Conducting clinical trials during the COVID-19 pandemic—a collaborative trial network response

Robison, Laura; Cho, Yeoungjee; Viecelli, Andrea K.; Johnson, David W.; Hawley, Carmel; Valks, Andrea; Paul‐Brent, Peta‐Anne; Stastny, Ruth; Varghese, Julie; Kiriwandeniya, Charani; Pascoe, Elaine M.; Vergara, Liza A.; Fahim, Magid; Boudville, Neil; Krishnasamy, Rathika; Reidlinger, Donna

doi:10.1186/s13063-021-05200-0

Cited by 9 publications

(7 citation statements)

References 14 publications

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“…However, the study was not able to be completed within 6 months, primarily due to temporary interruptions caused by the Christmas holiday period and a 2 weeks of COVID outbreak in the hospital in April 2021. 23 Overall, these results suggest that conducting a prebiotic trial in kidney transplant recipients is feasible.…”

Section: Discussionmentioning

confidence: 89%

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study

Chan

Hawley

Pascoe

et al. 2022

Journal of Renal Nutrition

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Section: Discussionmentioning

confidence: 89%

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study

Chan

Hawley

Pascoe

et al. 2022

Journal of Renal Nutrition

Self Cite

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“…We hope that our manuscript assists trial sites that are not otherwise supported by a clinical trial network and that would benefit from the collective knowledge and experience of our ECFS-CTN member sites. Our advice for sites complements the recently published insights from another clinical trial network specialized in conducting nephrology investigator-initiated trials [ 14 ]. We also hope that our manuscript will serve as a starting point for continued conversation as well as sharing of experience to optimize best practice within the wider field of clinical trials.…”

Section: Discussionmentioning

confidence: 97%

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Koningsbruggen-Rietschel

Dunlevy²,

Bulteel³

et al. 2021

Trials

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The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites across 17 European countries and collated information on measures to mitigate the impact of the pandemic and ensure trial continuity. Here, we present recommendations on how to reduce the risk of SARS-CoV-2 exposure to patients and trial staff by implementing remote trial visits where possible, using home assessments, video and phone calls, electronic consent, and home delivery of study drugs. We discuss the practicalities of remote source data verification, protocol amendments, changing trial site location, and staff absences and home working. We outline recommendations on how to protect trial outcomes, including home assessments, safety reporting, protocol deviations, and recruitment challenges. Finally, we discuss the importance of continued access to study drugs via extension trials for some patients. This guidance was co-created from the shared knowledge and experience of sites in our network and was re-distributed directly to all ECFS-CTN sites to help mitigate the impact of further waves of the SARS-CoV-2 pandemic. We will also use this guidance to assist companies, academia, and consortia with future protocol design and risk mitigation plans. This guidance can be applied to clinical trials in other diseases and could help sites that are not supported by clinical trial networks.

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“…COVID-19 requirements during the study period included the option for telenutrition or in-person visits. Virtual visits were not a barrier to establishing rapport with the participants; others reported similar experiences with conducting clinical trials during COVID-19 restrictions [ 48 ]. The initial time allotted of one hour per data collection visit, however, was insufficient.…”

Section: Discussionmentioning

confidence: 99%

Anti-Inflammatory Diet for Women with Interstitial Cystitis/Bladder Pain Syndrome: The AID-IC Pilot Study

Gordon

Blanton

Ramsey

et al. 2022

MPs

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Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic condition characterized by pelvic pain coupled with urinary frequency and urgency. The underlying cause of IC/BPS is unknown; there is no cure. Dietary components exacerbate symptoms. The Anti-Inflammatory Diet for Interstitial Cystitis (AID-IC) employs a randomized, crossover design to evaluate the effect of a plant-based, low saturated fat diet on the quality of life of women with IC/BPS. Insights on the implementation of the protocol and reflections on the facilitators and barriers experienced during the pilot study follow. The logistics of the protocol proved time-consuming; however, the barriers were surmountable. Quantitative and qualitative findings suggest that the AID-IC therapeutic diet may have lessened symptoms and improved the quality of life for many of the women in the study.

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Conducting clinical trials during the COVID-19 pandemic—a collaborative trial network response

Cited by 9 publications

References 14 publications

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Anti-Inflammatory Diet for Women with Interstitial Cystitis/Bladder Pain Syndrome: The AID-IC Pilot Study

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