Abstract 1623P
Background
Phase I CT are a cornerstone in the treatment of cancer patients. Given the future uncertainties due to COVID19 pandemic, one of the concerns is the potential decrease of new phase I CT entering the clinic in subsequent years. Our aim was to evaluate the impact of COVID19 in the Start-up activities of the phase I Unit at Vall d´Hebron Institute of Oncology (VHIO).
Methods
We analyzed the activity of VHIO Clinical Trials Start-Up Unit from 2019 to April 2021. The number of new proposals/studies (NS), pre-selection site visits (PSSV), and site initiation visits (SIV) for phase I CT were analyzed. Specific measures in response to COVID19 pandemic were registered.
Results
Regarding NS, a 9.6% decrease was observed in 2020 in comparison to 2019 (132 vs 146 with an average of 11 NS/month vs 12.16 NS/month respectively). This was mainly due to a decrease during the first wave of COVID19 (Mar -May 2020) with 8.33 NS/month vs 12.66 NS/month in 2019. In 2021 (Jan to Apr), NS increased with an average of 17.25 NS/month. Sponsors were 56.4%Pharma vs 43% Biotech during 2020 and 47.05% vs 52.94% in 2021. Despite the decrease of NS in 2020, an increase of remote PSSV was detected (40 in 2019 vs 60 in 2020). During the first wave of COVID19 we performed an average of 5.66 PSSV/month vs 2.33 PSSV/month in 2019. In 2021, PSSV are still increasing with an average of 6.4 PSSV/month. Forty SIV were performed in 2019, 69 in 2020 and 17 from Jan-April 2021 (average 3.3 SIV/Month, 5.75 SIV/month and 4 SIV/month respectively). On the first wave, 4.33 SIV/month were carried out vs 5 SIV/month in 2019. Remote SIV were performed during COVID19, and hybrid (remote/on-site) during 2021. Documents to explain sponsors the measures undertaken for safe trial implementation have been generated (i.e. remote monitoring, shipment of medication, habilitating COVID free monitoring rooms and treatment wards).
Conclusions
Despite COVID19 and an initial decrease of new studies during 2020, the number of new proposals for phase I CT is increasing in 2021. This appears to be equal for biotech and big pharma proposals. Remote PSSVs are an efficient alternative to on- site visits. Digitalization and measures taken are effective to maintain the Clinical trial start up activity in VHIO and will probably remain after the pandemic is over.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Caixa Research Programe from Caixa Foundation.
Disclosure
C. Saura Manich: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Exact Sciences; Financial Interests, Personal, Advisory Board: Exeter Pharma; Financial Interests, Personal, Advisory Board: F. Hoffmann - La Roche Ltd; Financial Interests, Personal, Advisory Board: MediTech; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Philips; Financial Interests, Personal, Advisory Board: Piere Fabre; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Roche Farma; Financial Interests, Personal, Advisory Board: Sanofi-Aventis; Financial Interests, Personal, Advisory Board: SeaGen; Financial Interests, Personal, Advisory Board: Zymeworks; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Gran: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Eli Lilly and Company; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Merck, Sharp and Dhome España S.A.; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Piqur Therapeutics; Financial Interests, Institutional, Research Grant: Puma; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Synthon; Financial Interests, Institutional, Research Grant: Zenith Pharma; Non-Financial Interests, Member: Spanish Society of Medical Oncology (SEOM); Non-Financial Interests, Member: American Society for Clinical Oncology (ASCO); Non-Financial Interests, Member: SOLTI group (Academic research group in breast cancer); Non-Financial Interests, Member: Geicam (Spanish Breast Cancer Research Group); Non-Financial Interests, Member: American Association for Cancer Research (AACR). T. Macarulla Mercade: Financial Interests, Personal, Advisory Board: Ability Pharmaceutical, SL; Financial Interests, Personal, Advisory Board: Advance Medical HCMS; Financial Interests, Personal, Advisory Board: Batxer; Financial Interests, Personal, Advisory Board: BioLineRX Ltd; Financial Interests, Personal, Advisory Board: Celgene SLU; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Genzyme; Financial Interests, Personal, Advisory Board: Incyte; Financial Interests, Personal, Advisory Board: IPSEN Pharma; Financial Interests, Personal, Advisory Board: Lab. Menarini; Financial Interests, Personal, Advisory Board: Lab. Servier; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Merck, Sharp and Dhome; Financial Interests, Personal, Advisory Board: QED Therapeutics Inc; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi-Aventis; Financial Interests, Institutional, Research Grant: Agios; Financial Interests, Institutional, Research Grant: Aslan; Financial Interests, Institutional, Research Grant: AstraZecena; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Hallozyme; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Merimarck; Financial Interests, Institutional, Research Grant: Millenim; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Pharmacyclics; Financial Interests, Institutional, Research Grant: Roche; Non-Financial Interests, Member: American Society of Clinical Oncology - ASCO; Non-Financial Interests, Member: “Sociedad Española de Oncología Médica” – SEOM. A. Oaknin: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: Deciphera Pharmaceuticals; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Mersana Therapeutics; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Other, Travel and accommodation: AstraZeneca; Financial Interests, Personal, Other, Travel and accommodation: PharmaMar; Financial Interests, Personal, Other, Travel and accommodation: Roche; Financial Interests, Personal, Advisory Board: Merck Sharps & Dohme