In Maya Zlatanova’s article “Not Enrolling Patients? The One Explanation You Haven’t Considered Yet”, she highlights an important factor to patient recruitment in clinical trials – investigator fees. To illustrate the issue, she tells the story of a trial not recruiting any patients. Other competing trials at the same site, it turned out, paid a higher fee per patient.
The story is not intended to portray sites in a bad light – sites like any other business need money to stay in the game and keep serving the people they serve. Investigators are hardly to blame for making smart business decisions. And it’s important to note that this ‘business model’ is not universal – it depends on country-level regulations as well as the particular healthcare system and culture around research.
Still, is this the optimal way for sites to operate? And what are CROs and Sponsors to do in order to recruit despite competition? I’m suggesting a few possible strategies if simply outbidding the competition for patients doesn’t sound good enough.
Avoid competition from the get-go
At the feasibility stage of a new study, the CRO or the feasibility department within a Sponsor company can make an important decision – go to the most popular sites (which are not always the most suitable – read on to find out why) or choose sites with less competition.
This doesn’t always solely depend on sites, of course. There are also more ‘popular’ countries for conducting trials. A Sponsor company needs to carefully balance market access and patient recruitment within a trial. Where they’d like to sell their new compound is not always where the patients most in need are.
In these ‘popular’ countries (most of them in Central and Western Europe) the standard of care is usually very high. The drugs that your target patients have access to in their country are also a competitor. (By the way, you’re now able to check out on TrialHub which drugs are reimbursed in your target countries and at what point of their journey patients receive them.)
So, a CRO or a Sponsor is faced with a tough landscape. On the one hand, they have to compete with other clinical trials, and on the other – with the reimbursed drugs in their target countries.
What to do?
1. Consider other countries
As someone in charge of the planning of the clinical trial, you might want to consider countries with a lower standard of care that have the potential to boost recruitment.
This way, not only will less geographically fortunate patients have access to innovative treatments but you will also have to deal with less competition.
There are few potential pitfalls, though.
You might have to overcome a lower level of clinical trial awareness among patients. And you might have a difficult time finding sites that have the capacity to run your trial depending on the equipment that’s needed.
On TrialHub you can compare countries at a glance based on several important factors:
– competition
– average recruitment rate
– past experience, and
– startup timelines
You can also go more in-depth and check out how each individual country is ranking in terms of clinical trial awareness and advertising restrictions. This way, you can consider both the countries best for market access and patient recruitment.
2. Go to less experienced sites
Above I said that simply because a site is big and popular, it doesn’t make it the most suitable site for your trial. This is why on TrialHub we’ve added another dimension – site speciality.
A site may have worked on few trials altogether but if all or most of them were in your target indication, we consider this site to be specialized. If avoiding competition is on your mind, then you should consider smaller but highly specialized sites.
Sometimes, however, you will need additional information to go to a site you haven’t previously worked with. In those cases, you can contact our network of local experts – they have the experience to recommend highly motivated sites with capacity and can even help you discover new ones.
A change in sites’ business model
Another way to support patient recruitment on a larger scale is a change to the way sites operate. This is a matter of regulations and it’s not under the control of any CRO or sponsor company. However, in a discussion about patient recruitment challenges it should be mentioned as well.
A site’s ‘business model’ often depends on the country. In Spain, for example, every hospital has a foundation and money from clinical trials goes to the foundation to later fund other projects.
Our advisor Miroslava Prades, a Clinical Study Lead at QIAGEN, shared that the incentive for investigators to participate in clinical research has more to do with their own academic and career goals as well as it being generally encouraged in the medical community.
Spain’s model may not be universally applicable, especially considering that every country’s healthcare system is structured differently. However, in cases when investigators are paid per patient a sponsor may find themselves trying to outbid the competition for recruitment. This is a flaw in the model itself and should be addressed at the regulatory level within a country – especially if the goal is to support clinical research and innovation as a whole.
However, I should note that such a situation is more likely to happen if competing trials have similarities in their protocol, i.e. if a patient is simultaneously eligible for two competing studies at the same site.
Since a change in the sites’ business model on a large scale would take time, I suggest that in countries where investigators are paid per enrolled patient, sponsors take another route to avoid competition and/or have an honest conversation with the investigator before enrollment begins.
Are there any other solutions you can think of? How should stakeholders handle such cases? What is a good way to incentivise investigators to participate in research? Drop us a comment or send us a message.