All questions are shown as received by the Trust.
Name of person completing out this form:
Full name of the hospital or NHS Trust (specify):
Your role at the hospital:
Your involvement in oncology clinical trials:
Is your hospital/ NHS Trust a Cancer Unit, Cancer Centre or Centre of Excellence in Cancer Care?
1.Ia What tumour groups do you treat with systemic anti-cancer therapy at your centre?
1.Ib Since 2010, for what tumour groups has your organisation had clinical trials involving systemic anti-cancer therapy? Select all that apply.
1.Ic In TOTAL, how many clinical trials (interventional Phase 0 – III) involving novel or novel combination or novel way of administering systemic anti-cancer therapies for solid cancers did you have in the Oncology department on 31 Dec in each year (provide a snapshot number) since 2010?
1.Id Of the total number of clinical trials you reported in 1.Ic, how many were solely funded by the NHS and NIHR (thus excluding trials funded by charity, government research councils like MRC, academic institutions and commercial companies)?
1.Ie Of the total number of clinical trials you reported in 1.Ic, how many were PHASE 1 trials?
1.If Of the total number of clinical trials you reported in 1.Ic, how many were PHASE 2 trials?
1.Ig Of the total number of clinical trials you reported in 1.Ic, how many were PHASE 3 trials?
1.Ih On a separate note, how many Phase IV trials did you conduct in each year at your hospital/ Trust?
1.Ii Of the total number of clinical trials you reported in 1.Ic, how many involved another procedure such as surgery or radiotherapy in combination with the trialled systemic anti-cancer therapy within the trial?
1.Ij Provide the total number of adult patients enrolled in phase I – III solid-cancer systemic anti-cancer therapy trials on 31 Dec of each year at your hospital/ Trust:
1.Ik In each year, how many new Phase I – III clinical trials did you open for recruitment?
2.I Post-BREXIT, what regulatory changes have had the greatest impact on the initiation of oncology trials at your centre?
2.II Post-BREXIT, what regulatory changes have had the greatest impact on the conduct/ continuation of oncology trials at your centre?
2.IIIa Post-BREXIT, have you observed any specific challenges related to regulatory compliance for initiating new oncology trials at your centre?
2.IIIb If yes, please specify the regulatory challenges encountered:
2.IVa Have there been any notable changes in the regulatory reporting requirements for ongoing oncology trials post-BREXIT?
2.IVb If yes, please elaborate on the changes and their impact on trial conduct:
2.Va Have there been any changes in the timeline for regulatory approvals post-BREXIT for initiating new oncology trials?
2.Vb If yes, please specify the nature of delays and their impact on trial initiation:
2.VI How has the communication and coordination with regulatory authorities changed post-BREXIT in the context of oncology trials?
2.VIa Have there been any new documentation or compliance requirements introduced post-BREXIT for ongoing oncology trials?
2.VIb If yes, please provide examples of the additional documentation or compliance measures introduced:
2.VII How has the training and education of clinical trial staff in your centre been impacted by regulatory changes post-BREXIT?
2.VIIIa Have there been any changes in the requirements for informed consent processes for oncology trials post-BREXIT?
2.VIIIb If yes, please specify the nature of changes and their impact on the informed consent process:
2.IX How has the interpretation and implementation of Good Clinical Practice (GCP) guidelines evolved post-BREXIT in your centre?
2.Xa Where staff updated or educated on regulatory changes post- BREXIT?
2.Xb If yes, explain how:
2.Xc If no, explain why not:
3.I In each year, how many Phase 0 – IV clinical trials did you have to discontinue due to a lack of funding? Comment on the funding sources affected:
3.II Name all organisations, including your own, that sponsored and/or funded solid- cancer systemic-anticancer therapy trials at your centre in each year:
3.III How has the funding landscape for oncology pharmaceutical trials at your centre changed post-BREXIT?
3.IV If there has been a change, please describe the main factors contributing to the shift in funding availability:
3.V How has the change in funding impacted the continuity of ongoing oncology pharmaceutical trials at your centre?
3.VI Are there specific types of trials more affected by funding challenges (e.g., Phase 1, investigator-initiated trials, certain types of systemic anti-cancer drugs, combination therapies, for certain tumour groups)?
3.VII How has the uncertainty surrounding BREXIT impacted the willingness of funding organisations to support oncology trials?
3.VIII Answering on behalf of your organisation, are there any specific policy changes that would enhance funding opportunities for oncology trials post-BREXIT?
3.IXa Have you explored alternative funding sources or strategies to mitigate potential funding challenges post-BREXIT?
3.IXb If yes, please share details of any successful strategies or approaches implemented:
3.X To what extent have patient advocacy groups played a role in supporting or influencing funding for oncology trials post-BREXIT in or for your organisation?
3.XIa Have there been any changes in the criteria or preferences of funding organisations when considering proposals for oncology trials post-BREXIT?
3.XIb If yes, please elaborate on the key changes in criteria or preferences:
4.I Comment on collaborative challenges that affected or caused disruptions in the initiation or running of solid-cancer systemic anti- cancer therapy drugs:
4.IIa Have there been challenges in maintaining international collaborations for oncology trials post-BREXIT?
4.IIb If yes, please identify the main collaborative challenges faced:
4.IIIa Have changes in regulatory requirements impacted international partnerships in oncology trials?
4.IIIb If yes, please elaborate on the specific regulatory aspects causing challenges:
4.IVa In your experience, have collaborative challenges affected the timeline and efficiency of oncology trials?
4.IVb If yes, please provide examples or instances where collaboration challenges led to disruptions in trial initiation or conduct:
4.Va At your current NHS hospital, have there been challenges in aligning international ethical standards and practices for oncology trials post-BREXIT?
4.Vb If yes, please elaborate on the specific ethical challenges faced and their impact on collaborative efforts:
4.VI How has the exchange of trial-related data and information with international partners been affected post-BREXIT?
4.VIIa In your organisation’s experience, have there been any challenges related to differences in patient populations across international sites in oncology trials?
4.VIIb If yes, please provide examples or instances where differences in patient populations posed challenges to collaborative efforts?
4.VIII How has the exchange of expertise and specialised resources with international collaborators been affected post-BREXIT?
4.IX From your organisation’s perspective, what strategies or initiatives could enhance international collaboration in oncology trials in the post-BREXIT era?
5.Ia Have you become aware of or experienced any challenges related to the alignment of data privacy and protection regulations in international oncology trials post-BREXIT?
5.Ib If yes, please elaborate on the specific challenges faced and any measures
