Regulatory Focus™ > News Articles > Study: Clinical Trial Site Activation, Enrollment Difficulties Slow Product Approvals

Study: Clinical Trial Site Activation, Enrollment Difficulties Slow Product Approvals

Posted 15 January 2013 | By

A new study out from the Tufts Center for the Study of Drug Development (CSDD) indicates that it is difficult for companies to start up and enroll patients into clinical trials, with many trials taking almost twice as long as initially expected and more than one in 10 trials never enrolling a single patient.

The study's findings could have implications for regulatory professionals, who often oversee all or parts of the clinical trials process and are often responsible for making sure that trials are generating the statistically valid evidence necessary to meet rigorous approval standards and meet a huge number of other regulatory requirements.

The study, published 15 January 2013, looks at site activation rates at more than 150 trials involving nearly 16,000 sites.

Site activation refers to how many trials were able to get off the ground and enroll-or have the capacity to enroll-at least one patient. The lead-up process to activation is complex, requiring sponsors to negotiate the contracts to fund and staff the trial, gain institutional review board (IRB) (or equivalent) approval, obtain supplies of the product to be tested, and meet pre-enrollment regulations like informed consent and financial disclosure regulations.

The latter are particularly important for regulators, as irregularities may result in an investigational new drug application (or equivalent) being revoked and the trial shut down.

Activation Rates Differ Across Regions

The difficulty of getting a clinical trial up and running is significant, and its difficulties are only growing, notes the Tufts study.

The good news for regulatory professionals operating in European or Asian markets is that they are likely to have an easier time. Clinical site activation rates were highest in Western Europe (93%), Eastern Europe (92%) and in the Asia/Pacific region (91%). North America and Latin America, meanwhile, activated at 87% and 80% rates, respectively.

"High site activation rates reflect success with study startup and speed to recruit the first patients," noted Tufts. "These rates do not reflect the downstream challenges of retaining study volunteers through to the last patient, last visit."

Once a trial is up and running, the problems continue. Tufts found that just 89% of global sites met their target enrollment goals, a potentially big problem when it comes to proving statistical significance of generated data. Eleven percent of trials, then, are unable to ever enroll a single patient.

The study also noted a huge difference between the enrollment numbers exhibited by North American and European countries compared to Asia and Latin America. Western and Eastern European countries only met their target enrollment numbers in 69% and 75% of cases, respectively, while North American, Asian and Latin American countries did so in nearly all cases.

A Long Process

That data, however, hides some of the difficulties of enrolling patients in more developed countries, Tufts said. "Targeted patient enrollment numbers in North America and Europe are typically three to four times those targeted in emerging regions," it explained, which can contribute significantly to the time necessary to proceed with a clinical trial and its costs.

In fact, most trials wound up taking nearly twice as long to complete as a result of enrollment difficulties. Trials testing central nervous system (CNS) therapies, for example, increased an average of 116% relative to the intended goal. Oncology products fared the best, increasing just 71% in time on average.

The report goes on to note that many trial sites do not receive adequate support to market the trial, and recommends that contract research organizations (CROs) and others look into the use of social media tools like Twitter, YouTube and Facebook to better reach their target audiences. Some companies could be hesitant to use social media because of the "real and perceived restrictions by global region" and a general aversion to risk, the report added.

More information on the report may be found here (PDF).

Source: Kaitin KI, Editor. "89% of trials meet enrollment, but timelines slip, half of sites under-enroll." Tufts Center for the Study of Drug Development Impact Report. 2013 Jan/Feb;15(1)

Regulatory Focus newsletters

All the biggest regulatory news and happenings.