spacer
home > ict > winter 2021 > innovation in paediatric trials: conducting study visits at home
PUBLICATIONS
International Clinical Trials

Innovation in Paediatric Trials: Conducting Study Visits at Home


Patient participation in paediatric clinical trials involves the entire family, which presents unique challenges for both subjects and researchers. Logistical challenges on the family, such as transportation, childcare for other children, and balancing the substantial commitments of time and effort, often result in lengthy recruitment times and narrower patient populations for paediatric clinical trials. These same challenges also make evaluability, patient retention, and treatment compliance a struggle.

Fortunately, recent innovations in trial designs are addressing some of these barriers to recruitment and participation. Their new technologies and procedures help alleviate burdens for the subjects and their families without compromising the integrity of clinical trial procedures or the measurement of endpoints.

The Paediatric Patient Journey

To conceptualise the patient journey in the paediatric research space, imagine a parent of three children who agrees to have one child participate in a clinical trial. The challenges involved in simply getting to the clinic may mean excusing them from school, taking time off work, scheduling a babysitter for the other two children, or herding all three children into the car and finding ways to keep them entertained while at the clinic.

Families may also face additional challenges, such as changing or unstable housing, financial concerns, unreliable transportation, and changing phone numbers (1). These barriers and more can lead to poor treatment compliance or visit attendance during the course of the trial, or even to early withdrawal from the study

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Jamie Wardynski, MBA, is a Director of Clinical Operations atPaidion Research. Jamie has 10 years’ experience in operational delivery of clinical trials, including the recent implementation of a decentralised clinical trial in the paediatric research space.

jamie.wardynski@paidion.com


Kumar Ilangovan, MD, is a board-certified paediatrician, and clinical informatics physician serving as Medical Monitor atPaidion Research. He has worked both clinically and on multiple public and health services research studies spanning 20 years.

kumar.ilangovan@paidion.com


Jordan Godwin is a member of the American Medical Writers Association and a consultant Medical Writer at Paidion Research, where she writes and edits regulatory documents for paediatric clinical trials.

jordan.godwin@paidion.com


Betsy Reid is Co-Founder and Chief Operating Officer of Paidion Research. Betsy has 25 years’ experience in executive management of operations within academic, pharma, and CRO industries.

betsy.reid@paidion.com
Print this page
Send to a friend
Privacy statement
News and Press Releases

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Cambridge and Wetherby, UK, 29 November 2021: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase 1 clinical trial, ALS-6000-101, into clinical trial sites in the United States.
More info >>

White Papers

pAVEway™ expression system for the efficient expression of therapeutic proteins

Fujifilm Diosynth Biotechnologies

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titres and efficient scale up to GMP manufacture, whilst minimising many common issues seen in other expression systems, such as ‘leaky’ expression (expression of recombinant protein in the absence of inducer).
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement