Review of data quality following a transition to telephone follow up in phase III multicentre clinical trials as a result of the COVID-19 pandemic


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Lara Philipps1, Vicki Hinder1, Muneeb Mahmud1, Abdullahi Omar1, Stephanie Brown1, Clare Cruickshank1, Stephanie Burnett1, Isabel Syndikus2, Nicholas Van As1, Aliso Tree1, Emma Hall1
1Institute of Cancer Research (ICR), 2Clatterbridge Cancer Centre NHS Foundation Trust

Abstract

Background

Historically the majority of follow up for cancer clinical trials has taken place as in person clinical consultations with case report forms (CRFs) completed at the time and subsequently submitted to the co-ordinating clinical trials unit. At the start of the COVID-19 pandemic it became impractical to continue this.  Telephone follow-up was already allowed at some assessment time points in a number of clinical trials managed by the Institute of Cancer Research Clinical Trials and Statistics Unit.  In response to the pandemic  telephone follow up was permitted for all trial follow-up time points. Here we review the uptake of change to telephone and the impact on data collection within the PIVOTALboost, PACE-B and PACE-C trials prostate radiotherapy trials.

Method

Post-treatment follow-up assessments with visit dates between 07/03/2018 and 01/02/2021 (PIVOTALboost), 08/10/2012 and 10/02/2021 (PACE-B) and 24/01/2020 and 26/02/2021(PACE-C) were used.  We calculated the proportion of trial follow up appointments undertaken by telephone and in person over calendar time. Adverse event (CTCAE) data received was reviewed to ascertain if there was any difference in completeness and timeliness between telephone or face to face CRF data collection.

 

Results

The increase in use of telephone follow-up assessment was widespread and rapid with 2903/10968 (26%) of assessments taking place over telephone pre 01/03/2020 and 2503/2827 (89%) after. The use of telephone follow-up maintained CTCAE data collection with 99% of CTCAE assessments performed for both telephone and clinic follow ups. Considering completeness of CTCAE data: 4141/5348 (77%) of CTCAE assessments had all pre-specified CTCAE items completed during telephone follow-up compared to 6673/8285 (81%) via clinic (p<0.001). Differences in visit windows (time between actual and expected visit date) were statistically significant (p=0.009) but clinically unimportant: telephone (mean 1.2 weeks, sd 5.0); clinic (mean 1.0 week, sd. 4.7).

Conclusion

Use of telephone for post-treatment clinical trial follow up has minimal impact on the overall quality of collection of adverse event data in large phase III prostate radiotherapy trials.  Further work will consider whether there is any variation in reporting of grade 3-4 toxicities by modality of reporting.

Impact statement

Telephone consultations could have a profound impact on ease of clinical trial follow-up.