>>> CLINICAL TRIALS ARE THE WAY PHARMACEUTICAL COMPANIES AND OTHER HEALTHCARE RESEARCHERS DETERMINE WHETHER A NEW DRUG OR TREATMENT IS A.

BUT ONLY ABOUT 5% OF PEOPLE IN THE UNITED STATES PARTICIPATE IN CLINICAL TRIALS, AND ALMOST THREE QUARTERS OF THOSE PARTICIPANTS ARE WHITE.

THERE ARE SEVERAL REASONS FOR THAT LACK OF DIVERSITY AMONG TRIAL PARTICIPANTS, BUT IT CAN HAVE LIFE AND DEATH CONSEQUENCES FOR PEOPLE OF COLOR.

JOINING US NOW TO TELL US MORE ARE DR. JUKKA STEINBERG, A RESIDENT IN UPSTART AND GYNECOLOGY AT NORTHWESTERN UNIVERSITY SCHOOL OF MEDICINE -- FORESIGHT, FOUNDER OF THE LAZARUS CANCER FOUNDATION, WHICH WORKS TO IMPROVE CANCER OUTCOME FOR PATIENT BY PROVIDING GREATER ACCESS TO CLINICAL TRIALS, AND KENDALL WHITLOCK, HEAD OF DIGITAL OPTIMIZATION REAL-WORLD EVIDENCE CLINICAL TRIALS.

THANKS TO THE THREE OF YOU FOR JOINING US.

KENDALL WHITLOCK, I WANT TO START WITH YOU.

LAST YEAR, WALGREENS ANNOUNCED IT WAS ENTERING THE CLINICAL TRIAL BUSINESS IN A MOVE THAT COULD COMPLETELY DISRUPT THE CURRENT BUSINESS MODEL HOW CLINICAL TRIALS ARE DONE.

WHAT ARE THE BIGGEST PROBLEMS YOU SEE IN THE WAY CLINICAL TRIALS ARE CURRENTLY CONDUCTED?

AT LEAST WITH THIS LACK OF DIVERSITY AND PARTICIPATION?

>> THANK YOU SO MUCH FOR THE QUESTION AND THE OPPORTUNITY TO JOIN YOU THIS EVENING.

I THINK ONE OF THE BIGGEST FACTORS IS THAT TRADITIONAL CLINICAL TRIALS FROM THE SPONSOR PERSPECTIVE MAY HISTORICALLY GO BACK TO THE SAME LOCATIONS AND INVESTIGATORS AND SITES THAT HAVE HISTORICALLY BEEN USED SUCCESSFULLY IN THEIR TRIAL RECRUITMENT EFFORTS.

BUT WHEN THEY START TO UNPACK THE RECRUITMENT EFFORTS AND LOOK AT WHETHER OR NOT THERE IS DIVERSITY IN THE POPULATION OF PATIENTS WHO WERE RECRUITED, IT PAINTS ANOTHER PICTURE.

SO, BY RETURNING TO THE SAME SITES, THEY GET THE SAME ALLOTMENT OF THOSE WHO ARE GEOGRAPHICALLY PROXIMATE TO THEIR OWN LOCATION .

DIVERSIFYING CLINICAL TRIALS COMES THROUGH A VARIETY OF CHANNELS, ONE OF THEM IS THE USE OF DIGITAL TECHNOLOGY.

DURING THE COVID-19 PANDEMIC, WE SAW THE USE OF TELEMEDICINE, FOR EXAMPLE, THE SHIPMENT OF INVESTIGATIONAL MEDICAL PRODUCTS TO PATIENTS AT HOME, AND PATIENTS ELEVATING EXPECTATIONS THAT THEY WOULD HAVE OPTIONS IN THE CONVENIENCE AND ACCESS THEY WOULD HAVE TO ACCESS CARE, INCLUDING CLINICAL RESEARCH.

I WILL PAUSE BECAUSE I KNOW OUR TIME IS LIMITED.

