Abstract 1886P
Background
IC for Ph I trials is difficult as pts can misunderstand key design aspects; recent Ph I trial successes (eg. immune checkpoint inhibition) have further complicated the situation. We aimed to measure the quality of IC in our centre using a validated instrument testing objective (obj) and subjective (sub) understanding of key IC domains including trial purpose, risks and benefits.
Methods
We identified consecutive patients on Ph I trials in our unit from Sep - Dec 2019, collected demographic data, and administered Quality of Informed Consent Part A (QuIC-A,20 items, obj) and Part B (QuIC-B,14 items, sub). Primary endpoints were summary scores on QuIC-A and QuIC-B. No pts declined. All pts had undergone standard IC processes including access to extensive written material and at least 2 clinic appointments prior to consent.
Results
36 pts were evaluable - 19 (53%) were in a Ph I dose escalation trial and 17 (47%) were in a Ph I dose expansion trial. 18 (50%) were female, 16 (44%) were over the age of 65, 21 (58%) had a university education and 35 (97%) spoke English as their first language. 21 (58%) had been on trial for less than two months. The average QuIC-A (obj) score was 76 out of 100 (SD 10, 58–97) while QuIC -B (sub) score was 91 out of 100 (SD 8, 68–100). 100% (n=36) correctly identified that they were in a clinical trial and 81% (n=29) that they would be able to withdraw at any point. However, 15 (41%) reported that all treatments in their trial were standard for their type of cancer while 10 (28%) reported that their trial did not carry any additional risks or discomforts compared to standard treatments. 23 (61%) pts reported that they had not been offered alternatives to trial participation. There was no correlation between sub and obj scores (R 2 = 0.005). In planned analyses (two sample t-test), university education had a numerical benefit on obj score (76 vs 71, p=0.29) while age over 65 had no impact (76 vs 75, p=0.91).
Conclusions
While pts in our Ph I trials unit showed an excellent grasp of some aspects of clinical trials, they showed deficits in key domains of IC for clinical trials. This study demonstrates the need for research into interventions which can improve IC for Ph I pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Royal Marsden NHS Foundation Trust.
Funding
Has not received any funding.
Disclosure
A.R. Minchom: Honoraria (self): LOXO Oncology; Janssen Pharmaceuticals; Faron Pharmaceuticals; Bayer Pharmaceuticals; Novartis Oncology; Merck Pharmaceuticals. U. Banerji: Honoraria (self): Astellas; Novartis; Karus Therapeutics; Phoenix ACT; Eli Lilly; Astex; Novartis; Vernalis; Janssen; Boehringer-Ingelheim;Research grant/Funding (institution): Onyx Pharmaceuticals; Chugai; Astra Zeneca;Verastem; Honoraria (institution): BTG International; Full/Part-time employment, I am an employee of The Institute of Cancer Research, which is involved in the development of PI3K, HSP90, HDAC, AKT, ROCK, RAF, CHK1 and HSF1 inhibitors: Other; Travel/Accommodation/Expenses: Sierra Oncology - Program Meeting; ravel/Accommodation/Expenses: Bayer - Bay 19829 IM. J.S. de Bono: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Astra Zeneca; Astellas; Bayer; Cellcentric; Daiichi; Genentech/Roche; Genmab; GSK; Janssen; Merck Serono; Merck, Sharpe and Dohme; Menarini/Silicon Biosystems; Orion; Sanofi; Sierra Oncology; Taiho; Vertex Pharmaceuticals; Honoraria (self), Advisory/Consultancy: Bioxcel Therapeutics; Boehringer Ingelheim; Eisai; Pfizer; Qiagen; Aventis; Licensing/Royalties: Abiraterone; PARP inhibition in DNA repair defective cancers; PI3K/AKT pathway inhibitors. F. Boyle: Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy: Lilly; Roche; Pfizer. Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; J.S. Lopez: Research grant/Funding (institution): Roche-Genentech; Basilea; Genmab. All other authors have declared no conflicts of interest.