Exploring the Untapped Value of Alliance Partnerships


Ken Getz and Phil Birch on Evolving the Effectiveness of Alliance Partnerships

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Today, every large sponsor has engaged in at least one alliance partnership with a CRO. As much as 50 cents on every dollar is spent on CRO support of drug development activity, according to Ken Getz from the Tufts Center for the Study of Drug Development. “Despite decades of increasing reliance on CROs, trial success rates and overall drug development cycle times have not improved,” says Mr Getz. “And the cost to develop a successful drug continues to rise.” 

To examine how alliance partnerships could be better leveraged to improve R&D productivity, Mr Getz and colleagues recently collaborated with Dr Phil Birch, VP Innovation Strategy, Alliance Partnerships at ICON plc, on a study examining collaboration effectiveness across alliance partnerships at major pharmaceutical and biotechnology companies.  

“We suspected that partnerships or alliances were strategic in intent only, and that many were not realising their full potential,” says Mr Getz.  The study confirmed this hypothesis and identified specific actionable practices or tactics that, according to Mr Getz, could “drive the development of future alliance relationships to deliver value where it is not being leveraged.”

We asked Mr Getz and Dr Birch to reflect on their study.

Q: Your study identified numerous opportunities for strategic alliances to maximise R&D efficiency and productivity. Briefly, what opportunities merit the greatest focus and why?

KG: We found that many valuable elements of alliance partnerships in theory have not translated into practice. The key opportunities to improve productivity revolve around structuring and supporting teams. A CRO, for example, typically has little upfront involvement in programme planning and protocol design. Most CROs have little to no input into determining the feasibility of executing a protocol and what steps could be taken to optimise the design to ensure a higher level of execution. Overall, we found that for most relationships, the efficiency of execution did not match the broader vision for the partnership.

PB : In this study, we found that collaboration during trial design was a key opportunity to enhance R&D productivity. The lack of early engagement between alliance partners in the design and optimisation process was a missed opportunity that could be setting sponsors up for additional costs. If more time were spent on assessing whether the protocol is feasible, and whether sponsors could use technology to better locate and match patients to particular protocols, then many of those problems we observe could be mitigated. 
For example, if CRO experts can develop strong relationships with the individuals in the sponsor company who are responsible for designing trial protocols, many of the challenges we see today can be alleviated. This may not be a simple thing to make happen consistently, but I do think early collaborative engagement offers a straightforward opportunity to enhance productivity.

Q: Joint responsibility for study design represents a different operating model for many alliance partnerships. Why do you believe a collaborative approach is so valuable?

KG: Much of a partnership’s value derives from the CRO’s ownership of the roles they perform, ownership of the project itself, and a sense that they have an impact on the outcomes on which their performance will be measured. In many cases, we found that CRO staff had worked on more protocols in a specific disease condition than had the team at a sponsor company.

PB: Across the large majority of pharmas represented in this study, sponsors’ medical and statistical groups were not included in alliance partnership governance and operational structure.  As a consequence, opportunities for early engagement were limited, which meant that opportunities for collaboration on protocol optimisation were limited. Leveraging combined expertise through early engagement could improve site selection, patient recruitment, and overall enrolment times.

KG: Protocol complexity is inversely related to study performance. When a protocol is more complex, with more procedures and more stringent eligibility criteria, it results in lower recruitment and retention rates and a lengthier study with a higher number of protocol amendments. The CRO is often in a position where they could provide specific and practical input into ways to reduce the number of unnecessary procedures and improve the executional feasibility of the protocol.

Q: Would this approach enhance CROs’ accountability for trial performance?

KG: Yes, collaborative study design creates the foundation for true accountability. The measures that clinical teams typically use to evaluate their CRO partner’s performance are often measures that are most influenced by the design of the protocol itself. They often fall outside the control of the CRO partner. This includes the enrolment rate, the dropout rate, or the speed at which the trial is conducted.

As a result, one of the things we're suggesting is that, in fact, additional measures be created that provide some evaluative assessment of the nature of the collaboration itself: How well are the two parties coordinated? How well are the two parties leveraging the expertise and the value of their respective partners to support the success of the programme?

Q: What suggestions would you have for sponsors and CROs to evolve partnerships from “execution” to “design and execution”?

KG: The sponsor needs to carve out time for the CRO. It must either revise or adopt a process where the CRO has an opportunity to provide input and feedback before the protocol is finalised.

