Overheard at MAGI East 2023
The 2023 WCG MAGI East Clinical Research Conference held in Philadelphia last week brought together representatives of sites, sponsors, CROs and vendors to discuss key issues facing clinical trials. Here are just a few thoughts expressed by attendees and speakers at the conference.
- On involving underrepresented groups in clinical research, Quincy Byrdsong, vice provost for health affairs at Lipscomb University and member of the MAGI Steering Committee, urged sites and sponsors to go all the way with their community outreach efforts. “We shouldn’t expect any community to meet us halfway,” Byrdsong said. “We have to own it.”
- During a discussion of AI’s growing role in clinical research, Cheryle Evans, senior vice president of global clinical and biometric operations for Advanced Clinical, said she was “really excited about AI,” especially its potential to make data more accessible to people without a science or technology background and thus broaden the research workforce.
- Asked how much importance should be given to cybersecurity issues when developing or implementing new technology, Manny Lazaro, principal consultant with First Tracks Life Sciences Consulting, encouraged sites and sponsors to involve experts in early development. “Now, in the tech age, IT people need to be at the table,” Lazaro said.
- Karri Venn, COO and president of Centricity Research, reminded attendees to think of the impact on participants when selecting technology, such as wearable devices, for a trial. Unfamiliar devices, apps and software can be daunting for inexperienced users. “The burden isn’t just on the site, it’s on the patient.”
- “None of us planned to go into this industry,” said Stephanie Jones, manager of Versiti’s Clinical Trials and Research Office, when speaking about training for handling trial budgets. “We all got here by some ‘happy accident.’ That means that none of us have had the same training. We didn’t get to take a class in college that taught us how to negotiate a clinical trial agreement and the subsequent budget, and so what that looks like is each of our on-the-job trainings. If you’re a site coordinator, that’s going to look very different than if you’re a monitor or a CRA with a CRO. That experience paints and creates the lens that we each approach these budget negotiations. That leads to misunderstandings.”
- Venn also offered thoughts on trial staffing and retention. “People have to enjoy their jobs. They’re staying at their jobs because they like it. Having them do tasks they don’t like, ultimately, that’s part of our turnover issue. We need to get out of that mind frame and shift to, really, more who’s wearing the right hat in the right position.”
Finally, it may not be good poetry but it’s astonishingly on point: Trevor Cole, associate director of client delivery at WCG, presented a poem on inspection readiness generated by AI program ChatGPT. Cole reported that he input a variety of key words and output parameters into the program to produce this remarkable literary work:
Oh, the joy and the dread, it’s inspection time!
The FDA’s coming, it’s not a pantomime.
Clinical investigator, you must be prepared,
For their visit is looming, be not unawares!
They’ll come with their clipboards, all ready to snoop,
Checking every nook, every cranny, each group.
Your records, oh, they must be pristine and neat,
No room for mistakes, no room for deceit.
Your documents, organized, in perfect array,
Protocol deviations? No, not on this day!
Informed consent? Yes, it must be obtained,
Adverse events reported, no details unstained.
Ensure your staff is trained, oh, they must be adept,
For the FDA’s questions, they shall not accept
Any vague answers, any dubious reply,
Precision and clarity, oh my, oh my!
Oh, the FDA inspection, it’s quite a big deal,
But fear not, dear investigator, keep your zeal.
Be ready and confident, face them with a grin,
Show them your dedication, let your spirit win.
For in the end, it’s about patients, you see,
Ensuring their safety, their well-being, decree.
So be thorough, be diligent, in all that you do,
And the FDA’s visit shall bring no harm to you.
So march on, dear investigator, with pride in your stride,
Your research, your efforts, will never subside.
Embrace the inspection, let it fuel your fire,
And shine bright, dear investigator, never tire!
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