Enzyme wants to help radically improve healthcare by increasing the rate of innovation in digital health. Part of our approach is to foster community and create connections amongst resources and companies seeking advice.
This is one of a series of blogs done in collaboration with our network partners. Each post will highlight a different perspective on the vast and complex world of the life sciences product development.
We will be sharing curated topics of common debate and proven patterns. This will provide a platform for the community to promote their stories and areas of expertise.
Recently we asked Kimberly Martin, President and Principal Consultant at Boulder Clinical Science how Digital Health companies can plan for Clinical Trials. Boulder Clinical Science Research specializes in clinical trial protocol design and execution of the drug/device development cycle.
1. When should startups begin thinking about trials?
Clinical trials may be the biggest barrier to market for many Drug and Pre Market Approval (PMA) medical device start-ups. Clinical trials require both experience and expertise and can be expensive and challenging.
Many start-ups fail due to lack of a good clinical development plan and/or a poorly designed clinical trial. If a startups exit strategy is acquisition, the big companies are going to want FDA clearance and/or very solid evidence that the device is safe and effective along with evidence base that supports reimbursement.
My recommendation is to begin planning for it in your first round of fundraising. It will takes longer and be more expensive than you think it will be.
Clinical evidence is also valuable for 510(k) devices in terms of supporting a value proposition for the surgeon, hospital executives, private payers, and CMS. There are methods for an efficient trial design for an affordable investment, with a great return.
2. How should startups estimate the cost of clinical trials?
Costs vary and depend on the type of clinical trial and the size. An interventional prospective randomized controlled trial at 10 centers with 10,000 patients under an Investigational Device Exemption(IDE) or an Investigational New Drug(IND) versus an observational cohort study or a retrospective review for post-market evidence will have vastly different costs and produce different levels of evidence.
In addition, the costs of trials (basic and monitoring) differ depending on the complexity, amount, and data captured. Cost also depends on if the trial is conducted pre or post-market. If the trial is being conducted for regulatory approval, you will need to pay for any clinical care that is outside what the patient would receive if they were not in the clinical trial.
For example, a trial with an imaging endpoint that will require an MRI that they wouldn’t otherwise get in standard clinical care would require the sponsor to pay for the MRI as well as all the clinical trial data collection.
A very rough estimate is 20–30k per patient for a Phase II or III IND or IDE, prospective trial, and 5–10k per patient for a post-market retrospective cohort study to collect evidence to support a value proposition.
3. What are the common pitfalls of working with traditional Clinical Research Organizations (CROs)?
Traditional CRO’s are expensive and inflexible. Large CROs have a large infrastructure and (sometimes) shareholders to support, and as such, are very expensive.
Start-ups generally want to be involved in the decision making and the details of the project. Large CROs will not work this way.
Also, small or mid-sized companies will not get the same “A” team as larger organizations, but will still pay much more than they would for a smaller CRO that runs lean with very experienced staff.
Clinical trials are complex, and it’s difficult to predict unforeseen events that will run up the bill. It’s best to negotiate a set project rate if it’s possible. The upfront quote from a traditional CRO will be far lower than the actual final cost of the trial because it fails to account for the additional monitoring and other piecemeal charges that occur as the trial moves forward.
Look for a CRO that is strategic and scientific as well as operational. Large CROs are truly plug-and-chug. For example, monitors only monitor; they don’t have the skill set to troubleshoot problems or to have clinical insight in your therapeutic area. They will not be invested in your organization. They do their best to standardize as much as they can to maximize profit when in reality every single clinical trial is unique with its own challenges.
4. What services does Boulder Clinical Services provide?
Boulder Clinical Services provides Clinical Development Plans and FDA interaction for regulatory submissions for both device and drug products.
Some of their services are:
- Protocol design and development: the most efficient protocol design for the business goal from RCTs for regulatory approval, to real-world evidence, epidemiology, and late phase safety/observational cohort studies.
- Biostatistics and power calculations
- Clinical Trial execution
- Clinical evidence strategy toward business goals including reimbursement and new codes
- Publication strategy and scientific content
- Management consulting for the development of clinical affairs departments within your organization including:
- Education and Training
- Investigator meetings and advisory boards
Their website provides a comprehensive list of their services.
If you have any questions reach out to us at firstname.lastname@example.org.