EFPIA News release: New EU in vitro regulations delaying clinical trials

In a 20Mar2023 news release, the European Federation of Pharmaceutical Industries and Associations (EFPIA) that notes a large number of clinical trials in the EU are being delayed because of problems related to the implementation of the In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022.  EFPIA claims, the implementation of the regulation has been challenged by a lack of infrastructure, guidance, and coordination, triggering a series of unintended consequences. The release notes:

The number of clinical trials delayed is expected to run into the hundreds, affecting up to 42,200 patients over the next three years, according to a survey run by EFPIA. The legislation is also likely to result in delays to therapies reaching patients in Europe. 

 From the article:

The EFPIA member survey showed:

• Between 82 and 160 trials are currently being delayed in Europe, with an expected 238 to 420 trials to be delayed over the next three years.
• These delays mean that between 33,815 to 42,200 patients in Europe are expected to have delayed access to clinical trials over the next three years, around half of them (up to 27,400) being cancer patients.
• The launch of 89 therapies could be delayed because of this legislation, in innovative therapeutic areas such as oncology and rare diseases.
• Up to 400 trials are expected to enrol fewer patients, meaning some people missing out on innovative new treatments. These include trials for cancer, rare disease, neuroscience, inflammation, cell and gene therapies, paediatrics and cardiovascular diseases.
• 43% of companies surveyed said they expect delays of six to12 months to current clinical trials, with 48% expecting six to 12 month delays over the next three years.
• 67% of companies would consider reducing the number of EU trial sites if IVDR requirements remain the same, noting these trials would move to the US, Canada, UK, and Asia, among other locations.
• Compliance with the IVDR means IVDs used in clinical trials go through an assessment process when the diagnostic test result influences patient medical management. However, this process is currently complex and uncoordinated. It results in patients waiting longer to participate in clinical trials, or even not participating at all.

A number of recommendation were proposed by EFPIA to reduce the current barriers implemented by the IVDR.