Clinical Research and Regulatory Affairs

2021 ◽  
pp. 160-184
Author(s):  
Maria Teresa Herdeiro ◽  
Nélia Gouveia ◽  
Fátima Roque
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Devices ◽  
Clinical Studies ◽  
Market Access ◽  
Systems Of Care ◽  
Therapeutic Interventions ◽  
Knowledge And Skills ◽  
Regulatory Affairs ◽  
Before And After

Clinical research is a large umbrella, and it mainly includes the implementation of clinical studies/trials. This field is crucial to assess the value of new developments in healthcare, be it new therapeutic interventions, medical devices, or systems of care. In order to protect human rights, the implementation of clinical trials is complex and extremely costly. In this context, medicines and medical devices are strongly regulated products before and after the market authorization. So during their training, pharmacists must develop skills in the area of regulatory affairs, design and methodology of clinical trials, and other clinical studies, as well as in the management of clinical projects to be prepared for the challenges of the clinical research and market access processes. With that purpose, knowledge and skills for clinical research should be developed in association with regulatory affairs.

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

scholarly journals Remdesivir: Critical Clinical Appraisal for COVID 19 Treatment

Drug Research ◽  
2020 ◽  
Author(s):  
Saptarshi Chatterjee
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Promising Result ◽  
Drug Repurposing ◽  
In Vitro Studies ◽  
Therapeutic Molecules ◽  
Regulatory Aspect ◽  
Plausible Mechanism

AbstractRemdesivir is presently been considered as ‘molecule of hope’ to curb the menace of COVID19. Non-availability of any USFDA approved drug has led to several attempt of drug-repurposing and development of new therapeutic molecules. However, Remdesivir has been found to be effective against a broad range of virus including SARS, MERS and COVID 19 through in-vitro studies. Several clinical research attempt are presently being conducted showing promising result yet not conclusive. This review summarized all such clinical trials to critically appraise the usage of Remdesivir against COVID 19 along with the publications related to the results of the clinical studies. The present regulatory aspect i. e. Emergency Use Authorization (EYA) and information of molecule and plausible mechanism is also dealt.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

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.

The Potential of Brain-Specific Blood Biomarkers for TBI Patient Management, Diagnosis, and Clinical Research

Neurotrauma ◽  
2018 ◽  
pp. 189-210
Author(s):  
Olena Y. Glushakova ◽  
Alex B. Valadka ◽  
Ronald L. Hayes ◽  
Alexander V. Glushakov
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Patient Management ◽  
Therapeutic Interventions ◽  
Disease Monitoring ◽  
Management Tools ◽  
Secondary Insults ◽  
Short And Long Term ◽  
Type Of Injury

Rapid and continuous monitoring and analysis of biomarkers present in blood after TBI could serve as a reliable and useful tool to distinguish type of injury, predict secondary insults, and evaluate the efficacy of therapeutic interventions. The use of biomarkers in combination with current disease monitoring and management tools could improve management of TBI patients and improve clinical trials for TBI drug development. In this chapter, the authors discuss current clinical studies on brain-specific neuronal and glial biomarkers of TBI and their association with short- and long-term TBI outcome and secondary insults, as well the ability of biomarkers to distinguish type of injury and correlation with treatment.

scholarly journals The Critical Role of the Clinical Research Coordinator for Clinical Trials: A Survey in Oncology

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000015 ◽  
Author(s):  
Margherita Cinefra ◽  
Celeste Cagnazzo ◽  
Laura McMahon ◽  
Francesca Arizio ◽  
Sara Campora ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Research Team ◽  
Critical Role ◽  
Strong Support ◽  
Web Survey ◽  
Clinical Research Coordinator ◽  
Research Activities ◽  
Research Coordinator

