scholarly journals A decade of the Clinical Trials Transformation Initiative: What have we accomplished? What have we learned?

2018 ◽  
Vol 15 (1_suppl) ◽  
pp. 5-12 ◽  
Author(s):  
P Tenaerts ◽  
L Madre ◽  
M Landray
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Value Added ◽  
Project Selection ◽  
Project Team ◽  
Lessons Learned ◽  
Advanced Planning ◽  
Critical Issues ◽  
Multi Stakeholder ◽  
The Impact

The Clinical Trials Transformation Initiative reflects on 10 years of working to improve the quality and efficiency of clinical trials. This article highlights many of the Clinical Trials Transformation Initiative’s accomplishments and offers examples of the impact that the Clinical Trials Transformation Initiative has had on the clinical trials enterprise. After conducting more than 25 projects and issuing recommendations for specific strategies to improve the design and execution of clinical trials, some common themes and lessons learned have emerged. Lessons include the importance of engaging many stakeholders, advanced planning to address critical issues, discontinuation of non-value added practices, and new opportunities presented by technology. Through its work, the Clinical Trials Transformation Initiative has also derived some operational best practices for conducting collaborative, multi-stakeholder projects covering project selection, project team dynamics and execution, and multi-stakeholder meetings and team discussions. Through these initiatives, the Clinical Trials Transformation Initiative has helped move the needle toward needed change in the clinical trials enterprise that has directly impacted stakeholders and patients alike.

scholarly journals The impact of the COVID-19 pandemic on digital globalization

2021 ◽  
Vol 129 ◽  
pp. 06008
Author(s):  
Maria Loredana Popescu ◽  
Svetlana Platagea Gombos ◽  
Sorin Burlacu ◽  
Amza Mair
Keyword(s):  
Global Economy ◽  
World Economy ◽  
Value Added ◽  
Digital Transformation ◽  
Lessons Learned ◽  
Health Crisis ◽  
Main Research ◽  
Documentary Analysis ◽  
The Impact

Research background: After more than a year of the Covid-19 pandemic, we can investigate whether it caused a shock to the global economy, pushing for deglobalization, or on the contrary, it was a challenge for digital globalization and digital transformation of economies. Through this research we join the research contributions that examine the process towards digital globalization that characterizes the world economy, its impact on businesses, consumers, and governments. We also discuss the challenges posed by the crisis caused by the coronavirus pandemic to globalization and perhaps the acceleration of the digital transformation of economies. Purpose of the article: The aim of this research is to highlight the impact of the COVID-19 pandemic in the age of digital globalization. Methods: Documentary analysis, as the main research method, is doubled by a case study that allows us to highlight the specific characteristics of digital globalization. Findings & Value added: The findings of the research allowed us to highlight the essential aspects of digital globalization that were perhaps exacerbated by the Covid-19 pandemic, but which contribute greatly to understanding the phenomenon of globalization. Our research also reveals four lessons learned in the COVID-19 pandemic. We also present some considerations regarding the globalization after the health crisis.

Dare voce ai pazienti nella ricerca sulle malattie rare e sui famaci orfani / Giving patients a voice in the rare diseases and orphan drugs research

2018 ◽  
Vol 67 (1) ◽  
pp. 25-40
Author(s):  
Elena Mancini ◽  
Roberta Martina Zagarella
Keyword(s):  
Clinical Trials ◽  
Rare Diseases ◽  
Patient Reported Outcomes ◽  
Narrative Medicine ◽  
Orphan Drugs ◽  
New Drugs ◽  
Patient Centered ◽  
Patient Reported ◽  
Critical Issues ◽  
The Impact

