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An achievable efficacy target needs to be set while standardisation of trial outcomes and critical choices based on the vaccine development pipeline need to be made.
It is anticipated that these prognostic indicators will be used in the future evaluation of treatments that aim to slow the progression of ADPKD and will lead to improvement and standardisation of trial design [ 2].
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13 15 Lack of standardisation of clinical trial protocols, data recording and evidence thresholds are also cited as barriers.
will facilitate standardisation of test conditions and reproducibility between laboratories.
We anticipate that evidence from the DISCO-study will underpin the current efforts to enhance the transparency, standardisation and accessibility of trial information.
91 The UK START (Standardisation of Breast Radiotherapy) trial 92, 93 and a randomized Canadian study 94 prospectively validated two hypofractionated regimens delivering 41.6 Gy in 13 fractions and 42.5 Gy in 16 fractions, respectively.
Ten patients received 40 Gy in 15 fractions as part of the START B trial (NCRN Trial Standardisation of Breast Radiotherapy, 1998).
Hypofractionation in breast cancer radiotherapy entered clinical trials in the UK in 1986 with the Standardisation of Breast Radiotherapy pilot trial (START-pilot; n = 1410) and in Canada in 1993 with the Ontario trial (n = 1234) [18].
To ensure the standardisation of secondary resuturing, the trial team have provided recommendations for both the methods and materials to be used (table 1).
The UK Standardisation of Breast Radiotherapy (START) trials A and B [ 17- 19] presented only three of the QLQ BR23 scores in their analysis: breast symptoms, arm symptoms, and body image.
The long-term safety and efficacy of hypo-fractionated radiotherapy after breast-conserving surgery and mastectomy for operable breast cancer has recently been confirmed: (10-year results of Canadian [ 191] and Standardisation of Breast Radiotherapy (START) trials also suggesting generalisability to all subgroups of patients [ 192, 193].
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