Introduction Access to innovative medicine requires proper evidence from clinical trials with the growing demand of qualified and experienced personnel. The clinical research coordinator (CRC) plays an important role in the conduction of research activities and provides a strong support to the research team. In Italy, this role is not recognized at any institutional level and its professional outline is still indefinite. Several national associations (Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager) are committed to promoting the enhancement and recognition of the professional status of CRCs, underlining their role as fundamental. Methods A web survey, proposed by the AIOM CRC Working Group, was submitted to 319 Italian oncology sites with items focusing on the organization of sites, the research activities, the staff composition, and the presence of coordinators and the multidisciplinary team. Results A total of 115 sites (35.9%) responded to the web survey. Clinical studies were carried out at 88.7% of the investigated sites, and coordinators were on staff at 75.5% of the active investigational sites. Interestingly, there was a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities is believed to be essential for trial conduct in 82.4% of cases. Most sites retain that the quality of clinical research has absolutely improved (83.3%) after the implementation of a coordinator as member of the team. Conclusions Given the constant growth of the number of clinical trials performed at Italian oncology sites, the CRC proves to be an essential component of the research team. However, there is an urgent need to institute the professional role alongside the need to standardize the training of coordinators to establish the minimum requirements enhanced by qualifying courses.

Sex differences in experimental studies of depression: How can clinical research benefit?

2017 ◽  
Vol 41 (S1) ◽  
pp. s905-s905
Author(s):  
N. Kokras ◽  
C. Dalla
Keyword(s):  
Clinical Trials ◽  
Sex Differences ◽  
Clinical Research ◽  
Clinical Studies ◽  
Rating Scales ◽  
Experimental Studies ◽  
Preclinical Studies ◽  
Antidepressant Response ◽  
Preclinical Research ◽  
Behavioral Indices

IntroductionSex differences in depression and antidepressant response in humans are modestly studied and results are controversial. Experimental studies using animal models may provide insights that could be useful in clinical trials.ObjectivesThe objective is to summarize findings from preclinical studies on sex differences and suggest how such preclinical research might be of use in clinical research.AimsSpecifically it is aimed to summarize evidence for both sexes in relation to the phenotype of depression, its endophenotype and the antidepressant response.MethodsA selection of experimental studies on sex differences in stress and antidepressant response was performed and their findings were linked to potential confounders or methodological issues that might obscure the results of clinical trials.ResultsIn preclinical studies, behavioral indices and models are adjusted for both sexes, in order to properly identify sex differences in primary outcomes. This is not routinely happening in clinical studies when using depression rating scales, which is the analogue of behavioral indices. Moreover, preclinical studies show sex differences at the baseline behavioral response and underlying mechanisms that often converge following antidepressant treatment. This is also a neglected issue in human studies. Finally, preclinical research suggests that when researching on potential biomarkers for depression and antidepressant response sex should be an important factor to consider.ConclusionsCautious exploitation of findings on sex differences from preclinical research could improve the design and quality of clinical studies for disease biomarkers and novel antidepressants and facilitate the drug development in a gender aware manner.Disclosure of interestNK has received honoraria and travel support from Janssen-Cilag, Lundbeck, Sanofi-Aventis, Medochemie Generics and Elpen S.A. CD has received honoraria from Janssen-Cilag and travel support from Boehringer Ingelheim. None of those is relevant to this study.

scholarly journals Registration, Publication, and Outcome Reporting among Pivotal Clinical Trials that Supported FDA Approval of High-Risk Medical Devices Before and After FDAAA

2021 ◽  
Author(s):  
Matthew J. Swanson ◽  
James L. Johnston ◽  
Joseph S. Ross
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Medical Devices ◽  
Primary Efficacy ◽  
Cardiovascular Devices ◽  
Primary Efficacy Outcome ◽  
Outcome Reporting ◽  
Fda Approval ◽  
Efficacy Outcome ◽  
Before And After

ABSTRACTBackgroundSelective registration, publication, and outcome reporting of clinical trials distorts the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of FDA-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (Class III) medical devices before and after the U.S. Food and Drug Administration (FDA) Amendment Act (FDAAA) was enacted in 2007.MethodsUsing publicly available data from ClinicalTrials.gov, FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the PMA primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative).ResultsBetween 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 115 (85%) vs 7 of 24 (29%); p < 0.001) on ClinicalTrials.gov, and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44).ConclusionsFDAAA was associated with increased registration, results reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.

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