Health is a fundamental human right, yet health inequity is one of the major problems across the world. Although the pharmaceutical industry is more aware of this problem due to regulatory efforts to improve clinical trial diversity and access to medicine, there is still a lot of work needed.
Speaking in an exclusive interview with Clinical Trials Arena at the sidelines of the FT Global Pharma and Biotech Summit, Access to Medicine Foundation CEO Jayasree Iyer shared her thoughts about what role the pharma industry plays in clinical trial diversity and health equity.
Urtė Fultinavičiūtė: Over the past few years, regulatory agencies made clinical trial diversity and health equity one of their top priorities. How did it affect companies and their R&D processes?
Jayasree Iyer: If there is a real push for clinical trial diversity from a major regulator like the US Food and Drug Administration (FDA), it gets quite a lot of attention from the pharmaceutical industry. The difference is whether it is a fixed policy or a guideline. Having more inclusive clinical trials firmly embedded into the FDA requirement had a very strong ripple effect on the industry itself.
It is a different discussion whether that translates into global equity. People will adhere to trial diversity within the FDA requirement, but it doesn’t necessarily mean it will happen in clinical trials around the world. Every regulator is responsible for the region that they are regulating. You may do the bare minimum to respond to one rather than trying to do what is right for the whole world. This is what is happening in the industry. Companies are being more inclusive, but not in terms of global reach.
UF: What steps should sponsors take to ensure that their clinical trial design is applicable to all patient populations?
JI: The first step is having a clear policy in place for clinical trial design to be inclusive of different population segments and ethnically diverse. Also, looking at societal disparities and what is driving broader access to the eventual product.
The second thing is making sure that the ethical components of the trial design and trial staff behaviour are of a high standard. This goes back to the point of trust. One of the biggest reasons why Native Americans do not want to enrol in clinical trials is the fact that medical research used them in an inappropriate way in the past. There is fear and mistrust in the industry and study design itself, so building that trust is extremely important.
But trust is not only about the trial design and ethics behind it, it is also about trust in terms of the overall industry and science. If you have high prices on your drugs that are unavailable for low-income groups even in countries where you are active, then how can the population trust that it is for their benefit and not the benefit of your profit margin?
The third part is about being consistent about what happens after the trial is done. At the end of clinical trials, are you still going to make sure that all population groups get access to the treatment or will it be that only the wealthiest populations in the world will get access to it? It comes down to the price, but also the time it takes to get the product on the market and where the product is available. In some countries, if you only sell into a private system and not into the public system, then most people will not be able to access it.
UF: Decentralised clinical trials (DCTs) are often pinned as a way to increase diversity in clinical trials. Clinical Trials Arena previously reported how certain patient populations may mistrust technology or would rather avoid nurses coming into their homes. Even if digital tools are meant to increase diversity, they may not actually do so.
JI: Trial diversity comes with certain expectations in terms of the quality and ethics of implementing it. The more you decentralise, the more you need to have strong quality controls in place. Companies need to have the right oversight and make sure they are being respectful of different communities’ acceptance of trials. A one-size-fits-all approach is going to fail. Additional complexities come with decentralisation and not all companies are on top of it.
This is also one of the reasons why companies are cautious about how much they prioritise or embed healthcare equity into the way they operate because it comes with all these obligations. I don’t think it is an excuse, but if you want to have an impact, you have to consider all of the factors that are at play.
The field is changing and evolving, but it is not fast enough for patients.
UF: There is a lot of talk about diversity and health equity, but is there enough action?
JI: I don’t think there is a massive change. Out of 20 of the largest research-based pharmaceutical companies in the world, our latest Access to Medicine Index found that only six companies are embedding early access planning into their overall work. This means that they make access plans for all R&D projects in their pipelines from Phase II onwards.
One element of an access plan that we see some companies implementing is making post-trial access guarantees for clinical trial participants when trials have taken place in low- and middle-income countries. For example, by committing to registering the product in that country. But, while we see more clinical trials being done globally, does that mean that those trials are also inclusive and done in an ethical way? There are pockets of change, but scale and scope are the biggest problems.
If we want to see a systemic change, we need to see all companies doing this. And not because one regulator asked for it, but across the board. One big change of this will be the African Medicines Agency, which is going to be up and running soon. It will offer widespread support in different regions in sub-Saharan Africa. There will be a level of harmonisation in place, and also certain demands on how clinical trials will have to be run.
The field is changing and evolving, but it is not fast enough for patients.
UF: What advice would you give to sponsors who want to do better?
JI: If you envision your drug or treatment being accessible to as many patients as possible regardless of where they are, you have it in your power to do something about it. Clinical trial diversity, the early embedding of access planning, and making sure that your staff is remunerated on access and equity rather than the number of sales are key components.
