scholarly journals Clinical trials in the pandemic age: What is fit for purpose?

2020 ◽  
Vol 4 ◽  
pp. 58 ◽  
Author(s):  
Dan Hartman ◽  
Penny Heaton ◽  
Nick Cammack ◽  
Ian Hudson ◽  
Shawn Dolley ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Vulnerable Groups ◽  
Equitable Access ◽  
Fit For Purpose ◽  
Gates Foundation ◽  
And Migration ◽  
Scientific Questions

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.

scholarly journals Public Health Research Ethics and Clinical Research Ethics. How we differentiate?

2019 ◽  
Vol 9 (2) ◽  
pp. 22-25
Author(s):  
Zoheb Rafique
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Research ◽  
Research Ethics ◽  
Health Research ◽  
Public Health Research

This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly focused on the protection of individual participants and some of the research norms and accepted principles may be challenging when applying in some of the research contexts.  

scholarly journals The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

2022 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Personal Information ◽  
Human Subjects ◽  
Legal Framework ◽  
Current Status ◽  
Biological Research ◽  
Marketing Approval ◽  
Ethical Guidelines

In Japan, a law called the Clinical Trials Act went into being effective on April 1, 2018, and clinical research on human subjects conducted in Japan has been undergone major changes. Those other than clinical trials for marketing approval of drugs or medical devices are broadly classified into “specific clinical trials” and others, and regulations have been tightened for each. As a result, clinical interventional study was drastically reduced, and observational clinical study increased. For the observational clinical study, the two previous ethical guidelines were merged into the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” which was enacted in March 2021. The observational clinical study is now subjected to these ethical guidelines. In addition, changes are planned for the Act on the Protection of Personal Information, which greatly affects data collection in clinical research. Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework. Adapting to these changes is not an easy task, as it requires increased financial and human resources for all stakeholders.

Journey across epidemiology’s third variables: an anesthesiologist’s guide for successfully navigating confounding, mediation, and effect modification

2021 ◽  
pp. rapm-2020-101984 ◽  
Author(s):  
Joshua Levy ◽  
Rebecca Lebeaux ◽  
Brock Christensen ◽  
Tor Tosteson ◽  
Yvon Bryan
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Patient Outcomes ◽  
Clinical Studies ◽  
Effect Modification ◽  
Medical Interventions ◽  
Patient Health ◽  
Independent Variable ◽  
The Relationship

Observational clinical research studies aim to assess which exposures (treatments or other factors; independent variable) affect patient outcomes (dependent variable). These exposures include medical interventions in situations where clinical trials are not possible or prior to their conduct and completion. However, the assessment of the relationship between exposures and outcomes is not straightforward, as other variables may need to be considered prior to reaching valid conclusions. Here, we present three hypothetical scenarios in regional anesthesia to review the epidemiological concepts of confounding, mediation, and effect modification. Understanding these concepts is critical for assessing the design, analysis, and interpretation of clinical studies. These terms may be confusing to anesthesiologists and researchers alike, where such confusion could affect the conclusions of a clinical study, mislead the target audience, and ultimately impact patient health.

scholarly journals Impact of COVID-19 on Public Research Recruitment

2020 ◽  
Author(s):  
Yichuan Grace Hsieh ◽  
Holly Parker ◽  
Greg Estey ◽  
Stephen Lorenz ◽  
Mark Wylie ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Care ◽  
Public Research ◽  
Research Recruitment ◽  
Preliminary Results ◽  
Volunteer Recruitment

The coronavirus disease 2019 (COVID-19) pandemic created a major challenge for clinical trials recruitment as early attention was focused on matters of public health and clinical care, and research--outside of COVID-19-- essentially shut down. Rally with Partners (rally.partners.org), an Internet-based portal for clinical research volunteer recruitment, continued to support studies that continued their recruitment during this period and additionally, implemented several measures to support COVID-19 research. In this paper, we summarize our experiences and preliminary results.

Direct impact of clinical research in metastatic renal cell carcinoma (mRCC): A cost-effectiveness analysis of patient care outcomes and cost savings in a real-life scenario of a large public university hospital in Spain.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 637-637
Author(s):  
Silvia Garcia-Garro ◽  
Pablo Gajate ◽  
Esther Gómez-de-Salazar ◽  
Teresa Alonso Gordoa ◽  
Miguel Angel Rodriguez-Sagrado ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Research ◽  
Public Health System ◽  
Real Life ◽  
Cost Savings ◽  
University Hospital ◽  
Direct Impact

637 Background: Public health sustainability is a major concern worldwide. Clinical research is considered to leverage patient care outcome but also can lead costs savings and, subsequently, to maintain public health system. Thus, we analyzed the direct impact of clinical research in terms of improvement in clinical outcomes and costs related to research in patients with mRCC in real-life setting. Methods: We retrospectively collected data related to overall survival (OS) and direct health care costs from all mRCC patients who were treated with oral anti-tumour medication and followed at the Medical Oncology Department of Ramón y Cajal University Hospital in Madrid, between January 2010 and February 2017. A statistical analysis comparing the outcomes of patients included in clinical trials versus those not included was conducted. Results: In the study period, 65 patients were newly diagnosed with mRCC and received treatment. Those patients included in clinical trials showed higher median OS (91 vs. 29 months. HR 0.389; 95% CI: 0.150: 1.000; p=0.04). Median direct cost per mRCC patient in ‘real-life’ was €67,376. Median cost for a patient enrolled in at least one clinical trial was €53,673 vs. €63,834 for those who were never recruited for a trial. Participation in clinical trials contributed to a decrease in total health expenditure by 9.02% (€362,367), mainly due to reduction in the cost of medications and diagnostic tests (91.46% vs. 8.54%, respectively). Furthermore, clinical trial participants have required less number of hospitalizations (0.08 vs. 1.75) and emergency visits (0.39 vs. 3.2) per patient. Conclusions: Under the public health system perspective, participation in clinical trials is related to an improvement in overall survival as well as direct and indirect cost savings in mRCC patients.

scholarly journals Cardiovascular clinical trials in the era of a pandemic

2020 ◽  
Vol 9 (20) ◽  
Author(s):  
George CM Siontis ◽  
Romy Sweda ◽  
Stephan Windecker
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Data Collection ◽  
Clinical Research ◽  
Outcome Assessment ◽  
Incomplete Data ◽  
Research Funding ◽  
Trial Participants

Abstract COVID‐19 has reached pandemic levels in March 2020 and impacted public health with unpredictable consequences. 1, 2 The conduct of clinical research in areas unrelated to COVID‐19 has been disrupted and will be further affected. Researchers, trial participants and study personnel have to overcome challenges to sustain proper and safe conduct of clinical trials (i.e. logistical challenges, lower enrollment than expected, difficulties in follow‐up and outcome assessment/adjudication, incomplete data collection, research funding prolongation).

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

scholarly journals Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

2021 ◽  
Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Social Care ◽  
Research Nurse
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