Clinical Trials Regulations

The purpose of this manual is to provide the Principal Investigator, project managers, research and nurse coordinators or administrators, and all those associated with clinical research trials & studies, with an overview of the processes, committees and departments that they will work with throughout the submission, review, approval and conduct of the human subject study or clinical trial.

Clinical trials are medical research studies that involve using humans and animals. Before a person goes into any trial they will have to sign an informed consent document before testing the drug. The principal investigator will tell them about the benefits and risks of a trial before they agree to take part. The principal

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. The Nuremberg Code was the first international code laying ethical principles for clinical research. The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ in the year 2000 which were revised in 2006. These guidelines have elaborated the three basic ethical principles: respect for person, beneficence and justice. [J. Sanmukhani et al]. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals

The visit by the inspector is more critical to the success of the clinical trial. The visit by the sponsor representative is to ensure that the site is ready for inspection by the regulatory agency, while the visit by the inspector and the review of data by a regulatory agency may be the final stage that may lead to approval of a marketing

Considering that USA based ABC Company is planning to conduct clinical trials in ICH concern countries by following the ICH and USFDA guideline. The FDA encourages communicating with them before conducting clinical trial for the rare disease and follow ICH E5 guidance to provide references for regulatory and development strategies to authorize clinical data gathered in one region to be used for the evidence of product registrations in another region following the effect of ethnic factors (FDA, 1998).The regulatory attentions for planning a multinational pivotal phase III clinical trial for drug used for rare disease (Orphan drug by the FDA) which is touching less than 200,000 US population comprise the subjects enrolled in the clinical trials, clinical trial investigators, regulatory agencies, institutional review boards (IRB), and ethics committees, recommending physicians, formularies, and insurance companies. Phase III pivotal study should base on clinical trial designed and performed to acquire statistically important proof of efficacy and safety required by the USFDA for NDA approval. It should include examination with the goal to include statements into the label as well as postmarketing surveillance commitments. The Orphan Drug Act of 1983 gives intensive as well as flexibility of using a single study and subsidiary evidence, for example multiple event measures and extrapolation studies to the ABC Company (Praiser, 2014).

Drug trials may likewise be utilized to figure out if a current drug can be securely and adequately utilized for different sicknesses and/or conditions.

The key regulatory challenge for the Pharmaceutical sector (for Marketing Authorisation holders and Sponsors of clinical trials) in European Union is the new European Union Pharmacovigilance legislation to submit the information on Individual Case Safety Reports (ICSRs) related to medicinal products authorised in the European Union (EU) and investigational medicinal products (IMPs) studied in clinical trials authorised in the EU

A clinical trial is a prospective study comparing the effect and value of an intervention(s) against a control in human beings (Friedman & De Mets, 2010). It is an assured way of determining whether an intervention has the hypothesized effect since researchers have control of most of the cofounders involved in the studies. Each of the participants is followed onward in time from a defined point in time, which is the baseline for the study. Participants are randomly assigned to the various intervention options to create comparable intervention groups. A protocol is one of the requirements of a properly designed trial. A protocol, which is an agreement between the investigator, the participant and the scientific community, provides the background, objectives, design and organization of the trial. This is a document that is prepared way before participants are enrolled, and remains essentially unchanged unless for minor updates. Any major changes altering the direction of the trial need to be carefully justified; a rationale behind the changes should be clearly described.

Globalisation of clinical trials shortens the period of time required to conduct clinical testing, which further reduces the costs of drugs2. This results from the increased

Clinical trials in humans are the only way to prove the efficacy of a new treatment. This signifies the “bedside” component of research. There are various stages of the human trials. The first stage involves giving the drug to a group of around 20 to 80 healthy humans to help researchers understand how the drug is absorbed into the system (“From Lab,” 2014). This can also show any side effects that were not present or evident in the animal trials. The second and third stages involve people who have the disease or illness that the drug is intended to treat. The second stage comprises of a larger group of 30 to 300 people with the targeted disease and focuses on

The main purpose of a clinical trial is to determine if the treatment is safe and effective for human use, and is required by the Food and Drug Administration (FDA) before a treatment can be approved. There are, however, other reasons these trials are performed. They can be used to compare the new treatment to an already existing one to determine which is more effective, and to determine different ways in which to use current treatments in order for them to be most effective, easiest to use and provide the

Globalization has been adopted in many industries, in the pharmaceutical world, efforts around globalizing clinical trials into emerging markets have increased significantly. Noticeably there is increase in numbers of trials in areas like Asia Pacific, Central and eastern Europe, Latin America, and Middle East. Since 2002, 15% annual growth has been observed in the number of active FDA- regulated investigators bases outside the United State, while the number of U.S. based investigators has decreased by 5.5%.

Clinical trials are often practiced in determining whether a drug is validated for safe and effective distribution. They are branched into three stages and are generally sponsored by biotechnological companies (Rajan 67). The first and second stages are to determine whether the drug molecule is safe for

The pharmaceutical industry is one of the most heavily regulated of all industries and Pfizer is a global US based pharmaceutical company and in the pharmaceutical industry companies are regulated by the Food and Drug Administration (FDA), World Health Organization (WHO), and Medicines and Healthcare Products Regulatory Agency (MHRA). Each of these regulatory bodies focus on the manufacturer, drug sellers, and prescribing to physicians process. (World Health Organization). In accordance to the Internal Revenue Service, the US firms must meet government regulatory requirements. The drug company must get market approval and show it safe for human consumption through animal and human testing and prove it is effective for the illness and its intentions to alleviate. The scientific community established a four-phase method to establish effectiveness. First phase is animal and toxicity studies, second phase is the investigational new drug application filed to test small numbers of human and allow transportation of unapproved drugs. Thirdly, a large scale trials conducted with thousands of patients proves the product is effective against a specific disease. Human trial subjects must provide consent for the experimental group. Lastly, a post approval marketing testing which are conducted to generate marketing data for the competitive market (involves competitor products) (Internal Revenue Service, 2015) These measures must be in compliance with the FDA in

The pharmaceutical industry proficiency involved secondary research on oncology drug development, disease states, therapeutic area strategies and new treatment modalities. The proficiency in clinical trial methodologies, design and statistics enables to interpret and coordinate the clinical research and human biological specimens’ activities, documentation and support functions. The familiarity with clinical trial procedures, guidelines and regulations also ensures a high level of compliance, accuracy and integrity of study data by tracking and reviewing documentation for subject management, study-related findings and post-clinic action plans.