A6 JULY 8-14, 2020 HEALTH NEW PITTSBURGH COURIER Take Charge Of Your Health Today. Be Informed. Be Involved. COVID-19 trials must include Black community This month, the “Take Charge of Your up 25% of all COVID-19 cases in Allegheny ment phase. African American participants Health Today” page discusses vaccine tri- County (according to the Allegheny County are then typically interacting with an all- als and their relationship with Pittsburgh’s Health Department), yet only make up about white research team. This could lead to lower African American community. The current 13% of its population. We can’t afford not to retention rates. Including African Americans COVID-19 pandemic has increased pres- be included in the COVID-19 vaccine clinical throughout the entire process looks like gar- sure for the medical community to develop trials. nering input around recruitment and reten- a vaccine to combat COVID-19. The devel- In order to gain footing in research-inclu- tion plans, protocols and the dissemination opment of a new vaccine means that clinical sive spaces, it is my hope that studies include process. trials will eventually begin to recruit par- opportunities for community input on topics Establish pipelines for researchers from ticipants. We must ensure that COVID-19 like the value of participation. What is in it for the community. African Americans are usu- clinical trials will include African American community members who are asked to share ally an afterthought when conducting re- participants. Systemic racism in the United their lived experiences? What is the plan for search studies. Most researchers who are States is responsible for the medical mistrust returning results, including closing the loop receiving funding to study our communities among African Americans and could be part on the work in and with communities—par- often decide on a research question based on of the reason for their historically low partic- ESTHER BUSH ticularly black and brown communities that surface knowledge. However, we know that ipation in clinical trials. have been historically marginalized—to this is not an equitable process. Researchers In my role as codirector of the Community lic health’s sector failure to establish trust ensure that researchers are doing the work are instead contributing to the medical mis- PARTners core at the University of Pitts- keeps the Tuskegee stigma alive. they set out to do? Accountability in research trust by doing research on African Ameri- burgh’s Clinical and Translational Science The Community PARTners core and the environment means so much. When possible, can communities instead of with them. The Institute (CTSI) and as president and CEO Urban League are vigilant and hold our thinking about offering both day and evening Urban League of Greater Pittsburgh has of the Urban League of Greater Pittsburgh, I medical system accountable, ensuring Pitts- hours to participate in the research, provid- been partnering with CTSI for more than have made a commitment to inform and ed- burgh’s African American community that ing childcare and offering inroads to break 14 years now. In that time, I have learned so ucate people about how they can take charge this will never happen again. down defi nitions and ethical considerations much from CTSI leaders like Dr. Steve Reis of their health. State-sanctioned violence has In a 2015-16 Food and Drug Administra- and exploring safety and privacy in ways and my friend Dr. Elizabeth Miller. In turn, been perpetuated against African Americans tion report, of the women who participated that all participants understand, are critical they have also learned a lot from the African in the name of medicine since the United in cardiovascular trials in the United States, to making research inclusive. American community. This reciprocal rela- States’ inception. The “Tuskegee Study of only 3.2% identifi ed as African American, I have two recommendations for research- tionship between our two organizations has Untreated Syphilis in the Negro Male,” a while 78.7% of participants identifi ed as ers who want to increase African American helped to build a pipeline between research- United States’ Public Health Service-led re- white. The racial makeup of these studies participation in clinical trials. Be mindful ers and the African American community. I search study from 1932 to 1972, intention- does not refl ect the 13.7% of African Amer- that these suggestions are not a complete am extremely proud of the mutual trust and ally infected African American males with ican women in the country. This does not list and are only intended to initiate the di- respect our organizations have built. I look syphilis without their consent. The study’s seem to be an adequate sample of African alogue. forward to what we will continue to accom- participants were not adequately treated, American women and raises red fl ags on the Include us throughout the entire research plish together. and, in some cases, not treated at all, even by accuracy of treatment outcomes for all wom- process. Hiring a research recruiter that Thank you, readers. Please join the Take 1947 when penicillin was commonly used to en. Because we want studies of the current looks like us does not help to overcome the Charge of Your Health page next month treat the disease. We may not have any un- coronavirus pandemic to apply to all of us, barrier of mistrust. Even if the recruiter can when we talk about food insecurity, with ethical historical precedents like Tuskegee African American participation in clinical connect with the African American commu- particular insight into access during the in our city or universities; however, the pub- trials is essential. African Americans make nity, that relationship ends after the recruit- COVID-19 pandemic. Pittsburgh vaccine trials at forefront of COVID-19 research

