Why Trials managers are Important

Peter DavidsonDirector NETSCC, HTA

NHS Research community

HTA programme

The HTA programme

• Ensuring that high quality information about the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, provide care in, make policy for and manage the NHS

Successful trials

►Relevant ►Trustworthy►Clearly reported►Timely ►Value for money►safe for participants

BMJ Paper of the Year

2011

BMJ Paper of the Year

2011

CRASH2

Stages in a trial

►Planning and design►Application for funding►Conducting the trial►Analysis ►Reporting

Stages in a trial

►Planning and design►Application for funding►Conducting the trial►Analysis ►Reporting

Managers are important to all these

Vital contributions

►Project management►Balancing resources, specification and timetable

►Skills in delivering trials►Folk knowledge►Experience of overcoming difficulties►Professional approach to regulatory environment

►Attitude

Design stage

►Deliverability►Accurate estimation

►Timetable►Costs and resources

►Specific design features►Setting for recruitment►Incentives►documentation

Design into conduct

►Feasibility and pilot studies►Designing for clear objectives►Learning►Using results to modify main study

Conduct stage

►Approvals►Site set-up and management►Managing people

►Employed ►Associated ►Senior investigators

►Managing resources►Communication with funder

Later stages

►Continue to manage as part of the project►Resources►Individual contribution►Transfer of care beyond the trial►Ensure outputs are delivered►Reporting lessons from the management of the

trial

Challenges and hopes

►Complexity of the environment►End-to-end contribution►Delegation►Having a voice

►More recognition►More trial managers as grant applicants►Better partnership►Equal opportunities

Thank you

►For listening

►For managing so many successful trials

And thereby improving the health of the population

www.netscc.ac.uk

www.hta.ac.uk