The Health June 2023 | Page 26

Behind every innovative medicine , treatment and therapy is a clinical trial . Here ’ s a closer look at how they work

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THE HEALTH | JUNE , 2023

| Innovation |

What are clinical trials ?

Behind every innovative medicine , treatment and therapy is a clinical trial . Here ’ s a closer look at how they work

BY BIANCA MENDEZ

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CLINICAL trial is a research study that determines whether specific healthcare interventions - such as investigational therapies , medicines and treatments - are safe and effective . An equitable and diverse clinical trial is a critical step toward getting a medicine or treatment approved by regulatory agencies , such as the US Food and Drug Administration .
Before reaching the clinical trial stage , these investigational interventions may have already undergone other types of research and testing , depending on regulatory requirements , explains Rocio Lopez , Global Operations Head , Global Development , the Janssen Pharmaceutical Companies of Johnson & Johnson .
To confirm that the investigational intervention will consistently work as designed , various clinical trials are completed , and data is collected and submitted for approval to be used in patients with the condition being studied . This is the clinical trial process :
• Phase 1 : Researchers test the investigational drug or treatment in a small group of people to learn about its safety , including how it is absorbed by the body , what dosage should be used and potential side effects .
• Phase 2 : The intervention is given to a larger group of people to better understand ongoing safety , whether it works for a particular disease and the best dose .
• Phase 3 : The intervention is given to an even larger group of people . The main objectives are studying safety and side effects in bigger populations , whether it works for a particular disease and how it compares to already existing standard therapies . In some cases , there may be a fourth phase after the intervention is approved where researchers will study long-term risks , benefits and side effects during day-to-day use in the population .
While these phases are standard protocol for clinical trials , the actual length of the study depends on the intervention itself , what the trial is evaluating and the end goal , adds Lopez .
THE IMPORTANCE OF DIVERSE AND INCLUSIVE CLINICAL TRIALS
Often , participants find out about clinical trials from their doctor or patient advocacy organisation . If a patient has a condition and there are no approved treatments for it or the available treatments are not proving effective , a clinical trial could be an option , explains Lopez .
Recruiting participants from a variety of demographics is crucial to ensure research is representative of the incredibly diverse communities served .
Yet “ historically , most of the trials that have been conducted have produced data that underrepresents different demographics , such as Black and Hispanic patients ,” says Kate Owen , Global Development Head , Janssen .
That ’ s why Johnson & Johnson has made diversity , equity and inclusion a top priority when designing and conducting clinical trials . Additionally , the company also works to drive health equity through Our Race to Health Equity , which aspires to eliminate health inequities for people of colour and eradicate racial and social injustice as a public health threat .
“ By incorporating diverse and inclusive practices into every stage of our clinical trial process , more patients will have the opportunity to participate in clinical trials ,” says Owen . “ Together , we are building a world where health equity is the norm .” – The Health
This article appeared recently on the website of Johnson & Johnson
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