Clinical trials 101: everything you need to know
While research sites know their stuff about clinical trials, the same can’t be said about the general public. In the US today, it is estimated that half of the population may be completely unaware that clinical studies even exist! A lack of general awareness has, as a result, become a systemic issue that is responsible for decades of trial recruitment struggles and clinical research failures. They say ignorance is bliss - but, trust me, this really doesn’t apply to clinical research and the healthcare industry.
Whether your specialty is in Alzheimer’s clinical trials or in research on depression, the same clinical protocol applies. Today, we’ve summarized everything you need to know about clinical trials; and how you - the patient, research site or CRO - can use this information to get involved in spreading awareness and make the world a safer place. Check out our breakdown.
What are clinical trials?
Simply put, clinical trials are the best way to understand how the medicines and the medical practices we produce affect our health. When it comes down to it, clinical trials can be summarized in just a few simple steps.
Research sites work out the basic theory and pitch their ideas to clinical trial sponsors by means of a research plan. The idea undergoes some preliminary testing. Normally, the hypothesis is tested through observation of microorganisms and laboratory animals. Once deemed safe, the medication/practice needs to be checked and given the green light by government bodies in order to proceed with patient recruitment for human trials. Rest assured, before the drug goes anywhere near clinical trial patients, it must pass rigorous preliminary tests.
From then on, once the study is underway, it is just a case of adding more and more people. This is the primary factor in determining phase 1 clinical trials from those of a later stage. The reason why this happens is because it would be all well saying that 10 people were treated successfully with the tested drug, but what about the 7 billion other people in the world??
In late stage clinical trials, however, there is normally a slight twist in clinical protocol. This is generally the point where research sites will perform trials with a treatment group and a control group in order to be absolutely certain of the results produced from the earlier stage studies. Treatment groups receive the new medication, whereas control groups only ever get the older treatment or a placebo. What this means is that participants are normally blinded (which means that the patient is unaware of which group they belong to) and the effects of the new treatment can be analysed, without bias, side-by-side with that of the old.
Once, phase 3 clinical trials are successful, the US Food and Drug Association (FDA) can now decide if the treatment will be approved for market. No product currently on sale should be without this stamp of approval so consumers should be wary of substances that don’t have one or an equivalent.
For patients, the period after the clinical research has ended consists solely of after-care provided by research sites. Just because the trial itself has ended doesn’t mean that researchers no longer care. Research sites work with patients months after the study’s final day to ensure that the treatment continues to be effective and that the patient’s health is not compromised for the future.
Why does clinical research matter now?
If we’ve learnt one thing from the last 6 months, it’s this: the global pandemic has spotlighted the systemic issues of sex and race in clinical studies. With the Black Lives Matter movement
and various feminist groups making their mark, it’s now easier than ever to understand the impact prejudice has on society - and clinical research is no exception.
The fact is that, in 2014, a report by the Brigham and Women’s Hospital in Boston concluded that the science that informs medicine – including the prevention, diagnosis, and treatment of disease – routinely fails to consider the crucial impact of sex and gender. This, the report finds, “hampers our ability to identify important differences that could benefit the health of all”. Not only this, but it was also found that 8 over-the-counter medications were withdrawn by the US Food and Drug Association (FDA) between 1997 and 2001 due to ‘unacceptable risks to women’s health’.
Equally, racial preferences in clinical trials could mean disaster for particular ethnic groups. According to a recent report by the FDA, only 4% of cancer clinical trial participants are black, 4% are Hispanic and 15% are Asian. Yet, last year, the American Cancer Society reported a near-equal rate of incidence in both white and black patients. This ultimately means that the black population is severely under-represented in trials to cure an illness that affects them just as much as white Americans.
With studies showing that certain peoples can respond to the same medical therapy very differently, a lack of diversity in sex and race is not only damaging from a moral perspective, but it may also have potentially dangerous, undocumented results on part of the population. In the midst of a world-wide health crisis, the fact that our current medications may be unsuitable for part of the population is exactly why clinical research matters right now.
Are there any risks?
Generally speaking, there will always be risks attached to joining clinical research - but one thing that we can guarantee you is that these risks are calculated with the finest precision.
Throughout the clinical trial process, patients have access to one-to-one healthcare that normally functions on a round-the-clock system. This means that their health is constantly monitored and health professionals are on stand-by if, as in a tiny minority of cases, they were to take an adverse reaction to the medication. If your health is your priority, clinical trials are, a lot of the time, free and useful tools to better understand your healthcare needs.
Patients must also be aware that clinical trials work very hard to gain IRB approval that allows them to operate in the first place. This procedure requires clinical studies to demonstrate first-class training by their research staff and the ability to continuously review their findings for the sake of open communication and the ultimate safety of their patients. What everyone must understand about clinical trials is that research sites hold their patients’ health as a number one priority; so, when it comes to matters of safety, potential patients shouldn’t neglect their own health stressing about it.
If you have any other concerns about a clinical trial you're interested in joining, contact them directly as soon as you can. Clarity on risk is not only something that clinical research promotes at the heart of the industry, but it is also something that clinical studies must uphold under the rules of clinical trial ethics.
How do I get involved?
So you are interested in taking part, what now? We have a few solutions for you here that may spark your interest further.
Mindmate, the #1 health app, is the perfect everyday solution for monitoring your health and keeping up-to-date on the latest clinical studies in your local area. With free access to a wealth of brain-training games, easy-to-make recipes and step-by-step workout regimes, Mindmate is your new digital health diary and planner. Not only this, the app gives you access to virtual clinical trials and online questionnaires in one tap; allowing you to play your part in the crucial clinical research happening across the globe from the comfort of your own home.
For research sites / CROs: