4 aims for heart health clinical trials in 2020
It’s been a tough year for all clinical research - particular that of heart health. With over 440 clinical trials suspended since March 1st, many of which directly relate to heart research, some of the world’s deadliest diseases are no closer to being cured. The current issue, beyond this major health crisis, concerns itself with patient confidence and patient recruitment statistics today. With 15-20% of research sites failing to recruit a single patient for their clinical studies, it’s unlikely that finding cures for heart disease or stroke is going to be possible when trial recruitment is already improbable.
Stroke has been one of the world’s most prominent killers for decades now and, with COVID-19 being directly linked to cardiovascular disease and lung failure, there is - now more than ever - a mandate to change this normality. Today, we lay out 4 aims for heart health clinical trials this year; and consider what research sites and clinical trial sponsors alike can do to tackle the growing heart health crisis.
Eliminate gender bias
Each year, heart disease claims the lives of 1 in 3 women; and to make matters worse, 80% of these deaths could have been/can be prevented. While several studies promote the implementation of a healthy, balanced diet for decreasing the present risk, there is a large hole in heart disease research that puts women at a clear disadvantage to their male counterparts. ‘Research Goes Red’, an initiative by the American Heart Association and Verily’s Project
Baseline, looks to empower women to contribute to clinical studies and is only one of a few projects worldwide looking to eliminate gender bias in clinical research.
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 Not only this, but it was also found that 8 over-the-counter medications were withdrawn by the US Food and Drug Association (FDA) between 1997 and 2001 due to ‘unacceptable risks to women’s health’.
The result of excluding women means more than just restrictions on profit margins or making an “unremarkable” contribution to science. As the owners of those 8 drugs found out, inherent gender bias in clinical trials can be fatal. The clinical research industry holds women’s lives in the palm of their hands; so, saving your research’s validity also means saving lives.
Fight racial prejudice
Right now, BAME individuals are at a higher risk of dying from COVID-19 than their white counterparts. By the end of May, the COVID-19 mortality rate for black Americans (1 in 1,850) was 2.4 times as high as the rate for white Americans (1 in 4,400). This same report estimates that, if they had died of COVID-19 at the rate of white Americans, around 13,000 black Americans, 1,300 Latino Americans and 300 Asian Americans would still be alive today.
So, what exactly does all this mean for heart health research? In the past, it’s been so easy for us to look the other way and label it “a political issue”, “not our responsibility” or “beyond our control”. Now, however, the situation has changed. New evidence suggests that there is a strong correlation between representation in clinical trials and the health of minority 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 is not only damaging from a moral perspective, but it may also have potentially dangerous, undocumented results on part of the population.
Much like what is happening on social media with black awareness at the moment, heart health clinical research must act as thought-leaders in clinical trial education. It’s documented by the FDA in a recent post that minority populations may lack the core knowledge about clinical research opportunities, which, in turn, contributes to lower rates of representation in clinical trials. Yet, education on clinical studies should not just be for certain groups - it must be for all. In fact, a recent survey by Clinical Leader found that two-thirds of all respondents didn’t know whom clinical trials are targeted at, with high levels of stigma surrounding the topic of clinical research overall.
Continue to educate
The answer to the first two problems, as I have already alluded to, lies in education. Beginning in schools and ending in older years’ health courses, the importance of healthy dieting and lifestyle choices must be fundamental to everyday life. That fact is that around half of all Americans are not aware that clinical trials even exist.; and if we can take anything for this, it is that a lack of familiarity equals a lack of confidence.
In today’s society, there is a nationwide "not for me" attitude that can be easily countered by education. Success here comes down to research sites building a strong feasibility analysis (check out our top tip for managing your feasibilities here.) A plan that targets a specific demographic with the right, relatable sound bites is sure to counteract any concern. Use the data gathered from your initial research to outline your ideal candidate and relinquish any misconceptions. Share, retweet or regram to let people know if they can get involved. In short, focus your early efforts on spreading awareness. At the end of the day, the goal of research sites everywhere should be to make participation in clinical studies the accepted, the norm and the "for me".
Consider virtual trials
Last month, a survey by digital analytics firm, McKinsey & Company, found that more than 75% of consumers asked have experimented with alternative methods of shopping, such as the use of online shopping and delivery services. When we compare this with the fact that 4.57 billion people are online today, it’s clear that the developed world has now developed technology into their everyday routines. So, how do heart health clinical studies benefit from this?
Round-the-clock monitoring of a patient’s lifestyle choices is now a reality with the development of wearable tech. Today, clinical research shouldn’t have to rely as heavily on probability when it comes to determining the best course of action for treatment. Practitioners can now closely observe the patterns of their patients and intervene quickly if any unexpected incidents arise.
Recent developments from companies like Pfizer, Science 37 and Aicure also prove that clinical research can reap a wealth of benefits from virtualization (check out our breakdown of these developments here). Clinical trials are often delayed or fail due to difficulty recruiting research participants, and it is evident that virtual trials - especially in recent years - outshine their traditional counterparts in terms of recruiting successfully.
Virtual trial recruitment notes that distance, disability, and the need for frequent in-person visits are major barriers to participation in trials with standard clinical protocol; with a study in Alzheimer’s disease finding that home visits were the factor most likely to enable greater participation. The fact is that virtual research visits could reduce the time and travel burden of participating in research.
Carrying out clinical trials from the comfort of the participant’s home is the invaluable and entirely unique benefit of virtual trials. As public opinion sways towards safety and security above all else, when it comes to going digital, we recommend the sooner, the better.
Here, we’ve created the ideal patient recruitment dashboard to help researchers improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of par