VOICE-ACTIVATED - A Regulatory Reckoning of Authentic Engagement in Clinical Trials

VOICE-ACTIVATED - A Regulatory Reckoning of Authentic Engagement in Clinical Trials

In this follow-up to my keynote presentation at the meeting of the North Carolina Regulatory Affairs Forum (NCRAF) in conjunction with the Triangle Chapter of the ACRP, I’m reflecting— full-chested and unfiltered— on what it means to be voice-activated in an ecosystem that still hasn’t gotten the memo. Among other themes, I’m talking about the fallacy of “coercion” when it comes to compensating participants. I’m calling out the lazy copy/paste of outdated inclusion/exclusion criteria that keep too many out—and keep our data from ever being truly equitable or personalized. I’m challenging regulatory professionals to take action with something as simple and impactful as a “find and replace” to retire the word subject once and for all. This isn’t just critique. It’s a call to courage. A love letter to those of us who’ve been in the research chair— and a charge to those in power to shift how we show up. This was only the tip of the iceberg… and now it’s time to melt what’s been frozen far too long. Get the 'voice-activated' t-shirt to demonstrate your intentions. Read my 'Equity 'N Action' newsletter article on LinkedIn on the same topic. Still more at www.allisonkalloo.me. #VoiceActivated #ClinicalResearchReckoning #NCRAF #ACRP #NCRAF2025 #ACRPVoices #ParticipantPerspective #RegulatoryReformNow #CompensateFairly #InclusionNotIllusion #FindAndReplace #DataWithDignity #EthicsInAction #TechForTrust #TrialParticipantsMatter #Partners #ICF #Coercion #Compensation #IECriteria #ProtocolDesign #Bias #BakedInBias #PersonalizedMedicine #Iceberg Send a text [https://www.buzzsprout.com/twilio/text_messages/2360406/open_sms] #ClinicalTrials #HealthEquity #DiversityInResearch #UnderrepresentedCommunities #ClinicalResearch #Biopharma #RegulatoryAgencies #CROs #PatientAdvocacy #HealthInnovation #NoOrdinarySubjects #Podcast #HealthPodcast #MedicalResearch #ClinicalResearch #InclusionInResearch #HealthDisparities #PrecisionMedicine #PersonalizedMedicine #PatientCentricity #ResearchEthics #FDA #NIH #EquityInHealth #ChangeTheStatusQuo #MeaningfulSolutions #DEIinHealthcare #HealthDisparities #InclusionInResearch #PatientAdvocacy #PatientStories #HealthPolicy #HealthInnovation #Biotech #Pharmaceuticals #MedicalPodcast #EquityInHealth #RepresentationMatters #UnconsciousBias #CulturalCompetency #HealthJustice #ResearchEthics #UnderrepresentedCommunities #HealthOutcomes #ClinicalCare #HealthResearch

TRUTH, Not Trust, Is the REAL Currency in Clinical Trials

> In this episode, I touch on why truth, not just trust, is essential in clinical research. I challenge the status quo, advocating for radical transparency to empower participants and build genuine engagement. Read my more in-depth article in the newsletter, Equity 'n Action on LinkedIn. #MedicalResearch #Healthcare #TransparencyInResearch #TruthInTrials  #ResearchEthics #CommunityEngagement #RadicalTransparency #NoOrdinarySubjects #AllisonKalloo #ResearchTransparency #BeyondTrust #MarginalizedCommunities  #SystemicInequality #HistoricalTraumaInResearch #DEIinResearch #DataTransparency #AskTheQuestions #DemandTransparency #InformedChoice #PowerToThePeople #April2025 Send a text [https://www.buzzsprout.com/twilio/text_messages/2360406/open_sms] #ClinicalTrials #HealthEquity #DiversityInResearch #UnderrepresentedCommunities #ClinicalResearch #Biopharma #RegulatoryAgencies #CROs #PatientAdvocacy #HealthInnovation #NoOrdinarySubjects #Podcast #HealthPodcast #MedicalResearch #ClinicalResearch #InclusionInResearch #HealthDisparities #PrecisionMedicine #PersonalizedMedicine #PatientCentricity #ResearchEthics #FDA #NIH #EquityInHealth #ChangeTheStatusQuo #MeaningfulSolutions #DEIinHealthcare #HealthDisparities #InclusionInResearch #PatientAdvocacy #PatientStories #HealthPolicy #HealthInnovation #Biotech #Pharmaceuticals #MedicalPodcast #EquityInHealth #RepresentationMatters #UnconsciousBias #CulturalCompetency #HealthJustice #ResearchEthics #UnderrepresentedCommunities #HealthOutcomes #ClinicalCare #HealthResearch

