Frangou, Eleni;
Choodari-Oskooei, Babak;
Smith, Benjamin;
Bryant, Hanna;
Oza, Bhavna;
Shakeshaft, Clare;
Thorogood, Nat;
... Meade, Angela; + view all
(2022)
Adopt to adapt: Efforts to Keep the RAMPART Trial of Adjuvant Immunotherapy in Renal Cancer on Track in the COVID-19 Era.
Presented at: International Clinical Trials Methodology Conference (ICTMC 2022), Harrogate, UK.
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Abstract
Introduction: The RAMPART trial is an international, UCL-led, multi-arm multi-stage (MAMS) platform trial investigating the use of immune checkpoint inhibitors after nephrectomy in patients with renal cell carcinoma. It was initiated with a control (active monitoring) and two research arms (durvalumab monotherapy and durvalumab with tremelimumab) and has been open to recruitment since July 2018. Due to the COVID-19 pandemic, recruitment and treatment delivery was suspended for four months in the Spring/Summer of 2020 and accrual has only recovered in 2022. / Methods/Approach: The RAMPART team provided clear communication to sites on how to manage priorities during the temporary suspension and relaunch of the trial. The protocol was amended to ensure the safe treatment of patients and to offer flexibility to conduct consent and certain assessments remotely. Sites were asked to focus on the submission of high priority data to permit continued oversight of patient safety and allow primary outcome data to be collected. Data completeness has been carefully monitored and targeted data chases have been conducted to maximise data integrity. We have explored the extent to which the pandemic will prolong recruitment and follow-up, and the timelines for our primary analyses. To maximise options for patients and to aid accrual, we examined the impact of re-randomisation of control arm patients within the protocol, an approach that has been employed in other trials within the CTU in other disease areas. / Results Structure & Timelines: This section will contain an update on compliance, recruitment, sites open and timelines for analysis. In order to be able to present these adequately and robustly, we will use data up to September 2022. / Potential Relevance & Impact: The pandemic era has been challenging for clinical trials. Adaptations can be made to prioritise patient safety, to allow activity to continue where there is capacity and to ensure trial integrity is maintained.
| Type: | Poster |
|---|---|
| Title: | Adopt to adapt: Efforts to Keep the RAMPART Trial of Adjuvant Immunotherapy in Renal Cancer on Track in the COVID-19 Era |
| Event: | International Clinical Trials Methodology Conference (ICTMC 2022) |
| Location: | Harrogate, UK |
| Dates: | 03 - 06 October 2022 |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | https://ictmc.org/ |
| Language: | English |
| Keywords: | clinical trials, kidney cancer, renal cancer, MAMS trial, Platform trial |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10158092 |
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