scholarly journals Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19

2020 ◽  
Vol 51 (1) ◽  
pp. 5-13
Author(s):  
Joel Lexchin ◽  
Janice Graham ◽  
Matthew Herder ◽  
Tom Jefferson ◽  
Trudo Lemmens
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Regulation ◽  
New Drugs ◽  
European Medicines Agency ◽  
Approval Process ◽  
Health Canada ◽  
Clinical Trial Information

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.

Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

2004 ◽  
Vol 22 (22) ◽  
pp. 4626-4631 ◽  
Author(s):  
Lilia Talarico ◽  
Gang Chen ◽  
Richard Pazdur
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The Elderly ◽  
New Drugs ◽  
Cancer Drug ◽  
Cancer Therapies ◽  
Age Related ◽  
The Us

Purpose To analyze the age-related enrollment of cancer patients onto registration trials of new drugs or new indications approved by the US Food and Drug Administration from 1995 to 2002. Patients and Methods This study involved retrospective analyses of demographic data of cancer patients enrolled onto registration trials. The data on 28,766 cancer patients from 55 registration trials were analyzed according to age distributions of ≥ 65, ≥ 70, and ≥ 75 years. The rates of enrollment in each age group for each cancer were compared with the corresponding rates in the US cancer population. The age distributions of the US cancer population were derived from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute for the period 1995 to 1999 based on the 2000 US Census. Results The proportions of the overall patient populations aged ≥ 65, ≥ 70, and ≥ 75 years were 36%, 20%, and 9% compared with 60%, 46%, and 31%, respectively, in the US cancer population. Statistically significant under-representation of the elderly (P < .001) was noted in registration trials for all cancer treatment except for breast cancer hormonal therapies. Patients aged ≥ 70 years accounted for most of the under-representation. Conclusion Elderly were under-represented in the registration trials of new cancer therapies. Various strategies may be needed to evaluate cancer therapies for the elderly in prospective clinical trials and to improve cancer care in the elderly population.

scholarly journals INTELLECTUAL PROPERTY ON DATA OF COVID-19 OFF-LABEL TREATMENT AND DATA OF COMPASSIONATE USE OF MEDICINES AND ACCESS TO TREATMENT IN A PANDEMIC

2020 ◽  
Author(s):  
Оксана Кашинцева ◽  
Микита Трохименко
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Intellectual Property ◽  
Treatment Options ◽  
Legal Protection ◽  
New Drugs ◽  
European Medicines Agency ◽  
Compassionate Use ◽  
Access To Treatment ◽  
Off Label

The article concerns the issues of legal protection of data obtained as a result of off-label drugs therapy of COVID-19 and of data obtained of the compassionate use of medicines in treatment of COVID-19. The authorsargue that neither data on the use of off-label or on the basis of a compassionate use in the treatment of coronavirus (data obtained in solidarity clinical trials) are not determined as the information that should be protected from unfair commercial use.Regarding to the use of off-label for a new purpose of drag it is not be considered as a «new chemical substance», because the drug is already registered, and therefore known, and in the case of obtaining data in compassionate use, this information is removed from the trade secret regime by the WHO and EMA opinion. Such information is opened to use from the beginning. Therefore, in both of the above cases, it could notbe considered as an «unfair use» in the meaning of Art. 39 TRIPS Agreements.The WHO apply to the world community and informed about the «Solidarity» clinical trial for COVID-19 treatments». Solidified clinical trials of COVID-19 treatment compare four treatment options to evaluate their efficacy in COVID-19 therapy. Solidarity-based clinical trials aim to quickly identify which of the drugs tested slows disease progression or improves survival. New drugs can be added to solidarity studiesbased on new data.On April 3, 2020, the Committee for Medicinal Products for Human Use of European Medicines Agency (EMA) issued recommendations for compassionate use for remdesivir as the most promising treatment for COVID-19. The EMA explicitly states that the compassionate use is not part of the clinical trial in its usual meanings.IFLA (International Federation of Library Associations and Institutions) also wrote an open letter to WIPO urging WIPO to use all available flexible intellectual property mechanisms to maximize worldwide access to information (research data) on COVID-19 treatment.Thus, the legal regime of «Solidarity clinical trials and the WHO and EMA declarations lead us to conclude that all data obtained in the Solidarity clinical trials should not be monopolized by intellectual property, either as objects of patenting for a new scope / new purpose of treatment, or like an object of data exclusivity protection.

