1 In the UK, 1 in 4 Black men will be diagnosed with prostate cancer at some point in their lives. 1 That s double the 1 in 8 risk for the general male population. Participation of Black men on clinical trials is therefore vital if research into new and improved ways of preventing, diagnosing, treating and controlling prostate cancer are to give us answers that are applicable to this group. However, evidence shows that people from BME communities are often underrepresented in clinical trials, which potentially affects the external validity of trial findings, and is important when considering the safety and the efficacy of generalising new discoveries to all ethnic groups. 2 Unlike the USA there is no legislation mandating the inclusion of ethnic minorities in clinical trials and other research in the UK. Such representation, however, is clearly desirable from the viewpoint of both increasing scientific knowledge about the health of minority ethnic groups in the population and from the broad perspective of equity. This is highlighted in a review by Brooks (2003) 3 when referring to the (European Randomized Study of Screening for Prostate Cancer (ERSPC) study on which the current UK Prostate Cancer Risk Management Programme is based. Brooks reports that The major studies used to make prostate cancer screening recommendations included more than 250,000 men, less than 5,000 of whom were Black. These small numbers mean that the study results can t accurately measure the impact of screening in Black men. Yet, since these are the only large studies available, they have been used to establish screening recommendations for everyone. 1 The 1 in 4 lifetime risk statistic was worked out using information about men recorded as Black African, Black Caribbean and Black other. We did not include Black mixed as there was not enough data about this group in the records. Read more about how this was calculated here 2 M Hussain-Gambles, Ethnic minority under-representation in clinical trials. Whose responsibility is itanyway?, Journal of Health Organisation and Management 2003:17 3 Brooks D (2003). Why are black men negatively affected by prostate cancer more than white men? Accessed at:
2 The National Cancer Research Institute reported that various inequities in access to clinical trails exist, with older people and people from BME groups being less well represented in clinical trials 4. Johnson & Szczepura, (also Johnson et al., 2002) 6 also reported that within the national research register of over 1000 randomised controlled trials, only nine explicitly referred to ethnic minority or non-english speaking groups. The wider literature has reported that many factors may affect the representation of ethnic minority groups in clinical trials. There may be barriers inherent in study design, such as the absence of criteria for minority ethnic groups, consecutive case selection from defined populations or unsatisfactory ethnic group data collection. Generalised recruitment processes, language barriers, the importance accorded by clinicians to generalizability of study results, and attitudes to participation by members of minority ethnic groups all effect the representation of minority ethnic groups in clinical trials. 7 The need for clinical trials to ensure greater representation of patients from BME communities was highlighted as a call to action by the National BME Cancer Alliance 8 and steps need to be taken to ensure this happens. Our intention is to explore what barriers exist with regards to recruiting Black men to take part in clinical research by reviewing any existing evidence and carrying out qualitative research with Black men, key healthcare professionals and researchers. Through these methods we hope to; explore what factors impact on participation in clinical research amongst Black men such as perceptions of research, knowledge of research opportunities and understanding of the impact of participation explore the factors that influence/hinder the recruitment of BME research participants by healthcare professionals and researchers identify possible solutions for addressing the barriers identified. A report outlining the findings and possible solutions is required. Recruitment of Black men for the qualitative research would ideally represent an even spread across: Geographical locations in the UK 4 National Cancer Research Institute (2012). Action on access: Widening patient participation in clinical trials. Available at 5 Johnson MRD and Szczepura A. Representation of South Asian people in randomised trials. BMJ 2003; 327: Johnson MRD, Szczepura A, Illman J. Trial and error. CRE: Connections 2002 (Autumn): Aspinall, P (2014). Prostate cancer in men of Black ethnicity: Aetiology, outcomes, experiences, and gaps in knowledge. Unpublished literature review commissioned by Prostate Cancer UK. 8 National BME Cancer Alliance (2013). Our calls for action. Available at: (last accessed 28/02/14)
3 Age-groups (45 years and above) African and Caribbean sub-groups Whilst exploration of the beliefs and needs of men who have not taken part in research would be most useful to the project, we would also want to understand the motivations of a smaller number of men who have taken part, and their experiences. Prostate Cancer UK (formerly The Prostate Cancer Charity) fights to help more men survive prostate cancer, and benign diseases, and enjoy a better quality of life. We have three priorities: Supporting men and providing information. Finding answers by funding research. Leading change to raise awareness and improve care. Prostate Cancer UK will provide support in developing and refining the scope of the review, as well as providing ongoing support throughout regarding the relevance and interpretation of identified evidence. An indicative budget of 8,000 is available for this project, including VAT. Proposals will be assessed on the basis of value for money, but we also welcome other desirable elements to be included in proposals. An increased budget of 10,000 may be considered were added value can be clearly demonstrated. This research contract will be managed by Sarah Toule, Health Inequalities Manager. A member of the Evidence team and other relevant members of staff will be involved in steering and supporting the project. We anticipate three face to face meetings: An inception meeting in December 2014 A meeting to discuss and present draft findings in February 2015 Presentation of project report and findings to the charity in April 2015 All meetings will be at Prostate Cancer UK s London office. During the active phase of the research, we would expect fortnightly updates on progress via or telephone.
