Meeting Report

“Improving accrual and recruitment conduct in clinical trials with

children and other patients unable to consent for themselves”

MRC Hub for Trials Methodology Research Network Event hosted by

North West Hub for Trials Methodology Research

Thursday 5th May 2011, Liverpool Medical Institution

Aims

The meeting involved both the North West and Midlands Hubs for Trials Methodology Research. It’s main aims were to:

  • inform practitioners, researchers and ethicists about the RECRUIT study findings and other relevant research on how patients/families perceive being approached about clinical trials
  • discuss the potential role that supporting practitioners and improving their experience of approaching patients/families about trials might have in helping to optimise recruitment
  • identify how practitioners might best be supported in recruiting patients/families to trials

Attendance, delegates and accreditation

The meeting generated a high level of interest and was well attended. The venue had capacity for only 120 delegates,yet over 170people emailed to reserve a place. When all 120 places had been assigned we kept a waiting list and allocated places to those on the waiting list ifthese became available. Of the 120 delegates allocated a place, 117 attended. They comprised research nurses, doctors (various grades), clinical trial unit staff (e.g. trial co-ordinators),parents, ethics committee members and social scientists. Most were working on children’s trials,although delegates working on other trials involving proxy consent (e.g. stroke and dementia) were also represented. The meeting was awarded accreditation from the Royal College of Nursing for 5 study hours and approval from the Royal Medical Colleges for 4.5 Continuing Professional Development Credits. The programme for the meeting is appended to this report (Appendix 1).

Feedback from individual delegates

Overall views of the meeting

We asked delegates to complete a one page questionnaire (Appendix 2) about their views on the meeting and beliefs as relevant to itsaims; 72 questionnaires were returned. Delegates’ responses indicated that they were satisfied with the meeting:

Please indicate your response to the following statements about today’s meeting / Strongly agree / Agree / Neutral / Disagree / Strongly disagree
I was satisfied with the overall quality of the presentations / 37 / 31 / 1 / 0 / 0
I was satisfied with the overall quality of the discussions/break out groups / 38 / 30 / 3 / 0 / 0

Delegates’ positive opinions of the meeting werealso reflected their responses toan open ended question inviting comments on the meeting:

“Excellent meeting. Thought provoking. Useful breakout session.”

“The day has been very informative and stimulating”

“I found today's meeting really inspiring. It has reignited a passion that I have for doing my own paediatric research.”

Several delegates specifically pointed to how they valuedthe presentation that was given by members of the Medicines for Children Research Network - Young Person’s Consumer Group, which reported the findings from the children who had participated in the RECRUIT study:

“Good to have the "young person’s" consumer group presenting to the audience”

“The presentation from the MCRN Consumer Group was also very persuasive”

While qualitative feedback from delegates was positive overall, some (N=6) thought the meeting was too “focussed on Drs - not nurses” or indicated that they would have liked more recognition and discussion and of the role of nurses and non clinical staff in research and recruitment.

Views about clinical trial recruitment and how the meeting influenced these

We asked delegates for their opinions regarding one of the RECRUIT study findings – practitioners’ tendency to regard the invitation to enter a trial as a burden for patients/families. Delegates’ responses are below. Eighty five percent reported that the meeting had influenced their views regarding how patients/families experience being approached to enter atrial.

Please indicate your response to the following statements regarding views about clinical trials: / Strongly agree / Agree / Neutral / Disagree / Strongly disagree
There is a widespread view that asking patients/families to consider participating in a clinical trial poses a burden for them / 10 / 40 / 10 / 11 / 1
In the past I have tended to think that approaching a patient/family about participating in a clinical trial poses a burden for them / 6 / 29 / 19 / 17 / 1
Today’s discussions/presentations have influenced my views about how patients/families experience an approach about participating in a clinical trial / 26 / 35 / 10 / 1 / 0

Responding to an accompanying open-ended question about how the meeting had influenced their views, delegates wrote that they had been “surprised”, “encouraged” and “reassured” to learnfrom the RECRUIT study that patients/families werelargely positive about being approached to consider trial entry:

“I was surprised and encouraged by the RECRUIT trial's findings re: how patients/families experience being approached to participate in research

“Today's discussions and the presentation of the RECRUIT results have changed my views on the clinical trial recruitment burden patients’ experience. It was reassuring to find that families/pts are happy to be approached and this should be considered by the research team”

“RECRUIT study - it is encouraging to see parents’ perspective, dispelling some of my previous thoughts”

A few delegates indicated that they already believed that patients/families were generally happy to be approached about trials but that the meeting had “reinforced” or helped “cement” this view. Othersemphasised how themeeting would help them in discussing trials with families:

“Encouraged me to think more in depth about consenting children into trials and see from different angles”

“I am recently new to research. Being involved in today’s discussions has given me a great insight into patient/family experience and factors affecting consent and participation”

“Not to pre-judge and offer all patients the choice to be involved in research projects available”

“Will make me feel more comfortable in difficult situations approaching families re research”

Value of research on patients’ views about trials

Almost all delegates reported that research on patients/families views of trials was helpful:

Research that provides insights into how patients/families experience being approached about participation in clinical trials is useful for / Strongly agree / Agree / Neutral / Disagree / Strongly disagree
Practitioners in improving accrual and recruitment conduct / 47 / 23 / 2 / 0 / 0
Members of ethics committees in considering applications for ethical approval / 41 / 28 / 3 / 0 / 0

Training and support

Sixty percent of delegates indicated that they would like more support or training in clinical trial recruitment:

Please indicate your responses to the following statement / Strongly agree / Agree / Neutral / Disagree / Strongly disagree
I would like more support/training about recruiting to trials/discussing trials with patients and families / 18 / 22 / 22 / 4 / 0

Twenty nine delegates responded to an open ended question asking them to indicate what type of training and support would be useful. Most delegates commented that training on consent or communication training (N=9) would be useful. Others focussed on the need for training to be practical or structured and integrated into current training for doctors and nurses (N=5):

“For trainees in their training - both medical and nursing!”

