Participant demographics and beliefs on the retention of patients in clinical trials
| N (%) | |
|---|---|
| Participant role (N=87*) | |
| Haemophilia Nurse | 35 (40.2) |
| Haemophilia Study Coordinator | 38 (43.7) |
| Both | 14 (16.1) |
| Number of participants in clinical trials (N=75) | |
| 1-5 | 35 (46.6) |
| 6-10 | 27 (36.0) |
| 11-20 | 7 (9.3) |
| 21-30 | 3 (4.0) |
| 31-40 | 1 (1.3) |
| 41-50 | 2 (2.6) |
| Number of participants lost to clinical trials in preceding three years (N=70) | |
| None | 33 (42.8) |
| 1-5 | 26 (33.7) |
| 6-10 | 9 (11.6) |
| 11+ | 2 (0.02) |
| Do you think COVID-19 has impacted on patient participation in clinical trials? (N=79) | |
| Yes | 22 (28%) |
| No | 57 (72%) |
| Do you think your participants would leave studies prematurely if you didn’t make extra efforts to retain them? (N=72) | |
| Yes | 40 (55.5) |
| No | 8 (11.1) |
| Not sure | 24 (33.3) |
| Why do you think trial participants leave drug studies prematurely? (N=64; multiple answers possible, ranked highest to lowest) | |
| Loss of interest | 32 (50.0) |
| The study goes on for too long | 25 (39.0) |
| Too many visits (virtual or at centre) | 24 (37.5) |
| Visits are too time-consuming | 22 (34) |
| Lack of time | 21 (32.8) |
| Too much data collection (diary, quality of life assessments, etc.) | 19 (29.6) |
| Participation did not meet expectations | 18 (28.1) |
| Too difficult to comply with protocol requirements long term | 17 (26.5) |
| Timing of visits – would like evening hours/weekend – due to work/life situation | 14 (21.8) |
| Using electronic diary | 13 (20.3) |
| Too many blood tests | 12 (18.75) |
| There are unnecessary visits (e.g. dispensing visits) | 8 (12.5) |
| No compensation (travel) | 7 (10.9) |
| No updates on study results | 3 (4.6) |
Roles of Research Nurses and Study Coordinators in clinical trials
| N (%) | |
|---|---|
| What do you do to keep participants trial compliant? (N=67; multiple answers possible, ranked highest to lowest) | |
| Make the participant feel valued | 56 (83.5) |
| Keeping an open dialogue/good relationship | 56 (83.5) |
| Organise visits to fit with the patient‘s schedule | 53 (79.1) |
| Ensure patient has understood study information | 47 (70.1) |
| Discuss any concerns about complaints/side effects reported by patient | 45 (67.1) |
| Allowing an environment for patient to ask questions | 44 (65.6) |
| Discuss the diary data – make patients to know the data is important | 39 (58.2) |
| Show blood results | 36 (53.7) |
| Show global results and progress of the study | 36 (53.7) |
| Updating on individual participants trial information e.g. adverse events | 28 (41.7) |
| What do you do to facilitate retention? (N=71; multiple answers possible, ranked highest to lowest) | |
| Use technologies to communicate, support and remind (e.g. visits/diary entry) by text (SMS) email, etc. | 41 (57.7) |
| Provide updated study information | 32 (45.0) |
| Ensure timely coordination of study visit (patients do not have to wait) | 30 (42.2) |
| Coordinate all trial activities with routine clinical care | 23 (32.3) |
| Awareness education by re-training | 21 (29.5) |
| Goal setting | 20 (28.1) |
| Allow flexibility to accommodate participants’ needs | 18 (25.3) |
| Motivational interviewing | 18 (25.3) |
| Shared decision making | 17 (23.9) |
| Promote peer-to-peer support | 13 (18.3) |
j_jhp-2023-0017_tab_003
| QUESTION | ANSWER |
|---|---|
| Which country are you from? | Drop-down list |
| Are you a …. | Tick box: |
| ◯ Haemophilia nurse; | |
| ◯ Haemophilia study coordinator; | |
| ◯ Both | |
| Where do you mostly work? | Tick box: |
| ◯ Haemophilia centre; | |
| ◯ Clinical trials unit | |
| Do you think retention in haemophilia clinical drug studies is an issue? | Tick box: |
| ◯ Yes; | |
| ◯ No | |
| How many participants do you have in haemophilia drug trials at this moment? | Tick box: |
| ◯ 1-5; | |
| ◯ 6-10; | |
| ◯ 11-20; | |
| ◯ 21-30; | |
| ◯ 31-40; | |
| ◯ 41-50 | |
| How many participants have dropped out of haemophilia drug trials at your centre due to retention issues within the past 3 years? | Tick box: |
| ◯ 0; | |
| ◯ 1-5; | |
| ◯ 5-10; | |
| ◯ More | |
| Please indicate participants' reasons for dropping out of the trial | Free text: |
| Why do you think trial participants leave drug studies prematurely? (Please tick all that apply) | Tick box: (multiple answers possible) |
| ◯ Participation did not meet expectations | |
| ◯ Loss of interest/motivation | |
| ◯ The study goes on for to long | |
| ◯ Lack of time | |
| ◯ Too many visits (virtual or at centre) | |
| ◯ Visits are too time consuming | |
| ◯ There are unnecessary visits (e.g. dispensing visits) | |
| ◯ Timing of visits – would like evening hours/weekend – due to work/life situation | |
| ◯ Too much data collection (diary, quality of life assessments, etc.) | |
| ◯ Using electronic diary | |
| ◯ Too difficult to comply with protocol requirements long term | |
| ◯ Too many blood tests | |
| ◯ No compensation (travel) | |
| ◯ No updates on study results | |
| Do you think COVID-19 has impacted on patient participation in clinical trials? | Tick box: |
| ◯ Yes; | |
| ◯ No | |
| What do you do to keep participants trial compliant? (Please tick all that apply) | Tick box: (multiple answers possible) |
| ◯ Show blood results | |
| ◯ Show global results and progress of the study | |
| ◯ Make the participant feel valued | |
| ◯ Keeping an open dialogue/good relationship | |
| ◯ Ensure patient has understood study information | |
| ◯ Allowing an environment for patient to ask questions | |
| ◯ Organise visits to fit with the patient’s schedule | |
| ◯ Discuss the diary data – make patients know the data is important | |
| ◯ Discuss any concerns about complaints/side effects reported by patient | |
| ◯ Updating on individual participants trial information e.g. AEs | |
| ◯ Updating on global SAEs and reconsenting | |
| What do you do to facilitate retention? (Please tick all that apply) | Tick box: (multiple answers possible) |
| ◯ Motivational interviewing | |
| ◯ Shared decision-making | |
| ◯ Goal setting | |
| ◯ Use technologies to communicate, support and remind (e.g. visits/diary entry) by text (SMS) e-mail, etc. | |
| ◯ Promote peer-to-peer support | |
| ◯ Ensure timely coordination of study visit (patients do not have to wait) | |
| ◯ Allow flexibility to accommodate participants’ needs | |
| ◯ Provide updated study information | |
| ◯ Coordinate all trial activities with routine clinical care | |
| ◯ Awareness education by re-training | |
| Do you think your participants would leave studies prematurely if you didn’t make extra efforts to retain them? | Tick box: |
| ◯ Yes; | |
| ◯ No; | |
| ◯ Not sure | |
| Do you think you get enough support from sponsors to improve study retention? | Five-point Likert scale: |
| ◯ I completely agree; | |
| ◯ I agree a bit; | |
| ◯ I am not sure; | |
| ◯ I disagree a bit; | |
| ◯ I completely disagree |