Real-world studies no substitute for RCTs in establishing efficacy

The Lancet

Volumn 393, Issue 10168, 2019, Pages 210-211

  Gerstein, Hertzel C ^a   McMurray, John ^b   Holman, Rury R ^c  

^a HAMILTON HEALTH SCIENCES   (Canada)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DIPEPTIDYL PEPTIDASE IV INHIBITOR; INSULIN;

CAUSALITY; DIABETES MELLITUS; DIABETIC KETOACIDOSIS; DISEASE REGISTRY; DISEASE SEVERITY; DRUG EFFECT; DRUG EXPOSURE; ELECTRONIC HEALTH RECORD; EVIDENCE BASED PRACTICE; FOLLOW UP; GENERAL PRACTITIONER; HEALTH CARE ACCESS; HEALTH CARE COST; HEALTH INSURANCE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MORTALITY RATE; MORTALITY RISK; NOTE; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; THERAPY EFFECT; TREATMENT OUTCOME; DRUG APPROVAL; ECONOMICS; METHODOLOGY; OBSERVATIONAL STUDY; PROCEDURES; STANDARDS;

DRUG APPROVAL; HUMANS; OBSERVATIONAL STUDIES AS TOPIC; PRAGMATIC CLINICAL TRIALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 85060011561     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(18)32840-X     Document Type: Note

References (11)

1. National Academies of Sciences Engineering, and Medicine. Real-world evidence generation and evaluation of therapeutics: proceedings of a workshop. 2017, The National Academies Press, Washington, DC.
2. Franklin, JM, Schneeweiss, S, When and how can real world data analyses substitute for randomized controlled trials?. Clin Pharmacol Ther 102 (2017), 924–933.
3. Cavender, MA, Norhammar, A, Birkeland, KI, et al. SGLT-2 Inhibitors and cardiovascular risk: an analysis of CVD-REAL. J Am Coll Cardiol 71 (2018), 2497–2506.
4. Shaywitz, D, Will real world performance replace RCTs as healthcare's most important standard?. Forbes, May 11, 2018 https://www.forbes.com/sites/davidshaywitz/2018/05/11/will-real-world-performance-replace-rcts-as-healthcares-mostimportant-standard/#46a696ee3557. (Accessed 25 October 2018)
5. Gill, J, Prasad, V, Improving observational studies in the era of big data. Lancet 392 (2018), 716–717.
6. Rush, CJ, Campbell, RT, Jhund, PS, Petrie, MC, McMurray, JJV, Association is not causation: treatment effects cannot be estimated from observational data in heart failure. Eur Heart J 39 (2018), 3417–3438.
7. Nystrom, T, Bodegard, J, Nathanson, D, Thuresson, M, Norhammar, A, Eriksson, JW, Second line initiation of insulin compared with DPP-4 inhibitors after metformin monotherapy is associated with increased risk of all-cause mortality, cardiovascular events, and severe hypoglycemia. Diabetes Res Clin Pract 123 (2017), 199–208.
8. VanderWeele, TJ, Ding, P, Sensitivity analysis in observational research: introducing the E-value. Ann Intern Med 167 (2017), 268–274.
9. Gerstein, HC, Bosch, J, Dagenais, GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 367 (2012), 319–328.
10. Cefalu, WT, Kaul, S, Gerstein, HC, et al. Cardiovascular outcomes trials in type 2 diabetes: where do we go from here? Reflections from a Diabetes Care Editors' Expert Forum. Diabetes Care 41 (2018), 14–31.
11. Bowman, L, Mafham, M, Stevens, W, et al. ASCEND: A Study of Cardiovascular Events iN Diabetes: characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes. Am Heart J 198 (2018), 135–144.