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>

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

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

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.

Global drug development in cancer: A cross-sectional study of clinical trial registries

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2520-2520
Author(s):  
P. Hertz ◽  
B. Seruga ◽  
L. W. Le ◽  
I. F. Tannock
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Phase Ii ◽  
New Drugs ◽  
Phase Iii ◽  
Cancer Site ◽  
Cancer Type ◽  
Clinical Trial Registries ◽  
Global Drug Development

2520 Background: Clinical trials are increasingly funded by industry. High costs of drug development may lead to attempts to develop new drugs in more ‘profitable’ (i.e., more prevalent) as compared to ‘less profitable’ (i.e., more deadly) cancers. Here we determine the focus of current global drug development. Methods: We determined characteristics of phase II and III clinical trials evaluating new drugs in oncology, which were registered with WHO International Clinical Trial Registries between 01/2008 and 06/2008. Estimates of incidence, mortality, and prevalence in the more- and less-developed world (MDW, LDW) were obtained from GLOBOCAN 2002. Simple correlation analysis was performed between the number of clinical trials and incidence, mortality and prevalence per cancer site after log transformation of variables. Results: We identified 399 newly registered trials. Of 374 trials with information about recruitment, 322 (86.1%) and 39 (10.4%) recruited patients only from the MDW and LDW, respectively, while 13 (3.5%) had worldwide recruitment. 229 (58%) of trials were sponsored by industry and 324 trials were phase II (81%). Most trials (and most phase III trials) evaluated treatments for globally prevalent cancers: breast, lung, prostate, and colorectal cancer (Table). Prevalence of a particular cancer type in both the MDW and LDW correlated significantly with the number of clinical trials (Pearson r = 0.63 and 0.55; p = 0.01 and 0.03, respectively). In contrast, mortality in the MDW (Pearson r = 0.73; p= 0.002), but not in the LDW (Pearson r = 0.38; p= 0.17), correlated significantly with the number of clinical trials. Conclusions: Global drug development in cancer predominates in globally prevalent cancers, which are a more important cause of mortality in the MDW than in the LDW. Cancer sites that are major killers globally, and especially in the LDW (e.g., stomach, liver, and esophageal cancer) should receive priority for clinical research. [Table: see text] No significant financial relationships to disclose.

Clinician or Clinical Trialist: The Physician’s Dilemma

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Formal Training ◽  
Pharmaceutical Companies ◽  
Training And Education ◽  
Know How ◽  
Site Staff ◽  
And Training

The main objective is to help physicians carry out those aspects of clinical trials described in this book. . . .Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). . . . . . . —[ICH-GCP 2.8]. . . It is hardly rational to expect people to do things properly unless they are shown how, so that the importance of formal training and education for everyone involved with the pharmaceutical industry should be self-evident. The perpetuation of bad habits by those who are poorly trained and educated, whether in pharmaceutical companies or at investigator sites, is one of the root causes of the inefficiencies in drug development. Yet, while few people (whether or not they actually educate people properly) would dispute the importance of well-trained employees, it is uncommon for most companies to insist that all of those upon whom they depend are properly trained as well. Among those who are rarely trained to meet the required standards of excellence are CRO staff and investigators and their site staff. Negotiations with CROs rarely involve an assessment of how the various tasks are performed and whether or not they are carried out to the standards expected by the sponsor staff. This is not to imply that sponsor employees are better at what they do than CRO staff. What is true, however, is that sponsor employees should know how to do things the way the sponsor wants them done, which in turn should correspond to the sponsor’s notion of excellence. CROs will always profess to have all the processes requested by a sponsor, so that a laissez-faire attitude pervades negotiations. However, CROs quite understandably have their own ways of working, and unless alternatives are specified contractually, what the CRO does is what the sponsor gets. The next logical step after specifying what is wanted is to provide the necessary training for CRO staff. Where education and training are most needed and are carried out most poorly is in the case of clinical trial investigators.

Pharmaceutical Development Process

2019 ◽  
pp. 133-157
Author(s):  
Yaashikaa Ponnambalam Ragini
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Development Process ◽  
Human Life ◽  
Drug Application ◽  
New Drugs ◽  
Pharmaceutical Drug ◽  
Pharmaceutical Development

The most significant attribute of the pharmaceutical industry is its creations and advancements. The innovation of new drugs is necessary for improving the quality of human life and duration. Pharmaceutical drug development is a time-consuming, costly, and crucial process. The essential goal of drug development is to discover a dosage or dosage scale of a drug application that is both efficient in curing the desired disease and safe. Clinical trials including newly developed drugs that are directed in a progression of successive steps called stages to decide the security and efficacy of the new drug moreover the viability against the targeted diseases. There are four phases through which clinical trials are conducted. An investigational item can be assessed in more than one stage all the while in various clinical trials, and some clinical trials may cover two unique stages.

