[30 Second Overview]:
Importance of Representation: Increasing Black participation in clinical trials is essential to ensure new treatments are safe and effective for all demographics, as reactions can vary based on race, ethnicity, gender, and age.
Safety Measures in Clinical Trials: Modern clinical trials include strict regulations and oversight by the FDA and IRB to protect participants from harmful side effects and ensure the benefits outweigh the risks.
Informed Consent and Considerations: Participants are provided with comprehensive informed consent forms detailing potential risks and benefits and can consult with doctors and trial staff to make well-informed decisions about joining a trial.
The History of Medical Mistrust
When you hear “clinical trials”, you may first think of examples of medical mistrust between the US healthcare system and the Black community, such as the Tuskegee syphilis study or Henrietta Lacks. This mistrust, along with many other factors, has led to the Black community being under-represented in clinical trials as they avoid situations that have historically caused them harm.
This stigma must be broken so that the Black community feels comfortable and safe participating in clinical trials that may benefit them directly and benefit the Black community for generations to come through improved research and treatment options.
The Importance of Representation
Did you know that only 5% of clinical trial participants in the U.S. are Black? It’s crucial that Black people join clinical trials to ensure new treatments are safe and effective for everyone. People can react differently to treatments based on factors like race, ethnicity, gender, and age. Therefore, trial participants should reflect the diversity of the population affected by the health condition being studied.
Ensuring Safety in Clinical Trials
Today’s clinical trials have stringent laws and processes to protect participants from potentially harmful side effects and unfair treatment. The U.S. Food and Drug Administration (FDA) must review and approve an Investigational New Drug (IND) application before a clinical trial can start. This application includes results from lab and animal studies showing the treatment’s positive effects and safety. Additionally, an Institutional Review Board (IRB) ensures the benefits of the trial outweigh any risks.
Understanding Informed Consent
Before joining a clinical trial, participants read and sign an informed consent form, detailing the trial's potential risks and benefits. This form, reviewed with trial staff, ensures participants make well-informed decisions. It’s important to remember that the consent form is not a contract—participants can leave the trial at any time for any reason.
Tips for Considering Clinical Trials
Consult Your Doctor: Discuss the clinical trial and share the informed consent form with your doctor to understand your treatment options better.
Ask Questions: Engage with the trial staff to clarify any concerns. Inquire about the treatment, duration, visits, travel arrangements, potential payments, and safety measures.
By increasing participation and ensuring informed consent, we can enhance the diversity and effectiveness of clinical trials, benefiting everyone.
Join the Conversation on Clinical Trials
Join OHCEngage and continue the conversation on clinical trials in the Black community. Join for FREE and connect on the go through the Mighty Network app available for IOS and Android.
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