Key messages
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Recruitment to clinical trials is challenging under normal circumstances, and understanding patient and public attitudes to clinical research is critical for trial design.
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Previous studies have found that motivating factors for trial participation were mainly personal gain and altruism whilst deterrent factors were inconvenience and time commitment.
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We found that COVID-19 had both negative and positive impacts on patient attitudes to trial participation.
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Trial design and ensuring patient safety and minimising the risks of exposure to COVID-19, and highlighting these implementations are key for researchers wishing to resume trials in the post-COVID-19 era.
Introduction
Methods
Questionnaire development
Setting and study participants
Data collection
Data analysis
Results
Study population
Total | Willing to participate in trials (n = 21) | Unwilling to participate in trials (n = 32) | P-value | |
---|---|---|---|---|
Age (years) | 63.00 | 63.00 | 60.50 | 0.6039 |
Commuting time (min) | 40.00 | 40.00 | 32.50 | 0.1561 |
Gender | ||||
Male | 27 (51%) | 9 (43%) | 18 (56%) | 0.4064 |
Female | 26 (49%) | 12 (57%) | 14 (44%) | |
Travels independently | 46 (87%) | 18 (86%) | 28 (88%) | > 0.999 |
Level of education | ||||
Primary school | 5 (9.4%) | 3 (14%) | 2 (6%) | 0.6627 |
GCSEs | 8 (15.1%) | 2 (10%) | 6 (19%) | |
A/O levels | 15 (28.3%) | 6 (29%) | 9 (28%) | |
University degree | 25 (47.2%) | 10 (48%) | 15 (47%) | |
Ethnicity | ||||
Caucasian | 30 (56.6%) | 13 (62%) | 17 (53%) | 0.7002 |
Asian | 12 (22.6%) | 5 (24%) | 7 (22%) | |
Afro-Caribbean | 9 (17.0%) | 2 (10%) | 7 (22%) | |
Others | 2 (3.8%) | 1 (5%) | 1 (3%) | |
Employment status | ||||
Full-time | 22 (41.5%) | 10 (48%) | 12 (38%) | 0.3483 |
Part-time | 2 (3.8%) | 2 (10%) | 0 (0%) | |
Unemployed—seeking work | 5 (9.4%) | 1 (5%) | 4 (13%) | |
Unemployed—for health reasons | 3 (5.7%) | 1 (5%) | 2 (6%) | |
Retired | 19 (35.8%) | 7 (33%) | 12 (38%) | |
Student | 2 (3.8%) | 0 (0%) | 2 (6%) | |
Current treatments | ||||
Eye drops | 19 (35.8%) | 7 (33%) | 12 (38%) | 0.6511 |
Laser therapy | 8 (15.1%) | 4 (19%) | 3 (9%) | |
Surgery in the last 6 months | 14 (26.4%) | 4 (19%) | 10 (31%) | |
None | 27 (50.9%) | 10 (48%) | 17 (53%) | |
Number of co-morbidities | ||||
0 | 22 (41.5%) | 8 (36%) | 14 (64%) | 0.3152 |
1 | 24 (45.3%) | 13 (54%) | 14 (46%) | |
2 | 2 (3.8%) | 0 (0%) | 2 (100%) | |
3 | 2 (3.8%) | 0 (0%) | 2 (100%) | |
Previous trial participation | ||||
Yes | 9 (17.0%) | 5 (56%) | 4 (44%) | 0.4637 |
No | 44 (83%) | 17 (39%) | 27 (61%) |
Willingness to participate in research
Understanding of involvement in clinical trials
Category | Theme | Codes | Example excerpt(s) |
---|---|---|---|
The purpose of clinical research | Resolution | Developing new treatments Addressing different questions Evidence-based medicine | P22: “a lot, novel therapy, all the clinical governing things like providing evidence-based medicine from a patient perspective it may help therapy and better treatment” P38: “taking a sample of patients for a particular reason” |
Innovation | Valuable part of science Improving management of current conditions Part of drug development | P18: “well, they try out different procedures and drugs on volunteered people, sometimes give a placebo and they won’t know which one” P20: “it is something we all have to be tested for to see if suitable to put on market” | |
Progression | Improving patient care Improving services Helps the wider community | P1: “it’s necessary, have to have it to come up with treatments” P46: “testing out new treatments and advancing practice” | |
The process of clinical research | Participants | Experimentation Requires volunteers Animal testing | P9: “being guinea pigs” P22: “it depends on the trial; the first batch are people are those who put their necks on the line then after this it is safer” P34: “tested on animals and then on healthy people then on people whom the drug is demanded for” |
Intervention | Comparing two drugs Comparing two technologies | P48: “testing of new medication or technologies” | |
Follow-up | Time-consuming process Rigorous process Need to stay in hospital for the duration of the trial | P4: “from my knowledge, people stay in hospital for trials to be done until it is released to wider community” P52: “done one before; it was too demanding for me” |
Attitudes towards participating in clinical research
Category | Theme (n) | Sub-theme (n) | Codes | Example excerpt(s) |
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Motivating factors | Personal gain (16) | Aids own understanding of condition Find better treatments for own condition Financial reward Free services | P7: “help others, increase my own understanding of the eyes” P14: it will help people, it may improve my own treatment P18: “I think it could help my condition. Maybe reverse it and I am doing my best anything to enhance would be great” P51: “help keep my sight and improve it” P53: “for money and help research” P21: “depends on trial and if it’s in my interest improvement and well-being in life, if they can provide free services as incentives” | |