scholarly journals New Drugs - From Necessity to Delivery

2018 ◽  
Vol 31 (2) ◽  
pp. 69-75
Author(s):  
Ewa Kedzierska ◽  
Lila Dabkowska ◽  
Tomasz Krzanowski ◽  
Ewa Gibula ◽  
Jolanta Orzelska-Gorka ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Design ◽  
Drug Development ◽  
New Drugs ◽  
Google Scholar ◽  
Lead Compound ◽  
New Drug ◽  
Preclinical Trials ◽  
The Way

Abstract How to get a new drug to market? How much time does it take to go from the idea to implementation? In this study we followed the path drugs take from synthesis to introduction to the market. In doing so, articles in the PubMed and the Google Scholar database have been analyzed using the keywords: drug development, drug design, lead compound, preclinical trials, clinical trials. The available literature was subjectively selected due to its usefulness in the topic. Based on the obtained articles, we presented the stages that a would-be drug takes on the way from the idea to marketing. Herein, it is underlined that the process of creating new drugs is long, extremely labor-intensive, and involves many restrictions in the context of the use of animals, as well as humans

scholarly journals The Success Rate of New Drug Development in Clinical Trials: Crohn’s Disease

2010 ◽  
Vol 13 (2) ◽  
pp. 191 ◽  
Author(s):  
Jayson Lee Parker ◽  
Jillian Clare Kohler
Keyword(s):  
Clinical Trial ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Drug Development ◽  
Success Rate ◽  
Small Molecule ◽  
New Drugs ◽  
Press Releases ◽  
New Drug ◽  
Trial Testing

Purpose. To determine the risk of drug failure during clinical trial testing in Crohn’s disease and determine what steps can be taken to improve outcomes. This is the first study to quantify such risk for a single disease. Methods. Moderate to severe Crohn’s disease was investigated by reviewing press releases from 1998 to June 2008. Clinical trial failure causes were classified as commercial or clinical and compared with industry expectations. The risk of failure was also reviewed based on whether the compound was a small molecule drug or a biologic. Lastly, the role of the sponsor was examined, in determining whether the size of the firm involved in a drug program was predictive of the outcome of the study. Results. More than a120 press releases were reviewed yielding 37 drugs that met our search criteria. The cumulative success rate for drug development in Crohn’s disease is 19%, from start to finish of clinical trial testing. New drug approvals are dominated by protein based therapeutics in this indication. Commercial and clinical failures both contributed substantially to the failure rates of new drugs. Phase I clinical testing appeared to offer little risk mitigation with pass rates at 95%. Conclusion. Funding intended to advance Crohn’s disease must take into account the disease specific historical failure rate of drug development in forecasting any reasonable expectation of producing new therapies. As it currently stands, one in five drugs will be successfully approved that enter clinical trial testing in this indication. To manage this risk continued development of biologics over small molecule drugs may be warranted in this disease.

scholarly journals ELECTRONIC INFORMED CONSENT MODEL DEVELOPMENT FOR IMPLEMENTATION IN CLINICAL TRIALS IN UKRAINE

2017 ◽  
Vol 10 (12) ◽  
pp. 238
Author(s):  
Dobrova Vy ◽  
Zupanets KО ◽  
Kolodyezna Ty ◽  
Yuriytimchenko Timchenko
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
System Analysis ◽  
Model Development ◽  
New Drugs ◽  
Electronic Systems ◽  
New Drug

Objectives: The process of signing the informed consent (IC) is one of the essential procedures during organizing and conducting the clinical trial (CT) of any new drug. During this procedure, the volunteers should read the IC form that is often difficult to understand. Analysis of literature showed lack of experience in use of electronic systems in the IC signing in Ukraine. Abroad such systems are quite new. Thus, the aim of this work is the rationale for the introduction of electronic IC to CT drugs in Ukraine and the development of its general model.Methods: Experience in the use of electronic systems in IC signing analysis was carried out using methods of system analysis, synthesis, abstraction, and generalization.Results: Thus, during the signing process of paper forms risks and errors may arise such as loss of paper copies and signing of an incorrect version of the document by the volunteer. With the use of electronic forms, it is possible to prevent three categories of risks in preparation and signing, such as risks in the development, use, and auditing of IC forms. The opportunities of the electronic IC system to protect trial subjects in its use during organizing and conducting of CT were showed.Conclusions: The study showed that such systems are effective. Therefore, it seems appropriate to introduce electronic IC in CT of new drugs in Ukraine. We have formulated requirements to the system and determined its structure for optimal use.

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

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