-
2
-
-
85029886626
-
When and how can real world data analyses substitute for randomized controlled trials
-
Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials. Clin Pharmacol Ther 2017; 102: 924-33.
-
(2017)
Clin Pharmacol Ther
, vol.102
, pp. 924-933
-
-
Franklin, J.M.1
Schneeweiss, S.2
-
3
-
-
85079692503
-
-
National Academies of Sciences, Engineering, and Medicine. Washington, DC: National Academy of Sciences
-
National Academies of Sciences, Engineering, and Medicine. Examining the impact of real-world evidence on medical product development: Proceedings of a workshop series. Washington, DC: National Academy of Sciences, 2019 (http://nationalacademies.org/HMD/Reports/2019/examining -impact -real -world -evidence -on -medical -product -development -proceedings.aspx).
-
(2019)
Examining the Impact of Real-world Evidence on Medical Product Development: Proceedings of a Workshop Series
-
-
-
4
-
-
33847152253
-
When are randomised trials unnecessary? Picking signal from noise
-
Glasziou P, Chalmers I, Rawlins M, McCulloch P. When are randomised trials unnecessary? Picking signal from noise. BMJ 2007; 334: 349-51.
-
(2007)
BMJ
, vol.334
, pp. 349-351
-
-
Glasziou, P.1
Chalmers, I.2
Rawlins, M.3
McCulloch, P.4
-
5
-
-
84989187956
-
Interpretation of the evidence for the efficacy and safety of statin therapy
-
Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532-61.
-
(2016)
Lancet
, vol.388
, pp. 2532-2561
-
-
Collins, R.1
Reith, C.2
Emberson, J.3
-
6
-
-
85052708425
-
Real-world evidence and real-world data for evaluating drug safety and effectiveness
-
Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA 2018; 320: 867-8.
-
(2018)
JAMA
, vol.320
, pp. 867-868
-
-
Corrigan-Curay, J.1
Sacks, L.2
Woodcock, J.3
-
7
-
-
84898748408
-
The imperative of overcoming barriers to the conduct of large, simple trials
-
Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA 2014; 311: 1397-8.
-
(2014)
JAMA
, vol.311
, pp. 1397-1398
-
-
Eapen, Z.J.1
Lauer, M.S.2
Temple, R.J.3
-
8
-
-
0035880296
-
Comparison of evidence of treatment effects in randomized and nonrandomized studies
-
Ioannidis JPA, Haidich A-B, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001; 286: 821-30.
-
(2001)
JAMA
, vol.286
, pp. 821-830
-
-
Ioannidis, J.P.A.1
Haidich, A.-B.2
Pappa, M.3
-
10
-
-
34548356858
-
The impact of residual and unmeasured confounding in epidemiologic studies: A simulation study
-
Fewell Z, Davey Smith G, Sterne JA. The impact of residual and unmeasured confounding in epidemiologic studies: A simulation study. Am J Epidemiol 2007; 166: 646-55.
-
(2007)
Am J Epidemiol
, vol.166
, pp. 646-655
-
-
Fewell, Z.1
Davey Smith, G.2
Sterne, J.A.3
-
11
-
-
47249165270
-
Limits of observational data in determining outcomes from cancer therapy
-
Giordano SH, Kuo YF, Duan Z, Hortobagyi GN, Freeman J, Goodwin JS. Limits of observational data in determining outcomes from cancer therapy. Cancer 2008; 112: 2456-66.
-
(2008)
Cancer
, vol.112
, pp. 2456-2466
-
-
Giordano, S.H.1
Kuo, Y.F.2
Duan, Z.3
Hortobagyi, G.N.4
Freeman, J.5
Goodwin, J.S.6
-
12
-
-
70649113093
-
A most stubborn bias: No adjustment method fully resolves confounding by indication in observational studies
-
Bosco JL, Silliman RA, Thwin SS, et al. A most stubborn bias: no adjustment method fully resolves confounding by indication in observational studies. J Clin Epidemiol 2010; 63: 64-74.
-
(2010)
J Clin Epidemiol
, vol.63
, pp. 64-74
-
-
Bosco, J.L.1
Silliman, R.A.2
Thwin, S.S.3
-
14
-
-
84859726995
-
Credibility of claims of subgroup effects in randomised controlled trials: Systematic review
-
Sun X, Briel M, Busse JW, et al. Credibility of claims of subgroup effects in randomised controlled trials: Systematic review. BMJ 2012; 344: E1553.
