<abstract xmlns="http://www.w3.org/1999/xhtml">

<sec>
<h3>Introduction</h3>
<p>For retention in clinical trials of investigational medical products (CTIMPS), the strategy and tactics to keep enrolled participants from discontinuing participation (dropouts) are important. Haemophilia trials often have extended follow-up and require motivated participants who commit for the duration of the study, which may be underestimated at initiation. Study discontinuation may lead to inconclusive results and prolonged trials. Research nurses (RNs) and study coordinators (SCs) play an important role in clinical trials and are considered the link between principal investigator and study participants. We discuss the importance of the RNs and SCs in retention of participants, the barriers and challenges to retention, and the interventions utilised to support it.</p>
</sec>
<sec>
<h3>Methods</h3>
<p>We conducted a 12-question online survey at registration for a virtual research study update summit. The survey investigated the thoughts of RNs/SCs about retention in CTIMPS, their experiences and challenges, and interventions to prevent attrition.</p>
</sec>
<sec>
<h3>Results</h3>
<p>Eighty-seven RNs and SCs from 24 countries (Asia, Australia, Europe, the Middle East and North America) participated. The majority (62/75 responses) reported having 1-5 or 6-10 clinical trial participants (46.6% and 36% respectively); the remainder reported 11-40 trial participants. The majority reported no or few participants dropping out of haemophilia clinical trials in the preceding three years (42.8% and 33.7% respectively). RNs/SCs believed participants dropped out because of ‘loss of interest’ (50%), ‘study going on too long’ (39%), ‘too many visits’ (virtual or at centre) (37.5%), ‘visits are too time-consuming’ (34%) and a ‘lack of time’ (32.8%). Over half of RNs/SCs believed ‘dropouts’ would be higher if they did not make extra efforts in retention. The top interventions to retain participants were: keeping an open dialogue, organising visits to fit participant schedules, discussing adverse events, understanding the protocol, and allowing participants time to ask questions. Retention is achieved through flexibility, timeliness, combining trial activities with routine care, shared decision making and effective communication, including via contemporary technology.</p>
</sec>
<sec>
<h3>Conclusion</h3>
<p>This study investigating the retention role of RNs/SCs revealed low dropout rates in haemophilia trials. RNs/SCs are able to offer flexibility to trial procedures by, for example, scheduling visits within trial timing ‘windows’ to support and facilitate individualised follow-up. Patient-centred care and attention, including trust, attitude and expectations, aid successful retention and trial outcomes. This often unrecognised role is important in supporting people with haemophilia in clinical trials to promote good study outcomes.</p>
</sec>
</abstract>

Introduction
For retention in clinical trials of investigational medical products (CTIMPS), the strategy and tactics to keep enrolled participants from discontinuing participation (dropouts) are important. Haemophilia trials often have extended follow-up and require motivated participants who commit for the duration of the study, which may be underestimated at initiation. Study discontinuation may lead to inconclusive results and prolonged trials. Research nurses (RNs) and study coordinators (SCs) play an important role in clinical trials and are considered the link between principal investigator and study participants. We discuss the importance of the RNs and SCs in retention of participants, the barriers and challenges to retention, and the interventions utilised to support it.


Methods
We conducted a 12-question online survey at registration for a virtual research study update summit. The survey investigated the thoughts of RNs/SCs about retention in CTIMPS, their experiences and challenges, and interventions to prevent attrition.


Results
Eighty-seven RNs and SCs from 24 countries (Asia, Australia, Europe, the Middle East and North America) participated. The majority (62/75 responses) reported having 1-5 or 6-10 clinical trial participants (46.6% and 36% respectively); the remainder reported 11-40 trial participants. The majority reported no or few participants dropping out of haemophilia clinical trials in the preceding three years (42.8% and 33.7% respectively). RNs/SCs believed participants dropped out because of ‘loss of interest’ (50%), ‘study going on too long’ (39%), ‘too many visits’ (virtual or at centre) (37.5%), ‘visits are too time-consuming’ (34%) and a ‘lack of time’ (32.8%). Over half of RNs/SCs believed ‘dropouts’ would be higher if they did not make extra efforts in retention. The top interventions to retain participants were: keeping an open dialogue, organising visits to fit participant schedules, discussing adverse events, understanding the protocol, and allowing participants time to ask questions. Retention is achieved through flexibility, timeliness, combining trial activities with routine care, shared decision making and effective communication, including via contemporary technology.


Conclusion
This study investigating the retention role of RNs/SCs revealed low dropout rates in haemophilia trials. RNs/SCs are able to offer flexibility to trial procedures by, for example, scheduling visits within trial timing ‘windows’ to support and facilitate individualised follow-up. Patient-centred care and attention, including trust, attitude and expectations, aid successful retention and trial outcomes. This often unrecognised role is important in supporting people with haemophilia in clinical trials to promote good study outcomes.

Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials

The Journal of Haemophilia Practice

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Introduction
For retention in clinical trials of investigational medical products (CTIMPS), the strategy and tactics to keep enrolled participants from...

Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials

Article Category: Clinical Practice

Published Online: Dec 20, 2023

Page range: 128 - 137

DOI: https://doi.org/10.2478/jhp-2023-0017

Keywords
Retention, Clinical trials, Nurses, Haemophilia, Study coordinators

© 2023 Kate Khair et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Recognising the importance of the research nurse and study coordinators in enhancing retention of people with haemophilia in clinical trials

Article Category: Clinical Practice

Published Online: Dec 20, 2023

Page range: 128 - 137

DOI: https://doi.org/10.2478/jhp-2023-0017

KeywordsRetention, Clinical trials, Nurses, Haemophilia, Study coordinators

© 2023 Kate Khair et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Retention, Clinical trials, Nurses, Haemophilia, Study coordinators