New HRA approval leaflet

The Health Research Authority (HRA) has published a new brief leaflet setting out high level information about the HRA Approval process. It provides an overview, highlighting their aim to simplify and streamline the approval process. Detailed guidance is also available from the HRA website. For help or to share feedback, This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

New Wilson Disease trial recruiting now

8 Feb 2016

A phase 2, multi-centre, international therapeutic trial has been approved in the UK for patients with Wilson's disease. The Royal Surrey County Hospital, Guildford and Queen Elizabeth Hospital, Birmingham are the two UK sites, both of which have begun recruiting. Please refer to the letter to physicians for more detail and to get involved.

Registered Clinical Trials Units

27 Nov 2015

The UK Clinical Research Collaboration (UKCRC) Registered CTU Network is a network of academic clinical trials units (CTUs) that have been assessed by an international panel of experts in clinical trials research. This site is the authoritative web resource for information about the UKCRC Registered Clinical Trials Units. The information provided on this site is aimed at the following groups, both within and outside the UK:

  • Clinical researchers and investigators
  • Clinical research networks
  • Funders of clinical research (both industry and non-industry)


The site offers a resource for clinical researchers and funders wishing to identify CTUs that have expertise in centrally coordinating multicentre clinical trials, as well as in trial design, data management, and analysis. It provides comprehensive information and direct access to high quality CTUs across the UK which have achieved UKCRC Registration status.

Can aspirin stop cancer?

The world’s largest ever clinical trial looking at whether taking aspirin every day stops some of the most common cancers coming back launched on 22 October 2015. The Add-Aspirin phase III trial, the largest of its kind and funded by the NIHR HTA Programme and Cancer Research UK, aims to find out if taking aspirin every day for five years can stop or delay cancers that have been caught and treated at an early stage from returning. It will also study how the drug might do this. The study will recruit 11,000 patients who have recently had, or are having, treatment for bowel, breast, oesophagus (food pipe), prostate or stomach cancer. It will be open at more than 100 centres across the UK and will run for up to 12 years. Details of the trial and the background to it are available on the NIHR website.

Join the PANTS Study!

Inclusion of patients receiving Biosimilar Infliximab - Remsima™ & Inflectra™

Dr Tariq Ahmad

The latest version of the PANTS protocol allows the inclusion of Crohn's disease patients receiving Biosimilar Infliximab. Specifically this allows

  • Inclusion of anti-TNF naive Crohn's disease patients starting Remsima™ or Inflectra™
  • Existing PANTS study participants receiving RemicadeTM to switch to Remsima™ or Inflectra™

The PANTS study is a prospective uncontrolled cohort study investigating primary non-response, loss of response and adverse drug reactions to Infliximab and Adalimumab in patients with severe active luminal Crohn's disease. The study started in March 2013 and to date 1200 patients aged over 6 years have been recruited from 118 UK hospitals. The collection of clinical data is aligned and shared with the Royal College of Physicians UK IBD Biologics Audit (and in due course with the UK IBD registry), and individual patient laboratory data is released on the web portal.

Biosimilar Infliximab became available in the UK in February 2015 offering significant savings to the National Health Service. Extensive non-clinical and clinical data have shown comparability with the reference product, Remicade™. However the clinical data to date has emerged from the use of Biosimilar Infliximab in studies of patients with Ankylosing Spondylitis and Rheumatoid Arthritis. The PANTS study will report the initial UK experience of Biosimilar Infliximab in Crohn's disease, providing important post-authorisation data on efficacy (at week 14, 30 and 54), safety (to 3 years) and pharmacokinetics. We aim to include 225 patients treated with Biosimilar Infliximab as first-line anti-TNF treatment and 100 PANTS "switchers" over the next 12 months. Please do consider recruiting your patients to the PANTS study.

For further information please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 01392 406850

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