Many sponsors are currently piloting and implementing protocol feasibility review mechanisms and processes that incorporate input from internal operational staff. These processes could potentially give the CRO, being the primary strategic partner for executing those trials, a seat at the table.

In many sponsor companies, there is growing interest into soliciting input into protocol design. But that input typically comes from medical and clinical operations that ultimately dictates the protocol elements that will be preserved, approved, and finalised. To include CROs as a new and valued partner in this process, senior management support is required early on.

PB: A practical benefit of early engagement is that a CRO can introduce new strategies, such as adaptive design. This has the potential to improve development decision-making and reduce the number of protocol amendments, saving time and money in the long run. According to a CSDD Impact Report from earlier this year, if a CRO is able to eliminate just one protocol amendment, for instance, the sponsor could reduce cycle time by several months and also realise approximately half a million dollars in direct cost savings. The benefits would far outweigh the cost of adopting these new tools and processes.

In addition, CROs can provide sponsors with access to new approaches that seek to optimise site identification and patient recruitment. For example, with new EMR interrogation platforms such as TriNetX and the EHR4CR InSite initiative in Europe, we can vary inclusion/exclusion criteria to demonstrate their impact on the availability of patients for a specific protocol. This can greatly enhance our ability to match the right patients to a study and optimise the recruitment process.

KG: One final concept, in regard to partnerships focused on design and execution, is consistency. Some sponsor companies have established strategic alliances that are very broad in scope, covering all the functional areas supporting a given project or programme. Yet, clinical teams frequently choose to include niche service providers on an ad hoc basis. This results in unclear ownership of functional responsibilities and performance standards, which contrasts to the fundamental vision for the alliance partnership. Such inconsistent practices drive inefficiency. There is a need for a more disciplined approach to achieve a higher level of consistency, and ultimately greater efficiency.

Q: In the report, you cite the use of electronic medical records in trial planning and start-up as a critical target for innovation between CROs and sponsors. How can CROs use innovative EMR technology to develop effective strategies for sponsor organisations?

KG: This is an incredibly fertile area. EMRs can help CROs do everything from identifying the ideal patients for a given study to auto-populating case report forms. They can assist in identifying new therapeutic interventions and new populations that may respond to a given therapy. In many respects, the top CROs are trying to find ways to adopt and integrate EMRs into their development activity. Several CROs are looking to align with major health systems to work more closely with organisations that have established an EMR infrastructure. CROs are trying to find ways to accommodate EMR data with electronic data capture, specifically for sponsors.

PB: Querying EMR data allows sponsors to identify real patients at sites. As this technology becomes a routine practice in the feasibility and site identification process, significant benefits and efficiencies will be realised.

Working closely together, sponsors and CROs will be able to more accurately identify the right sites and right patients for their study. According to research from the CSDD, with today’s methods, about 11% of sites fail to enrol a single patient and 37% under-enrol. With the development of sophisticated tools to query EMR data reliably and consistently, a more definitive way of identifying patients that match a specific protocol will be realised. A future objective is to run trials with fewer sites, which would reduce cost and time significantly.

KG: EMR data promises to be a compelling tool to target patients far more effectively, as well as perform even more predictive analytical work.

Q: The report also identified patient centricity as a major opportunity for alliance partnerships. Beyond EMRs, how else do you believe that patient centricity will add value to alliance partnerships?

KG: In many respects, a patient-focused or patient-centric drug development philosophy can become a major force to drive better collaboration. It has become a focal point that the sponsor and the CRO are mobilising around. They both want trials that are more engaging and that enhance the patient's experience in a clinical trial, and so patient-centricity can be a unifier and partnership driver.

PB: I think the most significant element of this involves forming better relationships with sites and patients. A good example is a company ICON recently acquired, PMG Research. They've invested a considerable amount of time forming strong relationships with the healthcare institutes they're engaged with, and by extension, strong relationships with patients. The sites that PMG selects are usually the top recruiting sites because of their focus on engagement with investigators and patients, and the promotion of clinical research as a care option.

PMG also uses an approach where they ask patients about their opinions on particular protocols. They find out, for instance, whether a patient wants to participate in a particular study, or if it would be too burdensome for them to take part. This helps optimise the protocol from the perspective of the patient. It’s also a lead-in to decentralising the trial and lessening patient burden through a reduction in the number of site visits and undertaking a number of procedures at a location that is more convenient for the patient. Easing the burden on patients is a key factor in driving enhanced patient participation and retention, and a core element of patient-centricity.