For en tid tilbake kommenterte vi her det begredelige i at knapt tyve prosent av kliniske kreftstudier blir publisert. Den gang fantes bare det viktigste, nemlig studiet tilgjengelig. Nå er også lederartikkelen i The Oncologist tilgjengelig. Den er passende sjokkert, men med et bredere og mer informert perspektiv på årsaker: While there are inherent methodologic […]

For en tid tilbake kommenterte vi her det begredelige i at knapt tyve prosent av kliniske kreftstudier blir publisert.
Den gang fantes bare det viktigste, nemlig studiet tilgjengelig. Nå er også lederartikkelen i The Oncologist tilgjengelig.

Den er passende sjokkert, men med et bredere og mer informert perspektiv på årsaker:

While there are inherent methodologic limitations to the analysis undertaken by Ramsey and Scoggins, the possibility that fewer than one in five cancer clinical trials find their way to the peer-reviewed literature is thought-provoking and disturbing. Obviously a variety of reasons may underlie the failure to publish: flawed trial design, a failure to reach endpoints because of any number of problems (including inadequate accrual), negative results, and simple neglect on the part of the trial sponsor and the principal investigator. These problems, individually or in combination, may contribute to the failure to submit a manuscript for publication. […]
Dilts and Sandler have studied accrual patterns in four NCI-designated Comprehensive Cancer Centers and have made some remarkable conclusions [4]. Nearly 60% of trials opened for 5 years had fewer than five patients enrolled at each site, and, for >20% of studies, not a single subject had been accrued. Looking at the bigger picture, of all NCI phase I, II, and III trials opened and closed between 2000 and 2007, only 50%-60% achieved minimal stated accrual goals. So, while perhaps only one in five cancer clinical trials is ever published, of those unpublished, a significant percentage probably died for lack of accrual. Which potential statistic is the sadder, the low publication rate or the low accrual rate? In truth, they both are, as neither should be true.

Det er en del sørgelige tilstander, og tidsskriftet spør seg hva man kan gjøre for å rette opp problemene.
Selv om de modererer inntrykket av at hovedproblemet er publikasjonsbias fra dem som etterhvert er blitt hovedsponsorer for kliniske studier, nemlig industrien, skyves ikke dette under teppet. Ovennevnte leder tar det for seg, og det gjør også denne kommentatoren:

The apparent lack of access to the final efficacy and toxicity data for cancer clinical trials from all sponsors, but especially for industry-sponsored studies, poses multiple scientific and ethical questions. In the period 1959-1987, when the Division of Cancer Treatment at the NCI was the predominant sponsor of clinical new drug trials worldwide, the NCI supported peer-reviewed publications (Cancer Chemotherapy Reports and its successor, Cancer Treatment Reports) that were specifically devoted to the dissemination of cancer clinical trials results, both positive and negative, that frequently reported the outcomes of studies NCI was, itself, sponsoring. With the remarkable growth of cancer drug development activities outside the NCI, and in particular with the growth of studies of targeted cancer therapeutic agents developed by both large pharmaceutical firms and the biotechnology industry, and concomitant with the demise of the NCI’s own clinical trial publications, access to peer-reviewed, «negative» clinical trial results has contracted dramatically.

Her presenteres også hvilke grep som er på gang (fra NCI) for å bøte på problemene og hva de kan gjøre. Jeg liker tross alt tidsskriftets forslag til eget løsningsbidrag – basert på redaktørens skjønn om årsaker: «there is a need for a new venue for publishing all well-executed trials that fail to meet positive endpoints: «negative» in a sense, but valuable nonetheless.»
Jepp.
Så sant snakket og reglene om «a commitment to placing negative clinical trials in the public domain» er ment alvorlig, og skal tas alvorlig, så må det nok en vilje til å sørge for at det finnes noe sted å publisere sånt, selv for små og ikke imponerende studier. Spørsmålet er hvem som kommer til å finansiere, lese og behandle disse bidragene.