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Table 1 Deriving the factors affecting recruitment from facilitators and from barriers described in literature

From: Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

Prescott et al. [[37]]
Barriers to participation in clinical trials: patient and clinician barriers
Barriers Classification Factor derived
Patient barriers
Additional demands of the randomized controlled trials (RCT) on the patient Patient level factors Additional trial investigations
Additional procedures, additional appointments, time pressures, venepuncture, inpatient hospital stays, discomfort from medical procedures, length of study, worry about experimentation, uncomfortable procedures, travel and travel costs, extra costs Additional travel and extra costs
Duration of trial and follow- up
Patient preference for a particular treatment Patient level factors Patients’/parents’ preference for a particular treatment
Patients not wanting to change medication, not to take placebo, not to take experimental medication, not to take any medication, patient request for a specific intervention, strong patient preference for one treatment option Patients’/parents’ attitudes towards taking experimental medicine or placebo
Aversion to treatment choice by random allocation Treatment choice by random allocation
Worry about uncertainty Patient level factors Patients’/parents’ concerns about side effects of new drug
Efficacy of treatment on offer is unproven, distrust of hospital or medicine, fear of unknown
Concerns about information and consent Information and consent related factors Amount and complexity of trial information provided
Amount of information provided to research participants, wording of information, complexity of information provided, different forms of information presentation: written /verbal/video, limited reading skills and English not being the primary language, clinicians’ experience, difficulty in giving information, worry about level of information required and that information may be frightening, consent procedure barrier to recruitment Patient level factors Clarity in presentation of trial information
Clinical team factors Experience and training of clinical team seeking consent
Social and emotional dynamics of trial discussion
Consent rate
Language or cultural barrier
Difficulty in approaching patents for consent
Clinician barriers
Time constraints Clinical team factors Clinical workload
Time pressures from usual clinical practice, time demands of recruitment and follow-up
Staffing and training Clinical team factors Research experience of clinical team
Lack of trained staff, no additional support, lack of research experience in clinicians, lack of available support staff Availability of designated research team
Availability of research staff out of hours
Presence of designated research nurse/practitioner
Rewards and recognition Excluded Information available from the Chief Investigator
Economic incentives
Impact on doctor patient relationship fear of Adverse effect on doctor-patient relationship, perceived conflict in their role as clinicians and researchers Clinical team factors Clinician attitude to involving patients in research
Concern for patients
Concern about treatment toxicity, side effects, burden of trial for patients including travel distance and costs, reluctance to recruit severely ill patients
Problems in complying with the protocol Clinical team factor Clinician preference for a particular treatment
Trial level factor Study protocol compared to clinical practice
Campbell et al. [[38]]
Hypothesis of factors tested for association with recruitment success
Trials with complex trial design do not recruit as well as simple trials Trial level factor Trial design
Less well-funded trials do not recruit well Trial level factor Funding
Trials without dedicated trial management expertise do not recruit as well as those with trial management expertise Trial level factor Trial management
Trial with multidisciplinary input recruit better than those that do not have this input Excluded Information available from the Chief Investigator
Trials with consumer involvement recruit better than those that do not Excluded Information available from the Chief Investigator
Trials that have a successful pilot phase recruit better than those that do not have a pilot phase Trial level factor Previous feasibility assessment
Previous pilot trial
Trials that have dedicated paid local coordinators recruit better than those that do not   Trial management
Cancer trials recruit better than non cancer trials Trial level factor Being a drug/cancer trial
Drug trials recruit better than non-drug trials   Being a drug/cancer trial
Trials funded through a response-mode funding have different recruitment rates to those funded through a commissioned process Trial level factor Funding
Reasons for delays in recruitment to the included cohort of trials
Problems with central staff, local research staff, internal problems (for example, staff) Site level factor Number of trained staff
Clinical team factor Motivation of clinical team
Local clinical arrangements, merging/reorganization of trusts, major relocation of services, department policies Site level factor Local clinical arrangements
Funding issues Trial level factor Funding
Delays in ethical clearance Excluded Information available from the Chief Investigator
Research and Development (R&D) delays, time delay since grant application
Delays in supply of drug/placebo Excluded Information available from the Chief Investigator
Adverse publicity about medical research, external problem (for example, publicity) Trial level factor Publicity by the trial team
External publicity