-
(2012)
BMJ
, vol.344
, pp. e1553
-
-
Sun, X.1
Briel, M.2
Busse, J.W.3
-
15
-
-
84979197675
-
Applying results from clinical trials: Tranexamic acid in trauma patients
-
Roberts I, Prieto-Merino D. Applying results from clinical trials: Tranexamic acid in trauma patients. J Intensive Care 2014; 2: 56.
-
(2014)
J Intensive Care
, vol.2
, pp. 56
-
-
Roberts, I.1
Prieto-Merino, D.2
-
16
-
-
84883692288
-
Randomized clinical trials - Removing unnecessary obstacles
-
Reith C, Landray M, Devereaux PJ, et al. Randomized clinical trials - removing unnecessary obstacles. N Engl J Med 2013; 369: 1061-5.
-
(2013)
N Engl J Med
, vol.369
, pp. 1061-1065
-
-
Reith, C.1
Landray, M.2
Devereaux, P.J.3
-
17
-
-
77956401725
-
Equipoise lost: Ethics, costs, and the regulation of cancer clinical research
-
Stewart DJ, Whitney SN, Kurzrock R. Equipoise lost: Ethics, costs, and the regulation of cancer clinical research. J Clin Oncol 2010; 28: 2925-35.
-
(2010)
J Clin Oncol
, vol.28
, pp. 2925-2935
-
-
Stewart, D.J.1
Whitney, S.N.2
Kurzrock, R.3
-
18
-
-
84860886707
-
-
Public consultation paper. Brussels: European Commission, (Publication no. ENTR/F/2/SF D(2009) 32674)
-
Assessment of the functioning of the "Clinical Trials Directive" 2001/20/EC. Public consultation paper. Brussels: European Commission, 2009. (Publication no. ENTR/F/2/SF D(2009) 32674) (https://ec.europa.eu/health/sites/health/files/files/clinicaltrials/docs/2009_10_09_public -consultation -paper.pdf).
-
(2009)
Assessment of the Functioning of the "Clinical Trials Directive" 2001/20/EC
-
-
-
20
-
-
85019835089
-
PCSK9 inhibition to reduce cardiovascular risk: Tempering expectations
-
Waters DD, Hsue PY. PCSK9 inhibition to reduce cardiovascular risk: Tempering expectations. Circ Res 2017; 120: 1537-9.
-
(2017)
Circ Res
, vol.120
, pp. 1537-1539
-
-
Waters, D.D.1
Hsue, P.Y.2
-
21
-
-
85066483412
-
Canagliflozin and renal outcomes in type 2 diabetes and nephropathy
-
Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019; 380: 2295-306.
-
(2019)
N Engl J Med
, vol.380
, pp. 2295-2306
-
-
Perkovic, V.1
Jardine, M.J.2
Neal, B.3
-
22
-
-
0037031061
-
MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20, 536 high-risk individuals: A randomised placebo-controlled trial
-
Heart Protection Study Collaborative Group
-
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20, 536 high-risk individuals: A randomised placebo-controlled trial. Lancet 2002; 360: 7-22.
-
(2002)
Lancet
, vol.360
, pp. 7-22
-
-
-
23
-
-
85030329600
-
Effects of anacetrapib in patients with atherosclerotic vascular disease
-
The HPS3/TIMI55-REVEAL Collaborative Group
-
The HPS3/TIMI55-REVEAL Collaborative Group. Effects of anacetrapib in patients with atherosclerotic vascular disease. N Engl J Med 2017; 377: 1217-27.
-
(2017)
N Engl J Med
, vol.377
, pp. 1217-1227
-
-
-
24
-
-
84928585961
-
Registry-based randomized clinical trials - A new clinical trial paradigm
-
James S, Rao SV, Granger CB. Registry-based randomized clinical trials - a new clinical trial paradigm. Nat Rev Cardiol 2015; 12: 312-6.
-
(2015)
Nat Rev Cardiol
, vol.12
, pp. 312-316
-
-
James, S.1
Rao, S.V.2
Granger, C.B.3
-
25
-
-
85034427766
-
Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement
-
Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol 2017; 35: 3737-44.
