Regulatory Requirements and Quality Standards in India’s Clinical Trials Journey

2021 ◽  
pp. 283-302
Author(s):  
Bobby George ◽  
Shrinivas Krishnarao Kulkarni ◽  
Nilima A. Kshirsagar
Keyword(s):  
Clinical Trials ◽  
Quality Standards ◽  
Regulatory Requirements

scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

Challenges in Opening and Enrolling Patients in Clinical Trials

2017 ◽  
pp. 139-143
Author(s):  
Julie M. Vose ◽  
Meredith K. Chuk ◽  
Francis Giles
Keyword(s):  
Clinical Trials ◽  
Scientific Integrity ◽  
Cancer Therapies ◽  
Regulatory Requirements ◽  
Cancer Treatments ◽  
Contract Research ◽  
Trial Conduct ◽  
Slowing Down ◽  
Research Organizations ◽  
Trial Participants

Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and costly to implement and often are variably interpreted by institutions and sponsors and sponsors’ representatives, including contract research organizations. Some of these requirements are essential to protect the safety of trial participants, to promote the scientific integrity of research, or to ensure that trial conduct is efficient and adequately resourced. Such requirements are important to preserve. However, some requirements do not fulfill any of these goals and, in fact, hinder research and slow patient access to safe and effective treatments. This article discusses some of the identified issues that are slowing the process of cancer clinical trials, such as conservatively interpreted guidelines by pharmaceutical companies and contract research organizations; overprotective language for contracts; and patient protections by health systems and universities. The article also discusses possible solutions to these problems that are slowing down the cancer therapies that patients need.

scholarly journals Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements?

2012 ◽  
Vol 33 (9) ◽  
pp. 1049-1057 ◽  
Author(s):  
F. Zannad ◽  
W. G. Stough ◽  
S. J. Pocock ◽  
P. Sleight ◽  
W. C. Cushman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Regulatory Requirements ◽  
Current Shift

scholarly journals The Stages of Drug Discovery and Development Process

2019 ◽  
Vol 7 (6) ◽  
pp. 62-67 ◽  
Author(s):  
Amol B Deore ◽  
Jayprabha R Dhumane ◽  
Rushikesh Wagh ◽  
Rushikesh Sonawane
Keyword(s):  
Clinical Trials ◽  
Drug Discovery ◽  
Drug Development ◽  
Development Process ◽  
Regulatory Requirements ◽  
Drug Discovery And Development ◽  
Biological Targets ◽  
New Drug ◽  
Initial Discovery ◽  
New Research

Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine ultimately approved for clinical use and new research tools may be needed to investigate each new target.  From initial discovery to a marketable medicine is a long, challenging task. It takes about 12 - 15 years from discovery to the approved medicine and requires an investment of about US $1 billion. On an average, a million molecules screened but only a single is explored in late stage clinical trials and is finally made obtainable for patients. This article provides a brief outline of the processes of new drug discovery and development.   

Quality Assurance: National and International

1981 ◽  
Vol 44 (7) ◽  
pp. 553-555 ◽  
Author(s):  
THOMAS W. HOLZINGER
Keyword(s):  
Quality Assurance ◽  
Process Control ◽  
Communication System ◽  
World Wide ◽  
Quality Standards ◽  
Regulatory Requirements ◽  
Company Policy ◽  
The World ◽  
Approval Procedure ◽  
Control Procedures

In this age of instant communication, product quality complaints or adverse publicity originating from any point on the globe can have potentially world-wide repercussions and devastating effects on any firm operating on an international basis. For this reason, effective Quality Assurance must ensure that all products made by a firm throughout the world are safe, wholesome and in compliance with company quality standards and all applicable regulatory requirements. Borden, which operates food and dairy plants in more than 22 countries and markets its products in more than 100 countries, is committed to establish in all non-U.S. food and dairy plants the same standards of product safety and quality required of domestic plants. To achieve adherence to this company policy on a world-wide basis, Corporate Quality Assurance put into effect a comprehensive program entailing a formula approval procedure, quality and process control procedures, a process deviation reporting and evaluating system, plant sanitation inspections, product compliance audits and an effective communication system.

The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes

2021 ◽  
Vol 10 (2) ◽  
pp. 83-99
Author(s):  
Marta Zuccarelli ◽  
Benjamin Micallef ◽  
Mark Cilia ◽  
Anthony Serracino-Inglott ◽  
John-Joseph Borg
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Phase I ◽  
Clinical Development ◽  
Phase Iii ◽  
Regulatory Requirements ◽  
Safety Concerns ◽  
Emerging Trends ◽  
Over Time ◽  
The Eu

Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims to describe the regulatory experience of approving biosimilars in the European Union (EU) within the EU framework, identify emerging trends in the EU regulatory pathway when approving biosimilars and discuss where the EU biosimilar framework is heading. Methods: Marketing authorisation applications (MAAs) submitted up to 2019 were retrieved from the public domain. The European public assessment report database was searched for approved biosimilars and clinical development programmes of biosimilars belonging to the same class were reviewed. In order to observe if biosimilars released onto the market increased safety concerns, we compared disproportionate adverse event reports pre- and post-licensure. Results: Up to December 2019, 90 MAAs were submitted and 53 biosimilars were approved for 14 different biologicals. Total number of clinical trials (both phase I and III) steadily goes up driven by an increase number of approvals in later years, while the average number of both phase I and III trials decreased over time with some with Pegfilgrastim biosimilars being approved without conducting any phase III clinical trials. No new safety concerns were identified from the analysis of disproportionate adverse event reports. Discussion: Clinical development programmes of biosimilars and the requirements set for biosimilars approval are changing over time. Biosimilars approved seem to be as well tolerated as the reference products when approved based on stringent regulatory requirements. Conclusion: Regulation of biosimilars is progressing as more knowledge is gained.

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