de España, SA; Financial Interests, Institutional, Funding: Abbvie Deutschland; Financial Interests, Institutional, Funding: Advaxis Inc.; Financial Interests, Institutional, Funding: Aeterna Zentaris; Financial Interests, Institutional, Funding: Amgen; Financial Interests, Institutional, Funding: Aprea Therapeutics AB; Financial Interests, Institutional, Funding: Clovis Oncology Inc; Financial Interests, Institutional, Funding: EISAI limited LTD; Financial Interests, Institutional, Funding: F. Hoffmann –La Roche LTD; Financial Interests, Institutional, Funding: Regeneron Pharmaceuticals; Financial Interests, Institutional, Funding: Immunogen Inc; Financial Interests, Institutional, Funding: Merck, Sharp & Dohme de España SA; Financial Interests, Institutional, Funding: Millennium Pharmaceuticals Inc; Financial Interests, Institutional, Funding: PharmaMar SA; Financial Interests, Institutional, Funding: Tesaro Inc.; Financial Interests, Institutional, Funding: Bristol Myers Squibb; Non-Financial Interests, Leadership Role, Executive Board member as a Co-Chair: GEICO; Non-Financial Interests, Leadership Role, Phase II Committee and Cervix Cancer Committee Representative on behalf of GEICO: GCIG; Non-Financial Interests, Officer, Faculty Member Gyneacological Track for ESMO 2018 and Chair of Gyneacological Track for ESMO 20: ESMO; Non-Financial Interests, Member: ESMO; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member: GCIG; Non-Financial Interests, Member: SEOM; Non-Financial Interests, Member: GOG. J. Carles Galceran: Financial Interests, Personal, Advisory Board: Astellas Pharma; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Johnson & Johnson; Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Novartis (AAA); Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Institutional, Invited Speaker: Janssen-Cilag International NV; Financial Interests, Institutional, Invited Speaker: Laboratoires Leurquin Mediolanum SAS; Financial Interests, Institutional, Invited Speaker: Lilly, S.A; Financial Interests, Institutional, Invited Speaker: Medimmune; Financial Interests, Institutional, Invited Speaker: Novartis Farmacéutica, S.A; Financial Interests, Institutional, Invited Speaker: Sanofi-Aventis, S.A. E. Felip: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Beigene; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Bristrol Meyers Squibb; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Glaxo Smith Kline; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Medical Trends; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bristrol Meyers Squibb; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Medscape; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dome; Financial Interests, Personal, Invited Speaker: Peervoice; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Springer; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Invited Speaker: Touch Medical; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Medical Trends; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Personal, Advisory Board: Peptomyc; Financial Interests, Personal, Advisory Board: Regeneron; Financial Interests, Personal, Advisory Board: Syneos Health; Financial Interests, Personal, Advisory Board: F. Hoffmann-La Roche; Financial Interests, Personal, Invited Speaker, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Merck Sharp & Dohme Corp; Financial Interests, Institutional, Invited Speaker, Clinical Trial: AstraZeneca AB; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Daiichi Sankyo Inc; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Exelixis Inc; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Merck KGAA; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Janssen Cilag International NV; Financial Interests, Institutional, Invited Speaker, Clinical Trial: GlaxoSmithKline Research & Development Limited; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Abbvie Deutschland GmbH & Co KG; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Novartis Farmaceutica SA; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Bayer Consumer Care AG; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Takeda Pharmaceuticals International; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Boehringer Ingelheim International GmbH; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Pfizer S.L.U.; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Amgen Inc; Financial Interests, Institutional, Invited Speaker, Clinical Trial: Bristol-Myers Squibb International Corporation (BMS); Financial Interests, Institutional, Invited Speaker, Clinical Trial: Mirati Therapeutics Inc; Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO; Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). E. Garralda: Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: F.Hoffmann/La Roche; Financial Interests, Personal, Invited Speaker: Ellipses Pharma; Financial Interests, Personal, Advisory Board: Neomed Therapeutics1 Inc; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Janssen Global Services; Financial Interests, Personal, Invited Speaker: Seattle Genetics; Financial Interests, Personal, Expert Testimony: TFS; Financial Interests, Personal, Advisory Board: Alkermes; Financial Interests, Personal, Advisory Board: Thermo Fisher; Financial Interests, Personal, Invited Speaker: Bristol-Mayers Squibb; Financial Interests, Personal, Advisory Board: MabDiscovery; Financial Interests, Personal, Advisory Board: Anaveon; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Roche; Financial Interests, Institutional, Funding: Thermo Fisher; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Institutional, Funding: Taiho; Other, Other, Institutional Travel Grant: Bristol-Mayers Squibb; Other, Other, Institutional Travel Grant: MSD; Other, Other, Institutional Travel Grant: Menarini; Other, Other, Institutional Travel Grant: Glycotope. All other authors have declared no conflicts of interest.