4 Any queries should be ed to We will make every attempt to ensure that questions submitted are answered promptly. The deadline for the submission of proposals is 5pm, 1 December No submissions will be accepted after this time. An electronic copy of your proposal should be sent to together with: a signed form of tender (see Annex A below) a copy of professional indemnity insurance a summary of your most recent annual accounts Please let Prostate Cancer UK know if you intend to submit a tender by ing Sarah Toule at the above address. Proposals should be no longer than 8 pages in length (excluding CVs) and include the following: A summary of the proposal written in plain English. Introduction to your organisation and relevant experience for this project. Details and justification of the proposed method. Consideration of any risks to timely and quality delivery, including relevant ethical and other research governance issues. A project plan with clear timescales for each proposed task. Pen portraits of all team members to be involved, including their previous experience. Arrangements for managing the research and quality assuring outputs. Costs, including days per team member and day rates. Project costings should clearly highlight expected expenses and VAT (which can be charged). Detailed CVs should be annexed to the proposal. Shortlisted organisations will be notified by by 5pm on 3 December 2014 and asked to present their proposal at an interview at Prostate Cancer UK s London office on 9/10 December Proposals will be reviewed against the following criteria: A clear understanding of the purpose/objectives of the work and its importance to
5 men with prostate cancer. Reasonably timetabled schedule of work to ensure the deliverables defined are satisfactorily completed by the identified dates. Suitability and appropriateness of the research approach and methodology Relevance and nature of the organisation s experience and that of the specific team, including knowledge of the relevant policies and structures across the UK. Value for money and total price of the proposal. Clear leadership of the work including the name of an accountable individual. Appropriate arrangements for managing the work and monitoring its quality and the necessary communications. Organisational capacity to undertake the work wider team availability, support arrangements, percentage of individuals time spent on the contract. Overall quality of submission and adherence to requirements. 14 November 2014: ITT published 1 December 2014: Deadline for submission of tenders 3 December 2014 Shortlisted organisations notified 9/10 December 2014: Interviews (Prostate Cancer UK s offices / video conference) 10 December 2014: Successful contractor notified W/c 15 December 2014: Project initiation meeting and research commenced 27 February 2015: Meeting to discuss draft findings and report 18 March 2015: Final report agreed and submitted to Prostate Cancer UK April 2015: Presentation of findings to Prostate Cancer UK staff
6 I / We certify that this is a bona fide tender, and that I / we have not fixed or adjusted the amount of the tender by or under or in accordance with any agreement or arrangement with any other person. I / We also certify that I/we have not done or I / we will not at any time before the 14 February 2013 any of the following acts; (a) entered into any agreement or arrangement with any other person that he shall refrain from tendering or as to the amount of any tender to be submitted; (b) offered to pay or give or agree to pay or give any sum of money or valuable consideration directly or indirectly to any person for doing or having done or causing or having caused to be done in relation to any other tender or proposed tender for the said work any act or thing of the sort described above; In this certificate the word person includes any person and anybody or association, corporate or unincorporate, and any agreement or arrangement includes any such transaction, formal or informal, and whether legally binding or not. Signed:.. Date:.... Name:.... for and on behalf of. (Tenderer) Position Held. How did you find out about this tender:..