Cardiovascular DiseasesNCT03881969
Does Paying Subjects to Participate in Research Improve Recruitment
A study testing Financial Payment of £100 in people with Cardiovascular Diseases, run by University of Dundee.
Trial summary
Patient recruitment into clinical trials is a major challenge and the elderly, socially deprived and those with multiple co-morbidities are often under-represented. The idea of paying patients an incentive to participate in research is controversial and evidence is needed to evaluate this as a recruitment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Financial Payment of £100
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,015 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for inclusion in one of the 5 clinical trials involved in the paying patients trial.
Who cannot join
- -
About this study
Official title: Does Paying Subjects to Participate in Research Improve Recruitment and Increase the Proportion of Socially Deprived and Elderly Participants?
Patient recruitment into clinical trials is a major challenge and the elderly, socially deprived and those with multiple co-morbidities are often under-represented. The idea of paying patients an incentive to participate in research is controversial and evidence is needed to evaluate this as a recruitment strategy. This study aims to assess the impact on recruitment into five current clinical trials of a £100 incentive payment and whether this payment will attract more elderly and socially deprived patients.
Read the detailed description
In the UK, it is already common practice to reimburse out-of-pocket expenses eg travelling expenses and parking charges to patients participating in clinical research studies, but not to give any other incentives. This contrasts with healthy volunteer studies where financial payments are often made to encourage participation in studies.
There are few data on how payments to patients in the UK would influence the recruitment and demographic structure of patients recruited to clinical research studies.
The single biggest cost of clinical trials in the UK is the cost of recruiting suitable subjects. The Academy of Medical Sciences report on the UK clinical trials environment, "A new pathway for the regulation and governance of health research", provided a comprehensive review of the barriers faced in running clinical trials . However, other barriers to recruitment exist after these hurdles have been overcome. Importantly, in our experience, of 100 suitable subjects identified as suitable to be entered into a study only about 14% are actually randomised. Most of the identified suitable subjects do not reply to invitation letters from their doctor and some patients who do reply decline the invitation to participate. Campaigns to engage the public on the importance of research have had modest effects on improving the awareness about trials but no measurable effect on willingness to participate .
An important finding is that those subjects who do participate in clinical trials usually have much lower rates of events than predicted from observational data. This is probably because trials attract subjects who care about their own health and the health of others and these subjects exhibit good 'health behaviour'. Those subjects with less good health behaviour and who constitute the subjects who suffer more consequences from their disorders in the real world, do not participate in trials as readily. The result is that trial participants tend to be middle class, middle aged, low risk subjects. These subjects are unrepresentative of the population at large or the population who will eventually get most of the prescribing (lower class, elderly and high risk). In addition, including only low risk subjects may result in studies being abandoned because the low event rates make achieving a statistically reliable result futile.
How can we address this issue within an ethical framework?
The findings from one trial currently running casts some light on this issue. The Streamlined Celecoxib versus standard therapy Outcome Trial (SCOT) is currently running in both the UK and Denmark. Trial recruitment in Denmark is significantly better than in the Scotland. We think that this is because in Denmark, all patients pay the full price for their medications and trial participation means that they get their medication free. In Scotland where recruitment is lower, all prescriptions are free anyway so there is no such incentive. Thus there appears to be a financial incentive for Danish patients to participate.
The present proposal seeks to study the effect of payments on recruitment.
- Conditions
- Cardiovascular Diseases
- Being tested
- Financial Payment of £100
- Keywords
- Trial Recruitment, Incentive Payment, Patient Demographics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Payment of £100Behavioural
Also called No Financial Payment
No financial payment
| Study group | Role | What they receive |
|---|---|---|
| Financial incentive offered | Experimental | Patient offered £100 incentive payment in initial trial invitation letter. Receives: Behavioral: Financial Payment of £100 |
| No incentive. Payment not offered | Experimental | Patient sent standard trial invitation letter with no offer of incentive payment. Receives: Behavioral: Financial Payment of £100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient response to initial invitation letter
Number of positive responses to the initial invitation to participate in a clinical trial letter as determined by whether or not the patient was offered £100 incentive payment.
Measured: On Study completion Approx 1 year
Secondary outcomes (1)
Recruitement of elderly and socially deprived patients
To determine whether the offer of £100 incentive would result in increased recruitment of elderly or socially deprived patients. Social deprivation determined by postcode and Scottish Index of Multiple Deprivation (SIMD) score.
