Clinical trials have the potential to reshape healthcare and improve lives globally. However, to realise this fully, trials must be well-designed, ethically conducted, and efficiently managed. They need to answer key scientific questions that provide direct benefits to the people they aim to help.
The leaders of the European Federation of Pharmaceutical Industries and Associations (EFPIA) have warned that the proposed reforms to the European Commission’s (EC) Pharmaceutical Legislation should be revised as they believe they risk damaging Europe’s capacity for innovation and international competitiveness.
The much anticipated O’Shaughnessy report examining commercial clinical trials in the UK was published at the end of May 2023. Its findings have prompted the UK government to initiate a series of actions, in response to its 27 recommendations, that are designed to make the UK a world leader in this important part of the life sciences industry.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting public feedback on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Chancellor Jeremy Hunt has announced a comprehensive ‘Life Sci for Growth’ package of support for the UK life sciences sector, designed to grow the economy through improving regulation around clinical trials, manufacturing, skills and infrastructure.
The European Medicines Agency (EMA) has published its annual report for 2022, highlighting its challenges and successes in a year that saw it face ongoing and new public health emergencies.
Decentralised clinical trials (DCTs) are being used increasingly in the pharma industry for clinical research and the US Food and Drug Administration (FDA) has published draft guidance for those carrying out trials at non-traditional investigation sites.
Cancer diagnosis and treatment are set to be accelerated with the opening of England’s first Integrated Pathology Unit (IPU). The new facility will apply pioneering digital imaging and artificial intelligence to pathology, assisting clinical trial research programmes focused on developing tests for cancer.
The 2023 annual conference of the UK’s Association of the British Pharmaceutical Industry (ABPI) at the end of April had a theme of Growing the UK as a Global Hub for Life Sciences.
In order to strengthen the UK’s regulatory environment for clinical trials in an increasingly competitive global market, the government plans to prioritise safety and efficacy, while minimising regulatory burdens on trial sponsors.
