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Cost Breakdown for a Phase 1 Clinical Trial in Oncology: A CRO Quote - Sofpromed
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Cost Breakdown for a Phase 1 Clinical Trial in
Oncology: A CRO Quote
Patricio Ledesma
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Head Of Clinical Operations at Sofpromed
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Clinical Trial Costs
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Click here if you want to download a free clinical trial quotation
What is the cost of conducting a phase 1 clinical trial in oncology?
Oncology is one of the most common therapeutic areas when it comes to clinical trials.
Many biotech companies are working on drug development programs to combat cancer.
One of the most recurrent questions that oncology-focused emerging biotech companies
have is: What is the cost of running a phase 1 clinical study?
This article seeks to help biotech CEOs and operations managers —planning early phase
oncology trials— understand the cost of a phase 1 cancer trial in the United States.
The goal is to describe the cost items involved in a typical clinical research organization
(CRO) quotation. CROs are companies specialized in the management of clinical trials.
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Understanding the Main Cost Drivers in a Clinical Trial
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Biotech startups can obtain clinical trial budgets
fromforclinical
research organizations (CROs).
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CROs manage clinical trials the
from
have
clearbutton.
overall view of the
only beginning
cookies that willto
beend,
active ifso
youthey
only press
the a
ACCEPT
expenses
involved
in a clinical
study.
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Usually, CROs will provide a clinical trial quotation dividing costs in two big groups: (1) CRO
fast as checking the boxes you want.
personnel fees, and (2) pass-through costs
charged by third parties.
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The CRO personnel fees are those costs related to the CRO human resources dedicated to
managing the clinical study.
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This includes clinical research associates (CRAs), clinical project managers, clinical trial
assistants (CTAs), and pharmacovigilance specialists, among others.
On the other hand, pass-through costs have to do with any other cost charged by other
parties or vendors (e.g. travel, shipping costs, software licenses, central labs, hospital fees).
Differentiating between these two general cost types is very useful to understand a CRO
clinical trial budget.
CRO Service Fees
Going deeper into the CRO service fees, here is a summary of the main activities and tasks
involved in a phase 1 cancer trial:
Site identification and selection
Site contracting and payments
Site initiation and activation
Site management
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Onsite
monitoring
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Drug safety management
provide services for our website.
Medical monitoring
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Drug logistics
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Biological sample logistics
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Clinical supplies logistics
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Medical writing
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Project management
Documentation management
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Data management
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Statistical programming
All these services are normally provided by full-service CROs.
Some CROs provide more services than others, but most would cover the majority of the
above-mentioned tasks.
Clinical Trial Pass-Through Costs
The pass-through expenses of a clinical trial are those costs charged by other vendors
(different from the CRO).
In many cases CROs will subcontract these tasks and then invoice the clinical trial sponsor
for them.
This is convenient because in this way the sponsor does not have to deal with so many
vendors at the same time.
Here you can
see
a list
common
pass
through
involved
in a phaseINVESTIGACIÓN
1 clinical trial
in SL.
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Shipping: Physical files to sites
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Shipping: Physical contract documents to/from sites
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Shipping: Tumor samples from sites to central labs (translational)
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Shipping: Blood samples from sites to central labs (pharmacokinetics (PK) /
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translational studies)
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Shipping: Frozen blood samples to central laboratories
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Blood tubes and shipping packages
Office supplies: files, paper, and printing
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Payment per enrolled patient to clinical sites (medical procedures and tests)
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Site start-up costs
Site contract fees
Onsite selection visits (travel costs)
Onsite initiation visits (travel costs)
Onsite routine monitoring visits (travel costs)
Onsite close-out visits (travel costs)
Central pathology review (includes materials)
Central radiology review
Drug labelling, packaging, and distribution services (central depot to sites)
Electronic Data Capture (EDC) system for data collection (usage license and hosting)
Interactive Response Technology (IRT) system for drug management (usage license
and hosting)
Web platform for radiological imaging upload/download (usage license and hosting)
Electronic Trial Master File (eTMF) for document management (usage license and
hosting)
Pharmacovigilance platform for safety management (usage license and hosting)
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Pharmacokinetics (PK) central laboratory analysis
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provide services for our website.
