When visiting online communities where clinical research professionals congregate, I see research sites consistently pose the same question: “How do I get studies?” The answers that others provide often relate to networking with fellow industry professionals, putting information on Centerwatch, perusing clinicaltrials.gov, and other tactics designed to get on the radar of those involved in site selection. All of these suggestions are helpful.
However, these discussions often ignore the single most powerful strategy for attracting new studies. This strategy can be implemented immediately, and given the data and emerging industry landscape, its power will likely continue to grow in the future.
The Current Evidence
In 2009, Industry Standard Reports (ISR) interviewed 362 clinical trials stakeholders about the challenges of patient recruitment. According to the resulting report, CROs and sponsors believe that finding the right principal investigators is the most difficult aspect of patient recruitment. ISR also noted that 80% of respondents prefer to reach enrollment goals 10 per cent quicker, rather than cut costs by 20%.
Two years later, these CRO and sponsor attitudes have been confirmed by new per-patient cost data. A July 2011 report from Cutting Edge Information found that per-patient clinical trials costs rose an average of 70% across all development phases since 2008. Factors like site recruitment and vendor management played a significant role in these cost increases. More interestingly, increases in both of these areas were largely spurred by one cost driver.
While finding a sufficient number of general clinical sites is a challenge, the biggest driver behind higher vendor costs and site recruitment issues is an increasingly intense competition for top-performing investigator sites.
From a site perspective, two important conclusions can be drawn from the data in these reports:
- Top-performing sites will have a line of CROs and sponsors interested in working with them.
- CROs and sponsors will pay more to work with top-performing research sites.
In terms of quantity and quality of study leads, a research site’s best tool for attracting new studies is a reputation as a “top performer.” Sites with this reputation will have a steady flow of sponsors and CROs competing for their attention, as well as the leverage to negotiate favorable budgets.
Though the term “top performer” may seem like a somewhat nebulous concept, it is not. A concentrated focus on patient recruitment is enough to earn top performer status.
Who Are the Top-Performing Sites?
To be considered for a study, research sites must meet particular staff and facilities requirements. From a sponsor and CRO perspective, these requirements limit prospective sites to those who have the expertise and ability to adhere to basic research standards, follow the protocol, and provide good clean data. If there are any questions about the ability of a site to conduct quality research, that site won’t be considered for study participation.
But to move beyond merely meeting requirements and graduate to top performer status, sites must focus on patient recruitment as well. When sponsors and CROs talk about top-performing sites, they are referring to sites that have a consistently good patient recruitment record with the therapeutic indication in question, in addition to fulfilling the basic research quality standards mentioned above.
As sites think about their patient recruitment investment, the tendency is to merely consider the return this investment provides on short-term study-specific recruitment objectives. In fact, a smart patient recruitment investment can also be a crucial element for achieving longer term business objectives.
If you are a research site representative, the single best thing you can do for business development is to get serious about patient recruitment, thus securing your reputation as a top-performer. Stop going through the patient recruitment motions and concentrate on doing well with the studies you have now. Future studies will follow.
Given the emerging site selection landscape, this strategy will likely become even more effective in the future.
The Emerging Site Selection Landscape
I’ve already established that sponsors and CROs have a strong desire to work with sites who can deliver on (and exceed) enrollment targets. And now with the emerging site selection landscape, sponsors and CROs will be increasingly equipped to act on that desire.
For the most part, the site selection process has been extremely unsophisticated. For example, sponsors and CROs commonly use enrollment projections reported by sites to gauge site enrollment ability, though these projections are notoriously inflated. In the future, the promise of enrollment will no longer be sufficient to satisfy sponsors and CROs.
With the industry’s push to develop and utilize improved data analysis technologies, the site selection process will get much more sophisticated. For example, here’s a brief description of a program Genzyme recently implemented.
Genzyme has begun a similar program to better select sites that have a higher probability of enrolling patients for a given study, hiring a feasibility expert who has implemented a formal process to develop data-driven country and site selection strategies. Part of the process, including using data to review the past performance of particular sites.
Sponsors and CROs will increasingly leverage historical recruitment data to predict site recruitment performance. Site selection factors like industry relationships will continue to have some weight in the process, however, historical recruitment performance data will emerge as a crucial selection factor.
Not only do sponsors and CROs have a strong motivation to compete for top-performing sites, but they will increasingly have the tools to locate these sites. Therefore, sites with a serious commitment to patient recruitment will be at a huge advantage during site selection.
What About New Sites?
For new research sites, this data-driven trend might come as a disappointment. How can new sites compete when sponsors and CROs have little or no historical data with regard to their recruitment ability? Don’t fret.
This emerging landscape could actually be a favorable development for sites interested in breaking into the clinical research industry. Now that sponsors and CROs will have access to improved performance data tools, they will be able to identify underperforming sites with greater ease, thus “churning” through those sites more quickly.
It makes sense for a sponsor to take a chance on a new site with promise, rather than to continue working with a more experienced site that has consistently underperformed on recruitment. New sites that offer compelling patient recruitment potential will have the opportunity to displace sites who have consistently underperformed.
Before approaching sponsors, new sites need to think very carefully about their patient recruitment strategy and be able to communicate why they will outperform other sites.
Getting Serious About Patient Recruitment
Regardless of whether a research site is new or experienced, a serious, innovative recruitment strategy is the best way to attract interest from sponsors and CROs. Sites that use average tactics with average effort will likely have average enrollment results.
On the other hand, sites with innovative, data-driven recruitment strategies will garner consistent interest from a slew of sponsors. Top performing sites will have limited need to seek out studies because the studies will seek out them.
Thoughts? Any sponsors or CROs want to chime in with their insight into the site selection process? Sites, what has your experience been?