Questions

What is the cost range for running a clinical pilot study on the effect a mobile app can have in improving someone's health?

7answers

The answer depends on how many patients are in the study, how many investigational sites are in the study, and how long the study length is. Other facts that can affect the cost is what sort of materials must be provided to each patient (smart phones? tablets? etc.). So, the cost could be several hundred thousand dollars, or perhaps much more than that.


Answered 4 years ago

There is a huge range. We've done studies from as small as $10K, to as large as millions of dollars. Everything Stan said is true, there are many factors involved. Without knowing more information but guessing you're a small startup wanting to run something to validate your mobile app, I'd say you'd need about $15-20K along with the right research team.


Answered 4 years ago

In addition to the costs noted by Dr. Young for "investigator fees" you should also consider whether or not you have the proper operating framework in place across your organization to meet documentation and procedural requirements. Your entire SDLC needs to be validated before you can even begin to gather data about "efficacy" that you might want to use in a submission, marketing claim, or in support of a regulatory application in the future. Having released a mobile application in this space in addition to several web apps, I'm happy to discuss more details with you if you like :0)


Answered 4 years ago

I would look into ResearchKit and finding an academic partner like UCSF or Scripps to work with.

Independent doctors would probably charge hourly or project based.


Answered 4 years ago

It depends on what the mobile app actually does. However, I have a lot of experience with this. You should look for a managed care organization (MLTC) that will allow you to run your clinical pilot for free just for the use of your product.

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Take massive action and never give up.
Michael
Michael Irvin, MBA, RN
www.michaelvonirvin.com
PS – Many people have “Upvoted” my answers. Thanks to those who do this. I really appreciated.
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Answered 4 years ago

I see this question has been posted for a long time, but I'll answer it for you.

The cost for your study would depend on many factors. First and foremost, you would need to decide who your stakeholders will be (who will benefit from this app, and what organizations, groups, etc. would have an interest in this research?). You can then decide on who your subjects will be. The breath and scope of your study would need to be decided on next. An appropriate sample size would then need to be calculated (this is a process in and of itself). After this, you need to decide how best to test your app, and develop a methodology and procedure. Keep in mind that all of this I have mentioned so far would need to be supported by the relevant literature in the field or industry to which your app best applies. If you are doing this study for an institution, you must secure approval to conduct the study from whatever IRB (Institutional Review Board) your institution uses (This means you will have to write a proposal of some form). You are now ready to calculate what your study will (or should) actually cost! From there, you can search and apply for grants to secure the funds for your study. Grants is a whole other topic! Let me know if I can help. Good luck!


Answered 2 years ago

It depends. Is there a hardware component? Do you have a strategic partnership with a healthcare system? Do you want this published in a peer reviewed journal? Is the audience the FDA, academics, payers, providers, all of the above or a mix? How long will the pilot last? Do you need a dedicated FTE? Do you need access to an EMR or HIT? I'm happy to discuss more and have experience designing and implementing these types of trials.


Answered 2 years ago

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