“As a trainee in paediatrics - I feel further consent training is needed. It perhaps needs to be incorporated into paediatric training and also assessed in some way - ? in the ST7A assessment. Paediatric trainees get limited chance to be involved in recruitment/studies and this needs to be incorporated into training”

Rather than formal training, some delegates wanted the opportunity to discuss recruitment issues more informally (N=4) or pointed out that further dissemination of the RECRUIT study findings would be helpful (N=4).Several commented that training should not “hinder research”, which ruled out making training compulsory unless it could be integrated into existing training.

Feedback from discussion groups

Four parallel breakout groups were convened as part of the meeting to enable delegates to discuss the implications of the RECRUIT study and related researchfindings. Groupsconsidered the practice, policy and future research implications for improving accrual and recruitment conduct from one of the following perspectives:

Group A - Patients and their families

Group B - Clinical teams involved in discussing trials with patients/families

Group C - Research support teams/clinical trial units

Group D - Research ethics

There was widespread support among the groups that patients/families are indeed generally happy to be approached about trials. There was also considerable overlap between the groups on their views about RECRUIT’s implications for practice, policy and research. We havepresented this feedbackunder the main themes the groups identified:

Training and support

Groups wanted training for practitioners involved in recruitment to be enhanced so that it went beyond Good Clinical Practice training and covered patients/families’ views and experiences of clinical trials. However, there was some debate about the value of training on the process of communicatingwith families about trials. Some delegates felt practitioners were already competent communicators, while others thought training in discussing trials with patients/families would be helpful, particularly if it was aimed at practitioners with less experiencein recruitment. There was a strong view that additional training should not be compulsory in case it became a further barrier to practitioner involvement in recruitment. Groups wanted training to be offered to all staff who discussed trials with patients/families,and for its effectiveness to be evaluated.Suggestions for the delivery of training and support included online packages, shadowing and mentoring.

Fostering a supportive and motivating research culture

Groups wanted to foster a culture in which recruiting to trials and other clinical studies wasregarded as a normal part of everyday practice and for it to be recognised and valued. Suggestions included: educating the whole clinical team about clinical trials and their importance (not just those directly involved in recruitment); emphasising the importance of research within undergraduate and postgraduate practitioner curricula; linking specialties that have little history of research with those where the research culture is more established; commensurate reductions in the workload for practitioners involved in clinical trial recruitment; structures and processes that provided reminders when eligible patients/families are encountered and a requirement for justification when patients/families were not offered entry to a trial for which they were eligible.

Ethical considerations

Groups identified how information about trials served two distinct functions: meeting families’ needs and meeting regulatory requirements and that there was often a tension between the two. To make sure both functions were addressed, groups wanted to see further flexibility to separate these distinct functionsin face-to-face discussions and in information leaflets. To ensure understanding amongst ethics committees of trials that involve consent by proxy, groups suggested that practitioners from relevant specialties could be encouraged to join research ethics committees. Where there was debate about a trial’s equipoise, more openness about the REC’s deliberations might help to foster practitioners’ confidence regarding equipoise and thereby win their engagement with the trial.

Future research

As well as research to evaluate training for practitioners, groups suggested that research might be conducted to evaluate the effectiveness of different media for publicising research amongst families and explaining clinical trials to them. It was also suggested that similar studies to RECRUIT be conducted with broader groups practitioners, in other types of trials involving proxy consent and with fathers (as few had participated in RECRUIT).

Meeting outputs

Podcasts of the presentations will be made available on the North-West Hub for TrialsMethodology Research website. Following suggestions from breakout groups and individual delegates, a dissemination package on RECRUIT’s findings comprising Powerpoint slides, presenter notes and a background paper on the study will also be made available for download from the website to assist with dissemination of the findings to local trial teams, topic specific groups, local research networks and clinical trials units etc. Discussion regarding bids for funding to conduct further research on recruitment and recruitment training packages are underway.

Acknowledgements

Peter Brocklehurst, Patrina Caldwell, Anne Greenough, Ann Jacoby, Elaine McColl, Nicola Madge, Rosalind Smyth, Claire Snowden, Terence Stephenson, William van’t Hoff, Keith Wheatley, Paula Williamson and Bridget Young were applicants on the bid to the Hubs for Trials Methodology Research Networkgrant that supported the meeting. All were involved with the planning and delivery of the meeting.

Karen Barnes, Helen Hickey, Charlie Moneypenny, Sarah Moneypenny, Jennifer Newman, Georgia Semple, Haleema Shakur, Valerie Shilling, Emma Sowdenpresented at the meeting, or helped with its facilitation and organisation.

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