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| home > ict > winter 2021 > innovation in paediatric trials: conducting study visits at home |
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 PUBLICATIONS |
International Clinical Trials
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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
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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
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News and Press Releases |
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Novo Nordisk to Acquire Emisphere Technologies for $1.35 Billion
ROSELAND, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (“Emisphere” or the “Company”) today announced that it has entered into a definitive agreement with Novo Nordisk A/S (“Novo Nordisk”), whereby Novo Nordisk will acquire Emisphere, on a cash-free, debt-free basis, for $1.35 billion in cash. The consideration to be paid per share will depend on the amount of cash and debt at closing, but the Company currently estimates it to be approximately $7.82 per share based on approximately 170.9 million fully diluted shares outstanding. This price represents a premium of approximately 17% over the volume-weighted average Emisphere share price for the five trading days ending on November 5, 2020.
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Industry Events |
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DIA Europe 2021
15-19 March 2021, VIRTUAL CONFERENCE
DIA Europe is the must-attend event for all life science professionals
working in drug development, from discovery to marketed use. It
encourages open collaboration by bringing together representatives from
the entire spectrum of the life science landscape and facilitating
crucial discussions across several topic tracks: Clinical Development,
Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy,
and many more.
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