Wide Gaps in Patient Informed Consent Comprehension Impact Recruitment, Tax CRCs

Fraser Gibson, President, Advantage Clinical

There’s work to be done, according to a massive review of 30 years of journal article data and 103 studies that found just 52.1 percent to 75.8 percent of study volunteers understood different components of informed consent. “That’s not the result we’ve found in our own application, but that did surprise me,” says Nadine Nemunaitis, vice president of research operations for Mary Crowley Cancer Research Centers in Texas.

Topping the list of problem areas are the phenomena of patients not fully understanding the voluntary nature of participation, the fact that they can withdraw at any time, the basic nature of the study, and its benefits to the patient and others down the road. Some sponsors have launched programs to help narrow those gaps, including Eli Lilly and Company. The study found several other areas where patient informed consent is lacking to varying degrees (see chart below).

Components of Informed Consent
Source: Nadine Nemunaitis, vice president of research operations for Mary Crowley Cancer Research Centers in Texas

Meanwhile, there’s likely a cause and effect factor that impacts patient recruitment, says Fraser Gibson, an experienced clinical research professional who has worked as a study coordinator and regional monitor, and who is currently a senior clinical research associate (CRA) for Spectral Medical. As clinical trials become more complex and clinical research coordinators (CRCs) are increasingly asked to take on more tasks. Informed consent programs can often suffer as a result, because those professionals tasked with making sure patients truly understand a study are overwhelmed with a rising pile of responsibilities.

Referencing a recent Tufts study, Gibson paints a rather bleak picture:

  • The majority of studies do reach their recruitment goals (number of patients), though the timelines to study completion can be doubled
  • 80+ percent of trials do not meet recruitment timelines
  • 11 percent of sites fail to enroll a single patient
  • 37 percent of sites under enroll
  • 90 percent of delays in trial completion are due to sluggish patient recruitment

It’s time to take better care of those running a trial, says Gibson in a challenge to sponsors who’ve largely been doing it the same way for years. “We, as an industry, must consider utilizing intrinsic motivators to improve the productivity of our employees, colleagues, and collaborators,” he notes.

Gibson advocates leveraging a new type of professional to improve recruitment and overall trial workflow: the patient recruitment specialist. In this fairly new role, according to Gibson, professionals can help in a number of areas, including coordinating recruitment efforts across several sites, assisting in the setup of the logistics of complex trials, compiling and sharing knowledge between sites, and acting as a trained liaison between site and sponsor.

The patient recruitment specialist requires some specific skills, Gibson says:

  • Clinical Research Experience (e.g., as a CRC or CRA)
  • Indication Experience (e.g., intensive care unit nursing experience)
  • Communication and Public Speaking
  • Comprehensive Study and Therapeutic Knowledge
  • Soft Skills (e.g., as a “people person”)

Additional Resources

Gibson and Nemunaitis will present separate ACRP webinars with tips and tools to advance patient recruitment and informed consent programs.