HPV study bias
RESEARCH: Index of the human papillomavirus vaccine industry clinical study programmes and non-industry funded studies: a necessary basis to address reporting bias in a systematic review
Authors: L. Jorgensen, P. Gotzche and T. Jefferson
HPV vaccine is no longer a new story. However, Jorgensen et al., have determined that there is bias in a systematic review of the drug and of a public index of the HPV vaccines or a public index of non-industry funded studies. They indexed clinical HPV vaccine studies to address reporting bias in a systematic review of clinical study reports. The process was not easy. Obtaining the information on the vaccine's study programme from industries was a challenge as some industries took more than three years from the initial request. Further, only one of the four manufacturers provided information for their index. Nonetheless, based on the information the research team could obtain, they found that only half of the manufacturer's randomized clinical trials and follow-ups had been completed before FDA's Drug Approval Packages were approved. More than half of all studies by industries were never published; accessing unpublished studies could prove difficult. Further, as the research team stated, "non-industry funded research are not legally required to register their studies, adhere to industry reporting guidelines or produce clinical study reports unless their results are used to support a drug's marketing authorization application". Based on the research, the team advocates the registration and publication of all studies and data in the public domain whether the studies have been funded by industries or non-industry organizations to reduce reporting bias in systematic reviews.
Link to article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774129/
- Marina Kwak
Tag: transparency watch