Altruism (10) | Benefit to others Benefit to future generations | P7: “help others, increase my own understanding of the eyes” P13: “if there is, anyway, I can be helpful and anyone with my condition can help” P32: “help with future cure/treatment, research and interest” p48: “help future generations by coming up with new treatments” | ||
Contribution to innovation (12) | Improvement in management of conditions Help progression of field New solutions Sense of importance | P5: “it may help the development of medicine” P15: “it’s like learning, advancing science and better healthcare for people and for systems and can help people in hospital, helps remove excess burden” P30: “help improve medications” P31: “to help fellow people and advance medicine and science” P34: “help with the development of new drugs or treatment” | ||
Personal circumstances (2) | Lack of other options Benefit to relatives | P46: “no reasons at my age, worth trying anything” p48: “…last chance for my own health” P29: “can be helpful for my son” | ||
Factors preventing participation in trials | Lack of benefit (4) | Lack of relevance to own condition Potential of no significant findings Inadequate financial incentives | P3: “depends on the topic, if I thought it was beneficial to me” P32: “no guarantee of treatment working” P52: “not enough money and possible infections” | |
Inconvenience (27) | Time commitment Need to stick to appointments Interference with other activities Personal circumstances Commuting | P1: “wouldn’t have time, I do some part time work” P2: “don’t have time, I can’t be bothered and it’s too much hassle” P5: “time and personal circumstances, I have more operations coming up as does my wife” P13: “transport and getting there” | ||
Accessibility | Health condition (1) | Multiple co-morbidities | P27: “I am sick, I cannot move my arm after my stroke, my condition has already stopped me working” P10: “public transport is main concern” | |
Current circumstances (4) | Difficulty in commuting | |||
Personal experiences (10) | Multiple co-morbidities Bad experiences with medications Severity of condition | P19: “I have too many sicknesses” P43: “I’ve had a lot done to my eyes” P39: “bad experience with eye drops last year which was worrying” P49: “scared it might make my condition worse” | ||
Safety (31) | Current circumstances (8) | Fear of inadequate precautionary measures Minimise exposure to hospital environment | P14: “safety measures may not be taken” P21: “reluctance to take unnecessary risks especially in COVID and lockdown and going to places unnecessarily” P23: “I wouldn’t want to come into hospital more than I have to” P24: “possible side effects are worrying” P27: “I read about clinical trials at … Hospital, I do not want to be injected” P34: “worried about the life risk” P40: “depends on the stage of trials, not participate early on” | |
Interventions used in the trial (23) | Fear of harmful effects Previous trials gone wrong Reluctance to join trial at an early stage |
Influence of the COVID-19 pandemic on attitudes towards participating in clinical research participation
P14: “safety measures may not be taken”P21: “reluctance to take unnecessary risks especially in COVID and lockdown and going to places unnecessarily”P23: “I wouldn’t want to come into hospital more than I have to”
P10: “public transport is main concern”
Category | Theme | Codes | Example excerpt(s) |
---|---|---|---|
Positive influence | Increased awareness | Need for more research Realisation of the importance of research | P3: “could be more beneficial now” P4: “heightened my views” P37: “it will be more useful now” |
Altruism | Potential benefit to others | P26: “if I suffered from the virus then I may have wanted to help find a vaccine and go through the experience” | |
Negative influence | Safety | Avoiding unnecessary risks Fear of hospital environment | P21: “reluctance to take unnecessary risks especially in COVID and lockdown and going to places unnecessarily” P23: “more worried about the pandemic, I’ve been asked to shield” |
Emotional effects | Increased anxiety | P29: “made me more worried” P30: “worries me, don’t want to come into hospital” |
Patient attitudes to attending hospital for clinical vs research appointments
P8: “pleased to come as feel I need it badly”P46: “have no problem at all, hospital takes good precautions”
P22: “anxious as I am unfamiliar with how the new clinic is being ran; it’s a new way of providing care”P24: “very worried, this is my first time out of the house, I don’t leave without reason, my husband is disabled, and he may get it from me”P36: “nervous, the risk and reward is not balanced for me”
P26: “I am just here for hospital appointments”P32: “I’d be worried in the current climate”P23: “I wouldn’t want to come into hospital more than I have to”P3: “I wouldn’t want to come in as it would take up too much time and effort”