Activating clinical trials: a process improvement approach

Trials
Diego A MartinezBenjamin Djulbegovic

Abstract

The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contr...Continue Reading

References

May 8, 2002·The Journal of Clinical Endocrinology and Metabolism·David M Nathan
Mar 14, 2003·JAMA : the Journal of the American Medical Association·Nancy S SungDavid Rimoin
Apr 22, 2004·Journal of Health Services Research & Policy·Pelham BartonSuzanne Robinson
Apr 28, 2005·PharmacoEconomics·J Jaime Caro
Sep 30, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David M Dilts, Alan B Sandler
Dec 16, 2006·Clinical Trials : Journal of the Society for Clinical Trials·Robert M Califf
Feb 20, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Lelia DuleySalim Yusuf
Jun 4, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David M DiltsRobert Comis
Sep 23, 2008·American Journal of Therapeutics·Kenneth A GetzKenneth I Kaitin
Mar 4, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David M DiltsJeffrey Abrams
May 23, 2009·Health Research Policy and Systems·Jonathan M KaganWilliam M K Trochim
Jul 1, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Terre A McJoyntS Vincent Rajkumar
Aug 5, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Razelle KurzrockRobert C Bast
Nov 18, 2009·PLoS Medicine·Alex D McMahonGordon T McInnes
Jul 21, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrea Wang-GillamRamaswamy Govindan
Aug 5, 2010·Journal of the National Cancer Institute·John F Scoggins, Scott D Ramsey
Nov 11, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Steven K ChengDavid M Dilts
Aug 3, 2013·Evaluation & the Health Professions·David M Dilts
Aug 8, 2013·Clinical and Translational Science·James KiriakisAdam Rifkind
Jan 8, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David P Steensma, Hagop M Kantarjian
Jul 2, 2014·Clinical Trials : Journal of the Society for Clinical Trials·Scott R RosasJonathan M Kagan
Mar 1, 2015·Therapeutic Innovation & Regulatory Science·Yun Jung ChoiTae Won Kim

❮ Previous
Next ❯

Citations

Jan 18, 2019·JCO Clinical Cancer Informatics·Umit Topaloglu, Matvey B Palchuk
Jan 28, 2021·International Journal of Environmental Research and Public Health·Juan A Marin-GarciaJulio J Garcia-Sabater
Nov 28, 2020·Journal of Clinical and Translational Science·Sara GonzalesKristi Holmes
May 25, 2021·Contemporary Clinical Trials Communications·Colin CernikDinesh Pal Mudaranthakam

❮ Previous
Next ❯

Software Mentioned

VSM
SNA
NetDraw
Arena
DES

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Academic Medicine : Journal of the Association of American Medical Colleges
Stephen K Klasko
The National Medical Journal of India
Vikas Bajpai, Anoop Saraya
The Journal of Foot and Ankle Surgery : Official Publication of the American College of Foot and Ankle Surgeons
Paul J Kim
Journal of Community Hospital Internal Medicine Perspectives
Robert D ChowMihriye Mete
© 2022 Meta ULC. All rights reserved