Results 241 to 250 of about 1,105,809 (304)

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen, Débora D. Gräf, Christine E. Hallgreen   +2 more
wiley   +1 more source

Toward Better Conversations: Assessing Caregiver-Child Communication in Pediatric Oncology. [PDF]

Support Care Cancer
Skeens MA, Olsavsky A, Kochashvili M, Alshakhshir N, Basha M, Newman AR, Montgomery KE.   +6 more
europepmc   +1 more source

Overview of Regulatory Guidelines Related to Methods and Models for Small Populations

Clinical Pharmacology &Therapeutics, EarlyView.
This paper provides an overview of approaches and related guidelines from the EMA, FDA, and ICH that are relevant for obtaining clinical evidence for small populations to support regulatory decision making. The approaches are grouped into three categories: (1) maximizing the attainable sample size, (2) adapting the trial design to deal with a small ...
Laurens Sluijterman, Letao Li, Kristin E. Karlsson, Vincent Damotte, Sarah Zohar, Kit Roes, Joanna IntHout   +6 more
wiley   +1 more source

Nephrotoxicity and kidney outcomes in pediatric oncology patients. [PDF]

Nephrol Dial Transplant
Raymakers-Janssen PAMA, Leitzinger N, van den Berg G, Nijman J, Triest MI, Kilsdonk E, van Kessel IA, Hanff LM, van Grotel M, Wijnen MHWA, Wösten-van Asperen RM, Lilien MR, van den Heuvel-Eibrink MM, Fiocco M.   +13 more
europepmc   +1 more source

Codesigning Communication Interventions With Adolescents, Parents, and Clinicians in Pediatric Oncology: A Feasibility Study. [PDF]

Pediatr Blood Cancer
Christianson C, Farner H, Heidelberg RE, Brandt H, Hinds P, Mack JW, Kaye EC, RIGHTime Communication Collaborative.   +7 more
europepmc   +1 more source

Randomized clinical trials and informed consent in pediatric oncology: a Nordic comparative study of parents' experiences. [PDF]

Front Pediatr
Schröder Håkansson A, Andersson AC, Mellgren K, Mogensen N, Abrahamsson J, Stenmarker M.   +5 more
europepmc   +1 more source

Endocrine Late Effects of Targeted and Immune-Based Therapies in Pediatric Oncology. [PDF]

Cells
Ferrari V, Ranieri A, Ruggi A, Lanari M, Melchionda F, Prete A, Baronio F.   +6 more
europepmc   +1 more source

Managing Conflicting Prognostic Communication Preferences in Pediatric Oncology.

JAMA Netw Open
Christianson C, Stein E, Farner H, Mehler S, Batchelor E, Reeves C, Mack JW, Kaye EC.   +7 more
europepmc   +1 more source

When children speak, listening heals: advancing symptom screening in pediatric oncology. [PDF]

Transl Pediatr
Banks LC, Patel MI.
europepmc   +1 more source