Contract Clinical Research: A Rapidly Changing Marketplace

1996 ◽  
Vol 9 (6) ◽  
pp. 406-415
Author(s):  
Daniel Krichbaum ◽  
Alan Rosenthal
Keyword(s):  
Clinical Research ◽  
The United States ◽  
Considerable Change ◽  
Business Strategies ◽  
Quality Data ◽  
Scientific Integrity ◽  
Research Activities ◽  
Large Numbers ◽  
Research Organizations

Drug development in the United States has undergone considerable change over the past decade. The outsourcing of clinical research activities to Contract Research Organizations (CROs) continues to escalate in an attempt to speed drugs to market faster. The increasing use of business strategies at the investigational site level has fostered the emergence of specialty networks and Site Management Organizations (SMOs). SMOs offer pharmaceutical and biotechnology sponsors the ability to work with a tightly managed network of experienced professional multispecialty research centers that can enroll large numbers of patients and provide high quality data. While these organizations have fundamentally changed the way drugs are developed, they have also contributed to an acceleration of the process and an improvement in the scientific integrity and quality of the data.

scholarly journals Improving Specimen Labelling and Data Collection in Bio-science Research using Mobile and Web Applications

2020 ◽  
Vol 10 (1) ◽  
pp. 1-16
Author(s):  
Isaac Nyabisa Oteyo ◽  
Mary Esther Muyoka Toili
Keyword(s):  
Data Collection ◽  
Web Applications ◽  
Data Entry ◽  
Science Research ◽  
Quality Data ◽  
Quality Of Data ◽  
Data Entry Form ◽  
Research Activities ◽  
Daunting Task

AbstractResearchers in bio-sciences are increasingly harnessing technology to improve processes that were traditionally pegged on pen-and-paper and highly manual. The pen-and-paper approach is used mainly to record and capture data from experiment sites. This method is typically slow and prone to errors. Also, bio-science research activities are often undertaken in remote and distributed locations. Timeliness and quality of data collected are essential. The manual method is slow to collect quality data and relay it in a timely manner. Capturing data manually and relaying it in real time is a daunting task. The data collected has to be associated to respective specimens (objects or plants). In this paper, we seek to improve specimen labelling and data collection guided by the following questions; (1) How can data collection in bio-science research be improved? (2) How can specimen labelling be improved in bio-science research activities? We present WebLog, an application that we prototyped to aid researchers generate specimen labels and collect data from experiment sites. We use the application to convert the object (specimen) identifiers into quick response (QR) codes and use them to label the specimens. Once a specimen label is successfully scanned, the application automatically invokes the data entry form. The collected data is immediately sent to the server in electronic form for analysis.

scholarly journals Barriers to symptom management care pathway implementation in pediatric Cancer

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

scholarly journals REVISTAS ACADÊMICAS DE EXTENSÃO UNIVERSITÁRIA NO BRASIL

2014 ◽  
Vol 5 (2) ◽  
pp. 69-75
Author(s):  
Geraldo Ceni Coelho
Keyword(s):  
The United States ◽  
American Continent ◽  
Electronic Edition ◽  
Research Activities ◽  
Palabras Clave ◽  
Previous Decade ◽  
Distribución Geográfica ◽  
The 1960S

