Jonathan Kimmelman
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View article: Challenges of Conducting Risk‐Benefit Analysis of Early Phase Clinical Trials: Results of a National Survey of IRB Chairs
Challenges of Conducting Risk‐Benefit Analysis of Early Phase Clinical Trials: Results of a National Survey of IRB Chairs Open
Institutional review boards (IRBs) are charged with conducting risk‐benefit analysis for early phase clinical trials that often involve high levels of uncertainty regarding a trial's potential risks and benefits. Our study used a survey of…
View article: Weighing Open Science Against Research Participation Burden in Informed Consent: A Randomized Pilot Study
Weighing Open Science Against Research Participation Burden in Informed Consent: A Randomized Pilot Study Open
Deciding to participate in clinical research requires patients to evaluate various trial characteristics. This survey study measured the influence of trial characteristics (visit volume and open data sharing) on willingness to participate …
View article: Populations Addressed in Vaccines Approved via the European Medicines Agency
Populations Addressed in Vaccines Approved via the European Medicines Agency Open
Therapeutic and prophylactic agents require robust evidence before patient use. Randomized controlled trials are essential for evaluating safety and efficacy but often exclude specific populations that are also targets for the intervention…
View article: Meta-analysis of median survival times with inverse-variance weighting
Meta-analysis of median survival times with inverse-variance weighting Open
We consider the problem of meta-analyzing outcome measures based on median survival times, such as the difference of median survival times between groups. Primary studies with time-to-event outcomes often report estimates of median surviva…
View article: Proportion of patients in phase 2 oncology trials receiving treatments that are ultimately approved
Proportion of patients in phase 2 oncology trials receiving treatments that are ultimately approved Open
Background Many patients enroll in phase 1 dose expansion cohorts or phase 2 clinical trials (together referred to below as “phase 2”) seeking access to novel treatments. Little is known about the extent to which they benefit by enrolling.…
View article: Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum
Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum Open
BACKGROUND: We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week 50 postpartum body mass index in IMPAACT 2010. METHODS: Women with human immun…
View article: Progress in Cancer Therapeutics: Is There an Upper Limit on the Maximum Effect that Can Be Detected in Randomized Trials
Progress in Cancer Therapeutics: Is There an Upper Limit on the Maximum Effect that Can Be Detected in Randomized Trials Open
View article: Concordance of Efficacy and Safety in Phase Ib/Ii and Phase Iii Solid Tumour Treatment Trials
Concordance of Efficacy and Safety in Phase Ib/Ii and Phase Iii Solid Tumour Treatment Trials Open
View article: Supporting evidence in phase 2 cancer trial protocols: a content analysis
Supporting evidence in phase 2 cancer trial protocols: a content analysis Open
Background Phase 2 trials are instrumental for designing definitive efficacy trials or attaining accelerated approval. However, high attrition of drug candidates in phase 2 trials raises questions about their supporting evidence. Methods W…
View article: Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review
Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review Open
Regulatory guidance for preclinical efficacy studies often recommends a strong emphasis on the clinical relevance of animal models, intervention parameters, outcomes, and mechanism of action. Incorporating these recommendations into early …
View article: Survival Benefit Associated With Participation in Clinical Trials of Anticancer Drugs
Survival Benefit Associated With Participation in Clinical Trials of Anticancer Drugs Open
Importance Many cancer clinical investigators view clinical trials as offering better care for patients than routine clinical care. However, definitive evidence of clinical benefit from trial participation (hereafter referred to as the par…
View article: Contra el excepcionalismo en la investigación durante la pandemia
Contra el excepcionalismo en la investigación durante la pandemia Open
Las crisis no son excusa para bajar los estándares científicos.
View article: Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum
Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum Open
Background We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week 50 postpartum body mass index in IMPAACT 2010. Methods Women with human immunod…
View article: The impact of feedback training on prediction of cancer clinical trial results
The impact of feedback training on prediction of cancer clinical trial results Open
Introduction Funders must make difficult decisions about which squared treatments to prioritize for randomized trials. Earlier research suggests that experts have no ability to predict which treatments will vindicate their promise. We test…
View article: Large numbers of patients are needed to obtain additional approvals for new cancer drugs: A retrospective cohort study
Large numbers of patients are needed to obtain additional approvals for new cancer drugs: A retrospective cohort study Open
Patients endure risk and uncertainty when they participate in clinical trials. We previously estimated that 12,217 patient-participants are required to bring a new cancer drug to market. However, many development efforts are aimed at exten…
View article: Timing for First-in-Minor Clinical Trials of New Cancer Drugs
Timing for First-in-Minor Clinical Trials of New Cancer Drugs Open
View article: Supplementary Figure 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
PRISMA flow diagram.
View article: Data from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Data from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
The validity of preclinical studies of candidate therapeutic agents has been questioned given their limited ability to predict their fate in clinical development, including due to design flaws and reporting bias. In this study, we examined…
View article: Supplementary Text 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Text 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Double-coded extraction items. Eight extraction items prone to high interrater variability.
View article: Supplementary Figure 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
PRISMA flow diagram.
View article: Supplementary Figure 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Frequencies of captured time points per experiment. A) The last common time point (LCT) between control and treatment arms and B) the closest time point to day 14 after treatment initiation in the control arm. Filled bars in B) indicate st…
View article: Supplementary Figure 3 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 3 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Effect sizes for all tumor volume experiments (n=97).
View article: Supplementary Table 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Table 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Coding details for construct validity categories in Table 2. Adapted from our previous meta-analysis of the drug, sunitinib (5).
View article: Supplementary Text 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Text 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Search strategies for MEDLINE and Embase databases.
View article: Supplementary Table 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Table 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Coding details for internal validity categories in Table 2. Adapted from our previous meta-analysis of the drug, sunitinib (5).
View article: Supplementary Figure 3 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 3 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Effect sizes for all tumor volume experiments (n=97).
View article: Supplementary Figure 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Figure 2 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Frequencies of captured time points per experiment. A) The last common time point (LCT) between control and treatment arms and B) the closest time point to day 14 after treatment initiation in the control arm. Filled bars in B) indicate st…
View article: Supplementary Table 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Table 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Coding details for internal validity categories in Table 2. Adapted from our previous meta-analysis of the drug, sunitinib (5).
View article: Supplementary Text 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Supplementary Text 1 from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
Search strategies for MEDLINE and Embase databases.
View article: Data from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy
Data from Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy Open
The validity of preclinical studies of candidate therapeutic agents has been questioned given their limited ability to predict their fate in clinical development, including due to design flaws and reporting bias. In this study, we examined…