In Pharma Mobile Technology Makes Gains, Patient Enrollment Remains A Struggle

By Ed Miseta, Chief Editor, Clinical Leader

A new report has been released by Insight Pharma Reports with some eye-opening results sure to get the attention of clinical executives. The Patient Enrollment & Recruitment Market Study performed a survey of 100 clinical trial professional staff members regarding their experiences with patient enrollment and recruitment. Each was queried on several hot topics in the clinical trials space, including enrollment challenges, mobile technologies and bring your own device (BYOD), patient engagement, and technologies used to run trials. The 100 professionals surveyed came from every level in the trial process, including sponsors, CROs, vendors, trial sites, and patient recruitment organizations. Each group was able to shed some light on the bright spots emerging in clinical research while also noting the primary challenges that still exist with finding the right patients for trials.

Some of the key findings:

It should come as no big surprise that the top challenge in trial enrollment and recruitment is reaching enrollment goals. While efforts have been made to increase the visibility of clinical trials via the internet and social media, as well as interacting with patient groups, participation rates remain low. It was particularly interesting to read this on World Cancer Day, and knowing that a recent study found 85 percent of cancer patients were not even aware that participation in trials was an option. With one in five cancer trials failing to enroll enough patients to properly assess the new medication, this is not only an inconvenience for sponsors, it is a problem that will keep the costs of developing a new drug at $2.5 billion with a time investment of 10 years or more. It’s something the industry and patients can no longer afford, and is hurting efforts to get new medicines on the market. 

After recruitment challenges, respondents chose unrealistic protocols, hitting recruitment deadlines (which is likely closely tied to the first concern), and unrealistic timetables as their next major concerns. If you can’t find patients to enroll, then hitting recruitment deadlines will be difficult. Of course the difficulty in finding qualified patients can also be tied back to a protocol that has unrealistic requirements for patients, or which did not perform a proper feasibility study. Even if there are patients willing to take part in your trial, requiring them to spend four hours in a clinic a couple times a week might not be a realistic expectation.

Although reaching enrollment goals was the most common pain point noted in the survey, overall the studies do seem to be getting filled. According to the report, around 75 percent of respondents said they failed to meet enrollment targets between 5 percent and 25 percent of the time. Only 16 percent of respondents failed to meet their enrollment targets more than 25 percent of the time. Still, that doesn’t seem to be something for the industry to celebrate. I would like to see numbers on what 75 percent of companies missing their enrollment targets just 10 percent of the time is costing the industry.

The survey also has some interesting statistics on technology use in trials. As mHealth providers anxiously await the widespread adoption of mobile and wearable technologies in trials, about one-third of respondents expect expected mobile technologies to streamline their own clinical trial process within one to two years. While that is progress, and likely a nice jump over the last couple of years, it’s still disappointing the number is not higher. 

Many different systems continue to be employed in trials. Respondents cited 46 different CTMS products by name, while others mentioned home grown or custom systems.

Once you have a qualified patient take part in a trial, it’s good to keep in touch with that individual for possible inclusion in future studies. There are many ways to do so, including emails, phone contact, physical correspondence, and of course social media. More than 50 percent of respondents reported using birthday cards or holiday cards to stay in touch with their patient populations. Another 44 percent of respondents report using newsletters to stay in touch with their most valuable asset.

More than 50 percent of survey respondents report currently using clinical trial management software in their studies, with the next most frequently used technologies being risk-based monitoring and e-Source.

Mobile monitoring was the technology most respondents cited as the technology they were most interested in adding over the next two years.

One of the concerns of respondents was IT infrastructure. Although many would likely want to better incorporate mobile technologies in their trials, more than 60 percent of respondents noted the costs to upgrade IT infrastructure was their biggest hurdle with using those technologies to streamline their trials.

The complete report, for one user, is $399. To purchase and view the entire report, click here.