A systematic review aimed to assess whether drug regulatory agencies based their decisions on applications for extended-release methylphenidate for adult ADHD on select samples of trials. The study involved a case series of publicly available regulatory documents, matching an index of extended-release methylphenidate trials for adult ADHD with trials appearing in regulatory documents of extended-release methylphenidate applications.
Key Findings:
- 18 trials were indexed and matched with 13 drug applications (11 approved, 2 rejected) published by 7 agencies.
- Trials were missing in 7 (54%) of 13 applications, with a median of 4 trials missing (range 1-6).
- The median proportion of missing trial participants was 45% (range 23% - 72%).
Conclusion:
The study concluded that in this sample of extended-release methylphenidate drug applications for adult ADHD, 7 of 13 regulatory decisions were missing entire trials according to public documents. This is despite regulatory requirements that seem to stipulate that all available trials should be included in drug applications.
Keywords: Drug authorisations, Drug regulatory agencies, Clinical trials, Psychiatry, ADHD, Methylphenidate.
