Standards of quality

BioMedCom™ adheres to international standards for the conduct and reporting of healthcare research. The following publications are reflected in our standard operating procedures and templates:

  • Academy of Managed Care Pharmacy. The AMCP format for formulary submissions. Version 3.0. On Foundation for Managed Care Pharmacy website [updated 2009 Oct; cited 2012 Jun 13]. Available from: http://www.amcp.org/fmcpnet.aspx.
  • Albert T, Wager E. The COPE report 2003. How to handle authorship disputes: a guide for new researchers. On Committee on Publication Ethics (COPE) website [updated 2003; cited 2012 Jun 13]. Available from: http://publicationethics.org/resources/guidelines.
  • Baladi J-F, Canadian Coordinating Office for Health Technology Assessment. A guidance document for the costing process: version 1.0. On CADTH website [updated 1996 Aug; cited 2012 Jun 13]. Available from: http://www.cadth.ca/.
  • Berger ML, Mamdani M, Atkins D, Johnson ML. Good Research Practices for Comparative Effectiveness Research: Defining, Reporting and Interpreting Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report. Value Health. 2009;12(8):1044-52.
  • Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al.  The STARD initiative: towards complete and accurate reporting of studies of diagnostic accuracy. Clin Chem. 2003;49(1):1-6.
  • Busse R, Orvain J, Velasco M, Perleth M, Drummond M, Gurtner F, et al.  Best practice in undertaking and reporting health technology assessments. Working group 4 report. Int J Technol Assess Health Care. 2002;18(2):361-422.
  • Canadian Agency for Drugs and Technologies in Health. Common Drug Review Submission Guidelines for Manufacturers. On Canadian Agency for Drugs and Technologies in Health website [updated 2011 Nov; cited 2012 Jun 13]. Available from: http://cadth.ca/index.php/en/cdr/filing-submission.
  • Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada. On Canadian Agency for Drugs and Technologies in Health website [updated 2006 Apr; cited 2012 Jun 13]. Available from: http://www.cadth.ca.
  • Des Jarlais DC, Lyles C, Crepaz N. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361-6.
  • Drummond M, Barbieri M, Cook J, Glick HA, Lis J, Malik F, et al.  Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health. 2009;12(4):409-18.
  • Evers S, Goossens M, de Vet H, van Tulder M, Ament A. Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria. Int J Technol Assess Health Care. 2005;21(2):240-5.
  • Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, et al.  STrengthening the Reporting of OBservational studies in Epidemiology - Molecular Epidemiology (STROBE-ME): an extension of the STROBE Statement. PLoS Med 2011;8(10):e1001117
  • Garrison LP, Jr., Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007;10(5):326-35.
  • Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, et al.  Research Methods & Reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330.
  • International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. On International Committee of Medical Journal Editors website [updated 2010 Apr; cited 2012 Jun 13]. Available from: http://www.ICMJE.org.
  • ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008;17:200-8.
  • Jacobs P, Yim R. Using Canadian administrative databases to derive economic data for health technology assessments. On Canadian Agency for Drugs and Technologies in Health website [updated 2009 Mar; cited 2012 Jun 13]. Available from: http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/889.
  • Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al.  The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6(7):e1000100.
  • Marshall DA, Douglas PR, Drummond MF, Torrance GW, Macleod S, Manti O, et al.  Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada. Pharmacoeconomics. 2008;26(6):477-95.
  • Mauskopf JA, Sullivan SD, Annemans L. Principles of good practice for budget impact analysis. On ISPOR website [updated 2007; cited 2012 Jun 13]. Available from: http://www.ispor.org/workpaper/budget_impact.asp.
  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al.  CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
  • Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
  • National Institute Clinical Excellence. Guide to the Methods of Technology Appraisal. On National Institute for Clinical Excellence website [updated 2008 Jun; cited 2012 Jun 13]. Available from: http://www.nice.org.uk/page.aspx?o=114264.
  • Patented Medicine Prices Review Board. Budget Impact Analysis Guidelines: Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada. On Patented Medicine Prices Review Board website [updated 2007 May; cited 2012 Jun 13]. Available from: http://www.pmprb-cepmb.gc.ca/CMFiles/BIA-may0738LVV-5282007-5906.pdf.
  • Pharmaceutical Benefits Advisory Committee. Guidelines for the pharmaceutical industry. On preparation of submissions to the Pharmaceutical Benefits Advisory Committee. On Australian Government Department of Health and Ageing website [updated 2002 Sep; cited 2012 Jun 13]. Available from: http://www.health.gov.au/internet/main/publishing.nsf/content/health-pbs-general-pubs-guidelines-index.htm.
  • Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, et al.  Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health. 2005;8(5):521-33.
  • Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann Intern Med. 2010;152(11)
  • Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses: Panel on cost-effectiveness in health and medicine. JAMA. 1996;276(16):1339-41.
  • Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al.  Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283(15):2008-12.
  • Task Force on Principles for Economic Analysis of Health Care Technology. Economic analysis of health care technology.  A report on principles. Ann Intern Med. 1995;123(1):61-70.
  • The STROBE group. The STROBE statement: checklist of essential items for reports of observational studies. On STROBE Statement website [updated 2007 Oct 16; cited 2012 Jun 13]. Available from: http://www.strobe-statement.org, http://www.annals.org/cgi/reprint/147/8/W-163.pdf.
  • U.S.Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. On U.S.Food and Drug Administration website [updated 2009 Dec; cited 2012 Jun 13]. Available from: http://www.ispor.org/workpaper/FDAPROGuidance2009.pdf.
  • Weinstein MC, O'Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, et al.  Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices--Modeling Studies. Value Health. 2003;6(1):9-17.
  • World Association of Medical Editors. Recommendations on publication ethics policies for medical journals. On World Association of Medical Editors website [updated 2009; cited 2012 Jun 13]. Available from: http://www.wame.org/resources/ethics-resources/publication-ethics-policies-for-medical-journals/.
  • Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al.  Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.