Assessing Genitourinary Cancer Clinical Trial Accrual Sufficiency Using Archived Trial Data

PURPOSE Clinical trials often fail to reach their anticipated end points, most frequently because of poor accrual. Prior studies have analyzed trial termination, but it has not been easy to assess accrual estimates using international databases such as ClinicalTrials.gov because of limitations in accessing accrual information. Specifically, it is not easy to extract both anticipated and actual accrual of clinical trials. We designed a new algorithmic approach to extracting trial accrual data from ClinicalTrials.gov and used it to estimate the sufficiency of patient accrual onto genitourinary (GU) cancer trials. METHODS We queried ClinicalTrials.gov for completed/terminated phase II and III clinical trials for prostate, bladder, kidney, testicular, and ureteral cancers registered after 2007. We extracted trial characteristics from available XML files. We then used a Python algorithm to access prior trial registrations on the ClinicalTrials.gov archive site and extract both anticipated and actual accrual numbers. We then compared the actual accrual of each trial to its anticipated accrual and defined sufficient accrual as 85% of anticipated accrual. RESULTS The algorithm was 100% accurate compared with hand extraction in a small validation subset. A total of 925 trials were included, of which 840 (91%) had both anticipated and actual accrual. Only 418 (50%) trials had sufficient accrual (≥ 85% of anticipated). Considering only trials marked as successfully completed, 395/597 (66%) reached sufficient accrual. CONCLUSION GU cancer trials often do not meet their anticipated accrual goals. New approaches to trial conduct are direly needed. Our reproducible and scalable approach to extracting accrual information can be applied to analysis of ClinicalTrials.gov in future analyses in the hope of improving the efficiency of the clinical trials enterprise.

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Tildrakizumab: A Review of Phase II and III Clinical Trials

Annals of Pharmacotherapy ◽

10.1177/1060028018809522 ◽

2018 ◽

Vol 53 (4) ◽

pp. 413-418 ◽

Cited By ~ 8

Author(s):

Sree S. Kolli ◽

Sarah D. Gabros ◽

Adrian Pona ◽

Abigail Cline ◽

Steven R. Feldman

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Biological Therapy ◽

Common Adverse Effect ◽

Clinical Trial Data ◽

Trial Data ◽

Severe Psoriasis ◽

Phase Iii ◽

Physician Global Assessment ◽

Phase Ii And Iii

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.

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Sharing data from MS clinical trials: Opportunities, challenges, and future directions

Multiple Sclerosis Journal ◽

10.1177/1352458515608005 ◽

2015 ◽

Vol 21 (11) ◽

pp. 1365-1368 ◽

Cited By ~ 2

Author(s):

Timothy Coetzee

Keyword(s):

Multiple Sclerosis ◽

Clinical Trial ◽

Clinical Trials ◽

Clinical Trial Data ◽

Therapeutic Agents ◽

Research Community ◽

Trial Data ◽

Fundamental Question ◽

Future Directions ◽

Phase Ii And Iii

The treatment of people affected by multiple sclerosis, particularly the relapsing forms of the disease, has been transformed by the availability of various therapeutic agents. This landmark progress is due to an enormous foundation of clinical research and, particularly, numerous phase II and III clinical trials. Although the research community has many reasons to take pride in this progress, a fundamental question remains about whether opportunities for additional research are being lost due to inadequate clinical trial data sharing.

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Strategic inclusion of regions in multiregional clinical trials

Clinical Trials ◽

10.1177/1740774518813573 ◽

2018 ◽

Vol 16 (1) ◽

pp. 98-105

Author(s):

Seung Yeon Song ◽

Deborah Chee ◽

EunYoung Kim

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase I ◽

Phase Ii ◽

Phase Iii ◽

Local Study ◽

International Conference ◽

Trial Conduct ◽

Increasing Trend ◽

Phase Iii Trials

Background With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade. Methods The ClinicalTrials.gov registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017. Extracted data included phase, disease type, intervention, study start year, and region. Trial type was classified as either a local study or a multiregional clinical trial as per the International Conference on Harmonisation E17 guideline. Results Of 2488 phase I, 1855 phase II, and 1999 phase III trials included, the majority of phase I trials were local studies (76.8%), while the majority of phase II (66.0%) and phase III (72.2%) trials were multiregional clinical trials. The proportion of multiregional clinical trials showed an increasing trend for all phases ( p < 0.01). Although North America and Europe remained the main locations, increasing trends of inclusion of other regions, such as East Asia, were noted. Conclusion Globalization of drug development is evident with the increasing trend of multiregional clinical trial. Regulatory authorities as well as the pharmaceutical industry should prepare for the evolving setting of clinical research and problems that can arise from these changes.

