Cargando…
Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience
INTRODUCTION: Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of innovative and complex cancer care delivery research (CCDR) trials are being conducted within the Alliance with the aims...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364584/ https://www.ncbi.nlm.nih.gov/pubmed/35945621 http://dx.doi.org/10.1186/s13063-022-06536-x |
_version_ | 1784765175032709120 |
---|---|
author | Zahrieh, David Hillman, Shauna L. Tan, Angelina D. Frank, Jennifer L. Dockter, Travis Meyers, Bobbi Jo Cherevko, Cassie L. Peil, Elizabeth S. McCue, Shaylene Kour, Oudom Gunn, Heather J. Neuman, Heather B. Chang, George J. Paskett, Electra D. Mandrekar, Sumithra J. Dueck, Amylou C. |
author_facet | Zahrieh, David Hillman, Shauna L. Tan, Angelina D. Frank, Jennifer L. Dockter, Travis Meyers, Bobbi Jo Cherevko, Cassie L. Peil, Elizabeth S. McCue, Shaylene Kour, Oudom Gunn, Heather J. Neuman, Heather B. Chang, George J. Paskett, Electra D. Mandrekar, Sumithra J. Dueck, Amylou C. |
author_sort | Zahrieh, David |
collection | PubMed |
description | INTRODUCTION: Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of innovative and complex cancer care delivery research (CCDR) trials are being conducted within the Alliance with the aims of studying and improving cancer-related care. Because these trials encompass patients, providers, practices, and their interactions, a defining characteristic of CCDR trials is multilevel data collection in pragmatic settings. Consequently, CCDR trials necessitated innovative strategies for database development, centralized data management, and data monitoring in the presence of these real-world multilevel relationships. Having real trial experience in working with community and academic centers, and having recently implemented five CCDR trials in Rave, we are committed to sharing our strategies and lessons learned in implementing such pragmatic trials in oncology. METHODS: Five Alliance CCDR trials are used to describe our approach to analyzing the database development needs and the novel strategies applied to overcome the unanticipated challenges we encountered. The strategies applied are organized into 3 categories: multilevel (clinic, clinic stakeholder, patient) enrollment, multilevel quantitative and qualitative data capture, including nontraditional data capture mechanisms being applied, and multilevel data monitoring. RESULTS: A notable lesson learned in each category was (1) to seek long-term solutions when developing the functionality to push patient and non-patient enrollments to their respective Rave study database that affords flexibility if new participant types are later added; (2) to be open to different data collection modalities, particularly if such modalities remove barriers to participation, recognizing that additional resources are needed to develop the infrastructure to exchange data between that modality and Rave; and (3) to facilitate multilevel data monitoring, orient site coordinators to the their trial’s multiple study databases, each corresponding to a level in the hierarchy, and remind them to establish the link between patient and non-patient participants in the site-facing NCI web-based enrollment system. CONCLUSION: Although the challenges due to multilevel data collection in pragmatic settings were surmountable, our shared experience can inform and foster collaborations to collectively build on our past successes and improve on our past failures to address the gaps. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06536-x. |
format | Online Article Text |
id | pubmed-9364584 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-93645842022-08-11 Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience Zahrieh, David Hillman, Shauna L. Tan, Angelina D. Frank, Jennifer L. Dockter, Travis Meyers, Bobbi Jo Cherevko, Cassie L. Peil, Elizabeth S. McCue, Shaylene Kour, Oudom Gunn, Heather J. Neuman, Heather B. Chang, George J. Paskett, Electra D. Mandrekar, Sumithra J. Dueck, Amylou C. Trials Review INTRODUCTION: Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of innovative and complex cancer care delivery research (CCDR) trials are being conducted within the Alliance with the aims of studying and improving cancer-related care. Because these trials encompass patients, providers, practices, and their interactions, a defining characteristic of CCDR trials is multilevel data collection in pragmatic settings. Consequently, CCDR trials necessitated innovative strategies for database development, centralized data management, and data monitoring in the presence of these real-world multilevel relationships. Having real trial experience in working with community and academic centers, and having recently implemented five CCDR trials in Rave, we are committed to sharing our strategies and lessons learned in implementing such pragmatic trials in oncology. METHODS: Five Alliance CCDR trials are used to describe our approach to analyzing the database development needs and the novel strategies applied to overcome the unanticipated challenges we encountered. The strategies applied are organized into 3 categories: multilevel (clinic, clinic stakeholder, patient) enrollment, multilevel quantitative and qualitative data capture, including nontraditional data capture mechanisms being applied, and multilevel data monitoring. RESULTS: A notable lesson learned in each category was (1) to seek long-term solutions when developing the functionality to push patient and non-patient enrollments to their respective Rave study database that affords flexibility if new participant types are later added; (2) to be open to different data collection modalities, particularly if such modalities remove barriers to participation, recognizing that additional resources are needed to develop the infrastructure to exchange data between that modality and Rave; and (3) to facilitate multilevel data monitoring, orient site coordinators to the their trial’s multiple study databases, each corresponding to a level in the hierarchy, and remind them to establish the link between patient and non-patient participants in the site-facing NCI web-based enrollment system. CONCLUSION: Although the challenges due to multilevel data collection in pragmatic settings were surmountable, our shared experience can inform and foster collaborations to collectively build on our past successes and improve on our past failures to address the gaps. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06536-x. BioMed Central 2022-08-09 /pmc/articles/PMC9364584/ /pubmed/35945621 http://dx.doi.org/10.1186/s13063-022-06536-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Review Zahrieh, David Hillman, Shauna L. Tan, Angelina D. Frank, Jennifer L. Dockter, Travis Meyers, Bobbi Jo Cherevko, Cassie L. Peil, Elizabeth S. McCue, Shaylene Kour, Oudom Gunn, Heather J. Neuman, Heather B. Chang, George J. Paskett, Electra D. Mandrekar, Sumithra J. Dueck, Amylou C. Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title | Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title_full | Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title_fullStr | Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title_full_unstemmed | Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title_short | Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience |
title_sort | successes and lessons learned in database development for national multi-site cancer care delivery research trials: the alliance for clinical trials in oncology experience |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364584/ https://www.ncbi.nlm.nih.gov/pubmed/35945621 http://dx.doi.org/10.1186/s13063-022-06536-x |
work_keys_str_mv | AT zahriehdavid successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT hillmanshaunal successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT tanangelinad successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT frankjenniferl successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT docktertravis successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT meyersbobbijo successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT cherevkocassiel successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT peilelizabeths successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT mccueshaylene successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT kouroudom successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT gunnheatherj successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT neumanheatherb successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT changgeorgej successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT paskettelectrad successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT mandrekarsumithraj successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience AT dueckamylouc successesandlessonslearnedindatabasedevelopmentfornationalmultisitecancercaredeliveryresearchtrialstheallianceforclinicaltrialsinoncologyexperience |