Measured: Through study completion Approx 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study startJun 2012
- Primary completionAug 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881969
- Sponsor's protocol ID
- 2012 CV01
- Status last verified
- Mar 2019
- First submitted
- 7 Jan 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Paying Subjects to Participate in Research Improve Recruitment and Increase the Proportion of Socially Deprived and Elderly Participants?
- ClinicalTrials.gov ID
- NCT03881969
- Acronym / sponsor ID
- 2012 CV01
- Conditions
- Cardiovascular Diseases
- Keywords
- Trial Recruitment, Incentive Payment, Patient Demographics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient recruitment into clinical trials is a major challenge and the elderly, socially deprived and those with multiple co-morbidities are often under-represented. The idea of paying patients an incentive to participate in research is controversial and evidence is needed to evaluate this as a recruitment strategy. This study aims to assess the impact on recruitment into five current clinical trials of a £100 incentive payment and whether this payment will attract more elderly and socially deprived patients.
Detailed description
In the UK, it is already common practice to reimburse out-of-pocket expenses eg travelling expenses and parking charges to patients participating in clinical research studies, but not to give any other incentives. This contrasts with healthy volunteer studies where financial payments are often made to encourage participation in studies.
There are few data on how payments to patients in the UK would influence the recruitment and demographic structure of patients recruited to clinical research studies.
The single biggest cost of clinical trials in the UK is the cost of recruiting suitable subjects. The Academy of Medical Sciences report on the UK clinical trials environment, "A new pathway for the regulation and governance of health research", provided a comprehensive review of the barriers faced in running clinical trials . However, other barriers to recruitment exist after these hurdles have been overcome. Importantly, in our experience, of 100 suitable subjects identified as suitable to be entered into a study only about 14% are actually randomised. Most of the identified suitable subjects do not reply to invitation letters from their doctor and some patients who do reply decline the invitation to participate. Campaigns to engage the public on the importance of research have had modest effects on improving the awareness about trials but no measurable effect on willingness to participate .
An important finding is that those subjects who do participate in clinical trials usually have much lower rates of events than predicted from observational data. This is probably because trials attract subjects who care about their own health and the health of others and these subjects exhibit good 'health behaviour'. Those subjects with less good health behaviour and who constitute the subjects who suffer more consequences from their disorders in the real world, do not participate in trials as readily. The result is that trial participants tend to be middle class, middle aged, low risk subjects. These subjects are unrepresentative of the population at large or the population who will eventually get most of the prescribing (lower class, elderly and high risk). In addition, including only low risk subjects may result in studies being abandoned because the low event rates make achieving a statistically reliable result futile.
How can we address this issue within an ethical framework?
The findings from one trial currently running casts some light on this issue. The Streamlined Celecoxib versus standard therapy Outcome Trial (SCOT) is currently running in both the UK and Denmark. Trial recruitment in Denmark is significantly better than in the Scotland. We think that this is because in Denmark, all patients pay the full price for their medications and trial participation means that they get their medication free. In Scotland where recruitment is lower, all prescriptions are free anyway so there is no such incentive. Thus there appears to be a financial incentive for Danish patients to participate.
The present proposal seeks to study the effect of payments on recruitment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial incentive offered | Experimental | Behavioral: Financial Payment of £100Patient offered £100 incentive payment in initial trial invitation letter. |
| No incentive. Payment not offered | Experimental | Behavioral: Financial Payment of £100Patient sent standard trial invitation letter with no offer of incentive payment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for inclusion in one of the 5 clinical trials involved in the paying patients trial.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Payment of £100Also: No Financial PaymentNo financial payment | Behavioural | Financial incentive offered, No incentive. Payment not offered |
Primary outcome
Patient response to initial invitation letter
Time frame: On Study completion Approx 1 year
Number of positive responses to the initial invitation to participate in a clinical trial letter as determined by whether or not the patient was offered £100 incentive payment.
1 secondary outcome
Recruitement of elderly and socially deprived patients
Time frame: Through study completion Approx 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Payment of £100 in people with Cardiovascular Diseases, run by University of Dundee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient response to initial invitation letter (time frame: On Study completion Approx 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.