Improving safety reporting in randomised controlled trials
isabelle pitrou, Queen Mary University
16 June 2011
I have read the editorial of Goldbeck et al. with a great interest (1). It is true that reporting is of high importance in the case of randomised controlled trials (RCTs). This has been highlighted recently with several sanitary crises, particularly when the pain medication rofecoxib (Vioxx) was taken off the market in 2004 after being linked to an increased risk of cardiovascular events among long-term users. The drug¿s safety profile had been questioned since 2000 when findings from the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial showed a 5-fold higher incidence of myocardial infarction in patients taking rofecoxib compared with those taking naproxen, an effect somewhat attributed to a cardioprotective effect of naproxen (2). Despite this report, the drug was not withdrawn till 2004. Retrospectively it appeared that reporting of the trial data was misleading, insisting on the protective effect of the comparator (naproxen) instead of insisting on the risks associated with the drug tested (rofecoxib). The CONSORT guidelines for improving the reporting of RCTs have been implemented following this polemic, with several extensions comprising non pharmacologic interventions (3-4). Despite those recommendations, reporting of RCTs remains poor even in core and highly ranked journals (5). This is often related to a poor adherence to reporting guidelines and/or the existence of conflict of interests that distort the findings. Important efforts are still needed to improve reporting of RCTs, and prevent the occurrence of other safety crises in the future.
1. Goldbeck L, Vitiello B. Reporting clinical trials of psychosocial interventions in child and adolescent psychiatry and mental health. Child Adolesc Psychiatry Ment Health. 2011; 5: 4.
2. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000; 343 :1520-8, 2 p following 1528.
3. Schulz KF, Altman DG, Moher D, for the CONSORT Group: Research Methods & Reporting CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:332.
4. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148: 295-309.
5. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009; 169: 1756-61.
Child and Adolescent Psychiatry and Mental Health
Improving safety reporting in randomised controlled trials
16 June 2011
I have read the editorial of Goldbeck et al. with a great interest (1). It is true that reporting is of high importance in the case of randomised controlled trials (RCTs). This has been highlighted recently with several sanitary crises, particularly when the pain medication rofecoxib (Vioxx) was taken off the market in 2004 after being linked to an increased risk of cardiovascular events among long-term users. The drug¿s safety profile had been questioned since 2000 when findings from the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial showed a 5-fold higher incidence of myocardial infarction in patients taking rofecoxib compared with those taking naproxen, an effect somewhat attributed to a cardioprotective effect of naproxen (2). Despite this report, the drug was not withdrawn till 2004. Retrospectively it appeared that reporting of the trial data was misleading, insisting on the protective effect of the comparator (naproxen) instead of insisting on the risks associated with the drug tested (rofecoxib). The CONSORT guidelines for improving the reporting of RCTs have been implemented following this polemic, with several extensions comprising non pharmacologic interventions (3-4). Despite those recommendations, reporting of RCTs remains poor even in core and highly ranked journals (5). This is often related to a poor adherence to reporting guidelines and/or the existence of conflict of interests that distort the findings. Important efforts are still needed to improve reporting of RCTs, and prevent the occurrence of other safety crises in the future.
1. Goldbeck L, Vitiello B. Reporting clinical trials of psychosocial interventions in child and adolescent psychiatry and mental health. Child Adolesc Psychiatry Ment Health. 2011; 5: 4.
2. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000; 343 :1520-8, 2 p following 1528.
3. Schulz KF, Altman DG, Moher D, for the CONSORT Group: Research Methods & Reporting CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:332.
4. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148: 295-309.
5. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009; 169: 1756-61.
Competing interests
None.