A publicação de revistas multidisciplinares dedicadas à extensão universitária é um fenômeno notável em vários países da América. Os periódicos mais antigos desta natureza são dos anos 1960, nos Estados Unidos, quando surgiu o Journal of Extension. No Brasil, foram detectadas 29 revistas multidisciplinares dedicadas à extensão universitária ainda em atividade, e as mais antigas entre elas foram iniciadas nos anos 1990. Porém, outras revistas com perfil editorial semelhantes foram detectadas e, embora descontinuadas, iniciaram na década anterior. A região Sul apresenta 12 (41%) das revistas em atividade, e a região sudeste nove (31%), o que indica uma distribuição geográfica desigual no país. O número de revistas multidisciplinares dedicadas à extensão universitária cresceu muito, praticamente triplicando nos últimos dez anos. Nas revistas brasileiras, há uma forte predominância de trabalhos publicados cujo conteúdo se refere a relatos de experiências de projetos de extensão. Poucos são os trabalhos oriundos da pesquisa na extensão universitária, ou em temas que possam subsidiá-la. A qualidade editorial da maioria das revistas apresenta aspectos a serem aperfeiçoados, destacando-se, o corpo editorial e a periodicidade. Palavras-chave: edição eletrônica, extensão universitária, periódicos.     Academic Journals on University Extension in Brazil Abstract: The publication of multidisciplinary journals dedicated to university extension is a remarkable phenomenon in several countries in the American continent. The oldest publications of this nature date back to the 1960s in the United States, when the first issue of the Journal of Extension was released. In Brazil, 29 multidisciplinary active journals dedicated to university extension can be detected, being the oldest among them released in the 1990s. Other journals with similar editorial profile were detected in the previous decade, however, these publications were later  discontinued. In the Southern region of Brazil there are 12 (41%) of the extension journals in activity, and in the Southeast region there are nine (31%), indicating an uneven geographical distribution in the country. The number of multidisciplinary journals dedicated to university extension has almost tripled over the last ten years. In the Brazilian journals, there is a strong predominance of publications whose content regarding experience reports of extension projects. A few are derived from research activities in university extension projects, or on topics that may relate to it. The editorial quality of most journals shows areas to be potentially improved, especially regarding the editorial board and the periodicity. Keywords: electronic edition, university extension, periodicals.   Las revistas académicas de extensión universitaria en Brasil Resumen: La publicación de revistas multidisciplinares dedicadas a la extensión universitaria es un fenómeno notable en muchos países de América. Las revistas más antiguas de esta naturaleza son de los años 60, en los Estados Unidos, cuando surgió el Journal of Extension. En Brasil, se detectaron 29 revistas multidisciplinares dedicadas a la extensión universitaria y que siguen activas, siendo las primeras iniciadas en la década de 1990. Sin embargo, se verificaron otras revistas con perfil editorial similar y, aunque discontinuadas, se iniciaron en la década anterior. La región sur de Brasil tiene 12 (41%) de las revistas de extensión en actividad, y la región sudeste tiene nueve (31%), lo que indica una distribución geográfica desigual en el país. El número de revistas multidisciplinares dedicadas a la extensión universitaria ha crecido hasta casi el triple en los últimos diez años. En las revistas brasileñas, hay un fuerte predominio de artículos cuyo contenido se refiere a informes de experiencias de proyectos de extensión. Son pocos los trabajos son derivados de la investigación en la extensión universitaria, o en temas que puedan subsidiarla. La calidad editorial de la mayoría de las revistas muestra áreas de mejora potencial, destacando el consejo editorial y la periodicidad. Palabras-clave: edición electrónica, extensión universitaria, publicaciones periódicas.

The New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium: Organization, Objectives, and Activities

1998 ◽  
Vol 5 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Stuart A. Grossman ◽  
Joy D. Fisher ◽  
Steven Piantadosi ◽  
Henry Brem
Keyword(s):  
Brain Tumor ◽  
Brain Tumors ◽  
Clinical Research ◽  
Tumor Therapy ◽  
Laboratory Research ◽  
Primary Brain Tumors ◽  
Large Numbers ◽  
Neuro Imaging ◽  
Important Drug

Background: Despite advances in neuro-imaging, neurosurgery, radiation therapy, and chemotherapy, limited progress has been made in the treatment of patients with high-grade astrocytomas. The National Cancer Institute has attempted to speed advances in this field by funding CNS consortia to conduct innovative clinical trials in this patient population since 1994. Methods: The NABTT CNS Consortium is composed of a consortium headquarters and nine member institutions with outstanding multidisciplinary expertise, clinical and laboratory research capabilities, and access to large numbers of patients with brain tumors. Results: The objectives of the NABTT Consortium are to improve the therapeutic outcome for adults with primary brain tumors, to conduct basic science and clinical research, and to improve the care and quality of life of adults with primary brain tumors. NABTT's clinical studies have discovered important drug interactions between anticonvulsant and antineoplastic agents, defined the activity of paclitaxel and 9-aminocamptothecin in glioblastoma multiforme, tested a novel dose escalation strategy for brain tumor trials, and established new protocol “classes” to expedite and standardize clinical research in this field. Conclusions: Significant progress in the care of patients with primary brain tumors is likely to result from the highly focused and multidisciplinary efforts of the NIH-funded CNS consortia.