In the late 1940s and early 1950s, and indicate their interest in being a people in the United States were part of the phase-three study so that afraid of contracting , a highly the community is prepared for when contagious, disabling and sometimes the study begins. deadly disease. It hit children espe- As with any study, Drs. Martin and cially hard. At its peak in 1952, the Hoberman say it is necessary for the virus infected 60,000 children. Some COVID-19 vaccine study to include parents kept their children indoors people of any race, gender, sex or and isolated during the summer, a ethnicity. The more diverse a study season when the virus seemed espe- population is, the better the chance is cially rampant. Only a vaccine could that the vaccine will be effective for protect people from the disease. everyone. researchers Researchers are learning more about , MD, Julius Youngner, ScD, COVID-19 every day. Dr. Hoberman and colleagues had been working for says that while we cannot yet know years on a . Children in when a vaccine will be available, the Pittsburgh participated in the first different phases of the vaccine trials JUDITH MARTIN, MD ALEJANDRO HOBERMAN, MD small study of a potential vaccine. In are progressing quickly. But when it 1955, after a larger, nationwide trial, and the best fit for the community. The fessor of Pediatric Research, Univer- is time to conduct phase-three studies the vaccine was proved safe and effec- unit is multidisciplinary, with people sity of Pittsburgh School of Medicine, of , Drs. Martin and Hober- tive. It was widely considered to be a from internal medicine, pediatrics, professor of clinical and translational man want Pittsburgh to be in on it. monumental achievement in public family medicine, infectious diseases, medicine and codirector, Pittsburgh “We want our community to have the health that led to the eventual erad- vaccine development companies, Pitt’s Vaccine Trials Unit. advantages of a COVID-19 vaccine,” ication of new polio cases from the Clinical and Translational Science In- When the vaccines are ready for says Dr. Martin. “I see it as the best United States. stitute and from the community. phase three clinical trials, Drs. Mar- of both worlds: We’re bringing some- During the COVID-19 pandemic, we “Our job as scientists is to digest tin and Hoberman want to hit the thing to the community that’s poten- are, again, keeping our distance from what we learn about each of the vac- ground running. To do that, they say tially going to protect them, and they each other and waiting for a vaccine. cine options and bring to the commu- they first need to understand the can benefit from it earlier than the Many different vaccines are in de- nity the one we think has the best needs of the community and what peo- rest of the population. This is going to velopment around the world, includ- chance for success,” says Alejandro ple’s concerns are. Then, people will be another opportunity for Pittsbur- ing at the University of Pittsburgh. Hoberman, MD, Jack L. Paradise Pro- be asked to go to the online registry ghers to demonstrate that they can Drs. Alejandro Hoberman and Judith contribute to scientific progress.” Martin have conducted vaccine research in the region for 20 years through their Clinical Tri- als Unit. Now Pittsburghers will have another chance to partici- pate in studies that could change lives for the better worldwide. The unit is preparing to conduct a COVID-19 vaccine study in the region. The effort begins with creating a registry of people who may be interested in participat- ing in such a study. Creating a registry of interest- ed people will lay the ground- work for when a vaccine trial is ready to begin. Research stud- ies are a multi-phase, rigorous- ly monitored process. The first phase of a trial is a safety study, according to Judith Martin, MD, professor of pediatrics, Universi- ty of Pittsburgh School of Med- icine and codirector, Pittsburgh Vaccine Trials Unit. “A phase-one study isn’t look- ing at whether the vaccine works,” she says. “Phase one is when we’re just making sure the vaccine is safe and doesn’t cause harm. Phase two of the study is where we know the vaccine is safe, but we’re trying to figure out the dose and make sure it would be effective. Phase three builds on the findings of the pre- vious phases. We know the vac- cine is safe, and we’re fairly con- fident it’s going to work. Phase three studies are large scale with hundreds, if not thousands, of participants.” Currently, there are more than 100 vaccines in development around the world. To bring a COVID-19 vaccine trial to the area, the Pittsburgh Vaccine Trials Unit must evaluate each vaccine to see which is the safest