A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

New Oncogenic Drivers in Hepatocellular Carcinoma: Role of the RNA Binding Protein Hu antigen R

156 p. : graf.

Group size and decision rules in legislative bargaining

We conduct experiments to investigate the effects of different majority requirements on bargaining outcomes in small and large groups. In particular, we use a Baron-Ferejohn protocol and investigate the effects of decision rules on delay (number of bargaining rounds needed to reach agreement) and measures of "fairness" (inclusiveness of coalitions, equality of the distribution within a coalition). We find that larger groups and unanimity rule are associated with significantly larger decision making costs in the sense that first round proposals more often fail, leading to more costly delay. The higher rate of failure under unanimity rule and in large groups is a combination of three facts: (1) in these conditions, a larger number of individuals must agree, (2) an important fraction of individuals reject offers below the equal share, and (3) proposers demand more (relative to the equal share) in large groups.

Polilaktida oinarri duten 3D zelula-euskarri (scaffold) polimeriko biodegradagarrien diseinu, fabrikazio eta propietateak

[EU]Hiru dimentsioko inprimaketa etorkizun handiko teknologia bezala azaltzen zaigu gaur egun. Esate baterako, biomedikuntza arloan aukera berritzaileak ekar ditzake, baina baita hezkuntza, heziketa eta ikerketa munduetan ere. Teknologia berri honen abantailarik nagusiena prototipatze azkarrean datza, eta honi esker, mikro- eta makro- egitura definituak dituzten objektuak diseinatu eta fabrikatu daitezke modu lehiakorrean. Lan honen helburua 3D inprimagailu baten bitartez inprimaturiko polimero biobateragarri eta biodegradagarrietan oinarrituriko ereduen garapen eta fabrikazioan datza. Hala ere, lehenik eta behin, lehengaiak bai fisikoki eta bai termikoki karakterizatu behar dira, ondoren, 3D inprimagailuaren parametroen arteko erlazioa ezarri, eta azkenik, produktu finalaren egitura propietateak eta kalitatea aztertu. Aipaturiko lana aurrera eramateko erabili den materiala polilaktida (PLA) izan da, zeinen erabilera oso zabaldua dagoen medikuntza arloan inplante (torloju, iltze, plaka eta abar) moduan eta ehun ingeniaritzaren munduan.