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https://www.readbyqxmd.com/read/24231337/complying-with-the-european-clinical-trials-directive-while-surviving-the-administrative-pressure-an-alternative-approach-to-toxicity-registration-in-a-cancer-trial
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Thomas Leth Frandsen, Mats Heyman, Jonas Abrahamsson, Kim Vettenranta, Ann Åsberg, Goda Vaitkeviciene, Kaie Pruunsild, Nina Toft, Henrik Birgens, Helena Hallböök, Petter Quist-Paulsen, Laimonas Griškevičius, Louise Helt, Birgitte Vilsbøll Hansen, Kjeld Schmiegelow
The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol...
January 2014: European Journal of Cancer
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