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Compliance In Focus
Posted by Becky Perry on Wed, Aug 27, 2014

Research Awareness and Participation Barriers

An article was recently published in the Clinical Researcher entitled “Increasing Provider Research Awareness and Participation BarriersEngagement in Clinical Research Starts with Research Awareness:  Leveraging Education and Technology to Improve Participation”.  In this article, the authors indicated that whether directly or indirectly involved with clinical trials, increasing research awareness may increase health outcomes, study accrual, and patient safety.  Subsequently, the ability to enroll in a clinical research trial may improve patient care for some individuals and result in better outcomes for future patients.  Without increasing accrual, sites and sponsors are not able to efficiently conduct clinical trials.

Despite the number of clinical trials open nationally, the article sites these figures:

  • Currently, less than 5% of the U.S. population participates in clinical trials each year.
  • As a result [of the above], 85% of trials are delayed because of accrual challenges and,
  • 30% of studies do not enroll any subjects.

In order to meet the challenge of a lack of public awareness of clinical research, tools that increase the availability of useful information for clinical trials are being designed and implemented.  An example mentioned in the article included Informatics for Integrating Biology and the Bedside (i2b2) which gives researchers the ability to gather pertinent information from the electronic health records (EHRs) and develop novel ways to identify potential subjects.  Another resource is a Clinical Trial Management System (CTMS) which provides large volumes of data and acts as a digital dashboard for those managing the clinical trials.  Both of these tools have the potential to increase study awareness and, as a result, increase patient accrual.

Although these tools exist, many sites are not utilizing them for their clinical trials.  Hence, research study teams still have a difficult time identifying and recruiting potential subjects to participate in the clinical trials.  Interestingly, a recent survey, by Somkin, looked at the attitude of medical oncologists toward clinical trials.  The results indicated that there was a direct correlation between clinical trial awareness and willingness to enroll patients.   Not unexpectedly, low accrual impacts the individual site(s) and the sponsor; when the recruitment phase takes longer than expected, the duration of the study and overall costs increase.

The survey noted above was performed on providers at a large health system and looked at research awareness and overall opinion of the status of clinical research at that site.  The article provided these results:

  • 47% of respondents were unaware that any clinical trials or interventional studies were being conducted at the organization,
  • 62% were unsure whether their patients could be participating in clinical trials, and
  • 68% did not know whom to contact even if they had a question about a study.

Some of the most significant barriers to research at the organization were as
follows:

  • Lack of knowledge about ongoing research 78%
  • Shortage of research staff 45.8%
  • Insufficient research funding 45.8%
  • Difficulty following up or monitoring participants 32.2%

Research Awareness and Participation Barriers

Implementing new and/or advanced technology, such as the i2b2 or CTMS systems noted above can come with a high price tag.  Another suggestion to lower costs and increase accrual is to ensure proper site selection.  From a sponsor’s perspective, carefully choosing those institutions that have adequate resources, including time to devote to the study and designated research staff may provide beneficial in boosting the efforts to ensure the research study is being communicated to potential subjects.  Additionally, working closely on the recruitment efforts with those sites that have dedicated research study teams or are high-enrollers may have an impact on overall study accrual.

What are some other ways to improve research awareness?  Does your site struggle with this?  Have you adopted new and/or cutting edge technology to combat this challenge? 

 Photo Credit: AlicePopkorn

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Topics: Research Awareness, Participation Barriers, Clinical Research

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