Looking at the above list, it is very useful to note that the item “Payment per enrolled patient
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to clinical sites” can be substantial.
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ableclinics
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This
specific
refers to
topersonalize
the costs
charged
by hospitals
and
to advertising
the sponsor,
cover
thebymedical
andinexams
required
by the study
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The price of these clinical procedures and tests will depend on the number of hospital visits
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and the types of exams required (e.g. CT scans, ECGs).
For example, an oncology trial in advancedCookie
disease
with metastasis) may imply
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several visits and tests until the patient experiences tumor radiological progression.
In these cases the patient can be treated during several cycles and this will increase the
treatment cost.
On the other hand, a cancer treatment in localized disease (not metastatic yet) may only
imply a few cycles before surgery. In this case the treatment cost will be lower.
In general, clinical sites in the U.S. may charge from $25,000 up to $60,000 per patient for
medical procedures, depending on the complexity of the protocol and the number of visits.
Costs of Phase 1 Trials in the United States
Before providing more specific pricing for the services required in a cancer clinical trial, let’s
consider the average costs of phase 1 trials in the U.S.
According to Aylin Sertkaya (Key cost drivers of pharmaceutical clinical trials in the United
States) the average cost of a Phase 1 study conducted at a US site ranges from US$1.4
million (pain
and anesthesia) to US$6.6 million (immunomodulation), including estimated site
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overhead and monitoring costs of the sponsoring organization.
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Quote
Example
Phase
TrialandinareOncology
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several types:
technical cookies
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Finally, let’s see an actual quote
example
a active
phase
1 only
clinical
study
in cancer.
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The assumptions are as follows:
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Phase 1 clinical trial in oncology fast as checking the boxes you want.
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Total number of patients: 20
Total number of clinical sites: 5
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Start-up: 4 months
Recruitment period: 10 months
Treatment duration (for each patient): 6 months average
Follow-up (survival): 12 months
Study close-out activities: 3 months
Study total: 35 months
CRO service fees (summary): $1,323,000
Site identification and selection: $15,000
Site contracting and payments: $10,000
Site initiation and activation: $15,000
Site management: $250,000
Onsite monitoring: $125,000
Drug safety management: $80,000
Medical monitoring: $100,000
to the $15,000
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DrugWelcome
logistics:
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Biological
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cookies $30,000
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writing:
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$350,000
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them in our COOKIES
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Documentation
management:
$50,000
fast as checking the boxes you want.
Data management: $150,000
If you$100,000
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Statistical programming:
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PHASE 1 ONCOLOGY TRIAL GRAND TOTAL: US $2,823,000
Get a Full Quote for Your Clinical Trial
If you wish to receive a full CRO quote in PDF for your specific phase 1 clinical trial,
personalized according to your requirements, and including detailed pricing for each line
item, please make your request here:
Download a free clinical trial quotation
Sofpromed can help you manage your phase 1 oncology trial in the United States.
Don’t hesitate to contact us for any questions or comments about clinical trial
budgets and services: info@sofpromed.com
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Patricio Ledesma
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Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of
Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional
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consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical
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companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted
to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and
execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East
regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com
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Cost Breakdown for a Phase 1 Clinical Trial in Oncology: A CRO Quote - Sofpromed
Freelance CRAs for Clinical Trials in Georgia
Contract CRAs
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An Oncology CRO for Faster Clinical Trials
Oncology CRO
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Conducting Clinical Trials in France: A Comprehensive Guide
Contract Research Organization
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Oncology CRO Services: Accelerating Cancer Research for Biotech Companies
Oncology CRO
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Patricio Ledesma
Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is
the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, onestop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug
development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and
Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America,
and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com
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