>> LOST TO TALK ABOUT.

I KNOW ALL OF YOU CAN GIVE A 30 MINUTE PRESENTATION.

KENDALL, I WANT TO COME BACK TO YOU, BECAUSE OF THE NOTORIOUS EXPERIENCE EXPERIMENTS, WE ARE TALKING ABOUT HENRIETTA LACKS LATER IN THE SHOW, OFTEN CITED AS THE REASON WHY THE BLACK COMMUNITY DOES NOT TRUST THE MEDICAL COMMUNITY, AND IS RELUCTANT TO PARTICIPATE IN CLINICAL TRIALS.

DOES THAT TRESS WAY REMAIN A FACTOR?

WHAT OTHER ISSUES PREVENT PEOPLE OF COLOR AND BLACK PEOPLE IN PARTICULAR FROM GETTING INVOLVED?

>> I THINK THAT STORY OF TUSKEGEE IS ONE OF SEVERAL IN THE BARRIERS TO BLACK PARTICIPATION AND CLINICAL TRIALS.

YES THERE WAS GUIDANCE FOR FDA LAST YEAR, BUT WE KNOW THERE ARE 350 YEARS OF ATROCITIES ILLUSTRATED IN MEDICAL APARTHEID BY HARRIET WASHINGTON MANY YEARS AGO, THAT ILLUSTRATED THIS ISSUE IS NOT ONLY PERVASIVE IN AFRICAN-AMERICAN COMMUNITIES, BUT IN BLACK AND BROWN COMMUNITIES IN THE U.S. AS WELL AS GLOBALLY.

THIS DID NOT ONLY HAPPEN TO ONE SEGMENT OF SOCIETY, IT HAPPENED WORLDWIDE FOR HUNDREDS OF YEARS.

EVEN IN OB/GYN, WE HAVE STATUTES IN THIS COUNTRY OF MARION, CELEBRATED AS THE FATHER OF GYNECOLOGY, YET THESE EXPERIMENTS WERE DONE WITHOUT ANESTHESIA ON SLAVES.

SO SOME OF THOSE STORIES THAT WILL AFFECT GIVING AT CHRISTMAS DINNER TABLES, PASSED DOWN GENERATION AFTER GENERATION.

IF ALL THE PEOPLE KNOW IS THE NEGATIVES OF THE HISTORIC PAST, THEY MAY NOT BE OPEN TO LEARNING WHAT THERE IS IN PLACE IN TERMS OF CONTROL AND PROTECTIONS FOR PATIENTS AND PARTICIPANTS IN CLINICAL TRIALS.

>> DR. STEINBERG, IS BIAS AMONG THE ACTUAL RESEARCHERS, CONSCIOUS OR NOT, DOES THAT FACTOR INTO HAVING A CLINICAL TRIAL FULL OF PARTICIPANTS WHO ARE MOSTLY WHITE?

>> I THINK IT CERTAINLY FACTORS INTO THE HOMOGENEITY AMONG CLINICAL TRIAL PARTICIPANTS.

WE KNOW RIGHT NOW THAT PART OF THE PROBLEM THAT CAUSES THE LACK OF DIVERSITY IN CLINICAL TRIALS IS THE LACK OF DIVERSITY AMONG RESEARCHERS.

WE NEED TO PROMOTE AND ENCOURAGE AND SUPPORT DIVERSE RESEARCHERS AND EQUIP RESEARCHERS WITH THE TOOLS AND CULTURAL COMPETENCY TO RECRUIT DIVERSE PARTICIPANTS AND MAINTAIN THEIR PARTICIPATION THROUGHOUT CLINICAL TRIALS.

BIAS TRAINING, DIVERSITY EQUITY INCLUSION AND BELONGING TRAINING OUR FIRST STEPS, BUT EFFORTS NEED TO BE MADE IN EVERY ASPECT OF THE RESEARCH INFRASTRUCTURE TO REDUCE BIAS AND ENCOURAGE THE PARTICIPATION OF DIVERSE PARTICIPANTS.

