Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration.

Introduction: The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization.

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population-specific factors (e.

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review.

Translational paediatric drug development includes the exchange between basic, clinical and population-based research to improve the health of children. This includes the assessment of treatment related risks and their management. The objectives of this scoping review were to search and summarise the literature for practical guidance on how to establish a paediatric safety specification and its integration into a paediatric protocol.

Informed consent for neonatal trials: practical points to consider and a check list.

Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child's condition, the benefit-risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both.

Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review.

Background: Clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for mother and child. The safety of maternal treatments is a key issue for healthcare professionals and parents.

Objective: To analyse offspring data reported in clinical trials in pregnant women with diabetes, HIV infection or hypertension (three of the most common diseases in women of childbearing potential) and either treated prior to pregnancy for these chronic diseases or diagnosed and treated during pregnancy.

Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.

Aims: The pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear to be inconsistent with the emerging scientific evidence. Limited information is available on the safety profile of these agents in neonates.

Capacities and Competences for Drug Evaluation in European Neonatal Intensive Care Units: A Survey and Key Issues for Improvement.

Background:  Multicenter neonatal clinical trials aim to provide evidence-based drug evaluation, but recruiting neonates requires collaboration, standard procedures, and trained neonatologists.

Methods:  A questionnaire based on a previous Delphi study was sent to European neonatal intensive care units (NICUs) to collect their research experience and identify areas for improvement.

Results: Of 247 NICUs,79 (32%) responded: 69 were level III units and 10 were level II units.

Adverse Events under Tacrolimus and Cyclosporine in the First 3 Years Post-Renal Transplantation in Children.

Background: Progress in immunosuppression has reduced acute rejection, graft loss and mortality after renal transplantation. Adverse drug reactions are well described in adults but few data are available in children. Our objectives were to analyse the adverse events reported in the first 3 years post-transplantation in children receiving tacrolimus or cyclosporine-based immunosuppression and compare them with the information of the Summary of Product Characteristics.

[Transrectal prostatosonography. Follow-up in prostate cancer therapy].

Thirty-five cases of prostate carcinoma were followed after orchiectomy and during drug therapy using both ultrasound and digital palpation to measure the prostate. Following orchiectomy and drug therapy the prostate shrunk an average of one third within six months independent of the grading and staging of the carcinoma. The biggest shrinkage was observed in the first two months after therapy.

[Sonography of the efferent urinary tract. Suprapubic and intravesical methods].

The ability of sonographic methods to demonstrate the urinary passages and their abnormalities were studied systematically. The ureters can only be demonstrated if they are dilated. Sonography of the bladder can be used as a screening method for tumours, diverticula and stones.

[Transrectal prostate sonography in early cancer recognition].

Within a mass screening program 1016 patients were investigated by transrectal ultrasound. There is generally good correlation of palpation and ultrasound diagnostic. However, prostate carcinoma was less frequently suspected by ultrasound, 2 prostate carcinomas and 1 bladder carcinoma were detected, one prostate carcinoma was missed.

[The image of prostatic adenoma and cancer in transrectal sonography].

The transrectal ultrasonography of the prostate is introduced. The sonographic appearance of the adenoma and carcinoma in 357 histologically proven cases is evaluated. Shape, symmetry and definition of the capsule are more reliable differential criteria than the internal echogenicity.

[Transrectal prostatic sonography (TPS)].

A new imaging method of the prostate is described. After the introduction of a sonographic transducer into the rectum, the prostate, the urinary bladder and the seminal vesicles are scanned. Typical transverse sonograms of benign hypertrophy, abscess, calculous disease and carcinomas are presented.