Effectively presenting critical study endpoints in an abbreviated timeframe
A response to any message must be carefully crafted, considered and reconsidered before being sent, as we all know. One cannot reach into cyberspace and easily recall a transmission. Once the message is received, words therein are part of the proverbial audit trail critical to research documentation. This is why I hovered indecisively over my keyboard after reading a frustrating email from a co-worker that signaled an impending issue.
“So you’re telling me that I have less than fifteen minutes to present the protocol to the key opinion leader, who also happens to be the primary author?”
Her one word email response summed up the difficulty of the situation I faced: “Sorry.”
I stared at my computer screen and unsuccessfully wished myself back to Hawaii.
Before leaving for vacation, I had agreed to cover a site assessment meeting with a key investigator at an academic institution. Though the therapeutic area was complicated, I was familiar with the indication, and had previously monitored the site, so I was comfortable with the assignment. The meeting was scheduled to occur four days after my return from PTO. The circumstances were optimal for successful execution.
Unbeknownst to me, while I was out of the office, the site had requested that the meeting be rescheduled for two days earlier than planned. The aforementioned change had been agreed to without my knowledge; the irony was that the only one not consulted regarding the change, was the one most affected (me). The meeting change gave me less than a day (the day I returned from vacation) to familiarize myself enough with a 200 page protocol and accompanying slide deck to perform a rapid fire discussion with the physician expert. In under 15 minutes. On his lunch break.
The meeting was critical and not something I would reschedule, despite the obstacles before me. Fourteen years of monitoring experience had prepared me for a variety of issues, and I was not about to let my team down. In dealing with meetings and medicine, change is inevitable and must be dealt with precision and focus. I sent a confirmatory email agreeing to the change, to broker calm in the midst of potential conflict.
“Consider it done.”
My bravado did little to contain the panic I kept at bay as I exited Outlook to strategize my preparation. Presenting the study to the primary authoring physician would seem a simple enough process. He was well versed in protocol design. One would expect a token slide review, a swift facilities tour and gratuitous small talk to conclude the meeting. This could not be farther from the truth. This investigator was integral to study success and had been specifically selected by the sponsor for his expertise. The CRA conducting the assessment meeting, considering the particular audience, had to be knowledgeable without arrogance, engaging without being overly familiar, competent without being monotonous. The CRA was the first direct impression of the CRO. How the short meeting was conducted would strengthen or diminish credibility with the sponsor, and I was not about to facilitate the latter.
My mental Rolodex spiraled wildly with all the study elements I would review under normal circumstance. Investigational Product (IP) information and mechanism of action, therapeutic information, study objectives and endpoints, safety data and previous trial statistics, inclusion exclusion criteria, the study schedule of assessments, serious adverse event/adverse event reporting, enrollment, study duration, visit windows, Investigator’s Brochure, and investigator commitment. Now I needed to cut that by 60%, to prioritize the data presented to meet the unrealistic timeline imposed by the site.
My first priority was to read the protocol, to get a sense of study eligibility, endpoints and logistics. From that foundation I would make an efficient presentation:
- I separated the study schedule of assessments from the protocol, which would be the first point of presentation with the investigator. Investigators value straightforward information and there is no better way to start a protocol discussion than by providing a snapshot of the procedure schedule and timing.
- My next step was to abbreviate recent study drug safety data from the ongoing phase II study, which I placed on the next division of slide content. I know the investigator would be interested in this data, as he would not yet have had access.
- I then collated the most critical Inclusion/ Exclusion Criteria onto several slides, skipping criteria standard to most protocols (compliant population, reproductive and general medical info). I wanted to address what would most impact patient safety and identification, to help solicit feedback on enrollment capabilities.
- I purposefully added the enrollment information slide after eligibility criteria review. The global enrollment expectations for the study and each site would make more sense after the inclusion exclusion criteria slides and ensuing discussion. I would obtain a better sense of site enrollment capability and patient access if I completed strategic discussions in this order.
- The next slides would cover the primary and secondary study endpoints, study procedures and testing that influenced or generated endpoint data.
- The final slides would cover global/patient study duration, safety reporting requirements and 1572 section 9, Investigator Commitments.
Following these topics ensured I addressed everything required to complete minimum assessment standards. The pointed preparation would facilitate rapid execution and help ensure all meeting participants were positively engaged and informed. It would facilitate the impression of efficiency and professionalism required for such a critical meeting.
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. Email email@example.com
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