Current Issues Surrounding Women and Minorities in Drug Trials

1993 ◽  
Vol 27 (7-8) ◽  
pp. 904-911 ◽  
Author(s):  
Daniel P. Wermeling ◽  
Ada Sue Selwitz
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
New Drugs ◽  
Ethical Principles ◽  
Investigational Drug ◽  
Federal Regulations ◽  
Drug Trials ◽  
New Drug ◽  
Research Risks

OBJECTIVE: Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCES: Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.

scholarly journals New drug and clinical trial rules, 2019: an overview

2020 ◽  
Vol 7 (4) ◽  
pp. 278
Author(s):  
Swathi A. Annapurna ◽  
Srinivasa Y. Rao
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
New Drugs ◽  
Development Method ◽  
New Drug ◽  
The Government

<p>Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.</p>

Preclinical Principles of the Investigation of New Drugs

1972 ◽  
Vol 1 (1) ◽  
pp. 1-3
Author(s):  
F J Sanen
Keyword(s):  
Team Work ◽  
New Drugs ◽  
Drug Trials ◽  
New Drug ◽  
Preclinical Investigation ◽  
Research Challenge

From this presentation it becomes apparent that preclinical investigation of new drugs is a multi-disciplinary endeavour. The need for close team work between the various scientists is necessary to meet this complex research challenge successfully. With the development of an ever-increasing number of potent drugs, it is mandatory that the physician responsible for monitoring new drug trials broaden his understanding of preclinical investigations. In doing so, he will soon learn the need for consistent interplay between the preclinical scientist and clinician.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

Business versus science: High drug prices conspire against oncological research.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Approval ◽  
Point Of View ◽  
New Drugs ◽  
New Drug ◽  
Drug Registration ◽  
Ethical Point ◽  
Post Marketing ◽  
State Of Affairs ◽  
Drug Approval Process

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study (Preprint)

2019 ◽  
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

BACKGROUND Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. OBJECTIVE This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. METHODS In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. RESULTS The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. CONCLUSIONS The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14744

scholarly journals Risks associated with the ethical aspects of conducting clinical trials

2020 ◽  
pp. 61-68
Author(s):  
A. L. Khokhlov ◽  
E. A. Polozova ◽  
V. A. Komissarova ◽  
N. V. Chudova ◽  
L. G. Tsyzman
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Social Problems ◽  
Reliable Data ◽  
New Drugs ◽  
Ethical Aspects ◽  
Ethical Justification ◽  
Conducting Research ◽  
The Moment ◽  
New Research

Conducting of clinical trials is closely associated with the ethical justification, with ensuring the rights and safety of the subjects participating in them. Only through trials, it becomes possible to obtain reliable data for the inclusion of new drugs in practice, which are designed to save millions of lives. In the constantly developing field of clinical research, science does not stand still and it becomes necessary to conduct more and more new research: pediatric, geriatric, biomedical products and research involving acute social problems, and of course they all involve certain risks during their implementation. The question of the ethics of conducting research in the context of the COVID-19 pandemic is very relevant at the moment, when it is necessary to make quick decisions in the interests of all mankind, assessing all possible risks that they may entail.

scholarly journals Funding of clinical trials in Brazil for the development of new drugs: who are the sponsors?

2015 ◽  
Vol 2 (4) ◽  
pp. 75 ◽  
Author(s):  
Ricardo Eccard da Silva ◽  
Angélica Amorim Amato ◽  
Maria Rita Carvalho Garbi Novaes
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
The Other ◽  
New Drugs ◽  
Essential Medicines ◽  
Neglected Diseases ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Funding Sources ◽  
Other Hand

<p class="abstract"><strong>Background:</strong> A low rate of investment in science it is directly impacts the technological independence and capacity in health care costs. Knowledge of funding sources is critical to understand the problem and formulates hypotheses for future studies.</p><p class="abstract"><strong>Methods:</strong> Two databases were used: the System for Control of Clinical Research (SCCR) from the Brazilian Health Surveillance Agency (Anvisa), and the International Clinical Trials Registry Platform (ICTRP).  </p><p class="abstract"><strong>Results:</strong> From 2009 to 2012, 77% of the clinical trials approved by Anvisa were sponsored by transnational pharmaceutical industry. On the other hand, the national pharmaceutical industry sponsored 8% of the trials over the same period. The most frequent sponsor of clinical trials involving drugs registered in the ICTRP from 2011 to 2012 was the transnational pharmaceutical industry (43%). Among the trials with national sponsors, are those involving neglected diseases such as chronic hepatitis C (ICD X B18.2), cutaneous leishmaniasis (ICD X B55.1) and yellow fever (ICD X A95), which were all sponsored by national governmental foundations. None of the active pharmaceutical ingredients studied by the transnational pharmaceutical industry or the transnational biopharmaceutical company were in the national list of essential medicines. On the other hand, 83% and 66.6% of the active pharmaceutical ingredients studied by national private universities and the international governmental agency, respectively, are in the national list of essential medicines.  </p><p class="abstract"><strong>Conclusions:</strong> The national pharmaceutical industry and government still invests little in Research and Development (R&amp;D) activities, when compared with transnational industries. This affects directly its technological and innovation ability.</p>

scholarly journals Assessing Toxicity in Drug Trials in Liver Disease

2021 ◽  
Author(s):  
Morris Sherman
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Liver Injury ◽  
Viral Hepatitis ◽  
Liver Diseases ◽  
New Drugs ◽  
Drug Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

