Trials, tricks and transparency: how disclosure rules affect clinical knowledge

Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined the need for more transparency in clinical trials. We provide a theoretical framework which reproduces incentives for selective reporting and yields three key implications concerning regulation. First, a compulsory clinical trial registry complemented through a voluntary clinical trial results database can implement full transparency (the existence of all trials as well as their results is known). Second, full transparency comes at a price. It has a deterrence effect on the incentives to conduct clinical trials, as it reduces the firms'gains from trials. Third, in principle, a voluntary clinical trial results database without a compulsory registry is a superior regulatory tool; but we provide some qualified support for additional compulsory registries when medical decision-makers cannot anticipate correctly the drug companies' decisions whether to conduct trials. Keywords: pharmaceutical firms, strategic information transmission, clinical trials, registries, results databases, scientific knowledge JEL classification: D72, I18, L15

Male vs Female Lupus. A comparison of ethnicity, clinical features, serology and outcome over a 30 year period

Un estudi observacional de pacients amb LES, atesos al University College de London Hospital entre 1976 i 2005, es va dur a terme per revisar les diferències entre homes i dones amb lupus pel que fa a les característiques clíniques, serologia i resultats. 439 dones i 45 homes van ser identificats. L'edat mitjana al diagnòstic va ser de 29,3 anys (12,6), sense diferències significatives entre homes i dones. El sexe femení es va associar significativament amb la presència d'úlceres orals i Ig M ACA. No hi va haver diferències significatives en la comparació de les altres variables. Durant aquest període de seguiment de trenta anys, relativament poques diferències han sorgit al comparar les freqüències de les característiques clíniques i serològiques en homes y dones amb lupus.

Suboptimal Management of Coronary Risk in Daily Clinical Practice: Results from a Mediterranean Cohort of HIV-Infected Patients With Myocardial Infarction

Background: The incidence of cardiovascular events in HIV patients has fallen. Methods: We identified 81 patients with a history of coronary events from 2 hospitals in Spain to evaluate management of CVRF before and after the event. Results: The prevalence of coronary events was 2.15%. At the time of the coronary event, CVRF were highly prevalent. Decrease in total cholesterol (P=0.025) and LDLc(P=0.004) was observed. LDLc and HDLc were determined and the percentage of patients with LDLc &100 mg/dL remained stable at the last visit. Conclusions: The prevalence of coronary disease in our cohort was low. Although CVRF were highly.

ALK rearrangement in a selected population of advanced non small cell lung cancer patients. FISH and inmunohistochemistry diagnostic methods, prevalence and clinical outcomes

Anaplastic lymphoma kinase (ALK) rearrangements represents a new driver oncogenic event in non-small cell lung cancer (NSCLC). ALK positive patients account for a 1-7% of NSCLC patients. The objective of this study is to know the prevalence and clinical characteristics of ALK positive patients in a cohort of NSCLC patients and to compare inmunohistochemistry with D5F3 monoclonal antibody with gold standard method fluorescence in situ hybridation

Clinical application of differential time to positivity of blood cultures as a diagnostic method for catheter-related bloodstream infection.

La sospita de bacterièmia relacionada a catèter (BRC) necessita la retirada d’aquest, confirmant-se a posteriori només en un 15-25%. La diferencia en el temps de positivització d´ hemocultius (DTP) ha demostrat ser un mètode fiable per el diagnòstic de BRC evitant la retirada del catèter. Amb la intenció de comprovar la utilitat clínica de la DTP, l’hem comparada amb un mètode diagnòstic estàndard. Hem inclòs 133 pacients ingressats a una unitat de cures intensives portadors de catèters venosos centrals. 56 pacients s’han aleatoritzats. No hem trobat diferències significatives en quant a morbi-mortalitat en els 2 grups havent evitat 70% de retirada innecessària de catèters en el grup de DTP.