Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials (P=.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.

Flacco, M. E., Manzoli, L., Boccia, S., Puggina, A., Rosso, A., Marzuillo, C., Scaioli, G., Gualano, M. R., Ricciardi, G., Villari, P., Ioannidis, J. P. A., Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey, <<MAYO CLINIC PROCEEDINGS>>, 2016; 91 (8): 1021-1034. [doi:10.1016/j.mayocp.2016.04.032] [http://hdl.handle.net/10807/93120]

Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey

Manzoli, Lamberto
Secondo
;
Boccia, Stefania;Puggina, Anna;Gualano, Maria Rosaria;Ricciardi, Gualtiero;Villari, Paolo
Penultimo
;
2016

Abstract

Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials (P=.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.
Inglese
Flacco, M. E., Manzoli, L., Boccia, S., Puggina, A., Rosso, A., Marzuillo, C., Scaioli, G., Gualano, M. R., Ricciardi, G., Villari, P., Ioannidis, J. P. A., Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey, <<MAYO CLINIC PROCEEDINGS>>, 2016; 91 (8): 1021-1034. [doi:10.1016/j.mayocp.2016.04.032] [http://hdl.handle.net/10807/93120]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/93120
Citazioni
  • ???jsp.display-item.citation.pmc??? 3
  • Scopus 11
  • ???jsp.display-item.citation.isi??? 9
social impact