L’articolo ha l’obiettivo di mettere in luce potenzialità e criticità dell’inclusione della prospettiva dei pazienti nella ricerca sulle malattie rare e sui farmaci orfani. A tal fine, nella prima parte, si propone un’analisi epistemologica dell’utilizzo dei racconti dell’esperienza individuale della malattia nella ricerca scientifica e nei trial clinici, facendo emergere, anche attraverso gli strumenti della medicina narrativa, le sfide teoriche e operative poste dall’inclusione della soggettività del paziente e del vissuto di malattia nonché l’importanza della valorizzazione della prospettiva del paziente, sia in generale sia nella ricerca sulle malattie rare e sui farmaci orfani. Nella seconda parte, il testo analizza in particolare il ruolo degli esiti riportati dai pazienti o Patient Reported Outcomes (PROs), misure per la valutazione complessiva della salute basate sulla prospettiva dei pazienti stessi, incentrandosi sulla sperimentazione clinica nel campo delle malattie rare. In questo contesto, infatti, i racconti di malattia, raccolti e valorizzati da fonti istituzionali e associazioni di pazienti, hanno contribuito a far emergere importanti questioni critiche e difficoltà nell’impiego di outcome centrati sul paziente nello sviluppo di nuovi farmaci e trattamenti, generando una serie di documenti e raccomandazioni relative al loro utilizzo per il benessere della comunità dei malati rari. ---------- This paper aims to highlight the potentiality and criticality of including patients’ perspective in rare diseases and orphan drugs research. In the first part, we propose an epistemological analysis of individual narrations of disease experience as they are used in scientific research and clinical trials. With the help of narrative medicine approach, this analysis points out theoretical and operational challenges of a perspective that includes patient’s subjectivity and illness experience. Furthermore, it reveals the significance of patients’ standpoints in general and in rare diseases as well as in the orphan drugs research. The second part of our article focuses on the role of the Patient reported Outcomes (PROs) – which are measures for the health’s overall assessment based on patient’s perspective – by investigating the impact on clinical trials for rare diseases. In this context, illness stories, which are collected and promoted by institutional sources and patients’ associations, contribute to underline important critical issues at stake in the employment of patient-centered outcomes both in new drugs and in the treatments development. Moreover, these stories are crucial to elaborate documents and recommendations concerning the use of PROs for the rare patients’ community welfare.

The power of partnerships

2019 ◽  
Vol 47 (2) ◽  
pp. 193-202
Author(s):  
Christy Groves
Keyword(s):  
High School ◽  
High Schools ◽  
Best Practices ◽  
Information Literacy ◽  
Academic Libraries ◽  
Lessons Learned ◽  
College Level ◽  
Content Type ◽  
Formal Assessment ◽  
The Impact

Purpose A large, predominantly undergraduate university in Tennessee partnered with a local magnet school aiming to assist high school seniors with their college-level research assignment. The partnership began as a pilot, but quickly expanded to include other high schools as a result of initial successes. This paper aims to describe the development of the partnership and its importance in fulfilling a key component of college preparedness for gifted high school students. Design/methodology/approach This paper describes how the Library partnership commenced as a service to a local high school that required its students to access college-level research materials. The paper details how both the Library and the high school recognized the impact of collaborating to expose these students to the information literacy skills needed for college readiness. Findings The paper presents the challenges encountered when attempting to provide college-level information literacy instruction to large groups of students visiting a college campus. It concludes with best practices and lessons learned, as well as plans for formal assessment and future initiatives. Originality/value The author has presented at Library Instruction West, July 2018. A review of the professional literature demonstrates that other academic libraries have partnered with local schools for a variety of library-related initiatives. Therefore, the concept of partnerships between the Library and local high schools is not unique. However, this paper aims to describe challenges encountered, best practices, lessons learned and suggestions for future directions, including formal assessment, all of which could be adapted by other academic libraries as applicable.

scholarly journals Managing Clinical Trials for Alzheimer’s Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain

2020 ◽  
Vol 77 (4) ◽  
pp. 1805-1813
Author(s):  
Carla Abdelnour ◽  
Ester Esteban de Antonio ◽  
Alba Pérez-Cordón ◽  
Asunción Lafuente ◽  
Mar Buendía ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ad Hoc ◽  
Strategic Plan ◽  
Lessons Learned ◽  
Drop Out ◽  
Rt Pcr ◽  
Serological Tests ◽  
Clinical Trial Research ◽  
Research Activities ◽  
The Impact

