A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process.

Authors: Taheri, Shiva¹ (AUTHOR) s.taheri@ucl.ac.uk, Yorke-Edwards, Victoria^2,3 (AUTHOR), Sydes, Matthew R.^1,4 (AUTHOR), Isaacs, Talia⁵ (AUTHOR), Love, Sharon B.¹ (AUTHOR)

Source: Trials. 11/9/2024, Vol. 25 Issue 1, p1-9. 9p.

Subject Terms: *CLINICAL trials monitoring, *NEW trials, *CLINICAL trials, *QUALITY assurance, *MEDICAL research, *DELPHI method

MarketLine Company Profile: Clario.

Source: Clario MarketLine Company Profile. 6/11/2024, p1-17. 17p.

Subject Terms: *Clinical trials monitoring

Geographic Terms: Princeton (N.J.)

Company/Entity: Clario Inc.

Navigating investigator-initiated clinical trials: A call for guidelines & monitoring frameworks from an Indian context.

Authors: Kumar, Gunjan¹ (AUTHOR), Cherian, Jerin Jose¹ (AUTHOR), Mathur, Roli² (AUTHOR), Mukherjee, Aparna¹ (AUTHOR) aparna.sinha.deb@gmail.com

Source: Indian Journal of Medical Research. Aug2024, Vol. 160 Issue 2, p1-9. 9p.

Subject Terms: *CLINICAL trials monitoring, *CLINICAL trials, *MEDICAL research, *PUBLIC health research, *MEDICAL research personnel

Epistemic uncertainty in Bayesian predictive probabilities.

Authors: Liu, Charles C.¹ (AUTHOR) cliu17@gilead.com, Yu, Ron Xiaolong¹ (AUTHOR)

Source: Journal of Biopharmaceutical Statistics. May2024, Vol. 34 Issue 3, p394-412. 19p.

Subject Terms: *Clinical trials monitoring, *Probability theory, *Uncertainty (Information theory), Epistemic uncertainty, Optimal stopping (Mathematical statistics)

Determining the extent and frequency of on-site monitoring: a bayesian risk-based approach.

Authors: Xie, Longshen¹ (AUTHOR), Liu, Lin² (AUTHOR), Chow, Shein-Chung³ (AUTHOR), Lu, Hui¹ (AUTHOR) huilu@sjtu.edu.cn

Source: BMC Medical Research Methodology. 6/28/2024, Vol. 24 Issue 1, p1-16. 16p.

Subject Terms: *CLINICAL trials monitoring, *CLINICAL trials, *QUALITY control

Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture.

Authors: Yamada, Osamu¹ (AUTHOR) osamu.yamada.p7@alumni.tohoku.ac.jp, Chiu, Shih-Wei^1,2 (AUTHOR), Nakazawa, Toru^3,4,5,6,7 (AUTHOR), Tsuda, Satoru³ (AUTHOR), Yoshida, Mitsuhide³ (AUTHOR), Asano, Toshifumi³ (AUTHOR), Kokubun, Taiki³ (AUTHOR), Hashimoto, Kazuki³ (AUTHOR), Takata, Munenori^1,2 (AUTHOR), Ikeda, Suzuka² (AUTHOR), Kawabe, Yosuke² (AUTHOR), Tamura, Yuko⁸ (AUTHOR), Yamaguchi, Takuhiro^1,2 (AUTHOR)

Source: Trials. 6/14/2024, Vol. 25 Issue 1, p1-11. 11p.

Subject Terms: *CLINICAL trials monitoring, *CLINICAL trials, *CONFIDENCE intervals

Upstrapping to determine futility: predicting future outcomes nonparametrically from past data.

Authors: Wild, Jessica L.¹ (AUTHOR) jessica.wild@cuanschutz.edu, Ginde, Adit A.² (AUTHOR), Lindsell, Christopher J.³ (AUTHOR), Kaizer, Alexander M.¹ (AUTHOR)

Source: Trials. 5/9/2024, Vol. 25 Issue 1, p1-10. 10p.

Subject Terms: *CLINICAL trials monitoring, *FRUSTRATION, *FALSE positive error, *ERROR rates, *RESAMPLING (Statistics), *SAMPLE size (Statistics)

Sequential monitoring clinical trial by conditional power under drift fractional Brownian motion.

