CLINICAL TRIALS Clinical Trials in India are regulated under the Central Drugs Standard Control Organization (CDSCO) and Drugs and Cosmetics Act, 1940, respectively. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects with the objective of determining safety
The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained
Types of Clinical Trials and its importance. Target this keyword at the end of blog : Clinical Research Reviews Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones. Types of Classifications: In one way of classification it is based on the
Introduction Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their
Clinical drug trials are tests on drugs to find out if the outcome is a cure to the disease or not. In other words, clinical drug trials are done to figure out the effectiveness of the drug. Clinical drug trials are ethical because the scientists are trying to find hope and cures to diseases that may be taking over a person’s life. Chase, who has fragile X syndrome, showed signs that the drug he took in a clinical drug trial, minocycline, was working when he began to develop the abilities to understand
Introduction Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints
explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials. The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct. Introduction: Clinical Trial Outsourcing: Global Drug
marketing Surveillance in Clinical Trial Clinical trials containing new drugs are categorized into essential four phases (1). The drug development procedures are usually performed through the all phases over several years (1). The drug will be approved for use in the general population, if it successfully exceeds through the first three phases; I, II, and III. The fourth phase -IV- is called Post marketing Surveillance and/or Post approval studies (2). Postmarketing Surveillance Trial provides the safety
The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable
Outsourcing clinical trials raises many issues related to data integrity and quality control of clinical trials. Regulatory oversight, language barriers, the meaning of informed consent among a much poorer population, the quality of clinical care, and the ethical problem of raising a population's expectations for drugs that most of that population cannot afford are consequences of outsourcing clinical research. Most importantly, it raises the question of whether the results of clinical trials using one
of generic drugs. However, it is now witnessing regulatory challenges like delays in clinical trial approvals, uncertainties over the FDI policy, a uniform code for sales and marketing practices and compulsory licensing (M. Janodia, 2007). Key Regulatory Challenge: Delay in Clinical trial approvals India was considered to be the major hub for conducting clinical trials. The relatively low cost of conducting trials and a fast-growing population of 1.2 billion makes India an attractive destination for
In Marcia Angell’s article, “The Ethics of Clinical Research in the Third World,” she strongly argues the use of clinical placebo-controlled trials done in developing countries are unethical if an effective treatment already exists. Angell believes studies that compare potential new treatment with a placebo controlled group is ineffective and unnecessary. All research studies should offer the best standard of care and give participants the most beneficial outcome and treatment possible. The main
from Pharma as well as the CRO domain were interviewed . The primary focus of the interview was to collate opinions and experiences of these professional to build a baseline that will help develop a strategy for building Clinical trial related regulations across countries that are trial naïve . The following set of questions were discussed: 1. What are some of the challenges that you perceive that have arisen due to this unstable / changing regulations? 2. With the regulations getting stringent will
aspects of clinical research is ensuring the safety of new drugs, treatments, etc on patients. This is called pharmacovigilance or drug safety compliance. This safety aspect is monitored, implemented, and complied with in two ways. Firstly, the sponsor of the clinical research, usually a pharmaceutical organization, conducts drug safety tests at all the stages of the clinical trials they conduct wherever it is required by law. They also implement drug safety protocols at stages of the clinical research
ways to find the lead compound, they include nature, de novo, high- throughput screening and biotechnological methods. For many centuries drug... ... middle of paper ... ...d time. It consists of pre-discovery and discovery, development, clinical trials and manufacturing processes. During each step potential drugs are modified and side effects are reduced, even after manufacturing the drugs are monitored and periodically conditions of patients are reported to FDA. An investment of money by pharmaceutical
coronary heart disease (CHD) and stroke, which is the most common cause of death worldwide and in the United States10. Among the modifiable risk factors of CHD and stroke is the serum low density lipoprotein level (LDL)8, 11. Several randomized clinical trials have established that reducing the serum LDL level results in a reduction in the future risk of CHD and stroke in a linear relationship, in one study it was estimated that reducing the LDL by 1 % would reduce the risk by 1.7 %.1-4, 7, 9, 13 Lipid
Off- Label discussion before and During Clinical Trials INTRODUCTION: Off- Label drug use is usage of drugs, marketed medications for an indication (disease or symptom) that has never been approved by Food and Drug Administration (FDA), it also applies to population and dosage form that does not have approval from FDA. The product is already approved by FDA but for different indication, which is indicated on the label. Off- Label use is not inappropriate or dangerous, the product’s safety is already
As a QA Manager I would ensure that the following steps are followed in accordance with the ICH, GCP, HIPAA and FDA regulations and guidelines for clinical trial documentation management. a) Data Management System (DMS): Regulate the clinical data by enforcing stringent data management practices and mitigate the deviation in data collection and recording. The study protocol will define the source of data collection with Case Report Forms (CRFs), method of storage paper/ electronic and information
physics/9909033 (1999). Song, Fujian, Lee Hooper, and Yoon K. Loke. "Publication Bias: What Is It? How Do We Measure It? How Do We Avoid It?" Dovepress Journal, July 2013. Web. 23 Nov. 2013. Turner, Erick H., et al. "Selective publication of antidepressant trials and its influence on apparent efficacy." New England Journal of Medicine 358.3 (2008): 252-260. Watkins, Tom. "Papers Indicate Firm Knew Possible Prozac Suicide Risk." CNN. Cable News Network, 3 Jan. 2005. Web. 23 Nov. 2013. Wood, Susan F., and
Professor named Marcello Costa stated that “the substance may have a therapeutic effect on a person when in a doctor’s office or a professional in the medical field”. Placebos are also used as a control variable when testing new medicine in clinical trials. This is to help scientists evaluate whether the new drug produced is safe for a person to consume whilst ensuring it will work effectively and efficiently. A placebo is given to a person