There seem to be wide gaps in the FDA approval process as clinical trials data of 220 approved Orphan Drugs for rare diseases go missing in the US-based public registry ClinicalTrials.gov, finds a new study by three Indian researchers.
The research study was undertaken by a three-member team of Mohua Chakraborty Choudhury, Indraneel Chakraborty and Gayatri Saberwal and published in the PLOS Global Public Health journal on April 22, 2022.
The research findings assume significance as all clinical trial data including data for Orphan drug trials are supposed to be compulsorily registered with ClinicalTrials.gov.
“The team of researchers studied the FDA documents and identified 422 clinical trials linked to drug approvals, but they could not locate 220 trials data on the registry,” reported TranspariMED in a story headlined “No records found for 220 clinical trials of orphan drugs approved by the FDA”
The researchers hinted at the unethical aspect of non-reporting the clinical trials data of approved Orphan Drugs in the public domain by quoting what the International Committee of Medical Journal Editors and other organizations like HealthWatch UK had made in the past on the role of auditing.
Repercussions:
TranspariMED, which is known to work to end evidence distortion in medicine, writes on its website that “failure to register and fully report clinical trials harms patients, wastes taxpayers’ money, and slows down the development of new treatments, vaccines and cures.”
It also held in the story that insufficient and inconsistent data will “make it difficult for regulators, researchers and clinicians to determine the relevance and outcomes of clinical trials.”
Not surprisingly, the research team commented on the high level of inconsistencies in clinical trials data for Orphan Drugs: “If there are discrepancies in such a simple number [as patient enrolment], it throws into doubt the veracity of other information in the registry or submitted to the FDA.”