Women in Clinical Trials of New Drugs -- A Change in Food and Drug Administration Policy

1993 ◽  
Vol 329 (4) ◽  
pp. 292-296 ◽  
Author(s):  
Ruth B. Merkatz ◽  
Robert Temple ◽  
Solomon Sobel ◽  
Karyn Feiden ◽  
David A. Kessler
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
New Drugs

Regulation of Clinical Trials

2021 ◽  
pp. 195-212
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Information System ◽  
Clinical Trials ◽  
Well Being ◽  
The European Union ◽  
Approval Process ◽  
Clinical Trials Regulation ◽  
Clinical Trial Information ◽  
The Eu

This chapter discusses the publication of the European Clinical Trials Directive in 2001 and its incorporation into the law of Member States. It explores the intention of the Directive in harmonising the rules for conducting clinical trials within the EU to facilitate the internal market in medicinal products and to protect the rights, safety, and well-being of participants. It also covers the passing of the new Clinical Trials Regulation (CTR) by the EU in 2014, which was prompted by concern that the system for approving clinical trials was overly bureaucratic and that it was hampering multinational trials. The CTR could not come into force until the Clinical Trial Information System (CTIS), which is intended to provide a single coordinated approval process, became fully functional. This happened too late for the CTR to be automatically incorporated into UK law by the European Union (Withdrawal) Act 2018.

Participation of Women in Clinical Trials for New Drugs Approved by the Food and Drug Administration in 2000–2002

2009 ◽  
Vol 18 (3) ◽  
pp. 303-310 ◽  
Author(s):  
Yongsheng Yang ◽  
Alan S. Carlin ◽  
Patrick J. Faustino ◽  
Mónica I. Pagán Motta ◽  
Mazen L. Hamad ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Participation Of Women

Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials

2009 ◽  
Vol 27 (26) ◽  
pp. 4433-4440 ◽  
Author(s):  
Razelle Kurzrock ◽  
Susan Pilat ◽  
Marcel Bartolazzi ◽  
Dwana Sanders ◽  
Jill Van Wart Hood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Drug Administration ◽  
Strategic Alliance ◽  
Food And Drug Administration ◽  
Good Practice ◽  
New Drugs ◽  
Cancer Center ◽  
Institutional Review ◽  
Regulatory Submissions

Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.

Tricks of the Trade

2006 ◽  
Vol 8 (2) ◽  
pp. 133-146
Author(s):  
Timothy Scott
Keyword(s):  
Clinical Trials ◽  
Research Design ◽  
Drug Administration ◽  
Suicide Risk ◽  
Antipsychotic Drugs ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Professional Organizations ◽  
Design Strategies ◽  
Drug Studies

Before receiving Food and Drug Administration approval, drug manufacturers must conduct clinical trials of their new drugs. Although all drug studies can be manipulated, antidepressant and antipsychotic drugs are particularly vulnerable to bias. The bias is not limited to the makers of these drugs. Most psychiatrists and their professional organizations strongly favor the use of neuropsychopharmacologic agents even when justifying data are lacking. This article relates an example of this bias involving antidepressants and suicide risk and then discusses 10 common research design strategies that are used to obtain the desired conclusion rather than find truth.

scholarly journals Barriers, adoption, technology, impact and benefits of risk based monitoring

2016 ◽  
Vol 3 (1) ◽  
pp. 9 ◽  
Author(s):  
Bharat Kumar Shukla ◽  
Mohammed Saleem Khan ◽  
Veerabhadra Nayak
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Quality ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Source Information ◽  
The Us ◽  
Previous Decade

The expense and unpredictability of clinical trials have increased drastically as of late. Up to third of a clinical trials expense can now be credited to the customary on location audit of trial information. While powerful observing is basic to ensuring the prosperity of trial members and keeping up the respectability of definite results, it is presently by and large acknowledged that the procedure for clinical trial checking needs to change. A more brought together, hazard based methodology is currently the favoured technique for monitoring clinical trials, as per a few administrative offices, including the US Food and Drug Administration (FDA). The movement has demonstrated overwhelming to numerous associations, nonetheless, and it is now and again not clear where to start. Over the previous decade, the clinical research industry's standard to meet regulators monitoring commitments has included continuous and normal onsite monitoring visits with 100% source information confirmation (SDV). The conviction that "more is better" proceeds with new proof that onsite monitoring practices don't inexorably ensure persistent wellbeing and data quality.

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