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Joint BRC and CTU New Business Proposal Process
Do you have a research idea that aligns to the remit and themes of the NIHR Birmingham Biomedical Research Centre (BRC)? Is it people-focused research?
Please check the remit via the BRC website.
The Joint BRC and CTU New Business Proposal Process aims to simplify how you can access timely and coordinated support to successfully launch your new project. If your proposal fits our remit, BRC and CTU experts will help you develop your idea and prepare a successful funding application.
The BRC team can provide support and advice in the following areas:
- Equality, Diversity and Inclusion (EDI)
- Patient and Public Involvement and Engagement (PPIE)
- Academic capacity/training
- Patient-Reported Outcomes (PRO)
- Intellectual Property (IP)
- Use of biomarkers
- Use of data
- Communication/Dissemination
To obtain advice, please access the resources listed below to help guide your thinking about the support required. We then ask you to complete the short downloadable form below so we can ensure you are linked with the most appropriate experts for your needs. Please email the completed form to newbusiness@trials.bham.ac.uk and BirminghamBRC@uhb.nhs.uk.
Whilst we may provide general advice around costs you should include within your proposal (if you are developing one), this does not replace the roles and responsibilities of your local teams that support bid preparation/costing (e.g. UoB research facilitators or Research Application Service (RAS)).
Please note we may only be able to provide high-level support if the proposal does not fit with the remit and vision of the Birmingham BRC.
List of resources
PRO resources
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Use of PROs in trials
- Retzer A, Aiyegbusi OL, Rowe A, Newsome PN, Douglas-Pugh J, Khan S, Mittal S, Wilson R, O’Connor D, Campbell L, Mitchell SA, Calvert M. The value of patient-reported outcomes in early-phase clinical trials. Nat Med. 2022 Jan;28(1):18-20. doi: 10.1038/s41591-021-01648-4.
- Aiyegbusi, O.L., Roydhouse, J., Rivera, S.C. et al. Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection. Nat Commun 13, 6026 (2022). https://doi.org/10.1038/s41467-022-33826-4
- Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, et al. Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2018;21(6):742-7. Epub 2018/06/19. doi: 10.1016/j.jval.2017.09.009.
- Liu L, Choi J, Musoro JZ, Sauerbrei W, Amdal CD, Alanya A, et al. Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice. The Lancet Oncology. 2023;24(5):e197-e206. doi: 10.1016/S1470-2045(23)00110-9
- Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, et al. Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015;1(8):1051-9. Epub 2015/08/14. doi: 10.1001/jamaoncol.2015.2639. PubMed PMID: 26270597; PubMed Central PMCID: PMCPMC4857599.
- Hughes SE, Haroon S, Subramanian A, McMullan C, Aiyegbusi OL, Turner GM, et al. Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis. BMJ (Clinical research ed). 2022;377:e070230. doi: 10.1136/bmj-2022-070230.
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PPIE-EDI resources and tools
- NIHR Research Design Service Equality, Diversity and Inclusion Toolkit
https://www.rdsresources.org.uk/edi-toolkit - Improving Inclusion of under-served groups in clinical research: Guidance from INCLUDE project
https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435 - NIHR Race Equality Framework
https://www.nihr.ac.uk/documents/nihr-race-equality-framework/30388
- NIHR Research Design Service Equality, Diversity and Inclusion Toolkit
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Selection of PRO measures
- ePROVIDE (Mapi Research Trust). Provides resources to facilitate the development of endpoint strategy or identification of the right outcomes for studies. https://eprovide.mapi-trust.org/about/about-eprovide
- A resource to help you select the most suitable outcome measurement instruments. https://www.cosmin.nl/
- PROTEUS Consortium. Provides resources to guide the use of patient-reported outcomes (PROs) in clinical care, including planning the assessment strategy, collecting the data, interpreting the results, and using the findings to inform patient care. https://theproteusconsortium.org/proteus-practice/
- The mission of ISOQOL is to advance the science of quality of life (QOL) and related patient-centered outcomes (PCO) in health research, care, and policy https://www.isoqol.org/resource-center/
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Protocol guidance (SPIRIT-PRO)
- Calvert M, Kyte D, Mercieca-Bebber R, et al. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA. 2018;319(5):483–494. doi:10.1001/jama.2017.21903
- Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, et al. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021;11(6):e045105. doi: 10.1136/bmjopen-2020-045105.
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PRO analysis (SISAQOL)
- https://event.eortc.org/sisaqol/
- Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, et al. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. The Lancet Oncology. 2020;21(2):e83-e96. doi: https://doi.org/10.1016/S1470-2045(19)30790-9.
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PRO reporting guidance (CONSORT-PRO)
- Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, et al. Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension. Jama. 2013;309(8):814-22. https://jamanetwork.com/journals/jama/fullarticle/1656259
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Ethical and equitable utilisation of PROs
- Calvert MJ, Cruz Rivera S, Retzer A, Hughes SE, Campbell L, Molony-Oates B, et al. Patient reported outcome assessment must be inclusive and equitable. Nature Medicine. 2022. doi: 10.1038/s41591-022-01781-8.https://doi.org/10.1038/s41591-022-01781-8
- Cruz Rivera S, Aiyegbusi OL, Ives J, Draper H, Mercieca-Bebber R, Ells C, et al. Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines. 2022;327(19):1910-9. doi: 10.1001/jama.2022.6421
- Slade, A.L., Retzer, A., Ahmed, K. et al. Systematic review of the use of translated patient-reported outcome measures in cancer trials. Trials 22, 306 (2021). https://doi.org/10.1186/s13063-021-05255-z
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Tools for patient partners involved in the co-design of trials with PRO endpoints
- Cruz Rivera S, Stephens R, Mercieca-Bebber R, Retzer A, Rutherford C, Price G, et al. ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension. BMJ Open. 2021;11(6):e046450. doi: 10.1136/bmjopen-2020-046450.
*Note – Important to signpost for use with patient partners to support co-design of research with patientsRegulatory guidance- FDA Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009 https://www.fda.gov/media/77832/download
- FDA Patient-Focused Drug Development (PFDD) Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
- Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man The use of patient-reported outcome (PRO) measures in oncology studies, 2016 https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, 2020 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf
