The future of patient diversity in clinical trials
Over the last two weeks we have explored the issue of patient diversity in clinical trials; why the lack of it is an issue and what historically has been done about it. In this final part we look at what the future holds for clinical trials, and how real change can be made for future trials.
The opportunity for greater patient diversity
The current climate and conversation about the COVID-19 vaccine trials creates a great opportunity for change. The race to find a vaccine and bring an end to the pandemic situation has captured the media’s collective imagination. An increase in the mainstream reporting of clinical trials has brought greater awareness of the importance of clinical research, and of the need for diversity within that research, to a much wider audience.
We recognise that making fundamental changes to how trials are conducted and patients selected is no small feat. With the pressure to deliver drugs and medical devices to market – at a cost of around more than $2 billion and a timeframe that can take up to 15 years or more – working within tried and tested processes helps deliver these results and maintain the status quo. Yet patient recruitment is an essential part of the process – without patients and volunteers the trials cannot go forward.
Five ways we can promote diversity in clinical trials
As an industry, we must commit to greater patient diversity in research. Here are five ways we believe this can be achieved.
Making trials more ‘patient-centric’
While this is not a new idea, putting patients at the heart of clinical trial design represents a fundamental shift in approach within the research community that perhaps goes hand in hand with increasing diversity. In the past, studies have been conducted primarily to evaluate the safety and effectiveness of a new compound, vaccine or medical device, and not necessarily to the same degree the patient’s convenience or needs. Changing the thinking around trial design and execution to better include (and appeal) to more people can help overcome numerous barriers to participation.
And patient reported outcomes are increasingly included in the analysis of trial results. Physiological responses to the investigational product is important, but from a patient perspective what may be of most benefit is the impact to their everyday lives – does it enable them to get around more freely, does it reduce time taken away from work. By making trials more patient-centric from the start, these outcomes can be more effectively measured.
Early patient engagement
Early patient engagement – well before recruitment begins – helps to better understand the study from the patient’s perspective. This can not only improve the design of the trial by giving better insight on the real world practicalities of a study, but also the experience of the patient.
Guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) include patient input into clinical trial design in its ‘General considerations for clinical studies’ document.
It recognises that incorporating patients in trial design helps identify possible issues that may ultimately be a barrier to patient recruitment so that these can be addressed, ultimately, resulting in more effective patient recruitment and retention.
The constant development of technology can play a big role in helping to make trials more accessible. As well as the practical solutions to facilitate the conduct of trials – such as the ability to run trials remotely or technology to support trial activities – there’s also a wider opportunity for education in general.
People’s access to technology and information is increasing, and so too is the opportunity to engage with a wider audience. Individuals are better able to research their health and options now, and with this comes the opportunity for increased awareness, understanding and education of clinical trials.
Reviewing how research is conducted internationally
Looking more broadly at how we can tackle the issue of a lack of patient diversity, the industry should consider how research is conducted across the globe. Study sites tend to be established in western countries with populations that are predominantly white. We would like to see pharmaceutical companies and Clinical Research Organisations (CROs) explore the potential to set up more sites in countries within Africa, Asia and Latin America to ensure a more diverse representation of ethnicity.
Setting diversity ratios as a research funding requirement
Research funders also have a part to play in making sure there is greater patient diversity in clinical research. Diversity ratios could be made a mandatory part of any application for funding to ensure a more equal representation of ethnicity, age and sex in clinical trials.
This finalises our series of patient diversity blogs, but doesn’t close the book on the work we all need to do to increase patient diversity within clinical trials. Read our PRESS RELEASE – Clinical trials company calls for unity and action to address lack of patient diversity issued earlier this year.
Ensuring adequate patient diversity in clinical trials is an issue that Innovative Trials takes very seriously. We work hard to help our clients recruit and retain trial participants that are representative of the patient populations most in need of the treatment or vaccine in development. Find out more about how we can work with you to help ensure patient diversity in your research.