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Skupina znanstvenika iz cijelog svijeta izrazila je zabrinutost zbog ponavljajućih obrazaca podataka u studiji o ruskom cjepivu protiv koronavirusa Sputnjik V. koja je nedavno objavljena u uglednom medicinskom časopisu Lancet.
Podsjetimo, prema toj studiji, zasnovanoj na prve dvije faze kliničkih ispitivanja na 76 ispitanika, cjepivo Sputnjik V. pokazalo se sigurno i učinkovito te su nuspojave kod nekoliko ljudi bile ograničene na blage, kratkotrajne učinke, poput glavobolje ili crvenila na mjestu ubrizgavanja.
Cjepivo, nazvano Sputnjik V., u čast prvog umjetnog satelita koji je 1957. godine u svemir lansirao Sovjetski Savez, prvo je odobreno cjepivo protiv koronavirusa.
Kako navodi časopis Nature, 38 istraživača obratilo se putem otvorenog pisma autorima ruske studije te upozoravaju da se neki podaci u studiji dupliciraju te da nisu detaljno raščlanjeni.
"Iako je istraživanje opisano u ovoj studiji potencijalno značajno, način predstavljanja podataka izaziva neke zabrinutosti zbog kojih je potreban pristup izvornim podacima kako bi se to u potpunosti istražilo", navodi se u otvorenom pismu.
Traže pojašnjenja
Ono je objavljeno na blogu molekularnog biologa Enrica Buccija, koji je na čelu male talijanske tvrtke Resis posvećene komercijalizaciji alata i usluga za poboljšanje integriteta istraživanja podataka u znanstvenom publiciranju.
- Mi ne navodimo da je došlo do kršenja znanstvene procedure već tražimo pojašnjenja - kaže Bucci.
- Osnovni podaci studije trebali bi biti dostupni. Imamo puno upitnih podataka u smislu njihove prezentacije. Možda su podaci dobri, no ne možemo prosuditi – rekao je jedan američki epidemiolog Michael Favorov i jedan od potpisnika otvorenog pisma.
Istaknuo je da se odluka časopisa Lancet o objavljivanju studije bez temeljnih podataka čini neobičnom.
Naime, kada su istom časopisu objavljene kliničke studije o cjepivu protiv koronavirusa, koje su razvili Sveučilište Oxford i farmaceutska tvrtka AstraZeneca, popraćene su velikom količinom dopunskih podataka koje su drugi istraživači mogli detaljno proučiti.
U članku u Natureu navodi se da je časopis Lancet odbio komentirati svoju politiku pružanja podataka u prilog kliničkim ispitivanjima koje objavljuje. No, ugledni medicinski časopis objavio je izjavu u kojoj kaže da je "pozvao autore ruske studije cjepiva da odgovore na pitanja postavljena u otvorenom pismu Enrica Buccija” te da će i dalje pomno pratiti situaciju.
Bez odgovora
Glavni autor ruske studije, dr. Denis Logunov iz Nacionalnog istraživačkog centra za epidemiologiju i mikrobiologiju Gamaleja u Moskvi, odbio je odgovoriti na upite iz Naturea te je u izjavi za jedan ruski medij naglasio da nema namjeru odgovoriti na otvoreno pismo.
Porekao je da je bilo pogrešaka u publikaciji te dodao da je u kontaktu s Lancetom i da je "spreman razjasniti sva pitanja".
Podsjetimo, ruski predsjednik Vladimir Putin je 11. kolovoza objavio da je cjepivo Sputnjik V. odobreno kao sigurno za uporabu, iako još nije niti počela treća faza kliničkih ispitivanja što je izazvalo brojne kritike na stručnjaka na Zapadu, ali i predstavnika Svjetske zdravstvene organizacije (WHO).
Treća faza klinička ispitivanja cjepiva Sputnjik V. počela je 26. kolovoza, a u nju bi trebalo biti uključeno 40.000 ispitanika. Rezultati će biti objavljeni krajem studenog.
