Clinical research is about trial and error

Companies have been trying to expedite and optimise drug trials for ages. They’re the most expensive part of the drug development process and are often subject to setbacks in the process of identifying participants, getting them to enrol, and getting them to stay - among other hurdles.

For instance, right now there are more than 450,000 clinical trials in progress around the world - and 80% of them will be delayed because sponsors can’t find enough volunteers to participate.

This reality simply magnifies the fact that there is more competition than ever for limited resources, including qualified and interested participants, in-demand trial sites, and skilled staff.

Other common barriers result from inaccurate projections around recruitment and other key benchmarks throughout the trial. Increasing costs factor into the equation, too.

The good news is that there are steps the industry can take to not only get ahead of these challenges, but bring innovative treatments to people who need them even faster.

Don’t assume sites can enrol your study on their own

With multiple studies being conducted at the same time, everyone is competing for access to what seems like a finite pool of participants, especially in difficult-to-recruit spaces like Alzheimer’s disease.

In many cases, trial sites won’t be able to enrol all participants on their own, requiring the help of outside vendors to fill in the gaps. Databases built by sites often contain individuals who have already been contacted for their interest in trials, creating the illusion that there aren’t enough people to populate a study, but, in reality, there is plenty of room to expand the pool, given the right partner.

Consider, for instance, that at any given moment there are thousands, if not millions, of people around the world who might qualify for trials. But they either don’t know about them or don’t know how or why to get involved. Rather than limiting recruitment to perhaps more limited pools from sites, team up with partners who know how to activate currently unknown audiences to discover new participants, even if just ahead of time on a contingency basis. This will augment efforts, so that you’re not limited to the same wells of participants every time recruitment for a new study begins.

Use data to learn from the past and predict the future

Vendors and sponsors alike should have plenty of past public and proprietary data to reference when predicting what to expect for any given trial, whether in immunology, chronic weight management, or in other therapeutic areas.

Information from past studies can be leveraged to pinpoint where costs, opportunities, and bottlenecks are going to show up. It can and should also be used to set projections based on historical metrics, so that sponsors have a holistic view of the benchmarks they can expect. For instance, it can offer baseline insights into questions such as:

• How many potential participants are there?
• What are the best strategies to reach them?
• How many participants will enrol?
• How many participants are going to qualify?
• How long will recruiting take?
• How many will stay for the length of the trial?
• Why might some participants not show up?

When it comes to predicting critical trial outcomes, a good rule of thumb is: if it sounds too good to be true, it might just be.

Get sites’ attention and empower them with the right resources

I’m not the first to say this, and I won’t be the last: with more trials than ever, there’s also more competition than ever for research sites and resources.

Many sites are still facing staffing shortages and time constraints following COVID-19, making it more difficult for them to quickly activate. Then, even if a trial site has been secured and initial outreach yields a lot of interested candidates, it’s important to be aware of how thinly stretched they are. Even staff members that are working around the clock and giving their all to a trial still might not be able to give each individual as much attention as they would like, while still managing their other tasks. This can lead to otherwise interested participants falling out of the pipeline due to not receiving their desired level of follow-up or confusion about next steps.

It’s important that companies know how to remove these types of barriers and optimise limited resources. For instance, a good partner will see this site burden and rise to help empower them by providing pre-screened, qualified candidates for trials. This eliminates extra time commitments from already time-crunched staff, who would otherwise have to weed through under-qualified individuals. Instead, they can focus more on other aspects of running the trials.

Sites, sponsors, and recruitment vendors should see each other as partners, who must work closely to make trials successful.

Cut costs by balancing technology and the human touch, not by sacrificing quality

Many companies aren’t able to afford the costs associated with drawn-out recruitment processes or replacing participants that drop out mid-trial. As a result, they naturally begin looking for ways to reel in their budgets.

Because there are so many steps between making first contact with a potential participant and having that person complete the screening phase of a trial, it’s tempting to use technology to cut costs by automating all aspects of the trial process. But this approach can leave a lot to be desired.

Health care is inherently personal, and while technology can do a lot to augment processes and synthesise massive amounts of data, people will always seek out outlets where they feel appreciated and listened to.

Having skilled health professionals guide potential and confirmed participants through each and every step should be viewed as an investment, rather than a cost centre - especially considering the aforementioned costs of participant drop-off.

Diversity isn’t just a nice-to-have when it comes to trials

Diversity in clinical trials is critical to developing therapies with the potential to help all affected populations. This is not news to pharma, and there’s no lack of trying when it comes to building more diverse participant pools. There isn’t any one solution either.

Introducing more diversity isn’t just a matter of finding a vendor that knows how to run ads for people of colour, for instance. It requires securing geographic strategic sites that are accessible to the desired participants. It’s about ensuring that the principal investigators at the site are diverse, too. People want to feel comfortable with their healthcare professionals, including trial staff. Having caring and experienced professionals that look and sound like them can go a long way in keeping participants engaged.

And remember that diversity isn’t just about race; it’s about disability, gender, identification, class, and economics, too. As trials become progressively more diverse, the industry will gain access to more data that enables us to figure out how different people progress through the process and where the bottlenecks are.

The companies that succeed will be those who look at the associated problems and solutions holistically.

While there’s a lot more to say about each of these topics, a common thread among them is the need for a data-centred approach to trial recruitment and retention, but one that preserves the personal touch that makes people feel cared for.