Protocol-in-a-Day Workshop: Expediting IRB Approval for Junior and Senior Faculty.

Clinical trial design Clinical trial workshop Expediting protocol approval Faculty mentorship Multidiciplinary protocol review Oncology trials Protocol development

Journal

Journal of cancer education : the official journal of the American Association for Cancer Education
ISSN: 1543-0154
Titre abrégé: J Cancer Educ
Pays: England
ID NLM: 8610343

Informations de publication

Date de publication:
24 Jun 2024
Historique:
accepted: 17 05 2024
medline: 25 6 2024
pubmed: 25 6 2024
entrez: 24 6 2024
Statut: aheadofprint

Résumé

Delays in research protocol development may be a single factor that hinders the career progression of academic faculty. Structured educational guidance during this phase proves crucial in mitigating setbacks in Institutional Review Board (IRB) approval and expediting trial implementation. To address this, the Protocol-in-a-Day (PIAD) workshop, a comprehensive 1-day event involving members from six critical facets of RO clinical trial implementation, was established, offering significant input to individual protocols. Efficacy and satisfaction of the PIAD workshop were assessed through a 5-question survey and the average time from submission to IRB initial approval. The normality of the data was analyzed using the Shapiro-Wilk Test. Nonparametric data was analyzed using a Mann-Whitney U test for significance. A total of 18 protocols that went through the PIAD workshop were activated. The mean time to IRB approval for protocols that went through PIAD was 39.8 days compared to 58.4 days for those that did not go through the PIAD workshop. Based on survey results, 100% of PIAD participants said the PIAD workshop was useful and 94% of participants stated that the PIAD workshop improved the overall quality of their protocol. Participant surveys further highlighted substantial improvements in trial quality, language, and statistical design and revealed that all participants found the workshop helpful. Therefore, both junior and senior faculty benefitted from this educational program during protocol development, as both groups demonstrated shorter times to IRB approval than non-participants. This acceleration not only fosters efficient trial implementation but also supports academic faculty in their career development.

Identifiants

DOI: 10.1007/s13187-024-02460-7 PMID: 38914893
pubmed: 38914893
doi: 10.1007/s13187-024-02460-7
pii: 10.1007/s13187-024-02460-7
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s) under exclusive licence to American Association for Cancer Education.

