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Today’s episode of Heart of the Trial is all about the true heart of clinical research—the patients. Joining me is the brilliant Pauline Frank, who has spent years bridging the gap between clinical trial teams and patient advocates. If you’ve ever wondered how to improve patient engagement in clinical trials or why it’s so important, this episode is for you!

Highlights of the Episode:

• Meet Pauline Frank: A passionate advocate for increasing patient engagement in clinical trials, Pauline shares her journey and explains why getting patients involved early in the process is key to the success of studies.
• Breaking the Norm: Pauline discusses how traditional clinical trial designs often miss the mark by not incorporating patient feedback and how this leads to recruitment delays and high dropout rates.
• Changing Perceptions: There’s a common fear among trial teams that engaging with patients will slow things down or increase costs. Pauline breaks down why these concerns are often misconceptions and how true patient involvement can actually save time and money.
• Lessons from the Field: With over 17 years in the industry, Pauline shares eye-opening stories about how listening to patients has improved trial outcomes and reduced recruitment challenges.

Key Takeaways:

• The Power of Patient Voice: When patients are included in trial design and execution, recruitment rates improve, and dropout rates decrease—ultimately speeding up the entire trial process.
• Building Bridges: Pauline emphasizes the need for clinical teams and patient advocates to communicate better and start collaborating from the very beginning of the trial.
• Taking Small Steps: You don’t need to overhaul your entire system to start improving patient engagement—Pauline’s advice is to start small and learn as you go.

Episode Highlights:

• [0:01] Suzanne introduces Pauline Frank and the topic of patient engagement.
• [2:09] Pauline explains the misconceptions around the costs and delays of involving patients.
• [6:15] The reality of why 80% of trials face recruitment delays and how patient engagement can help.
• [11:22] Why getting patients involved early can save time and money in the long run.
• [18:00] Pauline shares success stories of trials that incorporated patient feedback.
• [24:40] The importance of education and communication in bridging the gap between patient advocates and clinical teams.
• [30:20] Pauline’s advice for anyone looking to improve patient engagement: “Start small and learn as you go.”

📞 Connect with Pauline Frank:

• LinkedIn: Pauline Frank
• Email: pauline@patientconnects.com

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

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Today we’re talking to Elizabeth Nelson, a powerhouse in the clinical research industry with over 25 years of experience in auditing, consulting, and training. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.

Her services have been requested by, and provided to, US federal agencies and military organizations, academic medical centers, industry Sponsors and Contract Research Organizations (CROs), Institutional Review Boards (IRBs), Clinical Investigators/clinical research facilities, and non-profit organizations. Buckle up for a thrilling conversation as we dive into the high-stakes world of clinical research compliance and hear jaw-dropping stories from Elizabeth’s career!

Highlights of the Episode:

• Meet Elizabeth Nelson: A clinical research quality expert, Elizabeth shares how she transitioned from a laboratory scientist to a clinical research auditor, driven by a passion for protecting patients and ensuring trial quality.
• Whistleblowing Wonders: Hear about the time Elizabeth and her team turned in a sponsor and two CROs to the FDA for unethical practices — a rare and courageous move in the industry!
• The Evolution of Clinical Quality: Learn how quality standards and auditing have transformed over the past two decades, and why independent oversight is more critical than ever.
• Auditor vs. Enforcer: Elizabeth reveals why she prefers to be a mentor rather than a “gotcha” auditor, emphasizing education over punishment to drive real change in clinical trials.
• Battling Bad Data: From finding identical blood pressure readings across multiple studies to uncovering falsified patient data, Elizabeth’s stories will leave you on the edge of your seat.

Key Takeaways:

• Protecting Patients First: Auditing is more than checking boxes; it’s about safeguarding the rights, safety, and well-being of trial participants.
• The Power of “Why”: Elizabeth’s work is rooted in a strong personal mission to ensure that research is conducted ethically and in the best interest of patients.
• Industry Shifts: The landscape of clinical trials is evolving, with more companies seeking mock audits and quality assessments upfront to avoid regulatory pitfalls.

