1239P - NHS-Galleri trial enrolment approaches and participant sociodemographic diversity

Background

Equitable access to early cancer detection is needed to reduce disparities in cancer burden, but ethnic minority and more socioeconomically deprived groups are underrepresented in clinical trials, limiting generalisability. The clinical utility of a blood-based multi-cancer early detection test for population screening is being assessed in a randomised controlled trial (NCT05611632). Here, we report enriched enrolment approaches (EEAs) used to recruit a diverse participant population aged 50–77 years.

Methods

Recruitment routes were: NHS DigiTrials, GP participant identification centres (PICs), self-referral. Enrolment took place in 11 mobile units at 151 locations in 10.5 mos. EEAs (NHS DigiTrials and PIC invitation targeting, community engagement, logistical barrier reduction) were used to boost ethnic minority enrolment, and target those in older and more deprived groups to ensure an adequate cancer event rate for assessing clinical utility. We examined (1) number of enrolled participants (all routes) vs national data and (2) number needed to invite (NNI; invited/enrolled individuals, NHS DigiTrials only), by age, sex, and proxied index of multiple deprivation and ethnicity.

Results

In all, ∼1.5 M individuals were invited and 142,940 enrolled (98% via DigiTrials) in 10.5 mos (Table). NHS DigiTrials invitation targeting increased enrolment in older and more deprived groups vs the national population. Other EEAs boosted ethnic minority enrolment. NNI was higher in most (22) vs least (4) deprived groups and in Black (33) and Asian (28) vs White (10) ethnicities. Table: 1239P

NHS-Galleri trial participant population characteristics versus those aged 50–77 years in England (age and sex), and those aged 50–79 in England and Wales combined (ethnicity and index of multiple deprivation, IMD)

*Office for National Statistics: Census 2021**2019 Population Estimates by Ethnic Group†2020 Populations by IMD decile

Conclusions

The NHS-Galleri trial used approaches that enabled rapid (10.5 mos) recruitment of a socioeconomically diverse population.

Clinical trial identification

NCT05611632; 3 November 2022.

Editorial acknowledgement

Medical writing assistance was provided by Emma B. Saxon (Nottingham, England).

Legal entity responsible for the study

GRAIL, LLC, Menlo Park CA.

Funding

GRAIL, LLC, Menlo Park CA.

Disclosure

C. Swanton: Financial Interests, Personal, Invited Speaker, Activity took place in 2016: Pfizer, Celgene; Financial Interests, Personal, Invited Speaker, October 26th 2020: Novartis; Financial Interests, Personal, Invited Speaker: Roche/Ventana, BMS, AstraZeneca, MSD, Illumina, GSK; Financial Interests, Personal, Advisory Board, AdBoard-November 12th, 2020: Amgen; Financial Interests, Personal, Advisory Board, Current-since 2018 : Genentech; Financial Interests, Personal, Advisory Board: Sarah Canon Research Institute; Financial Interests, Personal, Advisory Board, Joined October 2020 . Also have stock options: Bicycle Therapeutics; Financial Interests, Personal, Other, Consultancy: Medicxi; Financial Interests, Personal, Advisory Board, Member of the Science Advisory Board. Also had stock options until June 2021: GRAIL; Financial Interests, Personal, Other, Consultancy agreement: Roche Innovation Centre Shanghai; Financial Interests, Personal, Advisory Board, 29 November-1 December 2022: Novartis; Financial Interests, Personal, Invited Speaker, Oncology Collective-2nd Nov-4 Nov 2022-Atlanta, USA: Roche; Financial Interests, Personal, Advisory Board, ctDNA advisory Board-24th March 2023: AstraZeneca; Financial Interests, Personal, Invited Speaker, Pfizer Oncology 'Leading the revolution for the future: Pfizer; Financial Interests, Personal, Full or part-time Employment, Chief Clinician since October 2017: Cancer Research UK; Financial Interests, Personal, Ownership Interest, Co-Founder of Achilles Therapeutics. Also, have stock options in this company: Achilles Therapeutics; Financial Interests, Personal, Stocks/Shares, Stocks owned until June 2021: GRAIL, Apogen Biotechnologies; Financial Interests, Personal, Stocks/Shares: Epic Biosciences, Bicycle Therapeutics; Financial Interests, Institutional, Research Grant, Funded RUBICON grant-October 2018-April 2021: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant, Collaboration in minimal residual disease sequencing technologies: Archer Dx Inc.; Financial Interests, Institutional, Research Grant: Pfizer, Boehringer Ingelheim; Financial Interests, Institutional, Trial Chair, Chief Investigator for the MeRmaiD 1and 2 clinical trials and chair of the steering committee: AstraZeneca; Financial Interests, Institutional, Research Grant, Research grant from Oct 2019-July 2023-Genetics of CIN and SCNAs for Targeted Discovery (SCEPTRE): Ono Pharmaceutical; Financial Interests, Institutional, Research Grant, Research Grants from 2015: Roche; Financial Interests, Personal, Other, Co-chief investigator: NHS-Galleri Clinical Trial; Financial Interests, Institutional, Research Grant, from October 2022: Personalis; Non-Financial Interests, Principal Investigator, Chief Investigator for MeRmaiD 1and 2 clinical trials: AstraZeneca; Non-Financial Interests, Member of Board of Directors, From 2019-2022: AACR; Non-Financial Interests, Other, Board of Directors: AACR; Non-Financial Interests, Advisory Role, EACR Advisory Council member: EACR. V. Bachtiar: Financial Interests, Personal, Full or part-time Employment: GRAIL, LLC. A.R. Brentnall: Financial Interests, Institutional, Funding: GRAIL, LLC. I. Lowenhoff: Financial Interests, Personal, Full or part-time Employment: King's College London; Financial Interests, Personal and Institutional, Funding: GRAIL, LLC. J. Waller: Financial Interests, Institutional, Funding: GRAIL, LLC. H. Pinches: Financial Interests, Personal, Other: NHS DigiTrials. R. Smittenaar: Financial Interests, Personal, Full or part-time Employment: GRAIL, LLC; Financial Interests, Personal, Stocks/Shares: GRAIL, LLC; Financial Interests, Personal, Other: GRAIL, LLC. S. Hiom: Financial Interests, Personal, Full or part-time Employment: GRAIL, LLC. R.D. Neal: Financial Interests, Personal and Institutional, Coordinating PI: GRAIL, LLC. P. Sasieni: Financial Interests, Personal, Advisory Board: GRAIL, LLC; Financial Interests, Institutional, Funding: GRAIL, LLC; Non-Financial Interests, Personal, Advisory Role: NSV; Financial Interests, Personal, Speaker, Consultant, Advisor: Roche. All other authors have declared no conflicts of interest.