>> YOUR FOUNDATION AIMS TO INCREASE ACCESS AND DIVERSITY IN CANCER CLINICAL TRIALS.

HOW DID YOU BECOME AWARE OF THE ISSUE THAT ACCESS IN CLINICAL TRIALS WAS A PROBLEM?

>> I STARTED LAZARUS 17 YEARS AGO, BASED ON A FAMILY SITUATION WITH PANCREATIC CANCER.

I IMMEDIATELY BECAME FAMILIAR WITH THE BARRIERS TO CLINICAL TRIAL PARTICIPATION.

FOR US, MY FAMILY PERSONALLY, IT WAS KNOWLEDGE.

WE KNEW NOTHING ABOUT TRIALS UNTIL I STARTED LOOKING INTO IT.

AND WHEN I GOT MY BROTHER-IN-LAW INVOLVED IN A TRIAL, I GOT TO REACH INTO MY POCKET EVERY WEEK TO GET HIM WHERE HE NEEDED TO GO.

THOSE TWO THINGS MADE A BIG IMPRESSION ON ME, BECAUSE I HAD THE TIME TO BE ABLE TO IDENTIFY TRIAL OPPORTUNITIES FOR MY BROTHER-IN-LAW.

AND FORTUNATELY, MY FAMILY WAS IN A FINANCIAL POSITION TO SUPPORT HIM THROUGH THAT PROCESS.

THAT SEEMED KIND OF MORALLY AND FUNDAMENTALLY WRONG TO ME THAT HERE, MIKE 'S FAMILY GOT TO BENEFIT, BECAUSE HE WAS IN THAT SITUATION.

WHAT DO OTHERS DO, WHO ARE NOT IN THAT SITUATION?

SO, THAT WAS THE BASIS BEHIND LAZARUS.

AND AS WE STARTED TO HELP PATIENTS IDENTIFY TRIALS AND PROVIDE FINANCIAL ASSISTANCE TO THEM, TO COVER THE TRAVEL EXPENSE SO THEY COULD ACTUALLY GET WHERE THEY NEED TO BE AND OUR NETWORK STARTED TO GROW, WE HAD PRINCIPAL INVESTIGATORS AND CLINICAL RESEARCH COORDINATORS AND SOCIAL WORKERS CALLING US TO SAY, HEY, WE REALLY NEED YOU TO HELP US FIX THIS DISCONNECT AROUND OUR COMMUNITIES OF COLOR AND THEIR LEVEL OF PARTICIPATION IN CLINICAL TRIALS.

SO, WE TURNED OUR FOCUS TO THAT IN 2012, AND REALLY STARTED TRYING TO UNDERSTAND THE OTHER BARRIERS , PARAMETERS, ISSUES, AND SOCIAL DETERMINANTS OF HEALTH, REALLY GET A GRIP ON THE ENTIRE PICTURE SO THAT WE COULD DEVELOP A PLACE-BASED AND CULTURALLY APPROPRIATE PROGRAM TO INCREASE ESPECIALLY AFRICAN-AMERICAN BLACK PARTICIPATION.

BACK AND THAT LACK OF DIVERSITY, DR. STEINBERG, AND CLINICAL TRIALS CAN LEAD TO NEGATIVE HEALTH CONSEQUENCES DOWN THE LINE.

>> YEAH, I THINK ONE EXAMPLE THAT REALLY SUMMARIZES EXACTLY WHAT YOU'RE TALKING ABOUT, THE LACK OF CLINICAL TRIAL DIVERSITY DIRECTLY IMPACT HEALTH OUTCOMES WAS DEMONSTRATED IN THE RESEARCH OF DR. KENNY DOLL.

SHE INVESTIGATED UTERINE CANCER AND ENDOMETRIAL CANCER.

