Let Us Show You How We Work: Case Studies

We pride ourselves on an extraordinarily high rate of repeat clients and successful long-term client relationships. This often requires developing unique solutions to client issues – working within limitations and minimizing cost while simultaneously maximizing return. We thrive on coming up with client focused approaches to provide workable solutions to all types of projects. Below are some highlights to illustrate our approach.

Strategic Study Design

We were asked to conduct a randomized, controlled trial to gain more robust US-based data and facilitate uptake of a new technology in the US by providing key clinical and economic evidence to support payor coverage and physician adoption.

Challenges:

  • The current commonly utilized primary/secondary endpoints deemed “risky” from study design perspective
  • Use of composite endpoint unprecedented in the indication of interest

TTI Solutions:

  • Develop a composite endpoint to show multi-faceted benefits and reduce sample size
  • Gain payor feedback on composite prior to study initiation; validate composite endpoint.

Outcome:

  • Position as an opportunity to establish leadership position in disease indication.

 

 

 

 

 

Qualitative Study Design as Formative Research

We were asked to help the client gain better understanding of the facility perspective and value implications of using their new agent as a post-operative alternative to the current standard of care.

Challenges:

  • It was known that poor adherence to the post-operative regime created clinical repercussions; however, the effects of this on facility in terms of direct cost and indirect outcomes remained unknown
  • Limited data regarding physician preferences and perception of post-surgical adherence available

TTI Solutions:

  • Develop a step-wise progression of research which allows for adaptation of the research plan as more information became available
  • Develop and execute a qualitative study to gather data from key informants

Outcome:

  • The data produced unanticipated conclusions which resulted in a publication by the company which allowed for community awareness of the agent and avoided the need for larger scale studies

Innovative Database Study Design

TTi was asked to conduct a study to help the client demonstrate the value proposition for the use of a prophylactic device utilized to prevent surgically related adverse events.

Challenges:

  • Low incidence rate of the adverse effects prevented the use of a prospective study design
  • No single diagnostic or procedure code existed for the primary Adverse Event of interest and definitions of AE varied significantly and were not validated.
  • Results from previous studies regarding the costs were misaligned with clinical knowledge

TTI Solutions:

  • An administrative database study design utilizing a database with sufficient sample size
  • Development of an algorithm implementing diagnostic and procedure codes as well as charge code descriptions
  • Algorithm validated in a patient population and shown to have a high level of sensitivity and specificity

Outcome:

  • The client was able to demonstrate why previously published cost estimates were too low by utilizing the rigorous identification of leak events and comprehensive costs