Regulatory Forum Opinion Piece*: The Value of Publishing Negative Scientific Study Data.
Historically it has been easier to publish positive scientific results than negative data not supporting the research hypothesis. This appears to be increasing, with fewer negative studies appearing in the literature across many disciplines. Failure to recognize the value of negative results has important implications for the toxicology community. Implications include perpetuating scientific fields based upon selective or occasionally erroneous, positive results. One example is decreased vaccination rates and increased measles infections that can lead to childhood mortality following one erroneous positive study linking vaccination to adverse effects despite multiple negative studies. Publication of negative data that challenges existing paradigms enhances progress by stopping further investment in scientifically barren topics, decreases the use of animals, and focuses research in more fruitful areas. The National Toxicology Program (NTP) publishes both positive and negative rodent data. Retrospective analysis of the NTP database has provided insights on the carcinogenic process and in the gradual acceptance of using fewer animals in safety studies. This article proposes that careful publication of both positive and negative data can enhance product safety assessment, add robustness to safety determinations in the regulatory decision-making process, and should be actively encouraged by those determining journal editorial policy.
Covance Laboratories, Inc., Chantilly, Virginia, USA gary.boorman@Covance.com.
Gary A
GA
Boorman
ToxPath Sciences Ltd, Congelton, Cheshire, UK.
John R
JR
Foster
Covance Laboratories, Shanghai, China.
Victoria A
VA
Laast
U.S. Office of Facilities and Administrative Services/Center for Food Safety and Applied Nutrition/Food and Drug Administration, College Park, Maryland, USA.
Sabine
S
Francke
D000818:Animals; D015982:Bias; D035081:Editorial Policies; D006801:Humans; D011642:Publications; D012106:Research
bias; negative data; positive-outcome bias; publishing; regulatory science; research evaluation