Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children

Many medicines are used “off-label” in children outside the terms of the license. Feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children. To optimize pediatric trial development by promoting innovative trial design, c4c set up a European multidisciplinary advice service, including the voice of young patients and families, tailored to industry and academia. A network of experts was established to provide multidisciplinary advice to trial sponsors. Experts were selected to join clinical and innovative methodology expert groups. A patient and public involvement (PPI) database, to include the expert opinion of patients and parents/carers was formed. A stepwise process was developed: (1) sponsors contact c4c, (2) scoping interview takes place, (3) ad hoc advice group formed, (5) advice meeting held, and (6) advice report provided. Feedback on the process was collected. Twenty-four clinical and innovative methodology expert groups (>400 experts) and a PPI database of 135 registrants were established. As of September 30, 2022, 36 advice requests were received, with 25 requests completed. Clinical and methodology experts and PPI representatives participated in several advice requests. Sponsors appreciated the advice quality and the multidisciplinary experts from different countries, including experts not known before. Experts and PPI participants were generally satisfied with the process. The c4c project has shown successful proof of concept for a service that presents a new framework to plan innovative and feasible pediatric trials

Boron activation and diffusion in silicon and strained silicon-on-insulator by rapid thermal and flash lamp annealings

We present experimental results on the activation and diffusion behaviors of boron in silicon-on-insulator and strained silicon-on-insulator using standard rapid thermal processing treatments as well as flash lamp annealing. After boron implantation at different doses and at a low energy of 1 keV, samples were annealed to activate the dopants, and secondary ion mass spectrometry and Hall measurements were carried out to determine boron diffusion and the amount of activated dopants, respectively. In contrast to rapid thermal annealing, flash lamp annealing enables the activation without significant diffusion of dopants. In addition, we investigated the effect of coating the samples with antireflection layers to increase the absorbed energy during flash annealing. As a result, the activation was increased significantly to values comparable with the activation obtained with standard annealing. Furthermore, the relation between the observed boron diffusion and activation as a function of the implantation and annealing parameters is discussed in terms of the kinetics of the defects involved in these processes. (C) 2008 American Institute Of Physics