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ProjectGlobal Clinical Trials Analysis Client
Top 5 Multinational Pharmaceutical Company
Description
VOI was contracted to explore the suitability of 30 countries as locations for clinical trials with five compounds aimed at diseases in the oncology, endocrinology, rheumatology, nephrology and dermatology fields. The majority of countries with meaningful abilities to conduct clinical research were included in the evaluation set. These ranged from major research centers such as the U.S., France, Germany and Australia to countries with emerging clinical trial infrastructures, such as China, India, Brazil, Russia and South Africa.
Extensive primary and secondary research was conducted to determine the characteristics of each market that might affect clinical trial enrollment. First, we evaluated the structural environment for clinical research in each country. Factors considered in this phase included: nature of regulatory system, length of time required to obtain approval for trial initiation, motivations and incentives for physicians and patients to participate, cultural attitudes toward clinical trials and availability of the necessary human and technical resources.
Next, we collected disease-specific information in each country. For example, we examined epidemiological data, including incidence and prevalence statistics and the percentage of patients meeting the enrollment criteria for each trial. We also determined diagnostic pathways, the number of specialists treating the disease, the number of contacts each patient would have with investigators, investigators’ attitudes toward or prior experience with the therapeutic category and the likelihood that patients would enroll in the trials.
Using the findings from this extensive analysis, we constructed patient enrollment models to forecast recruitment schedules in the individual country and overall trial levels. Probability-based (Monte Carlo) forecasting techniques were applied to these models to determine the likelihood of meeting enrollment objectives on schedule in each country.
Results
Our client was able to consolidate the trials in a substantially smaller number of countries than originally planned. By eliminating countries with a low probability of meeting trial enrollment goals on schedule and concentrating trial activity in countries with a high likelihood of successful enrollment, our client was able to reduce the cost of each trial by 10% to 20% — the cumulative savings across all five trials was measured in the tens of millions of dollars. This was done without jeopardizing the overall probability of on-time trial enrollment.
ProjectQuality-of-Life Claims Analysis
Client
Top 10 Multinational Pharmaceutical Manufacturer
Description
As a point of competitive differentiation, our client sought to include quality-of-life improvements as a component of their marketing program. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.
VOI identified FDA and EMEA policies for inclusion of quality-of-life marketing claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.
Results
Our client incorporated our recommendations into the design of their late-stage clinical trials and was successful in obtaining regulatory approval for the necessary product labeling.
ProjectComparative Claims Analysis
Client
Top 10 Multinational Pharmaceutical Manufacturer
Description
Similar to the Quality-of-Life Claims analysis but for a different pipeline product, the same client wanted to include superiority claims against an existing product as part of their marketing effort. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.
VOI identified FDA and EMEA policies for inclusion of comparative claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.
Results
Our client incorporated our recommendations into the design of their clinical trials. This product is under regulatory review, but we expect that the comparative claims labeling will be granted.
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