Analysis methods for covariate-constrained cluster randomized trials with time-to-event outcomes

Authors: Amy M. Crisp, M. Elizabeth Halloran, Matt D. T. Hitchings, Ira M. Longini, Natalie E. Dean

Source: BMC Medical Research Methodology, Vol 25, Iss 1, Pp 1-10 (2025)

Subject Terms: Clinical trial design, Cluster-randomized, Constrained randomization, Time-to-event, Permutation test, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2288

Access URL: https://doaj.org/article/c3d760b31c4f4fb9b04f6841bde616c8

A new taxonomy of neuroprotective agents for stroke appropriate for the reperfusion era

Authors: Mersedeh Bahr-Hosseini, Jeffrey L. Saver

Source: Frontiers in Neurology, Vol 15 (2025)

Subject Terms: neuroprotection, acute stroke treatment, taxonomy, cerebroprotection, clinical trial design, reperfusion era, Neurology. Diseases of the nervous system, RC346-429

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fneur.2024.1514924/full; https://doaj.org/toc/1664-2295

Access URL: https://doaj.org/article/b4fe533382dd4070b6b342b8237bf78e

Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals

Authors: Chelsea Ye, Tatiana Shablinski, Susan E. Shoaf, Chris Chung, Michelle Bullock

Source: Contemporary Clinical Trials Communications, Vol 43, Iss , Pp 101396- (2025)

Subject Terms: Alternative clinical trial design, Decentralized clinical trial, Evidence-based medicine, Patient-centric clinical trial, Self-directed trial procedures, Medicine (General), R5-920

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2451865424001431; https://doaj.org/toc/2451-8654

Access URL: https://doaj.org/article/d78bd50709214ba4b347e10cfbcdf787

The impact of a patient advisory board on a clinical comparative effectiveness trial: a comparison of patient and researcher perspectives

Authors: Laura M Kernan, Monica Baczko Pearl, Adina Harri, Carol A Lambourne, Robert Schlegel, C. McCollister Evarts, Mary Beth Crummer, Conrad Persels, Nancy Mullen, Vincent D Pellegrini Jr

Source: Journal of Comparative Effectiveness Research, Vol 14, Iss 3 (2025)

Subject Terms: clinical trial design, comparative effectiveness research, patient advisory body, patient empowerment, patient engagement, patient involvement in research, shared decision-making, stakeholder engagement, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/2042-6313

Access URL: https://doaj.org/article/8a672a00cfd04d86ae052e3f44e31c11

Independent genetic strategies define the scope and limits of CDKL5 deficiency disorder reversal

Authors: Song, Xie ^{1, 2}, Xia, Zijie ¹, Martinez, Dayne ¹, Xu, Bing ^{1, 3}, Spritzer, Zachary ¹, Zhang, Yanjie ¹, Nugent, Erin ¹, Ho, Yugong ¹, Terzic, Barbara ¹, Zhou, Zhaolan ^{1, 4, 5, 6, ∗}

Source: In Cell Reports Medicine 18 February 2025 6(2)

Modernizing multiple myeloma clinical trial eligibility to improve equity and inclusivity by hematological parameters

Authors: Merz, Lauren ^{a, b}, Hartley-Brown, Monique ^a, Achebe, Maureen ^{a, c}, Cole, Craig ^d, Kanapuru, Bindu ^{e, †}, Banjo, Ola ^f, Mulligan, George ^f, Wozniak, Katie ^f, Young, Anne Quinn ^f, Cho, Hearn Jay ^{f, g, ⁎}

Source: In Seminars in Hematology February 2025 62(1):38-42

An efficient vaccine clinical trial: ACTG A5379 hepatitis B vaccine trial in persons with HIV

Authors: Kang, Minhee ^{a, ⁎}, Marks, Kristen M. ^b, Cox, Andrea L. ^c, Sherman, Kenneth E. ^d

Source: In Vaccine 10 May 2025 55

Global hepatitis B and D community advisory board: expectations, challenges, and lessons learned

