Case Studies

Comprehensive Data Management and Regulatory Services

Faced with the challenge of substantially reducing timelines for clinical evaluation and international regulatory submissions, a major multinational company created a "virtual" company. After evaluating an exhaustive list of CROs, Health Decisions was selected to coordinate data collection, cleaning, and reporting, and to complete US and European regulatory submissions. Health Decisions was selected based on "demonstrated excellence and the ability to substantially improve the time and quality of data handling and regulatory submissions" over other options. The pivotal Phase III study generated over 400,000 pages of CRF data, and the sponsor company estimates that Health Decisions saved 1.6 years and $30M in direct costs compared to if the company had done the work internally. This work was highlighted in an article in Forbes (March 20, 2000).

Cost-Benefit/Cost-Effectiveness Analysis

A new broad-spectrum antibiotic had been marketed without a clearly defined niche for more than a year. Recruited by the company to search for areas where the antibiotic provided a distinct advantage over other therapeutic choices, Health Decisions identified several promising possibilities. We focused on pelvic inflammatory disease (PID) for which the traditional therapy is doxycycline, which costs one-tenth the price of our client's antibiotic but generally has poor compliance. Health Decisions performed a cost/benefit and cost/effectiveness analysis and found the broad-spectrum antibiotic was indicated if it increased compliance by as little as 3-5 percent. Our analysis considered the direct economic consequences of treatment, including PID-related problems expected to occur in the future.

Based on the success of this effort, Health Decisions was retained to pursue a second area of use for the antibiotic–urinary tract infections–where it works extremely well but is expensive. After evaluating direct and indirect economic consequences of relapse and re-treatment and additional morbidity, our cost-benefit and cost-effectiveness analyses indicated that the antibiotic was favored over other antibiotic options.

Both areas and the publications that resulted from this work served as the basis for a major marketing initiative.

International Study

Recognizing the need to better define the role of certain contraceptives in protecting against sexually transmitted diseases, funding was secured for a clinical trial using the contraceptive sponge. After examining numerous sites around the world, Bangkok was selected as the study site. With careful attention to the special challenge of follow-up, we conducted the study in six months with a 93% follow-up rate. Our study was completed a year sooner than a similar study in the United States and at a fraction of the cost. Results of the study were published in the Journal of the American Medical Association and presented at several international meetings.