AbstractSince the early trials in viral hepatitis, more and more new drugs are being tested for use in various liver diseases. Since drug hepatotoxicity is a major cause of drugs under investigation not making it to market, the assessment of drug-induced liver injury in clinical trials of new drugs is crucial. This review will focus on the systems that are used to assess drug-induced liver injury in clinical trials and will discuss how some of these criteria are inappropriate or inaccurate in this function together with suggestions for improvement.

scholarly journals Why New Drugs, Treatments, and Medical Devices Still Needs to be Tested Clinically Before Making it Available in the Market? A Systematic Review

2019 ◽  
Vol 3 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Naiya Patel
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Target Population ◽  
New Drugs ◽  
Health Study ◽  
Evidence Based ◽  
Research Papers ◽  
New Drug ◽  
Public Health Study ◽  
Based Medicine

Objective Testing a new drug, treatment, and medical device clinically is critically important before prescribing it to patient. Not determining the drug’s safety and efficacy through clinical trials might impose life threatening outcomes on its consumers. The research paper describes the critical factors associated for testing any new drugs clinically, as limited research is performed in this field of public health. Study Design A qualitative systematic literature review was performed by mining relevant original peer reviewed research papers as well as some online resources like MedlinePlus due to limited availability of studies on such critical topic. Methods The databases used were Web of Sciences core collection, PubMed, Google scholar. The keywords used to search research papers were “clinical trials”, “testing new drugs”, “history of testing drugs”, “evidence-based medicine”. Conclusion Drugs which are prescribed to critical target population like pregnant women and children should be more often clinically tested if possible as majority of them are available in the market without Food and Drug Administration (FDA) approval. The abusive potential of any new drug could end up taking lives of innocent individuals. More evidence-based medicine can help translate research results on a heterogeneous population efficiently.

Evaluation of drug cost avoidance resulting from conduct of cancer clinical trials in a community-based oncology practice.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 66-66
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Brittany Glynn ◽  
Ryan Porter ◽  
Daniel Wellner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Plan ◽  
Cost Savings ◽  
Investigational Drug ◽  
Cancer Clinical Trials ◽  
Community Based ◽  
Hospital System ◽  
Cost Avoidance

66 Background: Aim: To prospectively evaluate cost avoidance during routine conduct of cancer clinical trials in a community based integrated delivery network (IDN) consisting of a health services provider group, a health insurance plan and a hospital system. Only 2%–7% of adult cancer patients participate in clinical trials nationwide [1]. Inadequate funding and concerns about financial viability have been identified as factors that impede clinical trial accrual in the community oncology setting. ‘Cost-avoidance’, defined as dollars that would have been spent to purchase medications but were not spent because of study-related interventions [3] has been proposed as one mechanism to overcome this. Methods: Anti-cancer and hematology drugs provided by intergroup as well as pharmaceutical industry-based trial sponsors to patients enrolled in oncology clinical research were tabulated. Analysis of cost avoidance was restricted to patients covered by the IDNs health plan. Additionally, drugs provided by the trial sponsor were included in the analysis only if they represented a normal standard of care for the disease state. Cost avoidance was defined as the net ingredient cost of the drugs that would have been spent by the health plan for patient care if drugs provided by trial sponsors were not available. Results: Between January 2020 and April 2021, 25 patients covered by the IDN were recruited into clinical trials. Cost savings resulted from 7 targeted and immuno-oncology medications. Net cost avoidance in 2020 was $1,229,798 while that in 2021 till date has been $892,783. The realized cost savings has allowed recruitment of additional clinical research staff as well as expansion of clinical research to rural regional sites served by the IDN. Conclusions: Anticancer drugs provided free of charge by clinical trial sponsors render significant cost savings, ensuring viability and even expansion of oncology clinical research in community based IDNs. References: National Health Expenditure Data. 2018, U.S. Centers for Medicare & Medicaid Services: Baltimore, MD 21244. McDonagh MS, M.S., Naden E., Costs and savings of investigational drug services. American Journal of Health-Systems Pharmacy, 2000. 57: p. 40-43.[Table: see text]

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