Références

Siegel RL, Miller KD, Fuchs HE, Jemal A, Cancer statistics (2022) CA Cancer J Clin. 2022;72(1):7–33. https://doi.org/10.3322/caac.21708
Panageas KS (2015) Clinical trial design for rare cancers: why a less conventional route may be required. Expert Rev Clin Pharmacol 8(6):661–663. https://doi.org/10.1586/17512433.2015.1088382
doi: 10.1586/17512433.2015.1088382 pubmed: 26517109 pmcid: 4724195
Williams E, Brown TJ, Griffith P, Rahimi A, Oilepo R, Hammers H, Laetsch TW, Currykosky P, Partridge S, Beg MS (2020) Improving the Time to activation of New Clinical trials at a National Cancer Institute-designated Comprehensive Cancer Center. JCO Oncol Pract 16(4):e324–e332. https://doi.org/10.1200/OP.19.00325
doi: 10.1200/OP.19.00325 pubmed: 32048941
Lai J, Forney L, Brinton DL, Simpson KN (2021) Drivers of start-up delays in global randomized clinical trials. Ther Innov Regul Sci 55(1):212–227. https://doi.org/10.1007/s43441-020-00207-2
doi: 10.1007/s43441-020-00207-2 pubmed: 32959207
Qazi J, DeHaai KA, Hawkins BM, Romano KD, Zaorsky NG, Chen RC, Showalter TN (2022) Demystifying radiation oncology clinical trial concerns for protocol scientific review and institutional review board committee members. Contemp Clin Trials Commun 27:100911. https://doi.org/10.1016/j.conctc.2022.100911
doi: 10.1016/j.conctc.2022.100911 pubmed: 35345873 pmcid: 8956792
Yeboa DN, Liao Z, Court L, Holliday EB, Spelman A, Herman J (2019) Protocol-in-a-Day workshop: a lean approach to clinical trial development and focus on junior faculty development. Adv Radiat Oncol 4(3):439–442. https://doi.org/10.1016/j.adro.2019.02.006
doi: 10.1016/j.adro.2019.02.006 pubmed: 31360796 pmcid: 6639744
Dilts DM, Sandler AB (2006) Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol 24(28):4545–4552. https://doi.org/10.1200/JCO.2005.05.0104
doi: 10.1200/JCO.2005.05.0104 pubmed: 17008693
Rolla K, Briggs S, Houston C et al (2019) Developing a standardized library of informed consent language to ensure consistency and quality across clinical studies at a large academic medical center. Presented at the 2019 PRIM&R Advancing Ethical Research Conference, Nov. 17–20, Boston. Poster: 25
Fairchild A, Bar-Deroma R, Collette L, Haustermans K, Hurkmans C, Lacombe D, Maingon P, Poortmans P, Tomsej M, Weber DC, Gregoire V (2012) Development of clinical trial protocols involving advanced radiation therapy techniques: the European Organisation for Research and Treatment of Cancer Radiation Oncology Group approach. Eur J Cancer 48(7):1048–1054. https://doi.org/10.1016/j.ejca.2012.02.008
doi: 10.1016/j.ejca.2012.02.008 pubmed: 22387181
Ranganathan P, Chinnaswamy G, Sengar M, Gadgil D, Thiagarajan S, Bhargava B, Booth CM, Buyse M, Chopra S, Frampton C, Gopal S, Grant N, Krailo M, Langley R, Mathur P, Paoletti X, Parmar M, Purushotham A, Pyle D, Rajaraman P, Stockler MR, Sullivan R, Swaminathan S, Tannock I, Trimble E, Badwe RA, Pramesh CS (2021) National Cancer Grid of India. The international collaboration for research methods development in oncology (CReDO) workshops: shaping the future of global oncology research. Lancet Oncol 22(8):e369–e376. https://doi.org/10.1016/S1470-2045(21)00077-2
doi: 10.1016/S1470-2045(21)00077-2 pubmed: 34216541 pmcid: 8328959
Wang-Gillam A, Williams K, Novello S, Gao F, Scagliotti GV, Govindan R (2010) Time to activate lung cancer clinical trials and patient enrollment: a representative comparison study between two academic centers across the atlantic. J Clin Oncol 28(24):3803–3807. https://doi.org/10.1200/JCO.2010.28.1824
doi: 10.1200/JCO.2010.28.1824 pubmed: 20644091
Ning N, Yan J, Dietrich MF, Xie XJ, Gerber DE (2017) Institutional scientific review of cancer clinical research protocols: a unique requirement that affects activation timelines. J Oncol Pract 13(12):e982–e991. https://doi.org/10.1200/JOP.2017.024299
doi: 10.1200/JOP.2017.024299 pubmed: 29019706 pmcid: 5728362
Lalani N, Griffith KA, Jones RD, Spratt DE, Croke J, Jagsi R (2018) Mentorship experiences of early-career academic radiation oncologists in North America. Int J Radiat Oncol Biol Phys 101(3):732–740. https://doi.org/10.1016/j.ijrobp.2018.03.035
doi: 10.1016/j.ijrobp.2018.03.035 pubmed: 29893281

Auteurs

Geina M Iskander (GM)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Adriana Cavazos (A)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Chinenye Lynette Ejezie (CL)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Victoria Cox (V)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Hunter Cheng (H)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Shelby Perez (S)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Albert C Koong (AC)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Jonathan Nguyen (J)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Joseph Herman (J)

Northwell Health Cancer Institute Radiation Medicine, Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA.

Sam Beddar (S)

Department of Radiation Physics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.

Zhongxing Liao (Z)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.

Debra Nana Yeboa (DN)

Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA. DNYeboa@mdanderson.org.
ORCID: 0000-0002-2901-7477

Classifications MeSH