scholarly journals The number, scope and geographic distribution of clinical researchers in Canada

2008 ◽  
Vol 31 (5) ◽  
pp. 222 ◽  
Author(s):  
Malathi Raghavan ◽  
J Dean Sandham
Keyword(s):  
Clinical Research ◽  
Geographic Distribution ◽  
Basic Research ◽  
Research Capacity ◽  
The United States ◽  
Research Grants ◽  
Principal Investigators ◽  
Randomized Controlled ◽  
Research Activities ◽  
The Ideal

Purpose: Despite international concerns about declining numbers of clinical researchers, the number of clinical researchers in Canada remains undocumented. Methods: The number and geographic distribution of clinical researchers in Canada and the scope of their research activities were estimated using, as an indicator, the data on clinical research projects funded by the Canadian Institutes for Health Research (CIHR). Results: Between fiscal years 1999-00 and 2006-07, 1,041 individual researchers—approximately 130 per year—were principal investigators (PIs) on clinical research grants. One hundred and 26 researchers received salary awards; 449 supervisors oversaw the clinical research activities of 230 fellows and 223 students with trainee awards. An additional 2,305 individuals served only as co-investigators on grants. Most (863 [83%]) PIs received funding for operating grants; 196 (19%) PIs received funding for randomized controlled trials. The institute of neurosciences, mental health and addiction funded the highest number of researchers (187 [18%] PIs, 40 [17%] fellows, and 73 [33%] students). Among provinces, Quebec led the nation with the highest number (45) of PIs per million population. Ontario had the highest number of clinical research fellows (10 per million population) while Quebec and Saskatchewan each hosted more students (11 per million). Conclusion: The number of Canadian investigators with funding for clinical research from CIHR was low. Although the ideal ratio of clinical to basic research capacity is not known, the possibility that the gap between laboratory-based research and clinical research is larger in Canada than in the United States is discussed.

Characterizing the Ex-Vivo Mechanical Properties and Corresponding In-Vivo Impact of Synthetic Urogynecological Meshes

2011 ◽  
Author(s):  
Andrew J. Feola ◽  
Pamela Moalli ◽  
Suzan Stein ◽  
Zegbeh Jallah ◽  
Jon Shepherd ◽  
...  
Keyword(s):  
Ex Vivo ◽  
Abdominal Wall Hernia ◽  
The United States ◽  
Pelvic Organ ◽  
Synthetic Mesh ◽  
Scientific Data ◽  
Societal Costs ◽  
Large Numbers

Pelvic organ prolapse and urinary incontinence are common conditions in women that significantly diminish quality of life. With roughly 225,000–280,000 women requiring surgery each year in the United States alone, societal costs are over a billion dollars annually (1). While repair with synthetic mesh products have become the surgical treatment of choice, these meshes require very little premarket testing because they are based on previously approved abdominal wall hernia products (510K devices). Thus, there is little scientific data on the efficacy of meshes for gynecological surgery. Moreover, with the recent FDA warning citing large numbers of unreported complications in patients, there is growing concern about the use of gynaecological mesh, especially for transvaginal placement (2). Thus, there is a need to examine the ex-vivo properties of these meshes and relate them to their in-vivo function and outcomes for gynecological applications.

Disparities among GU cancer patients referred to palliative care.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 114-114
Author(s):  
Saad Omar Atiq ◽  
James Helzberg ◽  
Nathan Hirshman ◽  
Zainab Atiq ◽  
Daniel J. George ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Palliative Care ◽  
Cancer Patients ◽  
The United States ◽  
Quality Data ◽  
Black Patients ◽  
Quality Of Life Scale

