Driving critical tenets of research
Monday, July 10, 2017
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
Quality in clinical trials conduct is much more than a targeted goal to achieve. It drives the critical tenets of clinical research—patient safety, data reporting and statistical analysis. Quality should not be assigned a timeline, but should be considered a status to which we aspire daily. It should not be reserved solely for what is critical, but applied to seemingly mundane activities most often underestimated for impact.
The quality of communication, the exchange of accurate information, is a large influencer of business relationships. Words legitimize the improbable; pivotal action hinges on the fact-based and thoughtful content. Therefore the degree of quality involved in the trials conducted should likewise be reflected in the message sent.
There has never been a researcher thankful for an impulsively sent email that would have benefited from a secondary review before transmission, nor relieved by the negative fallout from thoughtless words. Unfortunately, I have witnessed communication disasters that could have been prevented had the participants paused—for breath, logic and rational thought.
Premature conclusion or impulsive communication results in more rework than preliminary negative findings that may eventually be refuted. The CRA who suspects a protocol violation and issues the finding before final confirmation. The study coordinator who reviews the patient’s IP diary and questions (their) compliance with study drug before completing a final pill count on the returned blister pack. All factors must be considered before a conclusion is drawn to prevent the negative aftermath of impulse—panic, doubt, resentment.
Several years ago I was assisting a study team with site selection for a depression study. The initial investigator activation milestone was looming and the pressure was on to quickly evaluate the top sites. Based on a number of factors, sites were given priority status; prior experience with the sponsor, successful study conduct in the therapeutic indication, patient access and regulatory agency audit findings/debarment status. I was assigned a number of priority sites to evaluate in a short period of time, and was looking forward to visiting one site in particular. Their excellent reputation bespoke their expertise in the indication, and quality in research conduct.
From the onset their behavior exceeded all expectation. The site manager quickly returned my initial email and we had the site visit scheduled for the following week. They provided an engaging overview of their site capabilities in a digital flyer that captured, not overwhelmed, interest. The day of the visit, I was given a facility tour by the site manager that perfectly showcased equipment for processing samples, psychometric rating and patient treatment. Their impressive pharmacy was monitored by a continuous temperature monitoring system, with industrial size refrigerators and licensed nursing staff. The monitoring area boasted five large cubicles, high speed internet and a coffee/snack area. The charming investigator spent an hour discussing the study with me, providing feedback on endpoints that he felt would impact enrollment and patient retention. The research staff was enthusiastic and credentialed. The evaluation visit had been a dream; I was so impressed with their site that I had to stop myself from declaring my wholehearted recommendation to the site manager. But I adhered to a business principle I had learned early on that applies to most situations in clinical research: 1: wait a moment before proceeding, and 2: consider all facts before drawing a conclusion. The evaluation visit was not finished and, though I felt that it would conclude positively, it was not over till it was over, as they say.
The site manager and I finished the final questions in her office. I broached the topic of regulatory audits and a tight look crossed her face. She informed me that the investigator had been audited by the FDA six months prior and a 483 had been unfairly issued. She downplayed the audit findings and insinuated that the company managing the trial was to blame. Though my instincts told me there was more to the story than she was revealing, I remained neutral as we finished our discussion. I wanted to believe her story and recommend the site for the study, but due diligence mandated I review the audit documents before making a final recommendation to the sponsor. The site manager presented the audit paperwork to me before I left the building. She thanked me for my time and informed me that they were looking forward to study participation. I nodded, smiled and stayed silent.
That afternoon I reviewed the long audit report and numerous significant findings such as informed consent violations and study drug temperature excursions. It was difficult to reconcile the audit report with the investigative site I had just evaluated. Their gilded surface obscured potential quality issues that warranted further investigation before a final decision was made. At that moment I was thankful for the “pause” that revealed the need for critical investigation.
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 or tweet @ebwcra.
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