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Guest article

Transparency vital to sponsor-CRO relationship say PRO attendees

By Robert Loll , 12-Dec-2011
Last updated on 12-Dec-2011 at 10:52 GMT

In September Outsourcing-pharma held Patient Recruitment Outsourcing (PRO) in Boston, bringing together the movers and shakers in the recruitment sector.

Robert Loll, vice president of business development, shares his thoughts on the event with a particular focus on the fantastic interactive discussion the he led at the end of the first day.

After an insightful day of presentations that were largely directed to enhancing study enrollment with the right outsource partner for patient recruitment, we “turned the tables” and asked our audience to participate in an interactive discussion to draw from lessons learned and share their own experiences to improve the outsourcing process.

The theme of this interactive session began with “process improvement” and what practical insights sponsors and patient recruitment organizations (PRO’s) could share to improve the design and submission process for a patient recruitment proposal and support the selection of the right outsource partner to enhance study enrollment. The following are key discovery’s that were exposed over the following two hours.

The Importance of Transparency

Open and candid communication was a common characteristic that consistently described the most successful outsourcing partnerships. Mutually beneficial relationships were shared by multiple participants who entered into more strategic/alliance outsourcing models (less transactional) – who had a vested interest in long-term success so communication was critical.Some sponsors described the value of crafting a scorecard for each study and how they used this to help navigate the review process to ensure consistency and uniformity among the selection team.

Of particular interest was when a sponsor stated they openly share scorecard results with PRO vendors who request this so they can see how their company performed independent if they were awarded the study or not.The audience was asked what outsourcing practices they’d like to see discontinued.

Examples included outsourcing teams sending RFP’s to PRO’s that were never going to be selected, submitting RFP templates that had little relevance or information about the study, or requesting a comprehensive proposal within a week and not responding for a month. Process improvement for PRO’s included: doing a better job supporting strategic initiatives with relevant (evidence based) metrics, greater disclosure of third-party vendors, and avoid submitting a 30 page response when 15 can be equally effective.

The Impact of Price

While everyone understands the impact pricing can have on the final selection of a PRO partner it was particularly interesting to hear that some outsourcing/procurement teams distribute vendor proposals to their selection team after they strip the budget – allowing the team to initially focus on the best recruitment strategy that supports their study. Pricing models include a passionate discussion on the value and impact of having “skin in the game.”

Driven by a limited number of sponsor outsourcing teams and PRO’s who utilize this as a business differentiator, pay-for-performance pricing was a hot topic. While sharing risk with a vendor can be attractive on the surface to an outsourcing department (transferring operational risks), much of our discussion turned to the limited ability of a PRO to control risk and the many variables that ultimately impact study enrollment.

Secondary to this was the impact this model can have on the relationship between a PRO and the research sites they serve (competitive), the ethical implications some participants had with this model (incentives that could influence participation), and what specific metrics were at risk (qualified referral or a randomized patient). Many participants believed that sponsor/PRO relationships were already grounded by a PFP foundation: if the last campaign you executed did not perform, you will not be included to support downstream research studies.

The Voice of the Patient

If there was a “recruitment renaissance” taking place in our industry, we recognized the explosive growth of the internet and continued empowerment/engagement of the patient when it comes to finding and selecting a research trial to consider.

Sponsors recognized that some of their most successful PRO partners are those that go beyond “targeting” the right potential patient to truly understanding them – and many of them are capitalizing on the kinetic nature of Social Media. While predictable results and metrics are still being refined, full service PRO’s are expanding their research tools and digital/social media teams to capitalize on the information available and to carefully interpret patient perspectives before crafting a recruitment strategy.

These patient insights/perspectives are shared with the creative team to craft a campaign that will truly resonate with this perspective audience.Our interactive session was designed to take advantage of the intellectual capital that was present at the conference by sharing best practices, novel outsourcing approaches, controversial business models, and process improvement for our industry to enhance selection of the right PRO for the right study.

I would like to thank Joe Kim, Director Clinical Operations, Shire and Dan McDonald, VP Business Strategy, Excel Life Sciences for facilitating this session and their contributions to this summary.

If you have any questions regarding this interactive session or outsourcing patient recruitment to enhance study enrollment for your research studies, please contact Robert Loll at rloll@gopraxis.com.

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