Every patient deserves a chance to benefit from the latest medical interventions – and that’s why CSL Behring has joined with the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) as part of a consortium to bring diversity to clinical trial participation.
CISCRP’s latest and most ambitious initiative is the AWARE for All Program, which is a five-year program aimed at increasing knowledge regarding clinical trials within underserved populations, consisting primarily of minorities. CSL Behring is one of the 10 original companies within the drug development industry to be selected for inclusion in the initiative, and I have the honor of representing CSL Behring in this effort. The other nine original consortium members include Merck, IQVIA, Biogen, Otsuka, Janssen, WCG, Boston Scientific, EMD Serono and Pfizer. The group of participating organizations may be expanded by CISCRP as the initiative continues to grow.
The primary objectives for the initiative are to help patients:
- Learn what clinical research is and how it plays into public health.
- Understand the benefits, risks and safeguards in place to protect study volunteers.
- Meet local doctors and research participants.
- Receive information about next steps for those evaluating clinical research opportunities.
The goal of the initiative is to encourage and empower these underserved populations to become more knowledgeable about clinical trials and consider participation. We want to bridge the gap between clinical trials and underserved populations.
One goal for building that bridge is knowledge – helping people learn more about clinical trials and how they work. Though there’s plenty of online information available through government and private sources, it’s not helpful if people don’t know it’s there or how to use it.
Another objective is to understand the real barriers to trial participation so that they can be broken down to pave a clear path to clinical trial involvement for patients. One significant barrier that needs to be addressed are long-standing stigmas around clinical research as a result of past trials that were conducted unethically.
There are many historic examples of unethical practices associated with clinical trials – both before and after the Beecher Paper prompted the FDA and other regulatory bodies to impose regulations that protected the rights of study participants. Many of these unethical studies targeted subjects who were at a societal disadvantage, whether ethnically, economically or for some other reason. One of the most well-known examples of unethical clinical trial conduct is the Tuskegee Institute scandal – a syphilis research study infamous for its failure to properly inform and care for its participants – which lasted 40 years from 1932 to 1972.
My colleague Dr. Greg Kato, who spent decades treating patients with sickle cell disease before joining CSL Behring to lead research into potential treatments, notes that even though the Tuskegee experiments ended long ago, they continue to cast a shadow of distrust regarding clinical trials within the African-American community. For clinical trial awareness efforts to be successful, it is crucial that people understand the stringent regulations which are now in place to protect patient rights and emphasize information transparency based on international guidelines of good clinical practice.
The CISCRP consortium’s initial vision was to facilitate live educational events in five urban centers each year for five years, with the intention of providing health screenings, but the global pandemic prompted the organization to rethink how to operationalize its vision. The organization has since retooled the effort through virtual events.
Though CISCRP’s AWARE for All events are virtual, each will still focus on a specific urban center. Cities include Chicago, Philadelphia, Raleigh, Los Angeles and Miami, where I’m scheduled as a speaker.
CSL Behring has a long history of partnering with key organizations to support clinical trial access and transparency through patient awareness, partnerships with patient-facing organizations and public policy. However, the AWARE for All initiative is the first opportunity to work alongside other drug development companies to address this extremely important issue.
It’s our obligation as the developers of treatments for patients to do our part in making clinical trials available to everyone. We are honored and excited to stand united with our industry colleagues for the benefit of underserved and underrepresented populations.
For more information about CSL Behring’s involvement in the AWARE for All initiative, check out this post about the company’s involvement in the AWARE Industry Consortium.