Background: The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. Objective: To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. Methods: We describe participants’ clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. Results: A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. Discussion: The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.

scholarly journals (A45) When Nothing is Left Standing: Nursling's Integral Role during Disaster Response in Indonesia and Haiti

2011 ◽  
Vol 26 (S1) ◽  
pp. s13-s13
Author(s):  
G.T. Hynes
Keyword(s):  
Best Practices ◽  
Nursing Care ◽  
Disaster Response ◽  
Resource Constraints ◽  
Clinical Skill ◽  
Initial Response ◽  
Lessons Learned ◽  
Ethical Framework ◽  
Local Staff ◽  
The Impact

The purpose of this presentation is to compare the lessons learned in acute nursing care in the post-disaster settings of Aceh Jaya, Indonesia (2004) and Port-au-Prince, Haiti (2010). The impact of such disasters disproportionally affects populations made vulnerable by poverty, marginalization, and structural violence. The recognition of these vulnerabilities heightens the role of the nurse as an advocate for the ill and injured. In addition, the lack of adequate human and material resources on all levels necessitates insisting on best practices for patient care despite the resource constraints. Consideration of best practices begins with rigorous personnel selection of nurses adequately trained in emergency/critical care, complex humanitarian emergencies, and disaster response. A proficient level of resource-specific triage knowledge is required to adequately provide the most effective care to patients. Not infrequently, disaster nursing care involves being tasked with a clinical skill or procedures that would be outside the scope of practice in the home country. While the expansion to such practices often is justified by need, an ethical framework demands consideration of the central tenet of “first do no harm”. A heavy burden of coordination among other caregivers, family, and the local staff is required by nurses in this environment. The substantial challenges include communication and continuity of care during the initial response phase among multiple partners with varied backgrounds and goals. Drawing from experiences in Haiti and Aceh, this presentation seeks to define the best practices in disaster nursing care and explore the ethical considerations that arise in such challenging environments.

scholarly journals 2389

2017 ◽  
Vol 1 (S1) ◽  
pp. 38-39
Author(s):  
Molly Wasko ◽  
Elaine Morrato ◽  
Nicholas Kenyon ◽  
Suhrud Rajguru ◽  
Bruce Conway ◽  
...  
Keyword(s):  
Best Practices ◽  
Network Capacity ◽  
Lessons Learned ◽  
Academic Medical Centers ◽  
Conference Calls ◽  
Train The Trainer ◽  
Medical Centers ◽  
Academic Medical ◽  
Teaching Team ◽  
The Impact

