Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

148
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
148
Clinical Trials: Overview01:11

Clinical Trials: Overview

3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K
Clinical Trials01:16

Clinical Trials

6.9K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
6.9K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

NGSE-Corr: A technique for objective clinical evaluation of quantitative-imaging methods without a gold standard.

IEEE transactions on medical imaging·2026
Same author

Exploratory FDG PET/CT Imaging in mCRPC Patients Treated with Sipuleucel-T ± IL-7: A Phase II Trial Subanalysis.

International journal of molecular sciences·2026
Same author

Differences in amyloid PET positivity based on ethnoracial group and social determinants of health: The new IDEAS study.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same author

Pediatric thyroid cancer lung metastases and RAI: long-term results.

Journal of pediatric endocrinology & metabolism : JPEM·2026
Same author

Association of residential neighborhood disadvantage with amyloid PET positivity among cognitively impaired individuals.

Alzheimer's & dementia. Behavior & socioeconomics of aging·2026
Same author

<sup>18</sup>F-Fluciclovine for Detection of Recurrent Brain Metastases After Radiation Therapy: Image Interpretation Criteria and Diagnostic Performance From the PURSUE Study.

International journal of radiation oncology, biology, physics·2026

Related Experiment Video

Updated: Jul 20, 2025

Expedited Radiation Biodosimetry by Automated Dicentric Chromosome Identification ADCI and Dose Estimation
10:33

Expedited Radiation Biodosimetry by Automated Dicentric Chromosome Identification ADCI and Dose Estimation

Published on: September 4, 2017

15.8K

Discrepant Assessments of Progressive Disease in Clinical Trials between Routine Clinical Reads and Formal RECIST 1.1

Marilyn J Siegel1, Joseph E Ippolito1, Richard L Wahl1

  • 1From the Edward Mallinckrodt Institute of Radiology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110.

Radiology. Imaging Cancer
|August 4, 2023
PubMed
Summary

Routine clinical interpretations frequently overdiagnosed progressive disease (PD) in cancer clinical trials compared to formal RECIST 1.1 criteria. This could lead to patients being removed from trials unnecessarily.

Keywords:
CTCancerMR ImagingOncologyTumor Response

More Related Videos

Comprehensive Protocol to Sample and Process Bone Marrow for Measuring Measurable Residual Disease and Leukemic Stem Cells in Acute Myeloid Leukemia
09:57

Comprehensive Protocol to Sample and Process Bone Marrow for Measuring Measurable Residual Disease and Leukemic Stem Cells in Acute Myeloid Leukemia

Published on: March 5, 2018

29.4K
Detection of a Circulating MicroRNA Custom Panel in Patients with Metastatic Colorectal Cancer
08:12

Detection of a Circulating MicroRNA Custom Panel in Patients with Metastatic Colorectal Cancer

Published on: March 14, 2019

5.5K

Related Experiment Videos

Last Updated: Jul 20, 2025

Expedited Radiation Biodosimetry by Automated Dicentric Chromosome Identification ADCI and Dose Estimation
10:33

Expedited Radiation Biodosimetry by Automated Dicentric Chromosome Identification ADCI and Dose Estimation

Published on: September 4, 2017

15.8K
Comprehensive Protocol to Sample and Process Bone Marrow for Measuring Measurable Residual Disease and Leukemic Stem Cells in Acute Myeloid Leukemia
09:57

Comprehensive Protocol to Sample and Process Bone Marrow for Measuring Measurable Residual Disease and Leukemic Stem Cells in Acute Myeloid Leukemia

Published on: March 5, 2018

29.4K
Detection of a Circulating MicroRNA Custom Panel in Patients with Metastatic Colorectal Cancer
08:12

Detection of a Circulating MicroRNA Custom Panel in Patients with Metastatic Colorectal Cancer

Published on: March 14, 2019

5.5K

Area of Science:

  • Oncology
  • Radiology
  • Clinical Trials

Background:

  • Accurate tumor response assessment is critical for guiding cancer clinical trials.
  • Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 provides standardized criteria for tumor response evaluation.
  • Discrepancies between routine clinical interpretations and formal RECIST 1.1 assessments can impact patient management.

Purpose of the Study:

  • To determine the frequency of discrepant progressive disease (PD) interpretations between routine clinical and formal RECIST 1.1 criteria in solid tumor clinical trials.
  • To investigate the causes of discordance in PD assessments.

Main Methods:

  • Retrospective analysis of imaging response assessments from January to July 2021 in solid tumor clinical trials.
  • Comparison of routine clinical interpretations (RCIs) with local core laboratory interpretations (CLIs) using RECIST 1.1.
  • Analysis focused on discordant PD interpretations, identifying reasons for discrepancies.

Main Results:

  • Among 327 patients with PD on at least one read, 65% had concordant assessments.
  • Routine clinical interpretations (RCIs) overdiagnosed PD in 32% of cases compared to CLIs.
  • Erroneous target lesion measurements (58%) were the primary cause of RCI overdiagnosis of PD.

Conclusions:

  • Progressive disease (PD) is frequently overdiagnosed in routine clinical interpretations compared to formal RECIST 1.1 criteria.
  • This overdiagnosis can lead to inappropriate removal of patients from clinical trials.
  • Standardized application of RECIST 1.1 by trained radiologists is crucial for accurate tumor response assessment in clinical trials.