THE STANDARD TOOL FOR DIAGNOSING ENDOMETRIAL CANCER WAS DEVELOPED AND RESEARCHED DONE PREDOMINANTLY WITH WHITE PARTICIPANTS.

SHE IDENTIFIED THAT THAT GOLD STANDARD, WHICH IS NOW USED ACROSS THE UNITED STATES, IS MUCH LESS SUCCESSFUL AND MUCH LESS ACCURATE IN BLACK WOMEN.

WE KNOW THAT BLACK WOMEN ARE THREE TIMES MORE LIKELY TO DIE OF ENDOMETRIAL CANCER THAN WHITE WOMEN.

THIS DISPARITY HAS MANY FACTORS, BUT ONE CONTROLLING FACTOR IS THAT OUR TOOLS DEVELOPED THROUGH THIS RESEARCH DID NOT INCLUDE DIVERSITY AND DID NOT ACCOUNT FOR THEIR HEALTH.

THAT SEEMS LIKE A GOOD, OBVIOUS PLACE TO START.

DENA, WHAT ASSISTANCE DOES YOUR FOUNDATION PROVIDE FOR PATIENTS WHO WOULD LIKE TO PARTICIPATE IN CLINICAL TRIALS?

>> WE HAVE PATIENTS NAVIGATE THROUGH THE CLINICAL TRIAL OPTIONS TO IDENTIFY TRIALS THEY COULD POTENTIALLY QUALIFY FOR.

AND IF THEY NEED HELP WITH THE OUT-OF-POCKET EXPENSES, WE DO COVER THE TRAVEL EXPENSES FOR THE PATIENT AND TRAVEL COMPANIONS, SO THEY CAN GET WHERE THEY NEED TO BE WHEN THEY NEED TO BE THERE.

WE STICK WITH THEM THROUGHOUT THEIR JOURNEY.

>> AND WHITLOCK, WE HAVE ABOUT 45 SECONDS.

CAN YOU!

AND HOW WALGREENS AIMS TO DISRUPT THE MODEL HOW CLINICAL TRIALS ARE CONDUCTED?

>> WELL, I JOINED WALGREENS A YEAR AGO.

IT IS THE MOST EXCITING OPPORTUNITY OF MY CAREER.

THERE ARE THREE SERVICE LINES FOR THE REAL-WORLD EVIDENCE CLINICAL TRIALS BUSINESS.

THE PREDOMINANT THEME IS PATIENT RECRUITMENT.

WE KNOW THAT IS THE LION'S SHARE OF A BUDGET, AND THAT TRIAL RECRUITMENT IS OFTEN NOT SUCCESSFUL, SOMETIMES TRIALS HAD TO STOP BECAUSE RECRUITMENT IS POOR.

WE LEARNED DURING THE PANDEMIC THAT, AGAIN, THE USE OF DIGITAL TECHNOLOGY ENABLES TELEMEDICINE CONSULTATIONS.

IF YOU CAN MAKE THE CONVENIENCE OF THE TRIAL RELEVANT FOR THE EXPERIENCE THAT A PERSON HAS -- TRANSPORTATION IS A BIG ISSUE FOR MANY PEOPLE, AND IF YOU ARE TRYING TO RECRUIT PEOPLE WHO HAVE TO TAKE AN AVERAGE OF TWO HOURS TO REACH A SITE, THAT MAY BE A BARRIER TO PARTICIPATION.

IF YOU CAN HELP THEM WITH EITHER A VIRTUAL VISIT WHERE WARRANTED OR BY HELPING THEM WITH THE TRANSPORTATION TO A LOCAL SITE SUCH AS A WALGREENS, THAT IS A BETTER OPTION FOR PEOPLE.

>> KENDALL?

REAL-WORLD EVIDENCE.

I AM GLAD YOU WERE ABLE TO GET THAT THIRD ONE IN, BUT WE ARE OUT OF TIME.

I KNOW YOU ARE AT THE BLACK WOMEN'S