Evaluating the role of Clinical Study Reports, as unpublished sources of evidence for the use of sacubitril/valsartan in adults and its impact on evidence synthesis.

Evaluating the role of Clinical Study Reports, as unpublished sources of evidence for the use of sacubitril/valsartan in adults and its impact on evidence synthesis.

Clinical Study Reports (CSRs) are documents submitted by drug companies to organisations such as the European Medicines Agency (EMA) to evaluate new medications. They include information on the data and statistics involved in drug trials for these medications. When compared to information published in the usual medical journals, CSRs provide richer information on these trials and more detailed results. CSRs are becoming much more widely available so it is vital for researchers to be able to analyse these lengthy documents and draw conclusions from the information. This will hopefully provide greater knowledge on medications and improve decision making for medications which will ultimately benefit patients.In this project, it is planned that CSRs for a novel medication called Entresto which is licensed for use in heart failure, will be analysed. Information on the patient benefits and harms will be obtained from the CSRs. A thorough review of all published information on this medication will also be obtained and compared with that in the CSRs. It is planned to study the impact of CSR information on the areas of (i) Patient benefits and harms (ii) Appraisal of methodological quality.Following this, it may also be possible to use these estimates of treatment effects to perform a cost-benefit analysis of this medication. This would hopefully highlight the importance of using CSRs for costing of medications by decision makers.The overall aim of this project is to see whether any additional information held in the CSRs could improve our knowledge and improve decision making for medications.

[{ "PostingID": 4061, "Title": "NOVARTIS-CLCZ696B2228", "Description": "A multicenter, randomized, double-blind, parallel group study to assess the safety and tolerability of initiating LCZ696 in heart failure patients comparing two titration regimens" },{ "PostingID": 4062, "Title": "NOVARTIS-CLCZ696B2314", "Description": "A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction" }]