Research in the United Kingdom - Applied Clinical Trials


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Research in the United Kingdom The current initiatives and a historical overview of the clinical trial landscape.

Source: Applied Clinical Trials

The United Kingdom has a long history of involvement in clinical trials and has enjoyed a position of strength within biopharmaceutical research and development. There is widespread agreement across industry and government that this position is under threat, and has been for some time. This has led to a number of initiatives within the United Kingdom aimed at streamlining regulations and facilitating performance in clinical trials. The purpose of this article is to briefly chart the history of these initiatives, and provide the reader with a summary of the landscape for Phase II and Phase III clinical trials in the United Kingdom at present.

Historical perspectives

Concern in the late 1990s that the United Kingdom was losing its "market share" to other countries in Europe and other regions of the world led to the formation of a joint industry and governmental advisory body, the Pharmaceutical Industry Competitiveness Task Force (PICTF) in 1999. The PICTF committee examined threats to competitiveness for clinical trials in the United Kingdom under headings such as Start-up Time, Recruitment, and Research Quality and Research Costs, and in its final report published in 2001 made many key recommendations to address the issues.1

Shortly afterward, the Association of the British Pharmaceutical Industry noted that:

In recent years, the performance of UK sites involved in these international clinical trials has declined in terms of the speed of trial site initiation, patient recruitment, and quality of data generated, while trial costs have, in general, risen faster than in comparable countries. With increasing competition from research sites in the developing world and states in Eastern Europe, it has become more difficult for pharmaceutical companies to justify the inclusion of UK sites. Unless their performance improves, the extent of UK participation in international trials will continue to decline, with possible adverse consequences for the UK pharmaceutical industry more generally, as well as the status of the UK as a center of medical and research excellence.2

Immediately after the PICTF report was published in 2001, the Ministerial Industry Strategy Group, which is described by the Department of Health as "a high-level group bringing together government and pharmaceutical industry representatives" was formed and continues to meet twice each year with the aim to drive forward the implementation of the PICTF report recommendations.

In 2003, the Academy of Medical Sciences (a non-governmental group of UK-leading medical scientists) published a report entitled "Strengthening Clinical Research"3 which also identified the decline in clinical research activity in the United Kingdom and made several recommendations focused on increasing the perceived value of clinical research within the healthcare system of the United Kingdom. These recommendations were not aimed specifically at distinct areas, such as set-up, regulation, cost, recruitment, etc., but rather at more wide-reaching strategic approaches to encouraging clinical research in the United Kingdom. These recommendations included the creation of a national, government funded body (the National Network for Clinical Research) tasked with facilitation of clinical research at every level, and incentivizing doctors within the National Health Service (NHS) to become involved in clinical research.

The 2006 publication "Government Strategy—Best Research for Best Health"4 acknowledged that industrial and academic research and development was a crucial factor in ensuring UK patients benefitted for innovative new treatments. The strategy also acknowledged the challenges facing clinical trials in the United Kingdom and set out a five-year plan to address them. As a result of this report, the National Institute of Health Research (NIHR) was established in England in April 2006 in order to carry forward the vision, mission, and goals of best research for best health, including facilitating conduct of industry-sponsored clinical trials within the NHS. As part of the implementation of these plans, and perhaps in reference to the suggestions of the Academy of Medical Sciences, a national network for clinical trials was indeed established (the NIHR Comprehensive Clinical Research Network—CCRN).

In 2009, the UK government launched the Office of Life Sciences (OLS), dedicated to improving the operating environment for the pharmaceutical, medical biotech, and medical devices sectors. In December 2009 the OLS published its Life Sciences Blueprint5 including the important statement:

The Government will reinforce the need for greater emphasis on research and clinical trials in the next NHS operating framework, building on the existing commitment to include numbers of patients in clinical research in the metrics which trusts report in their quality accounts.

This statement is very important; at present there is little incentive in the United Kingdom for doctors, patients, or managers to engage seriously in clinical trials. With this latest initiative, for the first time the key performance indicators by which the success of chief executives of NHS hospitals are judged will include the number of patients in their hospitals who participate in clinical trials. This will hopefully increase the extent of high-level managerial commitment in NHS hospitals to drive forward the adoption and success of clinical trials.

In the last 10 years, therefore, there has been a number of government and industry initiatives in the United Kingdom focused on increasing the attractiveness of the United Kingdom as a location for clinical trials. The next questions are: what have these initiatives delivered to date, and what is the current landscape for set-up and delivery of clinical trials in the United Kingdom? In exploring the answer to these questions, the authors will focus on multi-center clinical trials conducted in secondary care within NHS hospitals. The landscape for clinical trials in primary care is largely the same, although there are some subtle differences which are beyond the scope of this article.


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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