-
(2017)
J Clin Oncol
, vol.35
, pp. 3737-3744
-
-
Kim, E.S.1
Bruinooge, S.S.2
Roberts, S.3
-
26
-
-
84978933473
-
Enhancing clinical evidence by proactively building quality into clinical trials
-
Meeker-O'Connell A, Glessner C, Behm M, et al. Enhancing clinical evidence by proactively building quality into clinical trials. Clin Trials 2016; 13: 439-44.
-
(2016)
Clin Trials
, vol.13
, pp. 439-444
-
-
Meeker-O'Connell, A.1
Glessner, C.2
Behm, M.3
-
27
-
-
40949130893
-
Ensuring trial validity by data quality assurance and diversification of monitoring methods
-
Baigent C, Harrell FE, Buyse M, Emberson JR, Altman DG. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials 2008; 5: 49-55.
-
(2008)
Clin Trials
, vol.5
, pp. 49-55
-
-
Baigent, C.1
Harrell, F.E.2
Buyse, M.3
Emberson, J.R.4
Altman, D.G.5
-
28
-
-
84861796027
-
The potential for central monitoring techniques to replace on-site monitoring: Findings from an international multi-centre clinical trial
-
Bakobaki JM, Rauchenberger M, Joffe N, McCormack S, Stenning S, Meredith S. The potential for central monitoring techniques to replace on-site monitoring: Findings from an international multi-centre clinical trial. Clin Trials 2012; 9: 257-64.
-
(2012)
Clin Trials
, vol.9
, pp. 257-264
-
-
Bakobaki, J.M.1
Rauchenberger, M.2
Joffe, N.3
McCormack, S.4
Stenning, S.5
Meredith, S.6
-
30
-
-
84898991433
-
Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection
-
Lindblad AS, Manukyan Z, Purohit-Sheth T, et al. Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection. Clin Trials 2014; 11: 205-17.
-
(2014)
Clin Trials
, vol.11
, pp. 205-217
-
-
Lindblad, A.S.1
Manukyan, Z.2
Purohit-Sheth, T.3
-
31
-
-
67649383249
-
Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs
-
Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 2009; 6: 239-51.
-
(2009)
Clin Trials
, vol.6
, pp. 239-251
-
-
Pogue, J.1
Walter, S.D.2
Yusuf, S.3
-
32
-
-
84977454439
-
Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates
-
Ndounga Diakou LA, Trinquart L, Hróbjartsson A, et al. Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates. Cochrane Database Syst Rev 2016; 3: MR000043.
-
(2016)
Cochrane Database Syst Rev
, vol.3
, pp. MR000043
-
-
Ndounga Diakou, L.A.1
Trinquart, L.2
Hróbjartsson, A.3
-
33
-
-
84898730677
-
Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative
-
Hlatky MA, Ray RM, Burwen DR, et al. Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative. Circ Cardiovasc Qual Outcomes 2014; 7: 157-62.
-
(2014)
Circ Cardiovasc Qual Outcomes
, vol.7
, pp. 157-162
-
-
Hlatky, M.A.1
Ray, R.M.2
Burwen, D.R.3
-
34
-
-
84957927612
-
Long-term safety and efficacy of lowering low-density lipoprotein cholesterol with statin therapy: 20-year follow-up of West of Scotland Coronary Prevention Study
-
Ford I, Murray H, McCowan C, Packard CJ. Long-term safety and efficacy of lowering low-density lipoprotein cholesterol with statin therapy: 20-year follow-up of West of Scotland Coronary Prevention Study. Circulation 2016; 133: 1073-80.
-
(2016)
Circulation
, vol.133
, pp. 1073-1080
-
-
Ford, I.1
Murray, H.2
McCowan, C.3
Packard, C.J.4
-
35
-
-
85041512311
-
Increasing the use of mobile technology-derived endpoints in clinical trials
-
Herrington WG, Goldsack JC, Landray MJ. Increasing the use of mobile technology-derived endpoints in clinical trials. Clin Trials 2018; 15: 313-5.
-
(2018)
Clin Trials
, vol.15
, pp. 313-315
-
-
Herrington, W.G.1
Goldsack, J.C.2
Landray, M.J.3
-
36
-
-
85020929263
-
Improving public health by improving clinical trial guidelines and their application
-
Landray MJ, Bax JJ, Alliot L, et al. Improving public health by improving clinical trial guidelines and their application. Eur Heart J 2017; 38: 1632-7.
-
(2017)
Eur Heart J
, vol.38
, pp. 1632-1637
-
-
Landray, M.J.1
Bax, J.J.2
Alliot, L.3
|