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The Management and Organization of Clinical Trials

The results of this research are available as either a full report, or as a document providing a summary of the findings. If you would like any further information about this study, please contact us. We would welcome your comments about the results of our research, and how the findings and recommendations may influence your professional practice.

Acknowledgements

We are grateful to our funders, the EPSRC through a WIMRC research programme, which enabled us to conduct this research project. The project was supported by a Specialist Scientific Advisory Board and the project team would like to thank this group for their guidance and advice throughout this project. Our thanks are extended to all individuals who participated in this research, by taking part in an interview or by completing the survey. We would like to extend our thanks to the following organisations for their assistance with administering our survey:

Association of the British Pharmaceutical Industry (ABPI), Association of the British Healthcare Industries (ABHI), BioIndustry Association (BIA), Contract Clinical Research Association (CCRA), Institute of Clinical Research (ICR), NIHR Clinical Research Network, NHS R&D Forum, CHAIN Network, Knowledge Transfer Network, and the London Biotechnology Network.

Major findings

There has been an overall improvement in the proportion of projects that complete within time over the last decade. However, this improvement is largely related to improvements in time to recruit patients, whilst the project set-up stage continues to be a significant challenge. There is a slight drop in the proportion of projects that reach the anticipated recruitment target expected from UK sites within agreed time frames. Projects led by pharmaceutical companies were more likely to complete on time and to patient recruitment targets, as compared to other projects led by commercial organisations and those led by non-commercial research groups. 45% of pharmaceutical-led projects completed on time, compared with 32% of non-commercial studies, and 24% of projects led by other commercial organisations. 68% of pharmaceutical-led projects completed on budget, compared to 64% of non-commercial studies and 48% of projects led by other commercial organisations.

From the analysis of the data derived from both phases of the study, the greatest challenges affecting the management of clinical research were found around four areas:

Regulation & Governance:
Successfully completing the governance approval process was identified as a particular challenge for project management. In particular, different types of research organisation naturally conduct different models of research, all of which experience dissimilar pressures in managing the regulatory and governance process. Researchers that do not adopt standard randomised controlled trial (RCT) models face particular challenges in the approvals process.
Knowledge & Expertise:
Retaining project team expertise was critical for successful project management. This underpinned many of the problems (e.g. recruiting and retaining patients) commonly associated with the conduct of all models of clinical research. However, skills shortages create particular difficulties for non-commercial and smaller commercial research organisations.
Networks & Strategy:
Project management is reliant on the development of successful working relationships between the research organisation and other key groups within the sector. Each research organisation must shape their strategy for research to fit in with the UK strategic context and to facilitate successful networking with other stakeholder groups.
Incentives & Drivers:
To develop and maintain a network of relationships, research organisations and policy makers must develop insight into what incentivises different organisations, communities and individuals to engage in clinical research. In practice this may require balancing dissimilar or even antagonistic actions. The heterogeneous groups that are critical to the UK’s clinical research sector require different levels of support to incentivise involvement with research projects.
The full report presents detailed findings and recommendations as to the many different challenges that influence the ease of managing clinical research projects within the UK.
 

Project Dissemination Event
'Managing clinical trials in the UK today: Challenging times'

Wednesday 9th September 2009 from 10.00am until 4.00pm
at The People’s Palace, Queen Mary University of London, Mile End Road, London E1 4NS

At this one day event we reported the major results of a 2 year EPSRC funded research project which sought to identify the key challenges for managing different models of clinical research in the UK today. Drawing on a large scale survey of over 200 clinical trials that have recently been conducted in the UK, together with in-depth interviews with all of the major stakeholders involved in clinical trials in the UK, we discussed the strengths of the UK clinical research base, along with the challenges that are currently encountered when conducting commercial and non-commercial trials, from the perspectives of the different stakeholders that are involved.
 
Presenters included:-
  • Dr David Gillen, Senior Medical Director, Pfizer
  • Professor Jacky Swan, Principal Investigator, University of Warwick
  • Professor Maxine Robertson, Principal Investigator, Queen Mary University of London
  • Dr Sarah Evans, Research Fellow, University of Warwick
  • Professor John Gribben, Professor of Experimental Cancer Medicine at Queen Mary University of London, and Head of R&D for Barts and The London School NHS Trust
 
Survey
In Spring 2009 we conducted an online survey about experiences of conducting and managing clinical research in the UK. This aspect of the research project aimed to identify the different models of clinical research that are being used and to evaluate the standards that are achieved across each in terms of patient recruitment, regulatory approval, time taken to open recruitment sites within the NHS etc.
 
