Academic sponsors of clinical trials in the EU are the worst offenders when it comes to not posting completed trial results in the EudraCT database.
As of April, the database included 57,687 EU clinical trials; more than 27,000 of the trials had been completed. Of the completed trials, 18,432 should have included a summary of the results in keeping with a rule that went into effect five years ago that required the summary to be posted within a year of a trial's completion or six months following the completion of a pediatric trial.
The EMA found that results had yet to be reported for 5,855, nearly 32%, of the completed trials that should have had results posted. The reporting compliance of academic and other noncommercial sponsors was much lower than that of company sponsors.
Fewer than 24% of completed trials with academic or other noncommercial sponsors had posted results; whereas more than 77% of trials sponsored by companies had results in the database.
"Academic sponsors or smaller companies often lack awareness or incentives to post clinical results," the EMA said. To remind them of their obligations, the EMA, European Commission and the Heads of Medicines Agencies sent a letter to all trial sponsors.
"Underreporting in general and selective reporting of trials with positive outcome may lead to potentially avoidable redundancies in the conduct of clinical trials and compromise the economic and scientific efficiency of clinical research," according to the letter. "In addition, unreported clinical trials with unfavourable outcome can have negative public health implications."
The letter specifically calls on academic and other noncommercial sponsors to post their trial results to "advance clinical research especially where commercial interest is weaker."