The need for increased harmonisation of clinical trials and economic evaluations

References

• Sculpher MJ, Claxton K, Drummond M, McCabe C. Whither trial-based economic evaluation for health care decision making? Health Econ 2006;15(7):677-87
   PubMed Web of Science ®Google Scholar
• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c322
   Google Scholar
• Calvert M, Blazeby J, Altman DG, CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the consort pro extension. JAMA 2013;309(8):814-22
   PubMed Web of Science ®Google Scholar
• Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ economic evaluation working party. BMJ 1996;313(7052):275-83
   PubMed Web of Science ®Google Scholar
• Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ 2013;346:f1049
   PubMed Web of Science ®Google Scholar
• Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining Standard Protocol Items for Clinical Trials. Ann Intern Med 2013;158(3):200-7
   PubMed Web of Science ®Google Scholar
• Gheorghe A, Roberts TE, Ives JC, et al. Centre selection for clinical trials and the generalisability of results: a mixed methods study. PLoS ONE 2013;8(2):e56560
   Google Scholar
• Kyte D, Ives J, Draper H, et al. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? interviews with research nurses and trialists. PLoS One 2013;8(10):e76625
   PubMed Web of Science ®Google Scholar
• Edwards RT, Hounsome B, Linck P, Russell IT. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials 2008;9(1):64
   Google Scholar
• Whitehurst DG, Bryan S. Trial-based clinical and economic analyses: the unhelpful quest for conformity. Trials 2013;14(1):421
   Google Scholar
• Tsoi B, Masucci L, Campbell K, et al. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences. Expert Rev Pharmacoecon Outcomes Res 2013;13(4):497-511
   PubMed Web of Science ®Google Scholar
• Donaldson C, Hundley V, McIntosh E. Using economics alongside clinical trials: why we cannot choose the evaluation technique in advance. Health Econ 1996;5(3):267-9
   Google Scholar
• Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374(9683):86-9
   PubMed Web of Science ®Google Scholar
• Raikou M, Briggs A, Gray A, McGuire A. Centre-specific or average unit costs in multi-centre studies? Some theory and simulation. Health Econ 2000;9(3):191-8
   Google Scholar
• Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment Program. Value Health 2010;13:867-72
   PubMed Web of Science ®Google Scholar
• Goeree R, Gafni A, Hannah M, et al. Hospital selection for unit cost estimates in multicentre economic evaluations: does the choice of hospitals make a difference? Pharmacoeconomics 1999;15(6):561-72
   Google Scholar
• Glick HA, Orzol SM, Tooley JF, et al. Design and analysis of unit cost estimation studies: how many hospital diagnoses? How many countries? Health Econ 2003;12(7):517-27
   Google Scholar
• Grieve R, Cairns J, Thompson SG. Improving costing methods in multicentre economic evaluation: the use of multiple imputation for unit costs. Health Econ 2010;19(8):939-54
   Google Scholar
• Drummond M, Barbieri M, Cook J, et al. Transferability of economic evaluations across jurisdictions: ISPOR good research practices task force report. Value Health 2009;12(4):409-18
   PubMed Web of Science ®Google Scholar
• Drummond M, Manca A, Sculpher M. Increasing the generalizability of economic evaluations: Recommendations for the design, analysis, and reporting of studies. Int J Technol Assess Health Care 2005;21(2):165-71
   PubMed Web of Science ®Google Scholar
• Fairclough DL, Peterson HF, Chang V. Why are missing quality of life data a problem in clinical trials of cancer therapy? Stat Med 1998;7(5-7):667-77
   Google Scholar
• Coyne KS, Tubaro A, Brubaker L, Bavendam T. Development and validation of patient-reported outcomes measures for overactive bladder: a review of concepts. Urology 2006;68(Suppl 2):9-16
   Google Scholar
• Basch EM, Abernethy AP, Mullins CD, Spencer MR. EV1 development of a guidance for including patient-reported outcomes (PROS) in post-approval clinical trials of oncology drugs for comparative effectiveness research (CER). Value Health 2011;14(3):A10
   Google Scholar
• Kyte D, Draper H, Calvert M. Calvert, Patient-reported outcome alerts: ethical and logistical considerations in clinical trials. JAMA 2013;310(12):1229-30
   Google Scholar
• Kyte DG, Draper H, Ives J, et al. Patient reported outcomes (PROs) in clinical trials: is ‘in-trial’ guidance lacking? a systematic review. PLoS One 2013;8(4):e60684
   Google Scholar