What I would have liked to know: diversity in clinical trials
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Clinical trials are a test phase for drugs, devices and procedures. These research studies assess the effectiveness and safety of medical intervention in humans.
Clinical trials are essential to advance medical treatments, including those of cancer. Historically, the tests have been widely conducted on white men. Now, health professionals examine how gaps in representation within these trials can affect processing approaches and patients’ results in different groups, such as ethnic women and minorities.
Health According to Anita Phung, a general practitioner who helps supervise the clinical trials conducted with Lindus Health, a medical research organization based in England. Experts like PHUNG defend a broader representation in clinical trials to extend treatment options and provide more individualized care. Understanding genetic differences could be particularly crucial to advance the prevention and treatment of cancer.
“Cancer is complex and the genetic variations between different people can further influence the results of the treatment. Researchers only scratch the surface of the importance of diversity in understanding health risks and the effects of drugs between different populations, “said Phung.
What do you want to have known the role of diversity in medical research earlier?
My religion: Previous clinical trials have been mainly carried out on a homogeneous population, which means people of the same environment. They were generally white men.
With hindsight, this means that many of the drugs I prescribe and the treatments that I recommend to my patients are based on very biased and potentially inaccurate data. For some drugs, available research has not taken into account the differences in sex or ethnicity.
Now that I know, I hope I can do more to facilitate a balance of representation in medical research. There is no unique medication. Different people can have different answers to the same drugs, which is why several types of similar drugs – and research behind them – are necessary.
How have clinical trials evolved to be more inclusive?
Phung: In the medical community, there was an increasing interest and a concentration on pharmacogenomic. This is the study of how genetic variations, or differences in a person’s biological composition, can influence the way the body reacts to drugs.
Your genetics can affect the way your body metabolizes a drug, the effectiveness of a medication for you and the side effects of the drug you experience. All of this plays in the way you react to a drug.
In general, I think people are more interested in the fight against inequalities and try to involve under-represented populations. I see more and more studies focused on ethnic minorities.
What do you want you to know earlier about how adequate representation in cancer clinical trials can affect people’s disease results?
Phung: Research focused on specific populations has been able to determine which drugs are the most effective in dealing with current conditions in these groups.
For example, my grandmother is in Southeast Asia, the Chinese background, is a non-smoker and has received a diagnosis of lung cancer. The hospital where she has been going to have genetic tests on her. At the time, I did not know lung cancer and genetic tests, so I did not understand why. But they were testing to see which drug she would respond most effectively and would give it the best results.
Its laboratory results have returned positive for an EGFR mutation, which is a change in the receptor of the epidermal growth factor which affects the growth and division of cells and can increase the propagation of cancer in the body. This mutation, as well as non -smoking lung cancer, is more frequent among the populations of East Asia.
If you test positive for this mutation, you are prescribed a different drug than if you test negative. Clinical trials have shown that the medication Gilotrif (AFATINIB) is the most effective in treating lung cancer non -small cells in Eastern Asia populations with an EGFR mutation, which indicates to health care providers that this drug should be first -line treatment for this group.
Consequently, my grandmother received the best treatment available for her, for someone from her history. If it had been prescribed a different medication, it may have had a lower or known prognosis more side effects. I am grateful that this extended research has been carried out.
What conversations should people have with their oncologist about personalized care?
Phung: It is important to be curious. Read the treatment your doctor recommends and ask questions. For example, was this treatment tested with people from my history-people of the same sex, ethnic or health? Are there differences in the way people could react to this treatment? What are the other treatment options?
Your doctor may not know all the answers, but he can find out. Too much information can be overwhelming, especially when you approach cancer treatment, but it is your doctor’s work to help you understand the information you need to make an informed decision.
For doctors, it is important not to make assumptions about how a person wants to approach their treatment against cancer. They should give their patients all the options. Some people may want to participate in a clinical trial for the greatest good, contribute to science and help develop better treatments, and that is also good. Join a clinical trial presents potential risks and advantages, and they should be weighed.
Knowing what you now know about the lack of representation in medical research, what would you say to your young person?
Phung: Think of the overview. Just because the directives tell you what you are supposed to do, you don’t necessarily need to follow them. The guidelines are guidelines, and many have been written on the basis of a single population. Be critical and really assess profile, safety and research behind the drug, especially if the risks and benefits have important results for the patient.
Having read more work on diversity in medical research made me think about my practice and examine the data even on the drugs I take and my loved ones take.