The cost of clinical trials is often seen as a prohibiting factor for many companies and organizations with clinical research aspirations. A quick Google search will yield varying results based on clinical trials in the U.S., with average pharmaceutical clinical trials ranging between $3.4M to $19M. However, little to no information exists about the cost of a clinical trial for Medical Devices, Nutraceuticals, Cosmetics, or Functional Food, and even less on the cost of a clinical trial in Canada. So how should you go about pricing a clinical trial out? When it comes to clinical trial costs, there are many factors at play, such as what type of clinical trial you’re looking to conduct, the phase of the trial (i.e. Phase I, II, III, or IV), how many participants you’re going to need, etc. Ultimately, there’s no one size fits all approach to pricing a clinical trial.
This article is going to take you through the exercise of creating a basic budget for a clinical trial in Canada. Because we can’t provide you with actual costs incurred by our clients due to NDAs, we’ll be sticking to fixed costs (such as regulatory submissions to Health Canada) wherever possible, and where we can’t find fixed costs, we’ll be using hypothetical values.
Let’s pretend that you are a nutraceutical company hoping to test the efficacy of a Natural Health Product (NHP) in Canada. Your NHP is already authorized for sale in Canada. You don’t have a proposal yet, but you have a null hypothesis and a study design prepared to test the effectiveness of your NHP on lowering stress. You’ve determined that your sample size will need to be around 200 participants in order to provide you with the statistical power necessary to test your null hypothesis. You’ve chosen the Greater Toronto Area (GTA) as the metropolitan where you would like to recruit participants because:
The GTA has a large and diverse population to support your trial; and,
Because the Regulatory Authority responsible is Health Canada, which is an ICH member, a criterion that was important to your funder.
Let’s make some assumptions based on the data above about what your trial is going to need:
Phase II Clinical Trial Based on the data provided, we know that your investigational product is already approved in Canada and the regulatory authority responsible (Health Canada) will allow you to bypass early phase research (Phase I) and go directly into a Phase II clinical trial.
Regulatory Documents Needed Since you’ll be conducting your research in Canada, you’re going to need a Protocol, an Investigator’s Brochure, a Case Report Form (CRF), and an Informed Consent Form, all of which will be submitted as part of your Clinical Trial Application (CTA).
Site Requirements You’re going to need a site in Toronto that will screen and enroll participants, is easily accessible, has the ability to do physical examinations and to take and store blood serum samples and send them to a lab for testing, store and dispense the investigational product, capture data electronically for easy monitoring, has the ability to report adverse events, and perform study closeout assessments.
Target Population Males and Females of any age with high levels of stress. To measure this quantitatively you will need to administer a questionnaire to measure your participant’s stress level index, as well as have participants consent to a blood draw for an ACTH stimulation panel (to measure stress levels biologically).
Recruitment You need 200 participants, which means you need to recruit at least 240 participants in anticipation of a 20% dropout (5% screen fail, 15% early termination). In order to successfully enroll 240 participants, and pre-screening at least 4,800 participants (based on an estimated 5% enrollment rate).
Study Design Double-blind, randomized, controlled trial.
Now Let’s Make a Budget
Site Costs: $85,400.00
Presumably, you’re not going to own the site in Toronto where you’re going to be conducting your trial. That means you’re going to need to contract a site capable of performing all of the tasks described in your study design. Fees will vary based on the site, so for this exercise, we will make some cost assumptions based on industry averages.
Trial Start-up Fee: $2,000.00 Many sites charge a site start-up fee (aka site contract fee, or an administrative start-up fee) that can range from $2,000.00 to $10,000.00. Let’s assume that we find a site on the low end of this spectrum.
Dispensing Fee: $4,000.00 When dealing with an investigational product (IP), many sites charge a dispensing fee to administer a dose of the IP (or placebo). Let’s assume the dispensing fee is $10.00.
Site Visit Costs: $2,000.00 There are 4 site monitoring visits to be performed with this clinical trial. A site qualification visit (SQV), a site initiation visit (SIV), an interim monitoring visit (IMV), and a close-out visit (COV). The overall cost here is assuming each of these visits takes 5 hours (1 hour for visit, 4 for paperwork) of a Clinical Research Associate’s (CRA) time, and that CRA is billable at $100/h.
Trial Close-out Cost: $500.00 Let’s assume it takes 5 hours of a CRA’s time billed at $100/h to reconcile clinical trial data and regulatory documents for study closure.
Storage Fee: $500.00 This is the cost associated with storing and keeping documents secure for the minimum ICH-GCP 15-year retention period. Let’s assume these are kept as paper copies and secured by lock and key in a filing cabinet (or similar space).
eCRF cost: $12,000.00 This is the cost associated with Electronic Data Capture (EDC) for at least 1 month. The average cost of an EDC licence for one month is $1,000.00. Assuming the contract is for one year.
