Evidence map›Paper›PMID 36506825›Full record

ArticleContemporary clinical trials communications2022

Bolstering the complex study start-up process at NCI cancer centers using technology.

Dinesh Pal Mudaranthakam, Sam Pepper, Alexander Alsup, Tara Lin, Natalie Streeter, Jeffrey Thompson, Byron Gajewski, Matthew S Mayo, Qamar Khan

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Evaluating the impact of delayed study startup on accrual in cancer studies.Contemporary clinical trials communications · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Dinesh Pal MudaranthakamDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Sam PepperDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Alexander AlsupDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Tara LinThe University of Kansas Cancer Center, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
Natalie StreeterThe University of Kansas Cancer Center, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
Jeffrey ThompsonDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Byron GajewskiDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Matthew S MayoDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
Qamar KhanThe University of Kansas Cancer Center, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
The University of Kansas Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The study startup process for interventional clinical trials is a complex process that involves the efforts of many different teams. Each team is responsible for their startup checklist in which they verify that the necessary tasks are done before a study can move on to the next team. This regulatory process provides quality assurance and is vital for ensuring patient safety [10]. However, without having this startup process centralized and optimized, study approval can take longer than necessary as time is lost when it passes through many different hands. Objective: This manuscript highlights the process and the systems that were developed at The University of Kansas Comprehensive Cancer Center regarding the study startup process. To facilitate this process the regulatory management, site development, cancer center administration, and the Biostatistics & Informatics Shared Resources (BISR) teams came together to build a platform aimed at streamlining the startup process and providing a transparent view of where a study is in the startup process. Process: Ensuring the guidelines are clearly articulated for the review criteria of each of the three review boards, i.e., Disease Working Group (DWG), Executive Resourcing Committee (ERC), and Protocol Review and Monitoring Committee (PRMC) along with a system that can track every step and its history throughout the review process. Results: Well-defined processes and tracking methodologies have allowed the operations teams to track each study closely and ensure the 90-day and 120-day deadlines are met, this allows the operational team to dynamically prioritize their work daily. It also provides Principal investigators a transparent view of where their study stands within the study startup process and allows them to prepare for the next steps accordingly. Conclusion/future work: The current process and technology deployment has been a significant improvement to expedite the review process and minimize study startup delays. There are still a few opportunities to fine-tune the study startup process; an example of which includes automatically informing the operational managers or the study teams to act upon deadlines regarding study review rather than the current manual communication process which involves them looking it up in the system which can add delays.

Indexed as

CancerOncologyStudy start-upTrial

Identifiers

PMID36506825
PMCPMC9727641
OpenAlexW4310444174

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.