Authors: Xia, Leixin¹ (AUTHOR), Chen, Baojiang¹ (AUTHOR), Lai, Dejian¹ (AUTHOR) dejian.lai@uth.tmc.edu

Source: Communications in Statistics: Simulation & Computation. 2024, Vol. 53 Issue 10, p4676-4684. 9p.

Subject Terms: *Clinical trials monitoring, *Stochastic processes, Wiener processes, Fractional powers, Motion analysis

MarketLine Company Profile: Clario.

Source: Clario MarketLine Company Profile. 7/19/2023, p1-18. 18p.

Subject Terms: *Clinical trials monitoring

Geographic Terms: Princeton (N.J.)

Company/Entity: Clario Inc.

Anticipating Near-Term Shifts in the Outsourcing Landscape.

Authors: Shah, Samir¹

Source: Applied Clinical Trials. Jan/Feb2024, Vol. 33 Issue 1/2, p16-21. 6p.

Subject Terms: *CONTRACTING out, *CLINICAL trials monitoring, *CONTRACT research organizations

Antidopaminergic medications in Huntington's disease.

Authors: Tan, Andrew M^1,2 (AUTHOR) andrew.tan@prilenia.com, Geva, Michal¹ (AUTHOR), Goldberg, Y Paul¹ (AUTHOR), Schuring, Henk¹ (AUTHOR), Sanson, Bernd-Jan¹ (AUTHOR), Rosser, Anne^3,4,5 (AUTHOR), Raymond, Lynn⁶ (AUTHOR), Reilmann, Ralf^7,8 (AUTHOR), Hayden, Michael R^1,3 (AUTHOR), Anderson, Karen⁹ (AUTHOR)

Source: Journal of Huntington's Disease. Feb2025, Vol. 14 Issue 1, p16-29. 14p.

Subject Terms: *HUNTINGTON disease, *CLINICAL trials monitoring, *SYMPTOMS, *COGNITION disorders, *CENTRAL nervous system

Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift.

Authors: Zhang, Peng^1,2 (AUTHOR), Shih, Weichung Joe¹ (AUTHOR), Lin, Yong¹ (AUTHOR) linyo@sph.rutgers.edu, Lan, K. K. Gordon² (AUTHOR), Xie, Tai² (AUTHOR)

Source: Statistics in Biopharmaceutical Research. Jan-Mar2025, Vol. 17 Issue 1, p102-112. 11p.

Subject Terms: *CLINICAL trials monitoring, *OVERALL survival, *TRIAL practice, *CLINICAL trials, *SAMPLE size (Statistics), *BROWNIAN motion

A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data.

Authors: Daher, André¹ (AUTHOR), Castro-Alves, Júlio² (AUTHOR), Amparo, Leandro¹ (AUTHOR), Pacheco de Moraes, Natalia¹ (AUTHOR), Araújo dos Santos, Thaís Regina¹ (AUTHOR), Gram dos Santos, Karla Regina¹ (AUTHOR), Siqueira do Valle, Cristiane¹ (AUTHOR), Hermoso, Maria¹ (AUTHOR) maria.hermoso@fiocruz.br, Catoia Varela, Margareth² (AUTHOR), Correa Oliveira, Rodrigo¹ (AUTHOR)

Source: PLoS ONE. 11/22/2023, Vol. 18 Issue 11, p1-14. 14p.

Subject Terms: *CLINICAL trials monitoring, *MEDICAL coding, *DATA libraries, *OPEN scholarship, *CLINICAL trials

Comparison of Hemodynamic Effects of Dose Response vs. Conventional Dosing of Propofol for Anesthesia Induction Under Bispectral Index Monitoring: A Clinical Trial.

Authors: Khazaeipour, Zahra¹, Khoshnam-Rad, Niloufar², Pestei, Khalil^3,4 khalilpesteh@yahoo.com, Samadi, Shahram^4,5

Source: Acta Medica Iranica. 2023, Vol. 61 Issue 9, p555-559. 5p.

Subject Terms: *CLINICAL trials monitoring, *PROPOFOL, *HEMODYNAMICS, *ANESTHESIA, *OPERATING rooms

Women's views about current and future management of Ductal Carcinoma in Situ (DCIS): A mixed-methods study.

