Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries

Abstract

Background Patient recruitment for clinical trials is challenging—only approximately one third of all trials recruit their participants as planned. The pharmaceutical industry’s views on recruitment success have not been comprehensively investigated, although the industry globally conducts almost one third of all clinical drug trials. This study explored patient recruitment success and failure factors and the role of electronic health records (EHR) in the recruitment of trial participants in the Nordic countries. Methods A descriptive qualitative interview study was conducted with 21 representatives of the pharmaceutical industry or contract research organizations operating in Finland, Sweden, Denmark, and Norway. The interviews covered 34 clinical pre-market drug trials. Qualitative data were analyzed using inductive content analysis. Results Four main categories were derived to represent both success and failure factors, whereas a fifth category represented only failure factors: (1) sponsor-related (protocol and trial preparation and feasibility evaluations), (2) site/investigator-related (access to patients, motivation, commitment and resources), (3) patient-related recruitment factors (medical need, patients’ role in their care and attitudes towards trials), (4) Sponsor—sites—patients collaboration factors, and (5) start-up related factors. EHR was the most important source of recruitment, utilized in 29 out of 34 trials discussed. Revision of the legislation regulating the secondary use of EHR was highlighted as the most effective measure to facilitate the use of EHR in recruitment of trial participants. Conclusions The industry representatives recognized quite well their own role in contributing to the success or failure of the recruitment: to facilitate recruitment of trial participants, many obstacles can be avoided with better trial preparation and proper feasibility evaluations. As access to patients represents one of the key success or failure factors of recruitment, and as the EHR is regarded the main source of searching for and finding patients, the development of EHR utilization appears to represent a powerful tool to improve patient recruitment.

Accelerating patient recruitment using social media: Early adopter experience from a good clinical practice-monitored randomized controlled phase I/IIa clinical trial on actinic keratosis

“…To accelerate conventional recruitment and reach recruitment targets, investigators often use static advertising tools such as flyers as well as electronic health records (EHR), including patient registries and databases [ 7 ]. In a recent study on industry-sponsored clinical trials, EHR were used in 85 % of surveyed Nordic trials, which is far above the 11 % reported globally [ 8 ]. Recruitment goals in Northern Europe, however, were only reached in half of the included studies.…”

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

“…Several studies show that African Americans are less likely to both qualify for and to participate in clinical trials due to several reasons such as mistrust in the system, lack of interest in clinical trials, fear and stigma associated with participation, and a perception that they may not be compliant with trial protocols (107)(108)(109)(110). Several strategies that have improved clinical trial participation for minorities and the underserved in other diseases may also be deployed in sarcoidosis (108,111,112). These strategies center around the need to address mistrust and misconception, promote increased information and awareness of the benefits of trial participation, and ensure that investigators and study personnel are fully trained in cultural and racial competencies (108,112).…”

Evaluation of factors associated with recruitment rates in early phase clinical trials based on the European Clinical Trials Register data

“…As previously described, the enrollment of research participants can be subject to the influence of various factors. Many of these factors have been discerned through surveys, studies, and interviews involving participants, and, in case of minors, their parents, as well as investigators 16,17 . Nevertheless, certain limitations exist in some of these studies, including inadequately sample size justification, reliability, and validity of research instruments, and challenges in the collection of data 18 .…”

“…Many of these factors have been discerned through surveys, studies, and interviews involving participants, and, in case of minors, their parents, as well as investigators. 16 , 17 Nevertheless, certain limitations exist in some of these studies, including inadequately sample size justification, reliability, and validity of research instruments, and challenges in the collection of data. 18 Furthermore, none of the aforementioned research endeavors has offered comprehensive list of facilitators and barriers to recruitment that effectively address this issue.…”