The key to drug development success is collaboration
Bridging drug discovery to drug development is a fundamental tenet in clinical research conduct that requires strategic collaboration. Successfully bridging investigational site relationship discovery to site development requires the same critical collaboration from study startup to study conclusion, and all pivotal points in between. The investigational site/study team dynamic will positively or negatively drive site performance in a clinical trial, and successful stewardship is key to this outcome.
Relationship development requires painstaking effort to bolster to fruition. It takes root in feasibility, and is nourished in study startup. This is accomplished by discovering the right sites for a particular therapeutic area, creating an approach to elicit interest (in feasibility) by using individuals who can “clinically speak” study basics to potential investigators during selection and by integrating important study endpoints/eligibility criteria into introductory study literature. Another critical step is the creation of a budget reasonable enough to incentivize through the cumbersome regulatory process. The last and most important step in relationship development is the assignment of experienced, professional monitors willing to work alongside their investigational sites through study challenges, with the charisma to guide recruitment and serve as a timely, accurate study resource to investigational staff. These are the developmental boosters that will ensure that an investigational site flourishes throughout the study cycle.
- Excellent stewardship is the cornerstone of successful business relationships. If there is an issue with an investigational site, or within a project team, don’t focus only on the origin of error, or point fingers. Focus on the team effort for problem solving and praise the effort toward resolution.
- Be a creative problem solver. Get up an hour early to help a site accommodate a teleconference outside of their time zone. Review and process essential documents from the site even if it is the regulatory specialist’s responsibility. The wonder of the “with” in working with others is that it promotes teamwork and success of the group effort.
- Be willing to wear different hats to accommodate different deadlines or requirements.
The sometimes complicated investigational site/CRA relationship dynamic can be simplified with positive communication. The perhaps trite adage, “It’s all in the delivery,” truly makes all of the difference. How a CRA delivers their site management message will fundamentally influence site perception of the sponsor, study management and, in turn, site performance. Using intimidation or criticism to manage a site may alienate the investigator and silence the message. Managing with collaborative professionalism ensures the CRA’s message is heard, completed and respected. The philosophy of service employed by successful CRAs requires compromise, but creates the teamwork required to problem solve.
I was once assigned to conduct a site assessment visit at a large health institution. It was an oncology study involving several study drug treatments and complicated procedures to support endpoint data. Due to nature of the design and facilities involved (laboratory, imaging), the entire visit took four to five hours. I was sure to emphasize time parameters when scheduling site assessments. With this particular institution, I was met with polite resistance to my request for additional time to complete the visit. The research manager informed me that they were prevented by institutional policy to provide more than three hours for the entire meeting. Though I repeatedly requested an extension, they would not relent. The research manager assured me that their extensive oncology experience and modern facilities would preclude the need for additional confirmation typically required for other sites. While I was aware of their status as an institution, I needed more than her reassurance to confirm capabilities. This situation required an appropriate balance of charisma and fortitude; acknowledgement of skill, the compromise of exception and the unspoken compliance required for completion. The sponsor strongly desired the site to participate, so I had to provide an equitable solution to meet all needs.
Site qualification activities included confirmation of site process, experience and logistics; all things clarified during the site interview. If the site manager was willing to provide this information before the visit, it would reduce the time on-site exponentially and accommodate their constraints.
I asked the site manager if I could email her a list of interview questions in lieu of obtaining the data (verbally) during the visit. She was amenable to this idea and thanked me for thinking ahead. She provided detailed information regarding institutional experience, process, staffing and logistics prior to the visit, which consequently shortened the visit duration to three hours. The firsthand information she provided was more accurate than the secondhand method historically used to collect data during site visits. I was able to craft a comprehensive report that showcased site capabilities and fulfilled sponsor expectations. The site relationship was strengthened with a creative solution that required very little additional effort by either party; it only required the willingness to compromise.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org.
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