Time to Share

February 1, 2015
Agnes Shanley

Agnes Shanley is senior editor of Pharmaceutical Technology.

Pharmaceutical Technology, Pharmaceutical Technology-02-01-2015, Volume 2015 Supplement, Issue 1

Data sharing and a common data model can improve CRO partnerships and trial results.

 

Few things can strain a sponsor’s relationship with a contract research organization (CRO) more than a missed clinical study deadline.  Missed deadlines often show the true character of the partnership, and even the most cordial professional relationship can quickly degrade into a blame game. As pharmaceutical company sponsors and their CRO partners work to improve drug development efficiency, more are learning the importance of sharing data across organizations.  This article explores how data sharing can strengthen working relationships and improve results.

The state of the union
Today, sponsors and CROs work together under various different operating models. On one end of the collaborative spectrum, sponsors develop strategic partnerships with selected CROs, in which they share technology, risk, accountability and decision-making, and even integrate some business processes.  On the opposite end, sponsor and CRO work rather independently, maintaining separate business processes. In this case, the sponsor relies on the CRO to deliver agreed-upon results.

In either case (and in any intermediate model), the collaborative spirit can dissipate the minute something goes awry in the execution of the trial. No matter how much risk sharing is built into the contract, no matter how long-standing the relationship, the two parties are not, and perhaps never can be, equal partners. The sponsor ultimately bears the most risk in the drug development process and depends upon the CRO to perform work according to a contract.

Regardless of the relationship model employed, it is in a sponsor’s best interest to build a strong and healthy alliance that delivers the performance expected. As information sources solidify and technology advances, there are now ways to shore up the relationship with improved communication and transparency. The following steps are recommended to sponsors intent on making the most of their CRO relationships to improve trial performance:

Use shared data to discuss study feasibility
When CROs prepare their bids and present their initial, detailed plans for study enrollment to a sponsor, they have approached the challenge with a certain body of experience, drawing on specific historical data and assumptions. These, in all likelihood, will be different from the sponsor’s own, and the proposed study timeline will reflect these differences.

At this stage, it is understandable that the data from which each party are working would be different, and sponsors should accept that “different data doesn’t automatically equate to better or worse data.” This is the perfect time to begin a dialogue about the nature and causes of the differences that come to light. By comparing experiences and assumptions, the sponsor and CRO can, ideally, “put their heads together” to arrive at a plan that incorporates the best knowledge and experience of both organizations.

This process takes a bit of patience, as it takes time to vet incoming information, explore differences, and jointly determine what enrollment plan is most realistic. The most advanced sponsors shorten the process by allowing prospective CRO partners to enter their historical information and assumptions into a shared platform that presents them alongside the sponsor’s own. The sponsor can then quickly spot the points of contention and focus conversations on areas of discrepancy (Figure 1). Some sponsors open the platform to multiple CROs so that they can make apples-to-apples comparisons across CROs and to their own data.

Establish early alignment
Perhaps the single most important piece to ensuring that trials commence, and then proceed, smoothly and according to plan is to establish a mutual understanding of all parties’ expectations. A team with representatives from each organization must come together to agree on the goals and ground rules for each project. While there will be a basic agreement in place governing the overall business relationship (most especially in strategic partnerships), this more detailed level-setting exercise needs to be completed with each research project. Specifically, the project team should agree upon the goals, timeline and interim deadlines, responsibilities, plan for resolving/escalating conflicts, and trigger points for moving to the mitigation plan. The project-specific plan and chosen metrics should, of course, allow the project managers to manage in a way that is respectful of the overall partnership between the sponsor and the CRO.

Share technology for optimal trial management
Regardless of the nature of the partnership, sponsors naturally need to monitor study progress closely. Using a shared technology platform can make this process more efficient, because it will give both sponsor and CRO an objective view of key performance indicators and analyze the same performance forecasts. When the performance-monitoring tool is shared, both parties have access to a “single version of the truth” for evaluating operational progress, diagnosing issues, and evaluating “what if” scenarios for corrective actions. In this environment, either party can proactively address any issues that arise.

  • When sponsors and CROs are open about sharing information during both the feasibility phase and study execution, the benefits accrue to all parties, and most especially to the smooth conduct of the trial. Sponsors that apply the approaches recommended here report that they:

  • Uncover misalignment in the early stage of trial planning-before it is allowed to create serious problems with the quality of study data or the adherence to timelines

  • Shift the conversation about feasibility from one riding on anecdotal evidence to one based on quantitative evidence

  • Develop a mutual understanding of, and appreciation for, the risk involved in the project

  • Foster a greater sense of accountability and investment in the results

  • Develop stronger alliances that benefit from shared ideas and decision making.

However, the most significant value in having a global planning and tracking platform and common data model between the sponsor and CRO is that it increases study predictability. This, in turn, improves performance and reduces costs.

Prior to adopting such an approach, one global pharmaceutical company was struggling with the fact that fewer than 40% of its trials were executing according to plan. As seen in Figure 2, performance began improving immediately upon implementation of a shared platform.

Over approximately three years, the company saw a 100% increase in the number of studies recruiting to plan (exceeding the goal to achieve a 50% increase). Given that daily operational costs for trials average $37,000, (1) this improvement saved the sponsor an estimated tens of millions of dollars across its trial portfolio.

Through a commitment to communication, sharing data and sharing technology platforms, sponsors and CROs can change the dynamics of their relationship to become more collaborative, efficient, and productive. By combining joint histories to build inputs and assumptions from the outset, they can devise the most realistic plan for trial execution together, with a shared understanding of expectations.

As the trial progresses, it is crucial that both parties share the same trial management platform and derive forecasts through the same methodology, giving access to the same milestones and data points for decision-making. Through this approach, global teams, once isolated, can be in alliance from beginning to end, leading not only to stronger collaboration, but also to the successful achievement of trial milestones.

Imagine if the industry as a whole could achieve gains like those realized by the company in the example cited. This model of sharing has the potential to impact the entire drug development process dramatically, bringing drugs to market on time and on budget.

Reference
1. “Boosting the Predictability of Clinical Trial Performance,” Gartner case study, 2007.

About the Author
April Lewis is the Head of Product Education for IMS Health’s Clinical Trial Optimization Solutions division.

Article DetailsPartnership Strategies in OutsourcingSupplement to Pharmaceutical Technology
Vol. 39, (2) Supplement
Pages: s49–s51
Citation: When referring to this article, please cite it as A. Lewis, “Time to Share,” supplement to Pharmaceutical Technology39 (2) 2015.

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