Helen B Higgins

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Objectives Large, simple, pragmatic, low-risk, maintenance treatment trials may seem straightforward to design, run and analyse. However, if trial case record forms (CRFs) are completed infrequently, the reliability of patient recall over these long time-periods is questionable, especially when recording individual incidences and severity of toxicities of(More)
Methods NEO-ESCAPE was a randomised two arm phase II study in inoperable ovarian cancer designed as an external pilot to inform a future phase III randomised controlled trial. The primary objective was to assess the feasibility of two new extended chemotherapy regimens with 44 patients required on each arm. If one or both treatment arms proved feasible, the(More)
Methods Neo-tAnGo and ARTemis are national 800-patient breast cancer trials assessing neo-adjuvant chemotherapy regimens, both with a secondary endpoint of radiological tumour response, assessing treatment effect in terms of change in tumour size. Both trials record radiological sizes at baseline, mid-way through and at the end of the chemotherapy regimens.(More)
Methods OPTIMA prelim, the feasibility phase, aims to recruit 300 patients to evaluate performance and health-economics of a number of multi-parameter tests to identify test(s) to be used in the main trial and to establish the acceptability to patients and clinicians of randomisation. Patients are randomised to the standard arm or to the “test-directed(More)
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