines already exist on the subject, in particular the notes of the European Medicines Agency (EMA) on computerized systems and electronic data in clinical trials, or the qualification of new methodologies for the development of medicinal products, and the guidelines for the FDA on digital health technologies for remote data acquisition in clinical investigations. But even the terminology diverges between the EMA, FDA, and other organizations. And the US-based Clinical Trials Transformation Initiative has published recommendations titled “Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials” with a checklist that urges sponsors to include digitally derived endpoints in clinical trials. early phase clinical trials and observational cohort studies to demonstrate that they are fit for purpose and to select the technology after selecting an outcome.

The topic of DHT will be further explored in a virtual workshop in December titled “Enhancing Patient-centric Outcome Measures and Clinical Trials Using Digital Health Technologies”1. The goal is to advance thinking on how to optimize DHD development, generation of evidence for validation and qualification, and regulatory pathways. Topics on the agenda include expectations and initiatives from EU and US regulators and perspectives from ethics committees, patients, universities, health technology assessment agencies and technology. The workshop also promises to explore the use of DHTs beyond parameters – for prognosis, patient selection and diagnosis.

The promising outcome of the workshop is an agreement to establish a roadmap to enable the use of DHT in drug development in Europe and beyond. In preparation, the EFPIA is carrying out a survey to gather information on experience with digital terminals for use in drug development.2 It wants to gather opinions on the current status and experiences in the environment current, to better understand what the obstacles and potential solutions could be.

The survey is open to academics; companies in the biotechnology, pharmaceutical and medical device sectors; patient groups; contract research organizations (CROs); and technology providers. He questions where the trials in question were conducted and how stakeholders were involved, ranging from technology development to regulation, and from clinical trials to analytical validation.

Respondents are also asked to rank the obstacles they have encountered specifically in the European environment, from a list ranging from regulatory obstacles and data privacy to lack of perceived value or lack of clarity on the steps development, through the challenges related to clinical interpretation or the implementation of good clinical practices in terms of data integrity or missing data.



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