scholarly journals Drug Tragedies: The Dark Epoch of Clinical Prosecutions That Made Manhood Mysterious Fatalities

2021 ◽  
pp. 10-15
Author(s):  
Hindustan Abdul Ahad ◽  
Chinthaginjala Haranath ◽  
Akkinepalli Anoohya ◽  
Janaki Tejaswini ◽  
Kuruva Veeresh
Keyword(s):  
Clinical Trials ◽  
Data Storage ◽  
Unethical Behavior ◽  
Safety Measures ◽  
Permanent Damage ◽  
Regulatory Authorities ◽  
Lack Of Knowledge

Today, the highest importance is given to the patient’s safety and ethics during the clinical trials. The regulatory authorities take each and every aspect into consideration to protect the safety, rights and consent of the subjects during the phases of clinical trials. Besides the applications like IND, NDA further strengthen these above parameters. However, all these safety measures are a result of our previous experiences in history such as Thalidomide tragedy, Sulphanilamide disaster, Nazi’s experiments, Tuskegee syphilis studies. All these disasters are due to unethical behavior, lack of knowledge on safety, no keen idea on pharmacovigilance, no proper data storage, inexperience etc., which led to many disasters resulting in the deaths of many innocent lives and some permanent damage to the persons consuming these drugs either by force or voluntarily. This article mainly focuses on the drug tragedies and drugs introvert from the market, due to the lack of knowledge on clinical trials.

scholarly journals National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nicola J. Rose ◽  
Paul Stickings ◽  
Silke Schepelmann ◽  
Marc J. A. Bailey ◽  
Chris Burns
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Regulatory Approval ◽  
Safety Measures ◽  
Discovery Research ◽  
Innovative Products ◽  
The Uk ◽  
Vaccine Availability ◽  
And Control

AbstractThe past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

scholarly journals Obstacles in conducting clinical trials in the Saudi Arabia

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan
Keyword(s):  
Clinical Trials ◽  
Saudi Arabia ◽  
Clinical Practice ◽  
Clinical Research ◽  
Strategic Plan ◽  
Good Clinical Practice ◽  
European Countries ◽  
Regulatory Authorities ◽  
Research Institution

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>

Efficacy and Safety of Lamotrigine in Pediatric Patients

2002 ◽  
Vol 17 (2_suppl) ◽  
pp. 2S34-2S42 ◽  
Author(s):  
John Messenheimer
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Regulatory Authorities ◽  
Treatment Of Epilepsy

Accumulating data suggest that lamotrigine, which has been available for adult use in epilepsy for more than a decade in clinical practice, also confers effective, well-tolerated control of a range of childhood epilepsies. Lamotrigine is currently approved for the treatment of epilepsy by regulatory authorities in 93 countries, more than 70 of which have approved its use in pediatric patients on the basis of data from well-controlled clinical trials. The controlled clinical trials data have been supplemented over the years by clinical practice data, primarily from uncontrolled studies, confirming or demonstrating additional efficacy of lamotrigine for a range of seizure types. This article reviews the data from well-controlled clinical trials and studies conducted in clinical practice to present an updated perspective on the efficacy and safety of lamotrigine in pediatric patients. (J Child Neurol 2002;17:2S34—2S42).

scholarly journals Regulatory authorities and orthopaedic clinical trials on expanded mesenchymal stem cells

2014 ◽  
Vol 38 (9) ◽  
pp. 1803-1809 ◽  
Author(s):  
Enrique Gómez-Barrena ◽  
Cristina Avendaño Solá ◽  
Carmen Painatescu Bunu
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Mesenchymal Stem Cells ◽  
Regulatory Authorities ◽  
Expanded Mesenchymal Stem Cells

scholarly journals Vaccinology in the era of high-throughput biology

2015 ◽  
Vol 370 (1671) ◽  
pp. 20140146 ◽  
Author(s):  
Helder I. Nakaya ◽  
Bali Pulendran
Keyword(s):  
Clinical Trials ◽  
Immune Responses ◽  
High Throughput ◽  
Protective Immunity ◽  
Molecular Signatures ◽  
Correlates Of Protection ◽  
Recent Advances ◽  
Induced Immunity ◽  
Experimental Challenge ◽  
Lack Of Knowledge