Setting up general practitioner (GP) practices took longer than anticipated Site level factor Time to open up site
Simultaneous other local research projects, competing research, conflict with other trials Site level factor Competing local research projects
Delays due to changes in data legislation, changes in technology Excluded Information available from the Chief Investigator
Fewer eligible than expected, smaller percentage agreeing to participate, recruitment targets too ambitious Trial level factor Lack of pilot/feasibility assessment
Site level factor Recruitment target
Absence of perceived clinical equipoise Trial level factor Clinical equipoise
Issues with procedures/interventions, trial process too demanding Patient level factor Additional trial investigations
Complexity of trial design, trial methodology considered too complex Trial level factor Trial design
Conflicting workload pressures, long waiting lists, additional theatre time required Clinical team factor Clinical workload
Language/written English difficulties Patient level factor Language or cultural barrier
Treatment preferences Patient level factor Patients’/parents’ preference for a particular treatment
Clinical team factor Clinician preference for particular treatment
Research not considered as priority Clinical team factor Perceived importance of research generally in clinical practice
Perceived importance of the particular research question
No local access to intervention Patient level factor Intervention available only in the trial
Case studies of trials: common factors in the successes of part B trials
Facilitator Classification Factor derived
Important/interesting research question, topic important, urgent need for research, important question, timely and managed to roll several questions into one study Clinical team factor Perceived importance of the particular research question
Good design/good protocol, pragmatic study Trial level factor Trial design
Study protocol compared to clinical practice
Clinicians keen to recruit to trial Clinical team factor Motivation of clinical team
Clinician attitude to involving patients in research
Drugs already tested, so easy to explain to patients Patient level factor Familiarity with experimental treatment
Did not demand extra effort from patients, Impact on practice running and costs minimized, minimizing work for health professionals Patient level factor Additional trial demands
No competing trials for those centers/patients Site level factor Competing local research projects
Drugs not available outside the trial Patient level factor Intervention available only in the trial
Excellent trial management, trial units helpful, caring, annual meetings for all concerned, role of trial steering group Trial level factor Trial management
Good planning and organization by Clinical Trials Support Unit (CTSU), CTSU responsive, efficient, central organization of many aspects of research
Good communication between trial team and clinicians, flexibility of trial teams Study team factor Communication and coordination among study team members at site
Good public relations/feedback/updates Trial level factor Trial publicity
Good funding, National Health Service (NHS) funding Trial level factor Funding
Trial run by good team/infrastructure, Principal Investigator (PI) well respected, PIs worked hard to keep collaborators on board, trial team communicative, responsive and alert to problems. Communication within team, between team and collaborating clinicians Study team factors Motivation of the study team at site
Clinical team factor Research experience of PI and study team members at site
Good trial team, good research assistants Communication and coordination among study team members at site
Team worked hard at how to explain the study to patients Communication and coordination between study team at site and Clinical Trials Unit (CTU)
Research experience of clinical team
Communication skills of clinical team
Role of research nurse Clinical team factor Presence of designated research nurse/practitioner
Study included everybody Trial level factor Patient inclusion criteria
Toerien et al . [[39]]
Study design, number of arms, control: active/placebo Trial level factor Trial design
Single/multicenter Excluded Information will be present
Intervention: drug/surgery/allied/others Trial level factor Being a drug/cancer/surgical/-----trial
Funding source Trial level factor Funding
Caldwell et al . [[40]]   
Recruitment strategies
Novel trial designs Trial level factor Trial design
Recruiter differences Information and consent related factors Experience and training of doctors clinical team seeking consent
Senior doctors and nurses seeking consent
Financial incentives for patients/participants Excluded Monetary incentives not acceptable for clinical research in United Kingdom
Methods of providing information Information and consent related factors Amount and complexity of information provided
Patient level factor Clarity in presentation of trial information
Consent rate
Treweek et al . [[2]]   
Recruitment strategies   
Design changes Trial level factor Trial design
Modification to the consent form or process Patient level factor Consent rate
Modification to the approach made to potential participants Information and consent related factors Amount and complexity of information provided
Clarity in presentation of trial information
Senior doctors and nurses seeking consent
Financial incentives for patients/participants Excluded Monetary incentives not acceptable for clinical research in United Kingdom
Modification to the training given to recruiters Information and consent related factors Experience and training of clinical team seeking consent
Greater contact between trial coordinator and trial sites Trial level factor Trial management