International HIV Clinical Trials Research Management Office
The International HIV Clinical Trials Research Management Office oversees a number of large national and international research programmes involving multi-centre clinical studies of HIV prevention technologies and treatment of HIV infection. The management office is part of the Department of Medicine at Imperial College London.
A Brief History
In 2000 Imperial College London launched the Microbicides Development Programme (MDP), one of the first international Public Private Partnerships (PPP) established to develop a new approach to reduce the risk of HIV acquisition in women. The partnership brought together 16 institutions in Africa, Europe and the US and led to the completion of a major phase III safety and efficacy trial which recruited close to 9,500 participants across four Sub-Saharan countries.
The size and scope of this £43 million initiative funded by DFID and the MRC required setting up an appropriate overarching Programme Management organisation to work alongside traditional trial management structures and to oversee the day-to-day administration and coordination of all non-trial activities such as cross-country programme management, financial reporting, liaison with funders and clinical sites, dissemination of trial results, and much more.
In 2002, Professor Jonathan Weber established the International HIV Clinical Trials Research Management Office (the Office) on the St Mary’s Campus in Paddington, with the task of providing highly skilled, highly responsive administration and management support to the MDP.
From then onwards the Office took over the grant management and administration of a number of other international multicentre HIV prevention trials including DART (£7 million), SPARTAC (£6.5 million), and AfrEVacc (£2.5 million).
In 2008 an £8.8m Wellcome Trust Strategic Award was awarded to Professor Weber for the creation of the UK HIV Vaccine Consortium (UK HVC). This led to the diversification and expansion of the activities of the Office, which then entered the realm of developing products for use in human trials, and thereby contributing to translating research from bench to bedside. New skills were added to the Office team who had to learn to navigate through the maze of intellectual property and to negotiate complex manufacturing agreements in line with EU regulations.
Our Customers and Collaborators
The MDP programme ended in 2009, and as other clinical studies were nearing completion a new generation of clinicians and researchers took advantage of the project management and grant application skills of the Office to develop their own programmes of early clinical and translational research.
Since its creation, the Office has provided critical support to clinicians and researchers to relieve them of most of the day-to-day administrative and management activities needed for grant application and management, allowing them to focus on developing a portfolio of clinical projects.
Currently the Office is led by two Senior Programme Managers supported by three project managers overseeing several awards including the first pan-BRC cooperative (CHERUB) which brings together 5 HEFCE and their NHS counterparts and the multicentre PopART HIV Prevention trial.
The Office currently provides award management support to Professor Robin Shattock and Professor Sheena McCormack and to Dr Sarah Fidler, Dr Alan Winston and Dr Graham Cooke as well as other clinicians and researchers in the department and beyond. Dr Fidler is a key investigator in the USD$100m+ international multicentre cluster randomized PopART trial, born out of the SPARTAC study, which is now led by the LSHTM. Dr Winston has secured funding from the MRC with support from the Office for a new HIV entry inhibitor with an Italian Biotech and continues to receive support for grant applications to the MRC, the EU and the Wellcome Trust as well as grant management support. With the arrival of Professor Robin Shattock in 2011 and Professor Sheena McCormack in 2012 new opportunities to do further developmental HIV translational research have arisen.
How we can help
The success of the Office is based on the provision of a one-stop, customer-orientated, highly responsive service. The staff in the Office have acquired and developed very specific skills in a large number of areas from project management, IP management, GMP/GCP, and contract negation to international finance reporting and liaison with a range of funders and partners. These are areas which require dedicated attention due to their complexity and the need to work closely with the private sector in a highly regulated environment (such as GMP manufacture, or milestone-based research). It is also based on an ability to coordinate and build bridges between people, services, institutions, and external organisations (funders, industry, NGO…)
Our knowledge and understanding of science and funding schemes as well as being part of cross institutional networks has built and strengthened collaborative research. As research increasingly requires highly specialized technologies and skills, the ability and capacity to bring together a broad range of stakeholders and to act as a unique point of contact with a number of shared research services and partners has been critical for securing grants from a range of funders and for successfully managing complex multicentre projects.
There is a pressing clinical need for a preventative HIV vaccine, novel HIV diagnostics and advancement of cure therapies. The Office contributes to the development and implementation of new projects and grant applications in these, and other, research areas to develop novel approaches to HIV prevention and treatment in collaboration with public sector funders, philanthropic organisations and Industry.