First in Human Clinical Study
Assumptions
· Technical Leadership is very gifted in engineering development and is able to create a technology solution that has the potential to transform patient care.
· Successful application of the technology will disrupt patient care models; Patients may be hard to find, not routinely seen by 1 obvious health practitioner; Innovation may require that disparate practitioners work together as not done previously, diagnostic or other equipment may be utilized in new ways (particularly CT, MRI, and Ultrasound imaging) to identify patients or to prepare them for treatment. Peri-procedural care protocols may need to be altered or new protocols written to fully exploit or measure the benefits of the new therapy.
· There are many types of patients who could benefit from the technology; Each sub-category of patient may need to be handled differently in the clinical evaluation. Alternative treatments may not have well-documented outcomes making it difficult to demonstrate medical benefit.
· Clinician thought models direct patients to other treatments or make it difficult to understand how your therapy should be deployed; thought models may need to be transformed in order to find and evaluate patients, prepare them for treatment and provide appropriate post-procedural care.
Questions
Do you understand today’s system well?
Do you have a vision for tomorrow’s system – the system you intend to create in which your innovation is well integrated and becomes the preferred treatment?
Have you identified the key decision-makers that will be affected by this change? What are their interests? Who will be eager for your innovation, who will resist it and why? How will you help those stakeholders see that change benefits them? If it does not benefit them, how will you compel change regardless?
Have you determined how your first clinical Use can inform you about future challenges of the enterprise - the FIH can be a test launch wherein you learn about the availability of patients, the opening of new indications, the way in which patient pathways are altered by your therapy and how to exploit this to your advantage.
Voyageur Offerings
· Conduct a Therapy Development Assessment for your innovation. This includes …
o Defining the ideal patients
o Establish plans to find those patients
o Preparing the patients for successful treatment (includes patient work-up and procedure planning, if important)
o Design treatment procedure with full consideration for HC Infrastructure - this is not simply writing an IFU; if your technology disrupts, you need to design it’s entry into the established system. Don’t assume this will be seamlessly accomplished by handing the technology over to the care providers. Without your thoughtful assistance, they will make mistakes and you will suffer the consequences.
Overall Clinical Program Development
Assumptions
You have an opportunity to change the trajectory of patient’s lives with your technology
There are current treatments for this medical condition but many patients have fully exploited those treatments and continue to suffer
Patients that are refractory to available treatments are too sick to try something new, patients who have not exhausted all available options are too well. Finding the ‘sweet spot’ requires keen insight
The patient pathway and natural history of the disease is varied and may not be well documented; there is no single, representative patient experience
You have several enthusiastic physician advocates eager to try your product in their practice; these practices are not like the majority of practices that will ultimately use your product, your advocates are exceptional and their perspective is unique.
Voyageur Offerings
Outline overall clinical program strategy that efficiently meets the needs of all audiences that will consume your clinical data.
Resource Planning: Facilitate “make/buy decisions” for your clinical project team that integrate with your overall business strategy, including exit planning.
Prepare Clinical Trial Documentation to facilitate planning, obtain study approvals from Ethical Committees/ IRBs, and regulators
Prepare for and conduct pre-submission meetings with FDA to confirm or refine development activities and clinical plans needed for clinical study approval
Recruit excellent clinical investigators train them and hospital staff for rapid and precise trial execution.
Clinical Project Management: Ensure ongoing excellence in execution.
Questions Impacting Clinical Program Strategies
Of the patient types you will ultimately treat, have you determined which is best for initial evaluation of the innovation and how to facilitate expansion to other patient types? Do you have a good understanding of the challenges each group will present and how a strategic sequencing can best address these challenges?
Have you defined the interests of key decision-makers who will impact the success of your innovation?
· Map future patient pathway and challenges that might stunt its development, delaying arrival or keep it from being fully realized (define Vital Uncertainties)
· Define experiments to test your plans for transforming the pathway – determine which challenges require invention and which are “simply” a matter of (careful) execution (reduce uncertainties in the most important categories).
Are you clear about what needs to be learned from each phase of your clinical program? Put simply, have you clearly established the right study objectives objectives? Have you carefully designed the clinical study to obtain those learnings?
Do you have clear criteria to proceed to the next phase of the clinical program? Have you consider how you will determine the next step in those instances?
How will the Objectives of each clinical phase fulfill the needs of your investors (current and future)? Are you deliberately designing the studies to build equity into the enterprise or are you assuming program progress naturally maximizes shareholder value?