Become The Clinical Partner Of Choice
By Ed Miseta, Chief Editor, Clinical Leader
Many pharmaceutical companies have started to look at their processes through the lens of valued, external partners. While companies will continue to evaluate the effectiveness of their external partners, many are increasingly looking in the mirror to see at what kind of partner they are to work with. This is leading many to evaluate how they can be a better partner and improve their own performance.
“There is a lot we can learn from our sites and investigators if we only take the time to listen,” says Theresa Devins, Boehringer Ingelheim Pharmaceuticals, Inc. “By listening to the sites, networks, and vendors you work with, many challenges, including patient retention, can be proactively addressed before the issues become insurmountable. In pharma we need to be patient-centric, but we also need to be site-centric. We should engage external partners and actually listen to what they are telling us.”
Partnerships take time to build and trust is one of the most important components. By tapping into individual strengths, the collaboration becomes satisfying on both sides. Strategic partnerships are becoming more common and important across the industry, and for that reason companies are looking to change the old paradigm of initiating sites and waiting for patients to appear. As electronic medical records (EMRs) become more robust and more broadly linked to other data systems, it is becoming more common to identify geographic locations of high disease prevalence. Additionally, many organizations are welcome partners with industry since they are eager to learn how to recruit study participants more quickly and efficiently.
“Partnerships also allow for creative and innovative solutions,” says Devins. “Some organizations are expanding their capabilities by utilizing mobile units where the study coordinators and other staff members could rotate across sites that are new to research. Patient visits could be scheduled during the time the rotating staff is at the site. Once the site builds their clinical research capabilities, each site will support its own staff.”
Understand Cultural Differences
Every organization has its own culture. At times, common goals can be difficult to identify and build on. Even within an organization, gaining consensus toward a shared goal may be challenging. For example, a study team may have specific quality indicators by which they are measured, such as speed of study start-up. On the other hand, new relationships take time to nurture and have some risk associated with them. In such cases, management support is needed so that trial teams become more comfortable in accepting smart risks and allowing new partnerships to develop. As Devins acknowledges, “You are only new to each other the first time.”
If that is true, how should you convince internal teams trying to expedite trial timelines that developing good study partners may mean accepting some risk? And how do you convince them that by working together there may be unprecedented gains (such as thoughtful insights) to help avoid costly mistakes during trial conduct?
“Many of the risks that exist in working with a new partner can often be offset by benefits that result from the relationship,” states Devins. “For example, an organization that may be new to clinical research could have extensive access to the patient population being studied. While there is some risk to working with a research-naïve site, its potential for rapid enrolment can move an entire trial along very quickly.”
Take A Look In The Mirror
Strategic partnerships exemplify the importance of building strong and trusting relationships. In fact, the entire industry has begun to understand the importance of relationships between sponsors and sites, CROs, and related vendors. Devins believes by growing strong partnerships, the needs of the sites and their patients become much clearer. Those needs also become less challenging when you are trying to address common issues.
“Better relationships are the cornerstone of patient- and investigator-centricity and will help us avoid costly mistakes in the long run,” notes Devins. “Gaining those insights and incorporating them into clinical development plans are critical to conducting successful programs and expediting the entire clinical trial process. Current thinking around patient-centricity is all about incorporating patient input into clinical trials, even before the protocol is finalized and enrollment begins. But those insights are also critical to solving the recruitment and retention problems plaguing pharma.”
Becoming a better partner also involves taking a close look at established processes and considering how to adapt them to meet patient and site needs. By listening to sites, investigators, patients, CROs, and other partners, pharma can put a process of continuous learning and improvement in place. In doing so, the term patient-centric would be more correctly replaced with customer-centric.
“Pharma is working hard to better interact with all of their partners, and I think we are making progress,” adds Devins. “Culture change is always a difficult thing to do. Listening to what you may be doing poorly is not always easy to accept. For many folks, it may be a bitter pill to swallow, no pun intended. But it is an exercise that we all need to perform if we want to improve the process.”