Authors: Nickel, Brooke^1,2 (AUTHOR), McCaffery, Kirsten^1,2 (AUTHOR), Jansen, Jesse³ (AUTHOR), Barratt, Alexandra¹ (AUTHOR), Houssami, Nehmat^1,2,4 (AUTHOR), Saunders, Christobel⁵ (AUTHOR), Spillane, Andrew^6,7,8 (AUTHOR), Rutherford, Claudia^9,10 (AUTHOR), Stuart, Kirsty^11,12,13 (AUTHOR), Robertson, Geraldine¹⁴ (AUTHOR), Dixon, Ann¹⁵ (AUTHOR), Hersch, Jolyn^1,2 (AUTHOR) jolyn.hersch@sydney.edu.au

Source: PLoS ONE. 7/21/2023, Vol. 18 Issue 7, p1-15. 15p.

Subject Terms: *DUCTAL carcinoma, *CLINICAL trials monitoring, *CARCINOMA in situ, *CLINICAL trials, *FOCUS groups, *OLDER women

Geographic Terms: SYDNEY (N.S.W.)

Serum biomarkers for monitoring response to tuberculosis treatment: an assessment of the effect of different covariates among slow and fast treatment responders.

Authors: Namuganga, Anna Ritah^1,2,3,4 (AUTHOR), Ssentalo Bagaya, Bernard² (AUTHOR), Chegou, Novel N.⁴ (AUTHOR), Mayanja-Kizza, Harriet^3,5 (AUTHOR)

Source: Biomarkers. Jul2023, Vol. 28 Issue 5, p466-476. 11p.

Subject Terms: *CLINICAL trials monitoring, *BIOMARKERS, *TUBERCULOSIS, *COUGH

Geographic Terms: KAMPALA (Uganda)

More than Just Rules: Raising the Bar in GCP Adherence.

Authors: Bahls, Christine

Source: Applied Clinical Trials. Jul/Aug2023, Vol. 32 Issue 7/8, p14-17. 4p.

Subject Terms: *CLINICAL trials monitoring, *CONTRACT research organizations, *LYME disease vaccines, *CLINICAL drug trials, *NATURAL language processing

A Conversation with Dean Follmann of NIAID.

Authors: Franck, Chris¹

Source: Amstat News. Apr2024, Issue 562, p21-23. 3p.

Subject Terms: *EBOLA virus disease, *CLINICAL trials monitoring, *COVID-19 vaccines, *COVID-19 pandemic

Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

Authors: Poythress, J. C.¹ (AUTHOR) joseph.poythress@astellas.com, Lee, Jin Hyung² (AUTHOR), Takeda, Kentaro¹ (AUTHOR), Liu, Jun¹ (AUTHOR)

Source: Pharmaceutical Statistics. Nov2024, Vol. 23 Issue 6, p1166-1180. 15p.

Subject Terms: *CLINICAL trials monitoring, *STATISTICAL process control, *FALSE alarms, *BEST practices

Comparing GBA1‐Parkinson's disease and idiopathic Parkinson's disease: α‐Synuclein oligomers and synaptic density as biomarkers in the skin biopsy.

Authors: Mazzetti, Samanta^1,2 (AUTHOR) samanta.mazzetti@gmail.com, Contaldi, Elena³ (AUTHOR), Basellini, Milo Jarno¹ (AUTHOR), Novello, Claudia¹ (AUTHOR), Calogero, Alessandra Maria^1,2 (AUTHOR), Straniero, Letizia^4,5 (AUTHOR), Garrì, Federica² (AUTHOR), Ferri, Valentina^2,3 (AUTHOR), Calandrella, Daniela^2,3 (AUTHOR), Del Sorbo, Francesca³ (AUTHOR), Asselta, Rosanna^4,5 (AUTHOR), Cereda, Emanuele⁶ (AUTHOR), Cappelletti, Graziella^1,7 (AUTHOR) graziella.cappelletti@unimi.it, Isaias, Ioannis Ugo^3,8 (AUTHOR), Pezzoli, Gianni^2,3 (AUTHOR)

Source: Brain Pathology. Nov2024, Vol. 34 Issue 6, p1-13. 13p.

Subject Terms: *PARKINSON'S disease, *CLINICAL trials monitoring, *NEUROLOGICAL disorders, *AUTONOMIC nervous system, *SKIN biopsy, *SWEAT glands