Episode Highlights:

• [0:00] Suzanne introduces Elizabeth Nelson and her extensive experience in clinical research.
• [2:14] Elizabeth’s career journey from the CDC to clinical quality management.
• [5:35] The shocking story of turning in a sponsor and two CROs to the FDA.
• [11:21] Why training is often overlooked but critical in compliance.
• [14:43] When training isn’t the answer: Why audits matter.
• [20:56] Auditing IRBs and the complexities of ethical review oversight.
• [27:15] Hilarious (and horrifying) stories of poorly calibrated equipment and clueless staff.
• [36:30] Why consistency is key: Elizabeth’s mantra for maintaining quality in clinical trials.
• [42:19] Elizabeth’s advice for new auditors and the future of quality management.

📞 Connect with Elizabeth Nelson:

• Email: enelson@regriskmanagement.com
• Phone: 304-6

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

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Today we’re diving into the exciting world where genetics meets pharmacology. Dr. Emily Cicali will uncover the mysteries of pharmacogenomics (PGX) and explain how your DNA influences your response to medications. Get ready for insights, real-world applications, and a touch of scientific magic!

Emily J. Cicali, Pharm.D., earned her Doctor of Pharmacy from Philadelphia College of Pharmacy in 2015. She completed a Pharmacy Residency at Tabula Rasa HealthCare in Geriatric Personalized Medicine. Afterward, she joined Tabula Rasa HealthCare as a Research Pharmacist and adjunct faculty, focusing on pharmacokinetics and pharmacogenomics.

In 2017, she transitioned fully into academia, completing a pharmacogenomics fellowship at the University of Florida. Cicali is now a Clinical Associate Professor, runs a virtual pharmacogenetics consultation service called MyRx, and focuses on implementing pharmacogenomics and studying phenoconversion for medication safety.

Highlights of the Episode:

• Pharmacogenomics 101: Discover how this DNA test focuses on liver enzymes to predict your response to medications.
• Why It Matters: Learn how understanding your genetics can reduce trial-and-error in prescribing, especially for depression and anxiety.
• Emily’s Journey: Follow Emily’s path from a student fascinated by genetics to an expert in PGX, highlighting her passion and success.
• Clinical Research Impact: Hear about Emily’s role in clinical trials and how PGX testing is improving patient outcomes in pain and mental health management.

Key Takeaways:

• Personalized Medicine: Understand the importance of personalized medication therapy and how PGX can help tailor treatments to individual patients for better efficacy and fewer side effects.
• Real-Life Applications: Learn about the real-world implications of PGX testing, from reducing opioid use in pain management to improving outcomes for heart attack patients.
• Patient Empowerment: Emily emphasizes the role of PGX in empowering patients by giving them more control over their healthcare and improving communication with providers.

Episode Highlights:
[0:54] Emily explains pharmacogenomics and its significance.
[2:09] The benefits of knowing your genetic makeup before starting medication.
[3:25] Emily’s career journey and her passion for genetics and pharmacy.
[6:34] How PGX testing is integrated into clinical practice at MyRx.
[10:54] Emily’s experience in clinical research and the impact of PGX on patient outcomes.
[17:39] The mechanism of drug metabolizing enzymes and their role in medication efficacy.
[20:23] How to discuss PGX testing with your doctor and insurance considerations.
[26:08] Real-life success stories and patient experiences with PGX.
[30:26] Emily’s hopes for the future of PGX and its broader implementation in healthcare.
[36:43] Resources and advice for listeners interested in PGX testing.

📞 Connect with Dr. Emily Cicali:
Website: https://ufhealth.org/myrx/
Email: MyRx@cop.ufl.edu
Phone: 352-273-6415
LinkedIn: https://www.linkedin.com/in/emily-cicali-pharmd-2164b2a4/

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!