Financial conflict of interest: analysis of association of source of financing and results in anesthesiology trials : diploma thesis

Autor: Škugor, Tonkica
Přispěvatelé: Puljak, Livia
Jazyk: chorvatština
Rok vydání: 2017
Předmět:
Popis: Dosadašnje spoznaje: Povezanost financijskih sukoba interesa i rezultata istraživanja kliničkih pokusa iz područja anesteziologije nije dovoljno istražena. To je područje istraživanja važno jer se liječenje boli danas smatra osnovnim ljudskim pravom, a olakšavanje boli je jedan od najvažnijih ishoda za pacijenta. Cilj: Cilj ovog istraživanja bio je procijeniti objavljene rezultate o učinkovitosti i sigurnosti u randomiziranim kontroliranim pokusima (engl. randomized controlled trials, RCT) koji su objavljeni u području anesteziologije od 2014. do 2016. godine te analizirati jesu li ti rezultati češće pozitivni u pokusima koje financira industrija u usporedbi s onima koji imaju neovisno financiranje. Metode: Analizirani su RCT-ovi objavljeni od 2014. do 2016. u sedam časopisa koji pripadaju prvoj kvartili kategorije anestezioloških časopisa prema bazi Journal Citation Reports. Izdvojeni su RCT-ovi koji su analizirali lijekove i medicinske proizvode kao intervencije. Analizirani su navedeni izvori financiranja, izjave o sukobu interesa, vrste intervencija i komparatora, i zaključci autora o djelotvornosti i sigurnosti istraživanih intervencija. Rezultati: Analiziran je 401 RCT, od kojih je većina imala financiranje iz neprofitnih izvora. U malom broju RCT-ova je navedena uloga sponzora, a u 71% radova je navedeno da ne postoji sukob interesa. U 61% RCT- ova koje je financirala industrija autori su bili zaposlenici sponzora. Industrijski financirana istraživanja češće su imala povoljne ishode za svoj proizvod po pitanju učinkovitosti i sigurnosti nego intervencije iz istraživanja financiranih iz neprofitnih izvora. Zaključak: Rezultati ovog istraživanja potvrđuju da RCT-ovi s industrijskim financiranjem češće objavljuju pozitivne ishode učinkovitosti i sigurnosti svojih intervencija nego oni s drugim izvorima financiranja. Stoga je nužna oprezna interpretacija rezultata istraživanja koje financira industrija. Background: An association between financial conflict of interest and study results of clinical trials in the area of anesthesiology has been insufficiently studied. This area of study is important because nowadays pain treatment is considered to be one of the main human rights, and pain relief is one of the most important outcomes for the patient. Aim: The aim of this study was to evaluate efficacy and safety results in randomized controlled trials published in the area of anesthesiology and to analyze whether those results were more often positive in the trials funded by industry compared to those that had independent funding. Methods: RCTs published between 2014 and 2016 in seven journals which belong to the first quartile of anesthesiology journals according to Journal Citation Reports were analyzed. RCTs which analyzed drugs and medical devices as interventions were singled out. The listed funding sources, conflict of interest statements, types of intervention and comparator and the conclusions of authors regarding efficacy and safety of studied interventions were analyzed. Results: We included 401 RCTs, most of which were funded by nonprofit sources. The role of sponsor was mentioned in few RCTs, and 71% of the trials stated nonexistent conflict of interest. In 61% of RCTs funded by industry, the authors were employees of the sponsor. The industry-sponsored trials more often had favorable efficacy and safety outcomes for their product than the interventions in the trials funded by nonprofit sources. Conclusion: The results of this study confirm that the RCTs funded by industry more often publish positive efficacy and safety outcomes of their interventions than those funded by other sources. Therefore, cautious interpretation of study results funded by industry is necessary.
Databáze: OpenAIRE
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