Vaccination has been tremendously successful saving lives and preventing infections. However, the development of vaccines against global pandemics such as HIV, malaria and tuberculosis has been obstructed by several challenges. A major challenge is the lack of knowledge about the correlates and mechanisms of protective immunity. Recent advances in the application of systems biological approaches to analyse immune responses to vaccination in humans are beginning to yield new insights about mechanisms of vaccine immunity, and to define molecular signatures, induced rapidly after vaccination, that correlate with and predict vaccine induced immunity. Here, we review these advances and discuss the potential of this systems vaccinology approach in defining novel correlates of protection in clinical trials, and in infection-induced ‘experimental challenge models' in humans.

scholarly journals Japanese pharmaceutical and regulatory environment

2002 ◽  
Vol 4 (4) ◽  
pp. 470-474 ◽  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Clinical Data ◽  
Regulatory Authority ◽  
Regulatory Environment ◽  
International Guidelines ◽  
Regulatory Authorities ◽  
Regulatory Changes ◽  
The World ◽  
Considerable Impact

Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.

Turning the light on inattention

2014 ◽  
Vol 54 (2) ◽  
pp. 507
Author(s):  
Cristian Sylvestre
Keyword(s):  
Decision Making ◽  
Scientific Research ◽  
External Factors ◽  
Personal Safety ◽  
Regulatory Authorities ◽  
The Past ◽  
Decision Making Framework ◽  
Traditional Approaches ◽  
Do So ◽  
Lack Of Knowledge

In the past few years, the number of articles and alerts (including some from regulatory authorities) attributing incidents to inattention and/or complacency has increased. Why do so many people still get hurt even though we do so much to try to keep them safe? Most incidents do not happen because the person was not competent, did not know about the hazard or what controls were required. Incidents typically happen because the person was not paying attention at the time; as a result, they get involved with a hazard. Traditional approaches to rectify this focus on: retraining, in case the problem was a lack of knowledge; reviewing the decision making framework, in case it was a bad decision or the wrong choice; and/or, disciplining, in case it was a deliberate act. The problem of inattention, however, cannot be solved by these approaches. For our inattention, we are accustomed to blaming tiredness, problems at home, outside distractions, and other external factors not in our control. Recent research has identified that more than 95% of personal safety incidents involved inattention (the autopilot mode) leading to an unsafe act. Co-incidentally, the latest neuro-scientific research has discovered that 95% of our actions are subconscious. People can not always control distractions and external factors, but they can influence their subconscious actions (their habits) so what they do in autopilot is the safest thereby preventing many incidents—not just for safety but also for other areas of business.

Antidepressant agents: from tricyclics to serotonin uptake inhibitors

1998 ◽  
Vol 28 (5) ◽  
pp. 1169-1178 ◽  
Author(s):  
S. GARATTINI ◽  
C. BARBUI ◽  
B. SARACENO
Keyword(s):  
Clinical Trials ◽  
Antidepressant Drugs ◽  
Antidepressant Activity ◽  
New Drugs ◽  
Clinical Tests ◽  
Serotonin Uptake Inhibitors ◽  
Regulatory Authorities ◽  
The Cost ◽  
Clinical Problems ◽  
Monoaminergic Mechanisms

Background. The number of antidepressant drugs available in the market has grown rapidly in the last few years. The present paper underlines some of the pre-clinical and clinical problems that call close attention from the regulatory authorities when approving new drugs.Methods. We present here a review of the literature.Results. A wide heterogeneity in the action of the various antidepressants precludes any single theory about the pathogenesis and therapy of depression. Antidepressant activity, in fact, may be achieved by acting on a number of different monoaminergic mechanisms. The variety in the neurochemical effects of antidepressants is not reflected in clinical trials, which tend to stereotypy. In many cases clinical trials aim at demonstrating equivalence rather than differences in efficacy. Regulatory authorities should, therefore, pay attention in accepting the equivalence of effects of a new drug in relation to a reference one: most clinical trials of new antidepressant drugs do not have the power to detect clinically relevant differences.Conclusions. Unconventional new pre-clinical tests are needed to generate antidepressants with a different mechanism of action. Clinical studies are needed to promote objective comparative evaluation of the cost, benefits and toxic effects of new antidepressants.

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