Monday, September 7, 2015

A broken design? Why we need to improve trial recruitment

Designing for better trial recruitment

Despite some improvement, many organisations still have difficulty committing to recruitment targets and we need to find out why.

Research by organisations like Tufts University shows nearly half of all sites fail to enrol a single patient and that, on average, recruitment takes twice as long to achieve as expected.

But while these findings illustrate the scale of the patient recruitment problem, they don’t explain why we as an industry face this challenge and it is important that sponsors and CROs consider what factors may impact recruitment.

Design

Obviously, trial design is important. You can’t control doctors’ decisions to recruit patients or guarantee patients will say yes, all you can do is establish the correct entry and eligibility criteria.

Just getting doctors excited and motivated to enrol patients in studies can be hard, especially if there are items such as complicated blood sampling protocols that could deter them from recommending participation.

Indeed, this may be why bigger sites with study coordinators tend to recruit patients more effectively. They have more staff skilled in handling a wider variety of study protocols.

Disease

Another key factor sponsors and CROs need to consider when thinking about patient recruitment is the disease they are studying.

Cancer is an area where clinical trials rely heavily on patient altruism. People who decide to take part don't always  benefit and indeed are normally unable to receive established treatments while involved in the trial.

Finding cancer patients for clinical trials is therefore a major challenge, which sponsors and CROs need to plan for appropriately.

Similarly, for conditions like diabetes for which reasonably effective treatments are already available, convincing patients to opt instead for an untested therapy can be a challenge.


Clinical change

But while design, disease and patient desire are obvious factors that impact recruitment, other less intuitive considerations also play a part.
Take for example public perception, which can impact trial timelines in a variety of ways. Sometimes negative press about Phase I trials can actually make it easier to find patients as people learn about the payments involved.

However, stories about trial participants being exposed to risk can have the opposite effect, which is particularly important in early phase cancer studies reliant on patient altruism.

Trends in trials

Another often unconsidered factor that impact both recruitment and the trial process as a whole is how a sponsor interacts with its CRO or CROs.

A few years ago it was very fashionable to have full service CROs, but the current trend is for more functional outsourcing where only activities like patient monitoring and data management are conducted by contractors.

This change between approaches can cause real problems as organisations may lose the expertise they had in a specific area when they outsource it, and once it is gone it can be very difficult to replace.

These issues are why PCT-Europe is so important. Allowing senior people to network and discuss the latest challenges in an environment free of the sales pitches you find at other conferences is extremely valuable.




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