have been identified, but there is no access to the level of data required, this should be stated. Summary of methodology of the relevant randomised controlled trials It is expected that all key aspects of methodology will be in the public domain; if a company wishes to submit aspects of the methodology in confidence, prior agreement must be obtained from NICE. Provide the information specified in sections 4.3.1 and 4.3.2. 3 to 6b of the CONSORT should be provided for all RCTs listed: brief description of trial design, including details Trial design – of randomisation if applicable. Eligibility criteria a comprehensive description of the eligibility – criteria used to select the trial participants, including any definitions and any assessments used in recruitment. Settings and locations where the data were collected – describe the locations where the trial was carried out, including the country and, if applicable, the care setting (for example, primary care [GP or practice nurse], secondary care [inpatient, outpatient, day case]). Trial drugs and concomitant medications provide details of – trial drugs and comparator(s), with dosing information and titration schedules if appropriate. Provide an overview of concomitant medications permitted and disallowed during the trial. Primary, secondary and tertiary outcomes all outcome – measures listed in the trial protocol, whether primary, secondary or tertiary, should be identified and completely defined. The rationale for excluding data on any of the outcomes listed in the study protocol should be provided. When outcomes are assessed at several time points after randomisation, indicate the
have been identified, but there is no access to the level of data required, this should be stated. Summary of methodology of the relevant randomised controlled trials It is expected that all key aspects of methodology will be in the public domain; if a company wishes to submit aspects of the methodology in confidence, prior agreement must be obtained from NICE. Provide the information specified in sections 4.3.1 and 4.3.2. 3 to 6b of the CONSORT should be provided for all RCTs listed: Trial design – brief description of trial design, including details of randomisation if applicable. Eligibility criteria – a comprehensive description of the eligibility criteria used to select the trial participants, including any definitions and any assessments used in recruitment. Settings and locations where the data were collected – describe the locations where the trial was carried out, including the country and, if applicable, the care setting (for example, primary care [GP or practice nurse], secondary care [inpatient, outpatient, day case]). Trial drugs and concomitant medications – provide details of trial drugs and comparator(s), with dosing information and titration schedules if appropriate. Provide an overview of concomitant medications permitted and disallowed during the trial. Primary, secondary and tertiary outcomes – all outcome measures listed in the trial protocol, whether primary, secondary or tertiary, should be identified and completely defined. The rationale for excluding data on any of the outcomes listed in the study protocol should be provided. When outcomes are assessed at several time points after randomisation, indicate the
user-guide-company-submission-evidence-2015-word-version.docx