How Clinical Trial Managers Can Ensure Diversity
In July 2020, there were 46,331 participants for the Pfizer COVID-19 vaccine. Out of this large number, there were only a few African American and other minority participants.
Unfortunately, a lack of diversity in clinical trials can affect the health care industry. Luckily, a clinical trial manager can ensure diversity and inclusion in clinical trials. If you want to learn more about diversity in clinical trials, then keep reading our informative guide!
What Is a Clinical Trial?
Before a new vaccine, medicine, medical device, or therapy can become available to the public, it must first go through various rounds of testing!
These medicines are sometimes tested on animals first, and then humans. The data is then used to determine the drug’s ability to safely treat other humans.
The U.S. Food and Drug Administration is the final stamp of approval that is needed for drugs to enter the public. The FDA also provides information on how certain drugs can affect people and the best use for said drugs.
How Does Diversity in Clinical Trials Help Future Patients?
Diverse clinical trials are very important as the same medicine can affect people differently. Or it can confirm that the medicine is showing continuous improvement on various test subjects.
The determining factors that clinical trial managers look at are the age, gender, weight, ad ethnic origin of a test subject. All these factors can greatly affect how a person responds to the medication. This is why it’s important to have diversity in clinical trials.
For example, there are instances where African Americans need a separate dosage or drug for ailments such as blood pressure, asthma, and heart disease.
There are also scenarios where these circumstances pop up. For example, Asian Americans process certain foods differently such as alcohol! That’s why having the best clinical trials supply and diverse group is important for a fair clinical trial!
Why Is Diversification Difficult for a Clinical Trial Manager?
Many clinical trial managers have a hard time gathering study participants for a clinical trial. Many potential participants have conflicting events like work, school, and child care. And of course, many participants are also worried about the safety of the trial.
Some minorities are also not able to participate because of a lack of trust and religious beliefs. Other factors that contribute are language barriers, lack of access, and daily requirements. But the problem is, those who are underrepresented in clinal trials, are also underrepresented in health care.
There are also other reasons why minters are not represented in clinical trials. The reason is that doctor referrals are also needed for a diverse clinical trial. But some doctors are hesitant to refer their patients because they do not want to lose their patients to other health care facilities.
Increasing Minority Participation in Clinical Research
There are ways doctors and trial managers can improve diversity in clinical trials. However, it’s not a one-step process. Many different options need to be incorporated to improve these outcomes.
1. Getting Connected to the Community
Clinical trials are not suitable for low-income or older patients as most of these tests are conducted in major cities. These tests are also miles away from rural areas. But the time and transportation costs may not be possible for the average person to get.
Not to mention, some clinical trials require participants to go to the doctorâ€™s office weekly. And if the participant does not have insurance, it can be extremely difficult and expensive to visit a doctor’s office regularly. But by connecting to smaller communities and health care centers, clinical trial managers have been able to access a wide variety of participants.
2. Reaching Out to Patient Advocacy Groups
Patient advocacy groups are great for getting connected to a specific patient population. So learning about patient advocacy groups can you get connected to patients with rare diseases that may not be as easy to access in regular recruitments.
You can connect with the advocacy group and inform them of your medicine and trial. You can also support them by sponsoring any informative campaigns.
Overall, it’s important that you build a transparent relationship. And once a relationship is established, a full partnership can grow and benefit both parties.
3. Mandated Diversity
True change begins with laws and regulations that start from the top and trickle to the bottom. So ensure that you work with clinical leads who are not shy about voicing their thoughts on the lack of diversity in clinical trials. Your committee should also be based on provable actions that aim to ensure diversity and representation at each stage of the trial.
4. Expand the Eligibility Criteria
Most clinical trials have strict eligibility criteria. But not all people are willing to even apply for the trial. But in the earlier steps, you should begin asking your agency for small adjustments.
We understand this may be hard as some agencies, especially if you have certain regulations to adhere to. And it’s always best to get this done at the earliest time!
The Future of Diversity in Clinical Trials
As a clinical trial manager, it’s important to adhere to the laws and regulations surrounding your trial. But if there is even a little bit of leeway for future changes, be sure to jump on the opportunity! The future of patents rights and health care depends on diversity in clinical trials.
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