114 Background: The role of palliative care in genitourinary (GU) malignancies has been understudied. Despite representing nearly 25% of new cancer diagnoses, with over 350,000 new cases diagnosed each year, few GU patients have been included in palliative care trials under the theory that symptoms are less severe for GU patients than other solid tumors. Early involvement of palliative care services improves the patient care experience, decreases healthcare utilization, is associated with survival benefit, and results in improved quality of life and mood. To further elucidate the role of palliative care in oncology, we must study its utility in subsets of malignancy like GU cancers, as needs for patients may differ by malignancy type. Methods: A retrospective cross-sectional analysis of initial outpatient palliative care visits was performed using data from the Quality Data Collection Tool for Palliative Care (QDACT-PC) database from 2014-2020. QDACT-PC is a web-based, point-of-care registry used by physicians across the United States to track quality metrics associated with patient consultations. Data was collected and analyzed from patients' initial visits including pain scale, dyspnea scale, feeling of well-being (Quality of Life scale), fatigue scale, constipation scale, palliative performance status (PPS), and preference for resuscitation status. Scales for these variables were 0-10, with the exception of a scale of 0-100% for PPS. Patients less than 18 and greater than 90 years old were excluded. Chi-squared and Student’s t-tests were used to compare categorical and continuous variables, respectively. Results: 824 GU oncology patients (358 prostate cancer patients, 251 bladder cancer patients, 215 renal cancer patients) were compared against all patients with non-GU cancers (7807 patients). Notably, non-GU patients reported higher rates of fatigue (4.50 vs. 4.13, p = 0.0013) and dyspnea (1.63 vs. 1.11, p < 0.0001) than GU patients. GU malignancies had non-significant higher reported pain (3.73 vs. 3.60, p = 0.3109) and constipation (1.96 vs. 1.83, p = 0.2319) and lower PPS (4.95 vs. 4.96, p = 0.8555) and QOL (4.55 vs. 4.73, p = 0.0962). Preference for resuscitation at the time of referral was similar between the two groups (p = 0.6339). Only 16.5% of prostate cancer patients referred to palliative care in this database were black, while black patients are often estimated to represent 30% of new prostate cancer diagnoses each year. Conclusions: GU patients represent 9.54% of cancer patients seen by palliative care while the incidence is nearly 25%. Traditionally, GU patients were underrepresented in palliative care trials under the notion of less severe symptoms; however, this study demonstrates that GU patients have as severe symptoms as non-GU patients, highlighting a disparity in referral to palliative care. Furthermore, the lack of representation of black patients suggests potential inequity and warrants further investigation.

scholarly journals Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer

2020 ◽  
Author(s):  
L Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background: To describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree.Results: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P=0.003). Conclusions: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic was not a major barrier to clinical research activities in pediatric oncology.Clinical Trial Registration: NCT04614662

scholarly journals Mortality of Centenarians in the United States

2020 ◽  
pp. 57-66
Author(s):  
Bert Kestenbaum
Keyword(s):  
United States ◽  
Mathematical Model ◽  
Main Part ◽  
The United States ◽  
The Other ◽  
Quality Data ◽  
Critical Examination ◽  
Death Rates ◽  
Historical Series

AbstractIn the United States, we have not yet reached the point where unedited numerators and denominators for death rates or probabilities are of satisfactory quality for measuring the mortality of centenarians. Ignoring this reality can lead to an estimation of extreme-age mortality which is unacceptable, as is the case for the NCHS’ Data Brief no. 233. Even the better-quality data from the Medicare health insurance program are beset by problems of (1) unreported or unrecorded deaths and (2) date of birth misstatement. On the other hand, there are steps that can be taken to improve the quality of the underlying data, so that the threshold age at which a mathematical model replaces actual data and closes out the life table is pushed further out.The paper begins with a description of the unacceptable results published in Data Brief no. 233 and a critical examination of their sources. The main part of the paper presents some steps to improve the quality of the Medicare enrollment counts. By rearranging the historical series on Medicare enrollment by cohort, it is possible to eliminate unreported and unrecorded deaths. A simple model is then introduced to deal with date of birth misstatement.

scholarly journals Impact of COVID-19 on clinical trials and clinical research: A systematic review

2020 ◽  
Vol 10 (3) ◽  
pp. 878-887
Author(s):  
Brijesh Sathian ◽  
Mohammad Asim ◽  
Indrajit Banerjee ◽  
Ana Beatriz Pizarro ◽  
Bedanta Roy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
The United States ◽  
Sudden Onset ◽  
World Health ◽  
Research Activities ◽  
The World ◽  
The Impact

Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing  a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19” AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

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