Authors: Fiona Borondy-Jenkins, Bright Ansah, Jacki Chen, Amanda Goldring, Yasmin Ibrahim, Shaibu Issa, Silvana Lesidrenska, Tanya Machado, Holly Moore, Richard Njouom, Prince Okinedo, Rhea Racho, Lori Scott, Beatrice Zovich, Chari Cohen

Source: Frontiers in Public Health, Vol 12 (2024)

Subject Terms: community empowerment, research participation, global advisory board, clinical trial design, drug development, hepatitis B, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fpubh.2024.1437502/full; https://doaj.org/toc/2296-2565

Access URL: https://doaj.org/article/0bdf520a046d44a3970c11670fe6768a

Clinical Trial Exclusion Criteria Affect Trial Inclusivity by Race and Sex

Authors: Robert J. Stanton, Yasmin N. Aziz, Heidi Sucharew, Mary Haverbusch, David J. Robinson, Elisheva Coleman, Felipe De Los Rios La Rosa, Stacie Demel, Simona Ferioli, Jason Mackey, Adam Jasne, Tracy E. Madsen, Eva Mistry, Sabreena Slavin, Michael Star, Kyle Walsh, Daniel Woo, Pooja Khatri, Joseph Broderick, Brett Kissela, Dawn O. Kleindorfer

Source: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 13, Iss 13 (2024)

Subject Terms: clinical trial design, diversity, inclusivity, Diseases of the circulatory (Cardiovascular) system, RC666-701

File Description: electronic resource

Relation: https://doaj.org/toc/2047-9980

Access URL: https://doaj.org/article/f18dd1e51146458fbd840f5eef246def

Nocebo expectations rather than placebo expectations affect topical pain relief: A randomized clinical trial

Authors: Yang, Mingxiao ^a, Li, Qing S. ^b, Baser, Raymond E. ^c, Li, Xiaotong ^b, Hou, Jason ^b, Mao, Jun J. ^{b, ⁎}

Source: In Biomedicine & Pharmacotherapy June 2024 175

Optimal trial design selection: a comparative analysis between two-arm and three-arm trials incorporating network meta-analysis for evaluating a new treatment

Authors: Fangshu Ye, Chong Wang, Annette M. O’Connor

Source: BMC Medical Research Methodology, Vol 23, Iss 1, Pp 1-12 (2023)

Subject Terms: Network meta-analysis, Clinical trial design, Evidence synthesis, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2288

Access URL: https://doaj.org/article/693ee24c63314549a8aeb66e4b148d80

Longitudinal resting-state EEG in amyloid-positive patients along the Alzheimer’s disease continuum: considerations for clinical trials

Authors: Elliz P. Scheijbeler, Willem de Haan, Cornelis J. Stam, Jos W. R. Twisk, Alida A. Gouw

Source: Alzheimer’s Research & Therapy, Vol 15, Iss 1, Pp 1-19 (2023)

Subject Terms: Longitudinal, Resting state, Electroencephalography, Alzheimer’s disease, Clinical trial design, Functional endpoint, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429

File Description: electronic resource

Relation: https://doaj.org/toc/1758-9193

Access URL: https://doaj.org/article/b22c66068dd54151a395614867fa8948

Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities

Authors: Nomathemba Chandiwana, Chelsea Kruger, Naomi Richardson, Sibongiseni Nxumalo, Nkoleleng Mashilo, Yengiwe Dineka, Ntanganedzeni Mudau, Hilary Johnstone, Wookyung Kim, Chung Ju, Sarah Arbe-Barnes, Anne Claire Marrast, Julia Flynn, Willem D. Francois Venter

Source: Trials, Vol 24, Iss 1, Pp 1-12 (2023)

Subject Terms: COVID-19, Clinical research management, South Africa, Drug repurposing, Outpatient, Clinical trial design, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/4e3d4b4757cf48489a270fb90bb13fa9

Estimating vaccine efficacy during open-label follow-up of COVID-19 vaccine trials based on population-level surveillance data

