Innovation, cost-effective processes, and emerging markets are probably three of the most common topics being discussed in the pharmaceutical and biopharmaceutical markets today. A new study by the KMR Group, a firm specializing in biopharmaceutical R&D performance, gives valuable insights into each of these topics as they relate to site selection and patient recruitment for clinical trials.
The company’s Enrollment Insights Study analyzes more than 11,000 clinical trials and 127,000 sites of clinical data to assess recent industry trends in recruitment and the factors influencing trial performance. For instance, factors that influence trial performance include the number of regions/countries involved in the trial, the region/country itself (as performance differs significantly), and the specific sites a company selects to conduct its randomization/dosing. All of these factors are areas a company can control, and by being more informed, a company can make better decisions in these areas and significantly improve the performance of a trial, specifically by reducing the time spent in the recruitment/dosing phase.
Assessing Emerging Markets
If you’re a biopharma or pharma executive in charge of patient recruitment, you know all too well how important it is to effectively gauge whether entering an emerging market will accelerate your recruitment strategies. KMR’s study charts what the right performance expectations should be in a specific country or region and illustrates the benefits of a more focused approach to recruitment through the use of cycle time and patient recruitment statistics.
Cycle times assessed include start-up, site initiation, and randomization. For start-up cycle times, the study measures the time from protocol approval to first subject randomized as well as the time it takes to get into each region. The study assesses how these cycle times are different depending on the number of regions and countries involved in the study as well as the size of the study. Patient recruitment statistics refers to the metrics used to define the performance of recruitment in a clinical trial. These metrics can be for the trial itself, a region, a country, or even a specific site; and they can include subjects randomized per site, subjects randomized per month, screen failure rate, and dropout rate.
In addition, the study highlights how well each of the participating 16 mid-to-large pharma companies performs for a given disease by region and country by providing each participant with its own industry ranking. Companies that score low on these rankings can use the information to develop improvement strategies that are location-specific.
Poland One Of Highest Performers
KMR’s study assesses performance by disease type (e.g. depression, Alzheimer’s, hepatitis, arthritis, diabetes, lung cancer, breast cancer, asthma, pain) in specific countries. Poland is consistently a leader in phase 2 and 3 studies, not just compared with other countries in Eastern Europe, but also globally. For example, Poland’s breast cancer performance is among the top globally, with a median 8.6 subjects per site, which is more than twice the rate of subjects per site in the United States (median value).
Poland leads the world in oncology studies more generally, with the number of subjects recruited per site per month at a median 0.9 subjects, compared with the global median of 0.4 subjects. As another example, sites for oncology trials in Poland were able to recruit 25% more patients than the other Eastern European countries.
The Benefits Of More Effective Enrollment Strategies
The results of the KMR analysis, which will be included in the report of its Enrollment Insights Study and presented this fall to participating companies, help participants reduce time to market and control costs through more effective enrollment strategies and operations, many of which are strongly influenced by geography. For example, by analyzing the performance of sites and incorporating their geographic locations, the best regions for recruitment for a specific disease can be identified. “Best” can be defined as a region where sites tend to randomize more subjects than in other areas or a region where subject recruitment is significantly faster. If a company can efficiently recruit the subjects required for a trial (quickly and with a high retention rate), it will reduce the time spent in the treatment/dosing phase of the trial. A company can then obtain results faster, which will inevitably reduce the overall cycle time at the project/portfolio level. Companies agree timing is critical, as patent expiration clocks are ticking throughout the development phase.
“Companies are interested in measuring their performance and comparing themselves against industry, but they also want to ask the key follow-on questions of how to improve,” explains Linda Martin, principal of KMR Group. “They want to understand how the way they do things can lead to enhanced performance. This study, with a focus on recruitment, is right on target to answer all of those questions. Recruitment consumes the most financial resources as well as time in a clinical trial. KMR’s Clinical Trial Cycle Time program reports that the time to randomize subjects in a Phase 3 oncology study typically accounts for about half of the overall cycle time — not an insignificant proportion. KMR has a large enrollment dataset that is provided directly via sponsor companies. The results of our analysis provide concrete enrollment performance data, which is being used by companies to employ more effective enrollment strategies, including modifying region-specific recruitment plans.”