OBJECTIVES/SPECIFIC AIMS: The goal of this abstract/presentation is to share lessons learned from participation in the NIH SBIR I-Corps Train-The-Trainer Program, discuss our experiences offering programs at our local institutions, and communicate our plans to develop an I-Corps@NCATS program that can be disseminated across the CTSA network. We believe that an I-Corps@NCATS program will enhance the process of scientific translation by taking best practices from NSF I-Corps and adapting the program to meet the needs of biomedical scientists in academic medical centers. By integrating I-Corps@NCATS training, we hypothesize that the clinical and translational investigator base will be better prepared to identify new innovations and to accelerate translation through commercialization. METHODS/STUDY POPULATION: The diverse, interdisciplinary team of investigators involved in this project span 9 CTSA Hubs, including UAB, Rockefeller, UC Denver, HMC-Penn State, UMass, UC Davis, Emory/Georgia Tech, Miami and Michigan. This team was funded by NCATS in 2015–2016 to participate in the CTSA I-Corps Train-The-Trainer Program in conjunction with the NIH-SBIR/STTR I-Corps national program. The goals were to observe the curriculum, interact with and learn from the NSF National Teaching Team and begin implementation of similar programs at our home institutions. Our I-Corps@NCATS team has been holding monthly, and more recently weekly, conference calls to discuss our experiences implementing local programs and to develop a strategy for expanding CTSA offerings that include innovation and entrepreneurship. Our experience revealed several challenges with the existing NSF/NIH I-Corps program offerings: (1) there is no standard curriculum tailored to academic clinical and translational research and biomedical innovations in the life sciences, and (2) the training process to certify instructors in the I-Corps methodology is a much more rigorous and structured process than just observing an I-Corps program (eg, requires mentored training with a national NSF I-Corps trainer). Our team is proposing to address these gaps by taking best practices from NSF I-Corps and adapting the program to create the I-Corps@NCATS Program, tailored to meet the needs of researchers and clinicians in academic medical centers. RESULTS/ANTICIPATED RESULTS: There are 3 primary anticipated results of our project. First, develop a uniform curriculum for the I-Corps@NCATS Program using the National Teaching Team of experts from the NIH’s SBIR I-Corps program. Second, build the I-Corps@NCATS network capacity through a regional Train-The-Trainer Program. Third, develop a set of common metrics to evaluate the effectiveness and impact of the I-Corps@NCATS Program across the community of CTSA Hubs and their respective collaborative networks. DISCUSSION/SIGNIFICANCE OF IMPACT: Over the past 10 years, CTSA Hubs have accelerated science by creating/supporting programs that provide research infrastructure, informatics, pilot funding, education/training, and research navigator services to investigators. These investments help to ensure that we are “doing science right” using the best practices in clinical research. Even so, it is equally important to make investments to ensure that we are “doing the right science.” Are our investigators tackling research problems that our stakeholders, patients, and communities want and need, to make sure that our investments in science have real-world impact? In order to accelerate discoveries toward better health, scientists need to have a better way to understand the needs, wants and desires of the people for whom their research will serve, and how to overcome key obstacles along the path of innovation and commercialization. To fill this gap, we propose that the CTSA Hubs should include in their portfolio of activities a hands-on, lean startup program tailored after the highly successful NSF Innovation Corps (I-Corps) program. We hypothesize that by adapting the NSF I-Corps program to create an I-Corps@NCATS program tailored to medical research, we will better prepare our scientists and engineers to extend their focus beyond the laboratory and broaden the impact of their research. Investigators trained through I-Corps@NCATS are expected to be able to produce more innovative ideas, take a more informed perspective about how to evaluate the clinical and commercial impact of an idea, and quickly prototype and test new solutions in clinical settings.

Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1,737 Eastern Cooperative Oncology Group investigators.

1994 ◽  
Vol 12 (9) ◽  
pp. 1796-1805 ◽  
Author(s):  
K M Taylor ◽  
M L Feldstein ◽  
R T Skeel ◽  
K J Pandya ◽  
P Ng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Eastern Cooperative Oncology Group ◽  
Oncology Group ◽  
Future Design ◽  
Actual Patient ◽  
Critical Issues ◽  
Accrual Rate ◽  
The Impact ◽  
Patient Accrual

PURPOSE We studied oncologists' attitudes and behavior with regard to their participation in randomized clinical trials. METHODS We surveyed the 1,737 physician members of the Eastern Cooperative Oncology Group (ECOG) using the Physician Orientation Profile (POP), a self-administered mailed questionnaire. A response rate of 86% was achieved (1,485 of 1,737); each physician's actual patient accrual was recorded. RESULTS All respondents indicated that they had a systematic pattern of patient preselection for entry onto trials beyond the formal inclusion/exclusion trial criteria. Eighty-nine percent stated that improving patient quality of life rather than prolonging survival was more personally satisfying. Sixty-two percent did not enter a single patient during the 12-month period following the survey, while 10% entered 80% of all patients during that time. Physicians overestimated their accrual rate by a factor of 6. Eighty-three percent defined randomization and adherence to trial protocol as a serious challenge to their ability to make individualized treatment decisions. CONCLUSION This study raises questions regarding the following: (1) the perceived generalizability of trial findings, (2) the role of end points other than survival for clinical trials, (3) the consequences of physician overestimation of patient accrual, and (4) the impact of randomized trials on the behavior of clinicians. Further investigation into these critical issues will provide meaningful recommendations to enhance the future design, implementation, and conduct of randomized clinical trials in cancer.

