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.
Understanding the Main Cost Drivers in a Clinical Trial
Biotech startups can obtain clinical trial budgets from clinical research organizations (CROs).
CROs manage clinical trials from beginning to end, so they have a clear overall view of the expenses involved in a clinical study.
Usually, CROs will provide a clinical trial quotation dividing costs in two big groups: (1) CRO personnel fees, and (2) pass-through costs charged by third parties.
The CRO personnel fees are those costs related to the CRO human resources dedicated to managing the clinical study.
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
- Onsite monitoring
- Drug safety management
- Medical monitoring
- Drug logistics
- Biological sample logistics
- Clinical supplies logistics
- Medical writing
- Site close-out
- Project management
- Documentation management
- Data management
- 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 of common pass through costs involved in a phase 1 clinical trial in oncology:
- Shipping: Physical files to sites
- Shipping: Physical contract documents to/from sites
- Shipping: Tumor samples from sites to central labs (translational)
- Shipping: Blood samples from sites to central labs (pharmacokinetics (PK) / translational studies)
- Shipping: Frozen blood samples to central laboratories
- Blood tubes and shipping packages
- Office supplies: files, paper, and printing
- Payment per enrolled patient to clinical sites (medical procedures and tests)
- 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)
- Pharmacokinetics (PK) central laboratory analysis
Looking at the above list, it is very useful to note that the item “Payment per enrolled patient to clinical sites” can be substantial.
This specific line refers to the costs charged by hospitals and clinics to the sponsor, to cover the medical procedures and exams required by the study protocol.
The price of these clinical procedures and tests will depend on the number of hospital visits and the types of exams required (e.g. CT scans, ECGs).
For example, an oncology trial in advanced disease (patients with metastasis) may imply 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 overhead and monitoring costs of the sponsoring organization.
CRO Quote Example for a Phase 1 Clinical Trial in Oncology
Finally, let’s see an actual quote example for a phase 1 clinical study in cancer.
The assumptions are as follows:
- Phase 1 clinical trial in oncology
- Total number of patients: 20
- Total number of clinical sites: 5
- Country: United States only
- 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
- Drug logistics: $15,000
- Biological sample logistics: $10,000
- Clinical supplies logistics: $8,000
- Medical writing: $30,000
- Site close-out: $15,000
- Project management: $350,000
- Documentation management: $50,000
- Data management: $150,000
- Statistical programming: $100,000
Pass-through costs (summary): $1,500,000
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:
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: firstname.lastname@example.org