Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

O Solovyeva, M Dimairo, CJ Weir, SW Hee… - BMC medicine, 2023 - Springer
Background Early phase dose-finding (EPDF) trials are crucial for the development of a new
intervention and influence whether it should be investigated in further trials. Guidance exists …

Challenges with novel clinical trial designs: master protocols

M Cecchini, EH Rubin, GM Blumenthal, K Ayalew… - Clinical Cancer …, 2019 - AACR
Abstract The 2018 Accelerating Anticancer Agent Development (AAADV) Workshop
assembled a panel of experts for an in-depth discussion session to present “Challenges with …

Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study

N Koonrungsesomboon, S Teekachunhatean… - European Journal of …, 2016 - Springer
Purpose This study aimed to evaluate the applicability of the principles and informed
consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in …

[PDF][PDF] SIDCER informed consent form: principles and a developmental guideline

N Koonrungsesomboon, J Laothavorn… - Indian J Med …, 2016 - academia.edu
The quality of informed consent forms (ICFs) remains an issue in clinical research. The
lengthy and complicated ICFs currently being used lower research participants' ability to …

Academic and Private Partnership to Improve Informed Consent Forms Using a Data Driven Approach

C Tendler, PS Hong, C Kane… - The American Journal …, 2024 - Taylor & Francis
Informed consent documents are central to the informed consent process and are required
for participation in clinical trials in the US The primary purpose of the document is “to assist a …

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback

AM Avinger, HC Sibold, G Campbell, E Abernethy… - BMC medical …, 2023 - Springer
Background Although patient advocates have developed templates for standard consent
forms, evaluating patient preferences for first in human (FIH) and window of opportunity …

A comparison of the quality of informed consent for phase I oncology trials over a 30-year period

L Malik, J Cooper - Cancer Chemotherapy and Pharmacology, 2018 - Springer
Purpose Efforts are underway in improving the informed consent process. The success of
these efforts to improve quality of informed consent forms (ICFs) for phase I oncology trials …

[HTML][HTML] Papel de los profesionales de la salud en el diseño, obtención y entendimiento del consentimiento informado: Una revisión

A Camargo, J Olmos, E Higuera-Dagovett… - … UDCA Actualidad & …, 2019 - scielo.org.co
El consentimiento informado es un proceso que tiene la intención de autorizar o llegar a un
acuerdo con el profesional para la realización de un procedimiento en el área de la salud o …

[PDF][PDF] Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials

O Solovyeva, M Dimairo, CJ Weir, SW Hee… - research.ed.ac.uk
Background Early phase dose-finding (EPDF) trials are crucial for the development of a new
intervention and influence whether it should be investigated in further trials. Guidance exists …

Role of health professionals in the design, obtention and understanding of informed consent: A review

A Camargo, J Olmos, E Higuera-Dagovett… - … UDCA Actualidad & …, 2019 - scielo.org.co
CAMARGO, Andrés et al. Role of health professionals in the design, obtention and
understanding of informed consent: A review. rev. udcaactual. divulg. cient.[online]. 2019 …