scholarly journals Lessons Learned Transitioning from Traditional Premedical and Medical Education to E-learning Platforms during the COVID-19 Pandemic within the United Arab Emirates

2021 ◽  
Vol 8 ◽  
pp. 238212052110258
Author(s):  
Siobhán M. O’Sullivan ◽  
Ali A. Khraibi ◽  
Wei Chen ◽  
Peter R. Corridon
Keyword(s):  
Medical Education ◽  
Best Practices ◽  
United Arab Emirates ◽  
Lessons Learned ◽  
Educational Systems ◽  
Student Responses ◽  
E Learning ◽  
Rapid Transition ◽  
Learning Platforms ◽  
The Impact

Educational systems across the globe were disrupted by the COVID-19 pandemic, and faculty, staff, and students had to rapidly transition to e-learning platforms. These groups had little preparation to cope with the challenges of this newly adopted system. However, as we begin to emerge from the COVID-19 era, efforts are being made to assess the impact of this transition and develop a framework of best practices to help educators prepare for possible future disruptions. This commentary aims to discuss some of the challenges associated with the rapid transition to the new academic environment, including the modes of instruction employed, technical obstacles encountered, student responses to change and efforts made to evaluate didactic and practical aspects of the curriculum in the contexts of premedical and medical education, at the newly established College of Medicine at Khalifa University of Science and Technology in the United Arab Emirates.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Transformation of the Tanzania Medical Store Department through Global Fund support: lessons learned from the field

2020 ◽  
Author(s):  
Patrick Githendu ◽  
Linden Morrison ◽  
Rosemary Silaa ◽  
Sai Pothapregada ◽  
Sarah Asiimwe ◽  
...  
Keyword(s):  
Global Fund ◽  
Interrupted Time Series ◽  
Lessons Learned ◽  
Interrupted Time Series Analysis ◽  
Monthly Basis ◽  
Quantitative And Qualitative Research ◽  
Before And After ◽  
Multi Stakeholder ◽  
Health Commodities ◽  
The Impact

AbstractBackgroundThe Tanzania government sought support from The Global Fund to Fight AIDs, Tuberculosis and Malaria (Global Fund) to reform its Medical Stores Department (MSD), with the aim of improving performance. Our study aimed to assess the impact of the reforms and document the lessons learned.MethodsWe applied quantitative and qualitative research methods to assess the impact of the reforms. The quantitative part entailed a review of operational and financial data covering the period before and after the implementation of the reforms. We applied interrupted time series analysis to determine the change in average availability of essential health commodities at health zones. Qualitative data was collected through 41 key informant interviews. Participants were identified through stakeholder mapping, purposive and snowballing sampling techniques, and responses were analyzed through thematic content analysis.ResultsAvailability of essential health commodities increased significantly by 12.6% (95%CI, 9.6-15.6), after the reforms and continued to increase on a monthly basis by 0.2% (95%CI, 0.0-0.3) relative to the preintervention trend. Sales increased by 56.6% while the cost of goods sold increased by 88.6% between 2014/15 and 2017/18. Surplus income increased by 56.4% between 2014/15 and 2017/18, with reductions in rent and fuel expenditure. There was consensus among participants that the reforms, were instrumental in improving performance of MSD.ConclusionMany positive results were realized through the reforms at MSD. However, despite the progress, there were risks such as the increasing government receivable that could jeopardize the gains. Multi-stakeholder efforts are necessary, to sustain the progress and expand public health.

Sign in / Sign up

Export Citation Format

Share Document