Authors: Mia Moore, Yifan Zhu, Ian Hirsch, Tom White, Robert C. Reiner, Ryan M. Barber, David Pigott, James K. Collins, Serena Santoni, Magdalena E. Sobieszczyk, Holly Janes

Source: Epidemics, Vol 47, Iss , Pp 100768- (2024)

Subject Terms: Clinical trial design, Randomized controlled trial, Vaccine, Counterfactual, Infectious and parasitic diseases, RC109-216

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S175543652400029X; https://doaj.org/toc/1755-4365

Access URL: https://doaj.org/article/0c1184e721274b25b668765f603565a2

Decentralized clinical trials: regulatory perspectives in Russia and the EAEU

Authors: M. A. Borzova, S. V. Semina

Source: Реальная клиническая практика: данные и доказательства, Vol 3, Iss 2, Pp 10-20 (2023)

Subject Terms: decentralized clinical trials, real-world data, international regulatory experience, patient-centred clinical trial design, umbrella trials, basket trials, Medicine (General), R5-920

File Description: electronic resource

Relation: https://www.myrwd.ru/jour/article/view/37; https://doaj.org/toc/2782-3784

Access URL: https://doaj.org/article/b0242671e85b41a1a95946fce6b1c465

Biomarkers navigate drug development: Pharmacology, effectiveness and safety

Authors: Daohong Chen

Source: Medicine in Drug Discovery, Vol 21, Iss , Pp 100174- (2024)

Subject Terms: Biomarker, Drug development, Clinical trial design, Pharmacy and materia medica, RS1-441

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2590098623000246; https://doaj.org/toc/2590-0986

Access URL: https://doaj.org/article/3ed7557afe7c422f90331bc26da5ae3e

Intramuscular ketamine vs. midazolam for rapid risk-reduction in suicidal, depressed emergency patients: Clinical trial design and rationale

Authors: Sumra Sajid, Ryan E. Lawrence, Hanga C. Galfalvy, John G. Keilp, Vivek K. Moitra, J. John Mann, Michael F. Grunebaum

Source: Journal of Affective Disorders Reports, Vol 15, Iss , Pp 100690- (2024)

Subject Terms: Ketamine, Emergency department, Intramuscular, Suicide, Clinical trial design, Mental healing, RZ400-408

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2666915323002275; https://doaj.org/toc/2666-9153

Access URL: https://doaj.org/article/ea248ce368e942d3ad5e1b9f51d5f2e3

Pediatric oncology drug development and dosage optimization

Authors: S. Y. Amy Cheung, Justin L. Hay, Yu-Wei Lin, Rik de Greef, Julie Bullock

Source: Frontiers in Oncology, Vol 13 (2024)

Subject Terms: pediatric, oncology, dosage optimization, Project Optimus, model informed drug development, clinical trial design, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fonc.2023.1235947/full; https://doaj.org/toc/2234-943X

Access URL: https://doaj.org/article/a33f9e0c7f654f328f3461dab95da55b

Looking ahead in early-phase trial design to improve the drug development process: examples in oncology

Authors: Alyssa M. Vanderbeek, Robert A. Redd, Steffen Ventz, Lorenzo Trippa

Source: BMC Medical Research Methodology, Vol 23, Iss 1, Pp 1-11 (2023)

Subject Terms: Drug development process, Clinical trial design, Simulation, Oncology, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2288

Access URL: https://doaj.org/article/27d79c47ccac4663996522080af93ca6

Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design

Authors: Xianwen Chen, Junnan Shi, Yunfeng Lai, Yan Xue, Carolina Oi Lam Ung, Hao Hu

Source: Chinese Medicine, Vol 18, Iss 1, Pp 1-22 (2023)

Subject Terms: Non-alcoholic steatohepatitis, Traditional Chinese medicine, Randomised controlled trial, Clinical trial design, Other systems of medicine, RZ201-999

File Description: electronic resource

Relation: https://doaj.org/toc/1749-8546

Access URL: https://doaj.org/article/efdf0027035d4691a931073da5cb409d