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Pain Management 2019 & Internal Medicine 2019 International Journal of Anesthesiology & Pain Medicine
ISSN: 2471-982X Page 27
JOINT EVENT
7th Edition of International Conference on
Pain Management
8th Edition of International Conference on
Internal Medicine &
Patient Care
&
March 25-26, 2019
Rome, Italy
Strategic and operational considerations in designing and
executing multicenter pain trials
Laurent Ecochard
Novartis Pharma AG, Switzerland
Pain is a symptom related to a heterogeneous group
of disorders. Pain can be further subdivided into
whether the origin of the pain is nociceptive, neuropathic,
or mixed nociceptive/neuropathic origin. Peripheral
neuropathic pain is a pain initiated or caused by a
primary lesion or dysfunction in the nervous system.
For the indication of the treatment of neuropathic pain,
FDA recommends to conduct one in each of atleast
three separate neuropathic conditions while EMA only
recommends two separate conditions (one trial each).
In this context, several investigational drugs have failed
to show benefit in reducing the pain intensity in the past
two decades and have led the sponsors of the same
compounds to terminate their programs of development
prematurely. Several design considerations are now
widely recommended to improve assay sensitivity and
increase the chance of success of the chronic pain
therapies under investigation. Besides these study design
factors, patient, study site and outcome measurement
factors have to be carefully taken into consideration.
Once the multi-centre pain trials are actively recruiting,
the operational teams frequently deal with difficulties to
identify the right candidates for enrolment and as many
screened patients do not qualify due to uncontrolled co-
morbid conditions and/or prescribed pain medications
that are not allowed per protocol. Given the prevalence
and incidence of neuropathic pain, there is a clear need
for better treatment as the related conditions have such
a severe impact on the patient’s ability to function on a
daily basis thus affecting overall quality of life, but also
represent a substantial burden for family and caregivers.
In this regard, innovative adaptive (enriched) study
designs may have a major impact on increasing the
probability of positive study results with these potential
better treatments that are randomly compared to placebo
as randomized placebo controlled multi center pain trials
are recommended in neuropathic pain.
Biography
Laurent Ecochard has completed his PhD in Physiology by Uni-
versity of Lyon, France. He has served as a study coordinator
in oncology and hematology units of Paris Public Hospital and
has acted as a Clinical Research Associate in different thera-
peutic areas across the pharmaceutical industry in France. He
has then endorsed responsibilities as Project Manager and
ultimately as Clinical Study Leader in General Medicines at
Novartis. He has published several papers in reputed journals
and is currently working as a Clinical Development Director on
the Olodanrigan Program of Development in Peripheral Neuro-
pathic Pain at Novartis Pharma AG, Switzerland.
Laurent Ecochard, Int J Anesth Pain Med 2019, Volume 5
DOI: 10.21767/2471-982X-C1-005