An impressive range of factors influences the way drugs interact with the human body. Varying lifestyles, diets, stress levels, body types, medical histories, physical environments, and countless other factors can alter the way a given drug or therapeutic treatment may impact the life of a patient.
The clinical trial process has not always taken seriously the implications of this complexity. Particularly in generations past, but too often continuing into the present day, contract research organizations (CRO) have relied far too heavily on some demographics – and all but ignoring others – when seeking participants for clinical medical trials.
Such an approach has already produced misleading results in some cases, partially defeating the purpose of clinical trials in the first place. Moreover, the habit of testing pharmaceuticals on some communities but not others has also led to an erosion of public trust, particularly among those who have been overlooked by researchers in the past.
A more inclusive research strategy, coupled with better community outreach efforts, can go a long way toward correcting for past oversights and injustices – while also building a stronger foundation for pharmaceutical development in the years ahead. To succeed, however, this effort must be handled with sensitivity and grace, along with a clear understanding of why the research practices of previous generations have fallen short of the necessary standards.
How oversights lead to overconfidence
Researchers who pretend that people are interchangeable can make serious errors. Medically significant differences extend far beyond broad categories like age and gender, and include things like whether the patient exercises regularly, or is regularly exposed to high or low levels of air pollution.
Asthma, for example, is more likely to affect those living in urban environments, as well as those who have unhealthy diets and live with greater social stress. In the West, disparities in COVID-19 patient outcomes have also been well documented, with ethnic minority populations having a much higher chance of hospitalization than their white counterparts.
The underlying causes for each disparity are not always known, but what is certain is that when CROs limit the clinical trial candidate pool to those demographic groups that are most easily accessible to researchers, their findings may differ from the real-world experiences of persons who are later prescribed the relevant medicines.
Indeed, the more homogeneous the pool of trial participants, the more likely it will be for the resulting data to send a strong and clear signal about the effects of a given drug – while also making it more likely that the same data set will paint a misleading picture about the drug’s effects on other population groups. Such outcomes, when they occur, end up costing drug manufacturers in terms of overall sales as well as reputation.
Bridging the gap
Although awareness of this issue is growing across the industry, a number of obstacles continue to discourage or prevent minority populations from participating in clinical trials. These barriers include:
- Public mistrust of the clinical trial process
- Lack of information and awareness about trials
- Scheduling, resource, and transportation constraints among participants
- Limited time-frames, as drug companies seek quick approval
Dealing with these challenges requires a multifaceted response. Some of the most promising solutions include:
- Establish a broad network of clinical trial sites in non-traditional locations. By setting up the necessary infrastructure in pharmacies and community health centers, CRO scan engage with greater numbers of potential participants in the places where they are already receiving medical attention.
- Hire diverse researchers and recruitment staff. People tend to be best at understanding, and engaging with, the very communities from which they come. By bringing aboard members of under-represented communities, and listening to their insights, CROs can become far more efficient and effective at expanding their participant base.
- Begin open-ended conversations with underserved communities. Historical wrongs create negative perceptions that can last for generations.CROs should be upfront about the mistakes made by the medical sector in the past, and equally transparent about what is being done to ensure fairer outcomes moving forward. Such earnest transparency is an important step toward rebuilding trust, which in turn is necessary for more diverse participation in clinical trials.
By establishing solid connections with a variety of communities CROs can actually increase the speed at which they can operate. This is because they will have access to a larger number of recruitment sources. Their clientele will appreciate these improvements in both the speed and the accuracy of their clinical research operations.
Towards a healthier system of clinical trials
As a Thai-based local and international CROn, Clinixir ensures diversity in our clinical trials through these and other initiatives. These efforts also benefit from strong strategic partnerships with renowned academic institutions across the country.
We believe that the development of drugs and therapies should be as inclusive and diverse as possible, so that the greatest number of people can enjoy the benefits of modern medical innovations. Clinical trials should not be about who has the easiest access to medical resources; they should be about improving the health of everyone, no matter their circumstances. Contact us today to find out more.