COVID19 PANDEMIC Prof Fionnuala Breathnach MD FRCOG FRCPI DCH DipGUMed MSc Associate Professor Obstetrics and Gynaecology RCSI Rotunda Hospital Dublin Network Lead for HRBMother and Baby Clinical Trials Network ID: 1045861
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1. THE CHALLENGES OF RUNNING A RANDOMISED DRUG TRIAL IN PREGNANCY DURING THE COVID-19 PANDEMICProf Fionnuala Breathnach MD FRCOG FRCPI DCH DipGUMed MScAssociate Professor Obstetrics and Gynaecology, RCSI Rotunda Hospital DublinNetwork Lead for HRB-Mother and Baby Clinical Trials Network
2. Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diabetes pregnancy HRB DIFA 2017
3. HRB-MBCTN Network Partners
4. TimelineNov 2014 Mar 2015 June 2015 Jun 2016HPRA approval for pilotEthics approval for pilotCTA for pilot completedPilot recruitment beganConfirmation of sponsorship for Main RCT from RCSIJul 2016DIFA application submittedNov 2016Feedback to reviewers on submitted DIFADec 2016Last Patient Last Visit for Pilot
5. TimelineMar 2017Jul 2017Aug 2017Nov 2017DIFA Grant awardedGrant Contract with HRB signedPilot Data MD submitted Start of RCSI sponsorship Office involvement June 2018HPRA approval for main studyEthics approval for main studyIssue raised by RCSI over indemnity - change in sponsor requiredJan 2019May 2019Notification to HRB of change in sponsor from RCSI to RotundaApproval by HRB of change in sponsor from RCSI to Rotunda
6. TimelineJun 2019Aug 2019Oct 2019Nov 2019SCA approval for main study Extension of SCA indemnity to university partnersCoombe CTA signed23 Dec 2019Rotunda CTA signedMay 2020First patient recruitedAug 2020Galway CTA signedNMH CTA signedOLOL CTA signedCork CTA signedLimerick CTA signed - TBA
7. RECRUITMENT-Target 360 over 36 months-To date 53 in 12 months-6th of 7 sites active since Jan 2021
8. COVID-19-related challenges & solutions ChallengesDominance of Covid-19 in hospital setting SolutionsWhat CAN we do?
9. COVID-19-related challenges & solutions ChallengesDominance of Covid-19 in hospital settingEffect of pandemic effect on staffing: -Working from home; Univ instructions -Research staff seconded to Covid-related care SolutionsWhat CAN we do?-Introductory Telephone consults -Safety assessment for individual sites-’Covid return to work on-line training module (hand-washing, C-19 precautions etc)
10. COVID-19-related challenges & solutions ChallengesDominance of Covid-19 in hospital settingEffect of pandemic effect on staffing: -Working from home; Univ instructions -Research staff seconded to Covid-related care3. High-risk patient cohort: Reluctance to embark on pregnancy? SolutionsWhat CAN we do?-Introductory Telephone consults -Safety assessment for individual sites-’Covid return to work on-line training module (hand-washing, C-19 precautions etc)Time
11. COVID-19-related challenges & solutions ChallengesDominance of Covid-19 in hospital settingEffect of pandemic effect on staffing: -Working from home; Univ instructions -Research staff seconded to Covid-related care3. High-risk patient cohort: Reluctance to embark on pregnancy?4. Risk assessment: Avoidance of research-only hospital visits SolutionsWhat CAN we do?-Introductory Telephone consults -Safety assessment for individual sites-’Covid return to work on-line training module (hand-washing; C-19 precautions etc)TimeAll research assessments aligned with clinically-indicated visitsRationalisation of some study assessments & Pharmacy visits
12. COVID-19-related challenges & solutions ChallengesDominance of Covid-19 in hospital settingEffect of pandemic effect on staffing: -Working from home; Univ instructions -Research staff seconded to Covid-related care3. High-risk patient cohort: Reluctance to embark on pregnancy?4. Risk assessment: Avoidance of research-only hospital visits5. Monitoring SolutionsWhat CAN we do?-Introductory Telephone consults -Safety assessment for individual sites-’Covid return to work on-line training module (hand-washing; C-19 precautions etc)TimeAll research assessments aligned with clinically-indicated visitsRationalisation of some study assessmentsMonitoring: Not HSE employees; MOU allows Univ employees to access patient records on site, but not remotely. Hosp will allow Univ employees to attend hosp but univ will not
13. Thank youfbreathnach@rcsi.com