Contagion of Doubt: How Misinformation Brought Measles Back

This episode of No Ordinary Subjects confronts the return of measles in the United States— a disease we once eliminated. We explore how rising vaccine hesitancy, fueled by years of politicized misinformation and erosion of public trust, has weakened our collective defenses and put us back at risk. Drawing connections between the sidelining of science during the COVID pandemic and today’s outbreaks, we dig into what herd immunity means, who gets left behind and at risk when it's compromised, and why protecting public health demands reconciliation with science-based expertise and the facts. #NoOrdinarySubjects #Measles #Vaccination #Immunity #Outbreak   #PublicHealth #PublicHealthCrisis #HerdImmunity #VaccineHesitancy   #TrustScience #ScienceNotSilence #StopTheSpread #MisinformationKills   #ProtectOurKids #HealthEquity #HealthJustice #CommunityImmunity   #FactsMatter #ThisIsPreventable #WakeUpCall #ReclaimPublicHealth   Send a text [https://www.buzzsprout.com/twilio/text_messages/2360406/open_sms] #ClinicalTrials #HealthEquity #DiversityInResearch #UnderrepresentedCommunities #ClinicalResearch #Biopharma #RegulatoryAgencies #CROs #PatientAdvocacy #HealthInnovation #NoOrdinarySubjects #Podcast #HealthPodcast #MedicalResearch #ClinicalResearch #InclusionInResearch #HealthDisparities #PrecisionMedicine #PersonalizedMedicine #PatientCentricity #ResearchEthics #FDA #NIH #EquityInHealth #ChangeTheStatusQuo #MeaningfulSolutions #DEIinHealthcare #HealthDisparities #InclusionInResearch #PatientAdvocacy #PatientStories #HealthPolicy #HealthInnovation #Biotech #Pharmaceuticals #MedicalPodcast #EquityInHealth #RepresentationMatters #UnconsciousBias #CulturalCompetency #HealthJustice #ResearchEthics #UnderrepresentedCommunities #HealthOutcomes #ClinicalCare #HealthResearch

The 2025 Reckoning: Refusing to Rewrite History

In this episode of No Ordinary Subjects, host Allison Kalloo unpacks the dangerous implications of the Trump administration’s latest executive order, Restoring Truth and Sanity to American History, which takes direct aim at the Smithsonian Institution—specifically, the National Museum of African American History and Culture. This isn’t just about rewriting history; it’s about erasing it. We explore how this calculated attack on historical integrity threatens not only cultural institutions but also industries that rely on truth—healthcare, technology, and business. What happens when systemic erasure extends to medical research, clinical trials, and AI development? What’s at stake when Black contributions are deliberately excluded from the national consciousness? This episode is a call to action. Beyond passive allyship, we discuss what it means to be an accomplice in the fight for truth. Because neutrality is not an option when history itself is under siege. Join the conversation. Send a text [https://www.buzzsprout.com/twilio/text_messages/2360406/open_sms] #ClinicalTrials #HealthEquity #DiversityInResearch #UnderrepresentedCommunities #ClinicalResearch #Biopharma #RegulatoryAgencies #CROs #PatientAdvocacy #HealthInnovation #NoOrdinarySubjects #Podcast #HealthPodcast #MedicalResearch #ClinicalResearch #InclusionInResearch #HealthDisparities #PrecisionMedicine #PersonalizedMedicine #PatientCentricity #ResearchEthics #FDA #NIH #EquityInHealth #ChangeTheStatusQuo #MeaningfulSolutions #DEIinHealthcare #HealthDisparities #InclusionInResearch #PatientAdvocacy #PatientStories #HealthPolicy #HealthInnovation #Biotech #Pharmaceuticals #MedicalPodcast #EquityInHealth #RepresentationMatters #UnconsciousBias #CulturalCompetency #HealthJustice #ResearchEthics #UnderrepresentedCommunities #HealthOutcomes #ClinicalCare #HealthResearch

Guidance with Teeth - Why the FDA Needs Enforcement Power

In this episode of No Ordinary Subjects, host Allison Kalloo exposes a critical flaw in how clinical trials are regulated in the U.S. The FDA can issue guidance, make recommendations, and encourage diversity— but it lacks the power to enforce meaningful change. Without Congressional action, clinical trial sponsors can continue treating inclusion as optional. It’s time to demand more than suggestions. Tune in for a frank discussion on why the FDA needs real authority and what’s at stake if we keep accepting business as usual. Read the companion article on LinkedIn. #NoOrdinarySubjects #RegulatoryPower #PatientAdvocacy #PublicHealth #HealthcarePolicy #DrugApproval Send a text [https://www.buzzsprout.com/twilio/text_messages/2360406/open_sms] #ClinicalTrials #HealthEquity #DiversityInResearch #UnderrepresentedCommunities #ClinicalResearch #Biopharma #RegulatoryAgencies #CROs #PatientAdvocacy #HealthInnovation #NoOrdinarySubjects #Podcast #HealthPodcast #MedicalResearch #ClinicalResearch #InclusionInResearch #HealthDisparities #PrecisionMedicine #PersonalizedMedicine #PatientCentricity #ResearchEthics #FDA #NIH #EquityInHealth #ChangeTheStatusQuo #MeaningfulSolutions #DEIinHealthcare #HealthDisparities #InclusionInResearch #PatientAdvocacy #PatientStories #HealthPolicy #HealthInnovation #Biotech #Pharmaceuticals #MedicalPodcast #EquityInHealth #RepresentationMatters #UnconsciousBias #CulturalCompetency #HealthJustice #ResearchEthics #UnderrepresentedCommunities #HealthOutcomes #ClinicalCare #HealthResearch