Evaluating Patient Follow-up And Complexity in Cancer Clinical Trials
Research type
Research Study
Full title
Evaluating patient follow-up and complexity in cancer clinical trials: Development of an objective methodology to define and quantify trial complexity, intensity and workload to improve operational management and enhance models of trial delivery.
IRAS ID
218440
Contact name
Helen Jones
Contact email
Sponsor organisation
University of Lincoln
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
Providing cancer patients with access to the latest treatment options, drugs and best supportive care through clinical research is an important focus for the NHS. Due to predicted increases in cancer incidence and survival rates it is necessary to study the operational delivery of clinical trials within the NHS in order to identify efficient processes and practices. Cancer studies are amongst the most complex in design with detailed, prolonged follow-up and intricate protocols. There is a need to optimise recruitment to trials but that comes with an attached difficulty in managing growing volumes of patients in follow-up.
This mixed-method research intends to undertake an in-depth review of cancer trial designs, interventions and organisational delivery of clinical research to identify efficiency constraints, impacts on resource, highlight best practices and support patient-centred models of care. Through qualitative and quantitative research methods and grounded theory incorporating surveys, questionnaires and semi-structured interviews the study will evaluate the volume of patient follow-up and complexity across a range of cancer trial designs and phases conducted at NHS sites. The data will be analysed to define operational frameworks and develop a trial rating and complexity assessment tool (TRACAT). The outcomes are aimed at supporting study evaluation and monitoring, feasibility assessment,workforce management and providing enhanced outcomes for cancer patients within the NHS.
Participants will include clinical research professionals, experienced in delivering cancer clinical trials, and cancer patients who have previously or are currently participating in a trial. As key stakeholders involved in cancer clinical research these participants play a crucial role in identifying issues within existing processes and are invaluable in providing insight and a grounded perspective to support the development of future research delivery models. The study duration is expected to run from July 2017 to June 2019.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0292
Date of REC Opinion
9 Oct 2017
REC opinion
Further Information Favourable Opinion