Clinical Researcher—April 2024 (Volume 38, Issue 2)

ON THE JOB

Elizabeth Weeks-Rowe, LVN, CCRA

 

 

 

Investigational sites are the crux of a clinical trial: the origin of study data, patient recruitment, and procedure execution. The principal investigator (PI) leads the investigational site study team as its members facilitate study activities and patient care/education. The investigational site facilities store the investigational treatments under study, hold essential documents that support the ethical chronology of trial activities, and house the diagnostic and trial management equipment necessary to achieve the study endpoint(s) and maintain timelines. The clinical trials lifecycle, as part of the overall drug development process, would not progress without investigational sites.

Study sponsors or contract research organizations (CROs) working on their behalf follow a methodical process to select appropriate investigational sites for study participation (study start-up), and effective relationship development is key to transforming a preliminary meeting into a flourishing partnership between these stakeholders.

The first impression created during site selection will impact the course of the ensuing relationship between the sponsor/CRO and investigational site, and this selection process must be conducted professionally at all costs. This effort does not subside once the proverbial dust of study start-up has settled. The following periods of study enrollment, maintenance, and close-out require equal finesse to continue an efficient collaboration between the parties that promotes patient safety and credible data collection throughout the study lifecycle.

CRAs and CRCs at the Epicenter

There is no predictive algorithm to ensure optimal relationship creation, development, and sustainability between the sponsor/CRO and the investigational site. It is influenced by such intangibles as perception, impression, and circumstance. It is impacted by such diverse variables as study budget, protocol feasibility, patient enrollment, data collection, reporting, and overall study conduct. The players involved can only control their efforts toward study success in an otherwise unpredictable environment, and a key component of the partnership’s success or failure is the clinical research associate (CRA)/site dynamic.

More specifically, the CRA/clinical research coordinator (CRC) dynamic is the epicenter of the overall relationship between sites and sponsors/CROs. The success of this relationship hinges on the willingness of the CRA and CRC to collaborate for the common goal of trial success. There are core absolutes to this relationship—one cannot fulfill his/her study responsibilities without the other, as the relationship is interdependent. One is not subordinate to the other; the relationship must be equitable—a dynamic commitment to an equal partnership, rooted in respect for collective experience over individual ego.

While there is no secret formula to guarantee success, there are intentional steps/behaviors that will help transform a fledgling introduction into a strong relationship between the CRA and CRC, which may lead to a lasting partnership between the sponsor/CRO and investigational site.

Respect, Professionalism, Transparency, Positivity, and Follow-Through

Respect and professionalism must be displayed in both directions from the inception of the relationship. The CRA must open the initial dialogue with the site cordially and continue that way. E-mails/instant message/telephone or video platform communications must display professional salutations, preliminary/constant courtesies, and clear content until conclusion. When this frames site communications, almost any challenge can be overcome as the relationship developed from a place of mutual respect.

For example, if a CRA is assuming site management from another CRA, the most professional move would be for the CRA to call the investigational site to make the initial introduction. This may seem old fashioned when e-mail is more efficient; however, electronic communications are impersonal. Think about this—the investigational site personnel could be feeling out of the study loop as they had not had sponsor contact for a while, and an introductory call from their new CRA shows effort and helps build preliminary trust that may have been lacking from an absence of communication. Subsequent communication can be completed via electronic mediums, but the initial reach out should be personalized.

In terms of transparency, when it comes to following the protocol, investigational sites are only as good as the information they are provided. CRAs are duty-bound to provide sites with clear sponsor instructions, accurate protocol directions, and transparent study updates. This is accomplished when the CRA keeps abreast of important study information and provides their investigational site partners with timely and factual updates. This will prepare sites during data deadlines and when implementing corrective action, and will promote efficiency during future monitoring visits. The sites rely on CRAs to provide the answers they seek, and transparency in information will perpetuate this reliance.

Meanwhile, an attitude of positivity is a true morale booster in the most challenging of situations. This does not mean artifice, or adopting a manner that seems disingenuous; this means providing encouragement to site personnel who may seem to be overwhelmed.

Overcomplimenting and false flattery diminishes genuine praise for a job well done, and makes it more difficult to discriminate between the two. However, a sincere compliment inspires effort and the desire to go the extra mile for our colleagues. CRAs should try complimenting CRCs in front of their PIs or site directors. A CRA should ask the CRC his/her opinion on how to resolve an issue. A CRA should remain open minded and encourage creative problem solving with their sites by maintaining an environment where all voices are encouraged to “bring forth” and contribute. This will transform a checklist/directive mentality sometimes assumed when disseminating information into a spirit of collaboration with their sites.

When thinking about how to be effective with follow-through, remember that, first, we are our words, then we are our actions. The phrase, “we are only as good as our word,” was never so apropos as it is for sponsors/CROs managing/maintaining successful relationships with their investigational site partners. There is no question that CRA responsiveness promotes site action by providing critical support for a site’s ability to proceed in the face of multiple challenges and accomplish the tasks set before it. A lack of responsiveness shows a lack of care; it inhibits site progress, which may impact patient safety and data quality.

Whether providing an answer to a critical protocol eligibility question or providing a range of dates for an impending site visit, CRA follow-through delivers clarity and control for site partners, which are critical tools for building trust. Even if the CRA does not yet have the answer for the site, a status update can alleviate worry that comes with the unknown. Further, when sites sometimes rely on this information for their livelihood, it is the least they deserve.

When Personalities Collide

Challenges are inevitable with interpersonal relationships. Individuals may be personally vested in an outcome which may elicit a stronger, more sensitive reaction. One individual may have caused or contributed to the underlying problem, while another may be experiencing illness or external stressors unrelated to work but affecting behavior on the job. No matter the situation, we must remain professional, even if everyone around us is not. That is the impression most remembered and is a strong negotiating tactic for resolving issues.

For example, I had a colleague who was assigned as a CRA at a large academic site, and the research manager was notoriously difficult. She would raise her voice to monitors and disagree with every directive. At first, my friend took everything personally, and alternated between frustration and anxiety after each monitoring visit. After a particularly challenging day, my friend was in the monitoring area stewing over recent events, when a contract CRA who had worked at the site for years gave her some sage advice.

“Stop taking the situation personally, for you will never get anywhere that way,” the contract CRA said. “You must be the bigger person, take your ego out of the equation, and stop trying to win every argument. Instead, be kind and compromise as much as you can. Uphold the protocol and patient safety, and report your observations factually. Offer solutions and always listen, even when you don’t agree with the opinion. That is all you can do.”

These simple measures enabled my colleague to deal more effectively with the research manager. She was able to control emotional reactions by a subtle shift in perception. This was not about being right or winning, but about ensuring study success for the site. She was able to better manage her expectations with the research manager by demonstrating extra patience, kindness, and compromise as previously recommended. This eliminated the “emotional” element and preserved the professional aspect of the salvaged relationship.

Conclusion

Trust is built with intention, focus, and consistent action. Trust is the cornerstone of a successful sponsor-site partnership—one that flourishes when the traits discussed earlier are demonstrated.

Elizabeth Weeks-Rowe, LVN, CCRA, has broad experience as a clinical research consultant, trainer, site evaluation and selection expert, content creator, and conference presenter. She is the author of The CRA’s Guide to Monitoring Research. Based in California, she last wrote for Clinical Researcher in June 2023 about “CRA Soft Skills for Pre-Study Evaluation Visits.”