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ICH E11
Clinical Investigation of Medicinal Products in the Pediatric Population
| Question | Answer |
|---|---|
| E11R1 was adopted bt the ICH Assembly under ____ on _________. | step 4; 18 Aug 2017 |
| It is the goal of this guidance to encourage and facilitate _____ pediatric medicinal product development internationally. | timely |
| The pediatric development program should not _______ of adult studies and availability of a medicinal product for adults. | delay completion |
| It should be noted that the most relevant safety data for pediatric studies ordinarily come from _________ exposure. | adult human |
| There is a need for pediatric formulations that permit accurate dosing and enhance patient compliance such as _______ | flavours, colours, liquids, suspensions, chewable tablets, etc. |
| Since development of pediatric formulations can be difficult and time consuming, it is important to consider the development of these formulations __________. | early in product development |
| For products exclusively used in pediatric populations, the entire development program will be conducted in the pediatric population except for initial _________ data (usually obtained from adults). | safety and tolerability |
| The presence of a ____________ for which the product represents a potentially important advance in therapy suggests the need for relatively urgent and early initiation of pediatric studies. | serious or life-threatening disease |
| A pharmacokinetic/pharmacodynamic approach combined with safety and other relevant studies could avoid the need for ______. | clinical efficacy studies |
| When _______ are being sought for the medicinal product in pediatric patients, or when the __________ of therapy are likely to be different in adults and pediatric patients, clinical efficacy studies in the pediatric population would be needed. | novel indications; |
| Pharmacokinetic studies generally should be performed to support _______ and determine pharmacokinetic parameters in different age groups to support _________. | formulation development; dosing recommendations |
| Measurement of ________ such as pain requires different assessment instruments for patients of different ages. | subjective symptoms |
| Normally the pediatric database is limited at the time of approval. Therefore, ________ is particularly important. | postmarketing surveillance |
| Any classification of the pediatric population into age categories is to some extent ________. | arbitrary |
| What are the possible/example age categorizations given in E11? (5) | (1) Preterm newborns, (2) term newborns (0-27 days), (3) infants and toddlers (28 days to 23 months), (4) children (2-11 years), (5) adolescents (12-16/18 years dependent on region) |
| Study design issues to be considered with neonates include: (4 things) | (1) weight and age, (2) small blood volumes, (3) small numbers of patients at a given centre, (4) difficulties assessing outcomes |
| By 1 to 2 years of age, _____ of many drugs on a mg/kg basis may exceed adult values. | clearance |
| Factors useful in measuring the effects of a medicinal product on children include skeletal growth, weight gain, _________. | school attendance, and school performance |
| In some cases, it may be appropriate to specifically assess the effect of puberty on a medicinal product by studying ________ pediatric patients. | pre- and postpubertal |
| As a rule, a pediatric subject is legally unable to provide informed consent. Where appropriate, participants should assent to enroll in a study. Age of assent is to be determined by _______. | the REB or to be consistent with local legal requirements |
| Participants of appropriate intellectual maturity should personally sign and date either a separately designed, _______. | written assent form or the written informed consent |
| Emancipated or mature minors (defined by local laws) may be capable of ________. | giving autonomous consent |
| Mechanisms should be in place to ensure that a study can be rapidly terminated should __________ be noted. | an unexpected hazard |
| A fundamental principle in pediatric drug development requires that children should not be enrolled in a clinical study unless necessary to achieve __________. | an important pediatric public health need |
| When obtaining child assent, relevant elements of informed consent should be provided that are ______. | appropriate to the child’s capability to understand |
| It may be necessary to reassess the assent of a child in recognition of their _________ and competency. | advancing age, evolving maturity |
| During clinical studies there is a requirement for obtaining adequate informed consent for continued participation from pediatric participants once a child reaches _______. | the age of legal consent |
| ______ regulations related to confidentiality and privacy of pediatric participants must be followed. | Local |
| The _______ of clinical research in pediatric drug development includes the registration of clinical trials on publicly accessible and recognized databases, and the public availability of clinical trial results. | transparency |
| A _______, not common regional requirements, is at the cornerstone of efficient pediatric drug development and timely delivery of safe and effective medicines for children. | common scientific approach |
| The neonatal period for term and post-term newborn infants is defined as the day of birth plus 27 days. The neonatal period for preterm newborn infants is defined as _________. | the day of birth through the expected date of delivery plus 27 days |
| In some cases, there are difficulties with generating data across a pediatric population due to a variety of ethical considerations and ________. | feasibility issues |
| Waiting to begin planning until adult development has concluded can ________ to generate meaningful data for pediatric drug development. | limit the opportunity |
| An approach to providing evidence in support a drug/treatment in a pediatric population when it can be assumed that the course of the disease and expected response to a drug would be sufficiently similar in the pediatric and reference population. | Pediatric extrapolation |
| When a drug is studied in a pediatric population, one should consider all factors which may result in different drug responses, such as______ factors that could impact on the extrapolation of data from one population to the other. | intrinsic (e.g., developmental) and extrinsic (e.g., geographic) |
| ____ can help quantify available information and assist in defining the design of pediatric clinical studies and/or the dosing strategy. | Modelling and Simulation |
| Well conducted M&S can inform on the pharmacokinetics, pharmacodynamics, ______ and safety of a drug. | efficacy |
| Three key practical factors to consider in pediatric clinical trials are ____________. | (1) feasibility, (2) outcome assessments, and (3) long-term clinical aspects, including safety |
| Pediatric drug development faces unique feasibility issues, including __________. (3 things) | (1) small number of eligible children for clinical research, (2) limited pediatric specific resources at research centers, and(3) the scarcity of dedicated pediatric trial networks |
| Strategies that foster _________ can facilitate participation, recruitment, and acceptability of a clinical study. | input from children, their caregivers, and the advocacy communities |
| A range of quantitative approaches to characterize the interactions between a drug and an organ system which could predict quantitative outcomes of the drug and/or system’s behavior in future experiments. | Modelling and simulation |
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