The ConDuCT Hub: Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials
Lead Research Organisation:
University of Bristol
Department Name: Social Medicine
Abstract
The overall aim of the MRC ConDuCT Hub is to provide the conditions for research staff to come together and develop new techniques to design and complete randomised controlled trials (RCTs). RCTs are the most powerful form of medical research that can change what doctors advise. RCTs can compare outcomes for patients receiving different treatments or compare new treatments with existing treatments, or a placebo (dummy treatment). Researchers assign participants to each treatment group at random to ensure that comparison between the two groups is scientifically accurate as all other things apart from the treatment are likely to be comparable in each group. Although RCTs provide good evidence, many are very difficult to design and complete, e.g. some are not completed because they are unable to recruit enough patients. Other RCTs are not started because the issues require complex design, conduct and analysis of results. The MRC ConDuCT Hub will concentrate on research that allows RCTs considered clinically important but too ?difficult?, to be undertaken successfully. The Hub should thus eventually lead to changes in clinical practice and better information for doctors and patients about which treatments to choose, based on the best evidence.
This will be achieved by bringing together an experienced team with different research backgrounds to develop new ways of carrying out RCTs. The Hub will be directed by a surgeon who works in the NHS and already carries out research to improve RCTs. Researchers in the Hub will work with other MRC Hubs across the UK and with NHS organisations in South West England and South Wales to carry out this work.
The ConDuCT Hub will provide a training programme of short courses and workshops based on each of six research themes. This will provide basic and advanced learning opportunities for researchers and clinicians designing and conducting RCTs. New courses and PhD studentships will be provided in the specialist research areas.
In conclusion, the ConDuCT Hub will bring together researchers and clinicians to improve the design of RCTs. This will lead to more and better RCTs being started and completed. The ConDuCT Hub will focus on tackling important questions about the best treatments and should lead to better information for patients and doctors making decisions about which treatments to use.
This will be achieved by bringing together an experienced team with different research backgrounds to develop new ways of carrying out RCTs. The Hub will be directed by a surgeon who works in the NHS and already carries out research to improve RCTs. Researchers in the Hub will work with other MRC Hubs across the UK and with NHS organisations in South West England and South Wales to carry out this work.
The ConDuCT Hub will provide a training programme of short courses and workshops based on each of six research themes. This will provide basic and advanced learning opportunities for researchers and clinicians designing and conducting RCTs. New courses and PhD studentships will be provided in the specialist research areas.
In conclusion, the ConDuCT Hub will bring together researchers and clinicians to improve the design of RCTs. This will lead to more and better RCTs being started and completed. The ConDuCT Hub will focus on tackling important questions about the best treatments and should lead to better information for patients and doctors making decisions about which treatments to use.
Technical Summary
The overall aim of the MRC ConDuCT Hub is to provide the environment and infrastructure for the conduct of collaborative methodological research that will lead to marked improvements in the successful design and completion of randomised controlled trials (RCTs). The Hub will focus particularly on developing nationally and internationally leading methodological research for RCTs considered ?difficult? because of methodological complexity, clinical controversy, or recruitment challenges. This will be achieved by bringing together a critical mass of experienced multi-disciplinary researchers to develop novel applications of research methods. The Hub will be directed by a clinician with an established record of collaborative work within RCTs. The Hub will work nationally with other MRC Hubs to support the conduct of challenging or complex RCTs, and regionally, the Hub will support RCTs in general in collaboration with UKCRC-registered Clinical Trials Units (CTUs) and the NIHR Research Design Service
The ConDuCT Hub comprises six major research themes: developing and integrating qualitative research methods to improve design and conduct, evidence synthesis and expected value of information for design and prioritisation, improving RCT monitoring and conduct, integrating patient reported outcomes and clinical data, and statistical and economic methods for design and analysis. Each theme will work individually and collaboratively to support the wider UK RCT network. Close links with CTUs will hasten translation of methodological findings into developing and ongoing RCTs.
The ConDuCT Hub will provide a training programme comprising short courses and workshops based on the methodological research themes to provide basic and advanced learning opportunities in RCT methodology and application for researchers and clinicians designing and conducting RCTs. Courses to be provided in the design and analysis of RCTs will include existing introductory courses for qualitative research methods, statistics and health economics; questionnaire design and analysis; and new courses including: integrating qualitative methods in RCTs, incorporating patient reported outcomes with clinical outcomes in RCTs and introduction to expected value of information for decision-modelling. There will also be one-day workshops for specific issues relevant to complex RCTs. PhD studentships will provide advanced training in RCT methodology.
In conclusion, the ConDuCT Hub will permit the rapid development of research methods for RCTs by enabling experienced and developing researchers to dedicate substantial time to each methodological theme, and, through existing and new inter-theme collaboration, enable the design, conduct and analysis of ?difficult? RCTs at the cutting edge of health improvement.
The ConDuCT Hub comprises six major research themes: developing and integrating qualitative research methods to improve design and conduct, evidence synthesis and expected value of information for design and prioritisation, improving RCT monitoring and conduct, integrating patient reported outcomes and clinical data, and statistical and economic methods for design and analysis. Each theme will work individually and collaboratively to support the wider UK RCT network. Close links with CTUs will hasten translation of methodological findings into developing and ongoing RCTs.
The ConDuCT Hub will provide a training programme comprising short courses and workshops based on the methodological research themes to provide basic and advanced learning opportunities in RCT methodology and application for researchers and clinicians designing and conducting RCTs. Courses to be provided in the design and analysis of RCTs will include existing introductory courses for qualitative research methods, statistics and health economics; questionnaire design and analysis; and new courses including: integrating qualitative methods in RCTs, incorporating patient reported outcomes with clinical outcomes in RCTs and introduction to expected value of information for decision-modelling. There will also be one-day workshops for specific issues relevant to complex RCTs. PhD studentships will provide advanced training in RCT methodology.
In conclusion, the ConDuCT Hub will permit the rapid development of research methods for RCTs by enabling experienced and developing researchers to dedicate substantial time to each methodological theme, and, through existing and new inter-theme collaboration, enable the design, conduct and analysis of ?difficult? RCTs at the cutting edge of health improvement.