1. Are you a utility company?
No.
(seriously...people do ask us this question quite frequently)
2. What is "clinical utility"?
Clinical utility refers to the ability of an intervention (whether it be administration of a therapeutic drug or vaccine, use of a medical device, use of a screening or diagnostic test, or administration of behavioral or cognitive therapy, for example) to improve medical outcomes (generally morbidity and/or mortality) with acceptable side effects.
For example, in the context of a novel screening or diagnostic test, clinical utility refers to demonstrated impact on hard outcomes like morbidity and mortality. It follows that some medical decision (e.g., to initiate a certain medication) is conditioned on the test result and demonstrably leads to the better outcomes.
As clinical utility is clearly intimately connected with value to patients, it is the most important determinant of physician usage of a therapeutic, diagnostic, or other intervention. Not surprisingly, it is also a critical driver of coverage and reimbursement decisions by managed care organizations and other payers.
3. What types of services do you provide?
Please see our consulting services page.
4. How do you prefer to explore a potential project?
We believe that outstanding relationships are critical to success, and this impacts the way we explore potential engagements. We prefer to initially meet (or speak by phone) and discuss potential projects verbally to explore how we can add significant value. In this process, we believe that it is important to take as much time as is necessary to obtain trust, a solid potential working relationship, and conceptual agreement with respect to project parameters. At this point, we prepare a formal project proposal that summarizes the results of the discussions.
If you have any questions or would like to explore whether we may be able to assist you, please send us a quick email or call.
5. Once conceptual agreement related to the project parameters is reached, how soon can we expect a formal project proposal?
It will be on your desk within 48 hours.
6. Can you provide a list of personal references?
Sure. Just drop us a line, and we would be happy to do so.
7. As Clinical Utility Consulting is a small consultancy, are you interested - and likely to be successful - in larger projects requiring more manpower and broader skillsets than you have in house?
We have meaningful relationships with a number of individuals and firms that allow flexibility in successfully responding larger or broader engagements. This allows our customers to access quality talent in key areas in an integrated and cost effective manner.
8. There is substantial political and regulatory uncertainty currently. Why should we invest in the area of clinical utility given the uncertain landscape that is ahead?
Many companies are beset by paralysis given the challenges of the financial markets, the political manuverings related to health reform, and uncertainties at the FDA. However, great opportunities are often hidden in great challenges. We believe that a number of key drivers will only increase the importance of clinical utility in driving commercial success in the future. Thus, it is rarely a bad move to evaluate your product(s) with respect to clinical utility and to think about how they could be better evaluated and positioned.