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Screening Intervention to Identify Eligible Patients and Improve Accrual to Phase II-IV Oncology Clinical Trials

Journal of Oncology Practice ◽

10.1200/jop.2012.000763 ◽

2013 ◽

Vol 9 (4) ◽

pp. e174-e181 ◽

Cited By ~ 4

Author(s):

Leo Chen ◽

Janice Grant ◽

Winson Y. Cheung ◽

Hagen F. Kennecke

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase Ii ◽

Patient Records ◽

Intervention Process ◽

Oncology Clinical Trials ◽

Clinical Trial Accrual

Manually screening patient records increased enrollment to specific clinical trials. A screening intervention process, involving a dedicated screening coordinator, should be considered to improve clinical trial accrual.

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A provider-focused, point-of-care technology to improve clinical trial accrual.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.29_suppl.309 ◽

2020 ◽

Vol 38 (29_suppl) ◽

pp. 309-309

Author(s):

Sidharth Anand ◽

Sarah Marie Larson ◽

Katrina Fischer ◽

John A. Glaspy

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Point Of Care ◽

Time Frame ◽

Trial Data ◽

Web Based ◽

Significant Burden ◽

Point Of Care Technology ◽

Clinical Trial Accrual ◽

Care Technology

309 Background: Low accrual to clinical trials is a significant burden to advancing research efforts, particularly detrimental to patients who may benefit clinically from enrollment in a promising trial. Low accrual has been linked to a lack of provider awareness of clinical trials at the point of care and current technology solutions have not adequately addressed this important issue. Methods: We aimed to develop a system to improve clinical trial access for patients throughout UCLA Hematology-Oncology through the development of a point of care web-based tool to allow providers to easily identify available clinical trials for their patients. First, we built a comprehensive database of current clinical trials at UCLA, with special emphasis on streamlined exclusion/inclusion criteria. We incorporated this database into a front-end web and mobile-responsive tool with a user-friendly interface allowing users to rapidly identify patients eligible for clinical trial enrollment. We launched this tool 1/15/2019 to 56 oncologists at UCLA Health. Results: From 1/15/19 to 6/14/19 we had had a total of 713 unique logins to the clinical trials website. This included “academic oncologists,” those oncologists specializing in a particular disease sub-type and often a ‘hub’ for clinical trials, with an average of 6.4 logins per oncologist, and “community oncologists” with an average of 18.8 logins per oncologist over that time frame. A brief survey of users who logged in over 4 times during that time revealed that on average, 4-5 additional patients per user were screened for clinical trials not previously identified. Conclusions: Clinical trial accrual can be enhanced through improved provider awareness of available trials at the point-of-care. A well-designed user interface with features to help facilitate provider navigation to available trials and quick inclusion and exclusion criteria were critical to the success of the tool. Although the web-based tool achieved its primary purpose in improving clinical trial awareness, its utility diminished over time due to the lack of real-time updates of trial data. Based on provider feedback, if the available trial data can be updated and maintained on a regular basis, this can be a valuable tool to improve clinical trial awareness and subsequently, accrual.

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Clinical Trial Data Management Software: A Review of the Technical Features

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666190207151500 ◽

2019 ◽

Vol 14 (3) ◽

pp. 160-172 ◽

Cited By ~ 1

Author(s):

Aynaz Nourani ◽

Haleh Ayatollahi ◽

Masoud Solaymani Dodaran

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Data Management ◽

Clinical Data ◽

Clinical Trial Data ◽

Trial Data ◽

Data Management System ◽

Management Systems ◽

Data Management Systems ◽

Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

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Longitudinal Analysis of Patient-Reported Outcomes in Clinical Trials: Applications of Multilevel and Multidimensional Item Response Theory

Psychometrika ◽

10.1007/s11336-021-09777-y ◽

2021 ◽

Author(s):

Li Cai ◽

Carrie R. Houts

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Latent Variable ◽

Patient Reported Outcomes ◽

Multilevel Models ◽

Latent Variable Models ◽

Trial Data ◽

Regulatory Science ◽

Measurement Information ◽

Patient Reported

AbstractWith decades of advance research and recent developments in the drug and medical device regulatory approval process, patient-reported outcomes (PROs) are becoming increasingly important in clinical trials. While clinical trial analyses typically treat scores from PROs as observed variables, the potential to use latent variable models when analyzing patient responses in clinical trial data presents novel opportunities for both psychometrics and regulatory science. An accessible overview of analyses commonly used to analyze longitudinal trial data and statistical models familiar in both psychometrics and biometrics, such as growth models, multilevel models, and latent variable models, is provided to call attention to connections and common themes among these models that have found use across many research areas. Additionally, examples using empirical data from a randomized clinical trial provide concrete demonstrations of the implementation of these models. The increasing availability of high-quality, psychometrically rigorous assessment instruments in clinical trials, of which the Patient-Reported Outcomes Measurement Information System (PROMIS®) is a prominent example, provides rare possibilities for psychometrics to help improve the statistical tools used in regulatory science.

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