Site Monitoring Costs: $34,400.00 Site-monitoring is a daily activity, officially tasked to a “site-monitor” (usually a Clinical Research Associate), and involves ensuring the health and safety of each participant and verifying that all data collected is as accurate as possible. Let’s assume that the site monitor is paid $100/h for the duration of the trial. Based on the study design the trial duration (including recruitment) will be 60 days in total. Based on 260 working days in 2023, there are roughly 43 working days in a 60-day total. 43 working days multiplied by 8 hours = 344 hours. 344 hours multiplied by $100 = $34,400.00 Here are some examples of a site monitor’s tasks:
Checks over informed consent forms, ensuring that they are properly signed off,
Ensures that all participants are eligible for the trial by checking inclusion criteria,
Verifies all case report forms are complete
Verifies all dosage forms for all clients are complete and adhered to
Ensures that all adverse events are reviewed by the PI and that the reports are completed and filed
Records and reports any risks of protocol deviation to the PI
Lab testing: $30,000.00 ACTH stimulation panels can cost between $50.00 and $150.00 according to sources online. $50/blood draw x 3 blood draws x 200 participants = $30,000.00
Participant Costs: $359,500.00
Participant costs are the accrued cost incurred by each individual’s participation in your trial, based on the study design above. We tallied up costs based on tasks performed by site staff, as well as compensation amounts, sample shipping costs, etc. Assume the following billable rates for staff:
Tasks that the Principal Investigator must conduct are marked as PI. Let’s estimate that the PI for this hypothetical study bills at $300/h
Tasks that can be delegated by the PI to other Clinical Staff are marked as CS. Let’s estimate that the CS bills their time at $100/h
Let’s also assume that the remainder of costs after billable tasks are:
Sample shipping costs: $100/sample
Reimbursement amounts: $100/visit
Travel voucher: $50/visit
Per Participant Cost: $1,750.00 The cost per participant is a subtotal of all the tasks within the table above
Adverse Event Reviews (5): $3,000.00 Let’s assume that you have 5 adverse events occur during the conduct of the study that needs to be reviewed and followed up on by the PI at $300/h
Adverse Event Reports (5): $3,000.00 The 5 adverse events require report writing that takes a couple of hours each and must be completed by the PI at $300/h
Screen Fails (10): $3,500.00 Not every person you recruit is going to be eligible to participate, even after they are pre-screened. Let’s assume you have 10 participants who are deemed ineligible by the PI (after logging billable time):
Signing of informed consent ($150×10); and,
Inclusion/exclusion criteria ($75×10),
medical history ($100×10),
physical exam ($150×10); and
concomitant medications ($25×10).
Outsourced Costs: $167,050.00
There are 3 remaining items to consider before we finalize our budget, 1) recruitment marketing costs, 2) regulatory submission costs, and 3) analysis and clinical study report. Let’s assume you need to outsource these costs to a consultant plus the administrative cost of regulatory submissions.
Recruitment Marketing Costs: $52,800.00 You need to enroll 240 people in the trial. You expect 10 (5%) to screen fail and another 30 (15%) to early terminate. You’re estimating a conversion rate of 5% based on industry averages for online platforms (Google Ads, Facebook, Instagram, etc.). That means you’ll need to generate 4,800 leads in order to capture 240 leads. Assuming a cost of $10/lead, you’ll need a recruitment budget of at least $48,000. Let’s also assume you find an ad agency to write, design, and run your ads that charges an extremely competitive management rate of %10 of the total budget: $4,800.00.
Clinical Trial Application: $0 According to Health Canada’s website, a CTA costs $0. However, because you don’t have a protocol or other supporting documents for your CTA, you will need to pay someone to help you.
Consulting Fees: $56,250.00 Your hypothetical consultant has quoted you a billable rate of $150/h
Protocol Creation: 150 hours
Informed Consent: 50 hours
Investigators Brochure: 75 hours
Case Report Form: 50 hours
Amendments: 50 hours
Analysis & Clinical Study Report: $55,500.00
The analysis of your findings will dictate whether or not your investigational product was effective at lowering stress based on 2 quantitative measures of stress: 1) Perceived Stress Scale, administered 3 times during each in-clinic visit, and 2) Blood Serum Cortisol (ACTH stimulation panel), tested each time during each in-clinic visit. That means you have 2 independent variables (IV 1: placebo & no placebo, IV 2: 3 different times), and 2 dependent variables (physiological stress vs perceived stress levels), which requires a Multivariate Analysis of Variance (MANOVA). This will require the purchase of statistical software such as SPSS or SAS. SPSS costs about $15k USD for a term licence (~$20,500 CAD) for the professional tier, which gives you access to all the tools you’ll need in order to complete the analysis.
Let’s also consider the time needed to run the analysis. A fully trained biostatistician will take at least 100 hours to analyze the results. If you do not have a biostatistician on staff you’ll need to hire a consultant for at least $100/hour which will cost about $10,000.00.
With the analysis complete you’ll need to write the Clinical Study Report (CSR). A CSR is a comprehensive document, some totaling over 50 pages in length with additional appendices. CSRs generally include a synopsis, ethical considerations, an introduction, study objectives, an investigational plan, participant information (such as protocol deviations and early terminations), efficacy evaluation, safety evaluation, and a discussion and overall conclusion. Let’s assume your CSR totals 50 pages and each page totals roughly 500 words. That’s 25,000 words. Let’s also assume your medical writer charges $1/word. That’s a total of $25,000.00
Site Costs: $85,400.00
Per Participants Costs: $359,500.00
Outsourcing Costs: $167,050.00
This hypothetical budget made a lot of assumptions when estimating this clinical trial budget. No “one-size-fits-all” template or approach will account for every hidden cost, such as amendments, the cost of a screen failure, or 3rd party expenses, etc. When building out a clinical trial, the best approach is to find a partner who can provide you with actual costs, not assumptions, based on the individual needs of your trial.
Disclaimer: This is a hypothetical clinical trial budget and does not reflect any actual costs you would find within a Clinical Trial proposal from dicentra. For a proposal of clinical trial services from us please request a free quote.
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