Experience and compromise make all the difference
Monday, December 5, 2016
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
It is the responsibility of the investigator to delegate to appropriately experienced staff. The scope of practice is defined by education, training and licensure. The investigator must recognize the capabilities and limits of staff to whom he/she has delegated study tasks, and assign accordingly.
Many years ago, I was tasked to evaluate a new CRA performing a pre-study assessment visit at a prominent cancer center. The oncology study had a data endpoint analysis looming, with at least 50 more patients needed for the critical deadline. The sponsor was targeting key investigators for the additional patient recruitment effort, and the study team was scrambling to identify and activate the noted sites, all of whom were prominent oncology physicians with large patient databases and experienced research staff. The CRA had already discussed the qualification visit parameters with the institutional study coordinator (SC), and the site was eager to participate.
The CRA I was evaluating appropriately referenced the protocol to answer my preliminary questions and demonstrated sufficient knowledge of the site assessment process. Together, the CRA and I met with the SC. The SC confirmed the appropriate investigator experience as per the feasibility questionnaire (seven years), as well as her own clinical experience (physician’s assistant). She also disclosed an additional RN with two years of research experience who would serve as the backup SC. I then learned that she (the primary SC) had only been involved in clinical research for three months and was serving as the primary SC on seven enrolling oncology studies with complicated indications. When we inquired as to an investigator training plan for the SC, she informed us that she was learning “on the job.”
Her inexperience was further revealed during the protocol discussion. She asked for clarification on common research terminology (double blind, wash-out) and had an inscrutable expression during the inclusion/exclusion discussion. This study needed rescue sites with seasoned staff ready to hit the ground running for swift patient identification and screening. This was not a suitable time to foster a research-naive SC with good intentions, but who lacked the experience for rapid study assimilation.
During the study external vendor/systems discussion, the principal investigator (PI) introduced himself and informed us he would return for the protocol discussion after his morning clinic. After his departure, the SC nonchalantly informed the CRA that she had scheduled 10-15 minutes for the PI discussion. The CRA was surprised by this declaration, as he had confirmed the requisite 30 minute discussion with the PI when first scheduling with the SC. The SC then informed the CRA that the time had changed as she and the PI were attending a hospital meeting during lunch. They would be gone for forty-five minutes of the pre-study visit.
This was yet another stumbling block to the assessment process because of the SCs lack of experience, as a research experienced site would not have planned a pre-study visit with a potential conflict. The CRA reminded the SC that he had requested the four hour time frame to appropriately assess the site. He asked if she could skip the meeting and finish the qualification visit, as he had to leave the site by early afternoon to accommodate his travel schedule. The SC was unwilling to compromise and insisted on leaving to attend the hospital meeting.
The PI then entered the conference room for the protocol discussion. The CRA swiftly reviewed the critical study endpoints, eligibility criteria, schedule of assessments and investigator responsibilities in light of their impending departure. He appropriately covered all required investigator components in less than twenty minutes. We then informed the SC we would resume the meeting upon her return.
During lunch, I asked the CRA for his feedback on the events of the morning. He correctly advised that the actions of the SC during the assessment visit demonstrated a level of inexperience potentially unsuitable to support the rapid rescue study effort. The CRA had scheduled the appropriate activities and time parameters with the SC, but she had dismissed them without notification. An experienced SC would have worked within the agreed timeframe and made alternate plans to cover her absence. However, as the study needed sites, we agreed to keep an open mind and suggested that the experienced RN serve as the primary SC and the current SC serve as backup SC. We would recommend further research training and documentation to support her learning process.
Later, we struggled to finish the facilities tour. The SC rushed us through pharmacy and records and had not arranged for us to confirm the imaging department. We were not able to fully confirm site equipment and therefore were not able to conduct an appropriate assessment. The final validation of our decision not to recommend the site was the SCs response to the suggestion that her experienced colleague serve as the primary SC to expedite the regulatory approval and patient screening process. She was displeased with our recommendation and informed us that her knowledge level was suitable for the role; there would be no changes to the SC designation. A latter suggestion of the same to the PI rendered a similar response.
We did not recommend the site for participation. The sponsor supported our recommendation. Inappropriate delegation had resulted in a missed study opportunity that could have been averted with the smallest 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 works in relationship development/study startup. Email email@example.com or tweet @ebwcra.
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