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Open Access 01-12-2022 | Methodology

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

Authors: Niina Laaksonen, Mia Bengtström, Anna Axelin, Juuso Blomster, Mika Scheinin, Risto Huupponen

Published in: Trials | Issue 1/2022

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.

Available only for authorised users

Sponsor1

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH GCP 1.53.)

Investigator1

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (ICH GCP 1.34.)

Protocol1

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (ICH GCP 1.44.)

CRA1

Clinical Research Associate (the Monitor) is representing the trial sponsor and is responsible for overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and the applicable regulatory requirement(s).

Phase I trials2

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Duration of Study: Several months

Purpose: Safety and dosage

Phase II trial2

Study Participants: Up to several hundred people with the disease/condition.

Duration of Study: Several months to 2 years

Purpose: Efficacy and side effects

Phase III trial2

Study Participants: 300 to 3000 volunteers who have the disease or condition

Duration of Study: Typically 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

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Title: 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
Authors: Niina Laaksonen
Mia Bengtström
Anna Axelin
Juuso Blomster
Mika Scheinin
Risto Huupponen
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06144-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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