This article is published as part of Capsticks’ Medical Malpractice and Casualty Forward View 2023.

The government’s response to the Medicines and Healthcare Regulatory Authority’s 2022 consultation on the future shape of clinical trials is awaited. If the proposals are adopted they are likely to have a significant impact on both organisations running clinical trials and trial participants.

The proposals are designed to encourage research - in particular the removal of obstacles to innovation (whilst maintaining robust oversight) and streamlining clinical trials regulation.

Reducing unnecessary burden on those running trials and embedding proportionality is central to the framework.

The suggestion that obtaining consent in ‘cluster trials’ (where approved medicines are given to participants to compare available treatments) should be simplified, is one example of how the proposals may have an impact on risk. At the moment written consent is required from every ‘cluster trial’ participant, despite the trial medicine providing little or no additional risk because the participant is randomised to have a standard treatment routinely prescribed for their condition.

Medical Malpractice and Casualty Forward View 2023

This article is part of Capsticks’ Medical Malpractice and Casualty Forward View 2023.

Read the other articles featured in this publication below:

• Spotlight on three appeal court decisions to look out for in 2023
• Concussion in sport: the next industrial disease claim?
• Courts will continue to take a robust approach to fraud, but defendants should be rigorous when assessing the strength of their case
• Private surgeons could face Covid-19 related claims
• Covid-19 public inquiry: private hospitals may face requests for statements and documents
• Government prepares for Personal Injury Discount Rate (PIDR) review
• There could be an increase in the cost of care claims, but a decrease in the cost of accommodation claims
• Private hospitals and MedTech companies will need to keep an eye on emerging product and general liability risks
• Legal liabilities for transport of the future: e-scooters and self-driving vehicles
• Fixed recoverable costs (FRCs) – timetable delayed
• Civil Procedure Rules Committee (CPRC) may be the bearer of good news for defendants

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To discuss how any of these issues may affect your organisation, please get in touch with Majid Hassan or Chery Blundell.