We collected responses from researchers who are involved in all different models of clinical research, including academic, commercial & contract-organisation-led, and pharmaceutical, biotechnology, medical devices and complex intervention categories of research, with the aim to produce a detailed and representative picture of how all types of clinical research are managed across the UK. We hope that our research will provide a better understanding of the challenges of clinical research in the UK and what kinds of management and organisation support success. This study provides much needed practitioner and policy advice on the challenges of trials management. From the findings, we plan to produce practically useful reports for Clinical Research Directors/Managers, focal Professional Associations such as the NIHR-CRN, ABPI and ICR, and UK Policy Makers on the status of the UK clinical research base, which will be available later this year.
 
Research Question
What are the key the challenges posed by different approaches to the management and organization of clinical trials for key stakeholders involved and how might these challenges be overcome?
 
Synopsis
This research responds to growing concerns expressed by UK scientists, clinicians and industrialists about the ‘translational gap’ between basic scientific discovery and innovations that will directly benefit patients, and about the decline of the UK’s clinical research base. Improving the efficiency and effectiveness of clinical trials is central to closing this translational gap. The management of clinical trials entails complex networks of relationships, often operating on a global basis, and increasingly involving large clinical research organizations and/or other service providers. This research provides the first extensive, systematic study and mapping of the different approaches to managing and organizing clinical trials in the UK context and the challenges these pose for key stakeholders involved, including industry, innovating scientists and clinicians, and the NHS.
 
Aims
To identify the key social, organizational and managerial factors that influence clinical trials with a view to improving the clinical research process. Specific objectives are to:
 
  1. Map alternative models of clinical research and identify the key challenges they generate.
     
  2. Identify barriers and enablers to clinical trials management in the UK clinical research sector.
     
  3. Identify the macro economic and policy drivers of the move toward outsourcing of clinical trials and consider the implications of this for clinical trials management.
     
  4. Develop new theory on ‘networked innovation’, focusing on clinical research as an exemplar.
     
  5. Produce practically useful reports/briefings for UK Policy Makers, Clinical Research Directors/Managers and focal Professional Associations on the status of the UK clinical research base, focusing on requirements for the successful management and organization of clinical trials in the face of medium term economic, regulatory and policy constraints.
Expected Outcomes
  1. A final report will focus on mapping approaches to clinical trials organization, the challenges these pose for management and the impact of shifts in the policy/economic context for clinical trials management. This will be widely available to key sponsors - the ICR, WCTU, and ABPI - and disseminated to other hospital and university-based Clinical Trials Units around the UK and the NHSI.
  2. Reports/briefings will be targeted at the DTI, DH and MRC focusing on the challenges of trials management and the impact of macro economic and policy shifts (e.g. global outsourcing of clinical research) in the medium term.
  3. A minimum of 4 academic papers will be developed for submission to top-rated journals.
  4. Survey tools/datasets will be available to academics and industry users subject to agreement.
Benefits to Society
Government, scientists, clinical practitioners and patient groups have expressed growing concern about the decline of the UK’s clinical research base and the gulf between basic research and innovations that directly benefit patients. This ‘translational gap’ “can only be bridged through the successful application of clinical research, testing and evaluating new concepts and interventions at the bedside and in carefully managed clinical trials” (AMR, 2003, p. 7). This project offers unique systematic research on the processes required to manage and organize different kinds of trials, and the impact on clinical trials management of wider structural changes (e.g. global outsourcing to large CROs) and shifts in regulation in the last decade. The research will provide much needed policy advice for the DTI and DH on the challenges of clinical trials management.
 
Benefits to Industry
Clinical trials pose probably the single largest cost (and risk) to R&D in the biomedical industry. Our previous research suggests that many industry and research organizations lack required knowledge in trials management. This research, in collaboration with the Warwick Clinical Trials Unit, the Institute of Clinical Research (ICR) and the Association of the British Pharmaceutical Industry (ABPI), will provide managers with a better understanding of how and why trials fail and what kinds of management and organizational processes support success. A report will be distributed to all 5000 UK members of the ICR and the 75 industry organizations of the ABPI (who collectively research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the NHS) and to Clinical Trials Units in UK universities and hospitals. A Scientific Advisory Board and a final workshop will engage representatives of these major stakeholder groups.
 
Academic Benefits
‘Networked innovation’ – i.e. innovation that occurs through ongoing negotiated relationships, which do not rely primarily on either market or hierarchical mechanisms of control – is a primary feature of the ‘knowledge economy’ and major area of academic debate. Using clinical research as an exemplar, and drawing from extensive research experience in IKON, this research will further theory on networked innovation processes in the particular context of healthcare innovation so supporting the WIMRC’s intellectual agenda on ‘lean healthcare’.
 

 

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Project Team:

Jacky Swan
Maxine Robertson
Sarah Evans
 
Download the project information sheet (PDF Document)
Download the final report (PDF Document)
Download the Summary of Findings report (PDF Document)