1. Consultants attitudes to consumer involvement in clinical research Rachel Thompson, Alan Horwich, Jim Laxton, Joe Flaherty, Andy Norman, Barbara Pearce, John Baart

2. Introduction  Consumer Research Advisory Group CRAG 4(7) consumers 1 Secretary 1 Clinical lead  Group Remit Work with researcher to ensure research is important to both HCPs and Consumers Produce consumer friendly protocols  Don’t know how many researchers are pro consumer involvement and how many currently work with consumers

3. Aims  To identify possible roles for members of the Consumer Research Advisory Group (CRAG)  To give group members the opportunity to gain an greater understanding of research through experience  To identify what training if any was needed  To identify any barriers to consumer involvement, those consultants experienced in working with consumers and the motivators

4. Materials A questionnaire was designed consisting of Y/N questions, open questions with free text response, and statements for comment on level of agreement or disagreement INVOLVE’S definitions of Consultation, Collaboration and User Controlled were given at the beginning of the questionnaire Name and contact details requested for those consultants wishing to work with the group members

5. 1. Are you aware that there are government initiatives to promote user involvement in clinical research?YES/NO 2. Have you ever been involved in clinical research that has consulted users for their views on the overall project design or patient information sheet?YES/NO 3. Have you been involved in clinical research that has collaborated with users in the entire research process eg design, monitoring, analysis and dissemination? YES/NO Questionnaire: Y/N Examples

6. What role, if any, do you think there is for users within the clinical research process? What specific training do you think the members would require? Please make any other comments you wish about the issues and challenges of user involvement in clinical research Questionnaire: Free Text Examples

7. 1.Collaboration results in a more user friendly research project thus aiding patient recruitment 2. Collaboration is time consuming with minimal benefits 3. Collaboration will result in loss of control over the research project due to the active involvement of users Strongly agree AgreeDisagree Strongly disagree Don’t know x Questionnaire: Statement Examples

8. Method Postal questionnaire was sent to 250 Consultants working in an oncology setting within the South West London Cancer Research Network. A reminder letter was sent after 2 weeks. The data was entered into an Access Database specifically designed for the study and then exported into Excel Spreadsheets for analysis Consultants were stratified according to their speciality, sub-speciality, place of work and previous research role

10. SOUTH WEST LONDON CANCER RESEARCH NETWORK Consumer Research Advisory Group “CRAG”

12. Survey of Consultants’ Views On User Involvement in Clinical Research

13. 250 questionnaires 93 responses

14. 157 non respondents 1 Unaware of Government initiatives or CRAG 2. Little or no interest in consumer involvement 3. Hostility to consumer involvement 4. To busy to fill in non essential forms

15. Principal investigators. V Other consultants.

16. 66% 34%

17. 28% 72%

18. 91% 9%

19. “What role if any do you think there is for users within the clinical research process”

20. Consultation Role Areas for Consultation Number% Patient Information2347% Practicability Assessment1327% Ethics1122% Quality of Life Issues714% Patient Support Services36% Legislation/Compliance12% Total no of consultants commenting on consultation 49

21. Consultation Role Areas for Consultation Number% Patient Information2347% Practicability Assessment1327% Ethics1122% Quality of Life Issues714% Patient Support Services36% Legislation/Compliance12% Total no of consultants commenting on consultation 49

22. Collaboration Role Areas for Collaboration Number % of consultants Study Design2456% Feedback/Review1228% Dissemination716% Viable Research Question614% Promotion49% Improving Communications12% Total no of consultants commenting on consultation 43

23. Collaboration Areas for Collaboration Number % of consultants Study Design2456% Feedback/Review1228% Dissemination716% Viable Research Question614% Promotion49% Improving Communications12% Total no of consultants commenting on consultation 43

24. Collaboration Study Design56% Feedback/Review28% “To ensure that protocols are acceptable to patients and that questionnaires are clear”

25. User Controlled Research 10 responses

26. User Controlled Research 10 responses “Decision making” “Research questions”

27. “What specific training do you think the members would require” 56 responses

28. Research Methodology Experience and/or knowledge of cancer No training

29. “…. knowledge of statistics” “For clinical trials they would need training in basic statistical theory and the practice of trials” Research Methodology

30. Experience and/or knowledge of cancer 8 respondents Considered essential by

31. No training 2 respondents

32. No training “None, they will only be consulted in their role as patients and not as experts” “No specific training since this may bias the actual benefit of asking potential patients for their opinion”.

33. “ Any other comments you wish to make about The issues and challenges of user involvement in clinical research” 29 (31%) of the 93 respondents

34. Positive Negative Miscellaneous.

35. Positive Negative 75% Miscellaneous. User selection Time commitment Cost Consumers’ lack of understanding

36. Positive Negative 75% Miscellaneous. User selection Time commitment Cost Consumers’ lack of understanding “Users will have to be carefully selected to check their reasons for wishing to become involved” “The usual difficulty is finding representatives with enough time and skills to contribute while not having narrow preconceptions due to personal experience”

37. Positive 20% Negative Miscellaneous. patient information research design

38. Positive 20% Negative Miscellaneous. patient information research design “use of simple English for the patient consent documents” “consultation with users is very …informative”

39. Positive 20% Negative Miscellaneous.

40. Positive 20% Negative Miscellaneous. “Needs to be simple and non bureaucratic” “This must not be done simply because it is seen to be politically correct” “User input has not been assessed – this is a project in itself”

42. 62%21%17%

43. 73% 15% 12%

44. 1The consultation of users in the clinical research process enables researchers to obtain user views without having to commit to acting on them

45. Qu. 2. Consultation is the most effective and efficient means of involving users in the clinical research process

46. 6Collaboration results in a more user friendly research project thus aiding patient recruitment

47. Qu. 8.Collaboration will result in loss of control over the research project due to the active involvement of users

48. Qu. 16. User involvement will help to obtain funding for a research project

50. User involvement will help to target or prioritise research projects

51. Users can help to interpret and understand research data once analysed