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Skupina znanstvenika iz cijelog svijeta izrazila je zabrinutost zbog ponavljajućih obrazaca podataka u studiji o ruskom cjepivu protiv koronavirusa Sputnjik V. koja je nedavno objavljena u uglednom medicinskom časopisu Lancet.
Podsjetimo, prema toj studiji, zasnovanoj na prve dvije faze kliničkih ispitivanja na 76 ispitanika, cjepivo Sputnjik V. pokazalo se sigurno i učinkovito te su nuspojave kod nekoliko ljudi bile ograničene na blage, kratkotrajne učinke, poput glavobolje ili crvenila na mjestu ubrizgavanja.
Cjepivo, nazvano Sputnjik V., u čast prvog umjetnog satelita koji je 1957. godine u svemir lansirao Sovjetski Savez, prvo je odobreno cjepivo protiv koronavirusa.
Kako navodi časopis Nature, 38 istraživača obratilo se putem otvorenog pisma autorima ruske studije te upozoravaju da se neki podaci u studiji dupliciraju te da nisu detaljno raščlanjeni.
"Iako je istraživanje opisano u ovoj studiji potencijalno značajno, način predstavljanja podataka izaziva neke zabrinutosti zbog kojih je potreban pristup izvornim podacima kako bi se to u potpunosti istražilo", navodi se u otvorenom pismu.
Traže pojašnjenja
Ono je objavljeno na blogu molekularnog biologa Enrica Buccija, koji je na čelu male talijanske tvrtke Resis posvećene komercijalizaciji alata i usluga za poboljšanje integriteta istraživanja podataka u znanstvenom publiciranju.
- Mi ne navodimo da je došlo do kršenja znanstvene procedure već tražimo pojašnjenja - kaže Bucci.
- Osnovni podaci studije trebali bi biti dostupni. Imamo puno upitnih podataka u smislu njihove prezentacije. Možda su podaci dobri, no ne možemo prosuditi – rekao je jedan američki epidemiolog Michael Favorov i jedan od potpisnika otvorenog pisma.
Istaknuo je da se odluka časopisa Lancet o objavljivanju studije bez temeljnih podataka čini neobičnom.
Naime, kada su istom časopisu objavljene kliničke studije o cjepivu protiv koronavirusa, koje su razvili Sveučilište Oxford i farmaceutska tvrtka AstraZeneca, popraćene su velikom količinom dopunskih podataka koje su drugi istraživači mogli detaljno proučiti.
U članku u Natureu navodi se da je časopis Lancet odbio komentirati svoju politiku pružanja podataka u prilog kliničkim ispitivanjima koje objavljuje. No, ugledni medicinski časopis objavio je izjavu u kojoj kaže da je "pozvao autore ruske studije cjepiva da odgovore na pitanja postavljena u otvorenom pismu Enrica Buccija” te da će i dalje pomno pratiti situaciju.
Bez odgovora
Glavni autor ruske studije, dr. Denis Logunov iz Nacionalnog istraživačkog centra za epidemiologiju i mikrobiologiju Gamaleja u Moskvi, odbio je odgovoriti na upite iz Naturea te je u izjavi za jedan ruski medij naglasio da nema namjeru odgovoriti na otvoreno pismo.
Porekao je da je bilo pogrešaka u publikaciji te dodao da je u kontaktu s Lancetom i da je "spreman razjasniti sva pitanja".
Podsjetimo, ruski predsjednik Vladimir Putin je 11. kolovoza objavio da je cjepivo Sputnjik V. odobreno kao sigurno za uporabu, iako još nije niti počela treća faza kliničkih ispitivanja što je izazvalo brojne kritike na stručnjaka na Zapadu, ali i predstavnika Svjetske zdravstvene organizacije (WHO).
Treća faza klinička ispitivanja cjepiva Sputnjik V. počela je 26. kolovoza, a u nju bi trebalo biti uključeno 40.000 ispitanika. Rezultati će biti objavljeni krajem studenog.
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16. svibanj 2024 00:59
