Below are some of the most commonly used terms and phrases associated with the pharmaceutical industry.
ABPI (ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY):
The trade association for more than 75 companies in the UK producing prescription medicines. It’s member companies research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS). The ABPI also represents companies engaged in the research and/or development of medicines for human use. In addition, its general affiliate membership is for all other organisations with an interest in the pharmaceutical industry.
ADR (ADVERSE DRUG REACTION):
Before a medicine is granted a licence so that it can be made available in the UK, it must pass strict tests and checks to ensure that it is acceptably safe and effective. All effective medicines, however, can cause side effects (also known as adverse drug reactions), which can range from being minor to being very serious. For a medicine to be granted a licence, the expected benefits of the medicine must outweigh the possible risks of the medicine causing adverse effects. In the pre-approved clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.
CANCER RESEARCH NETWORKS:
The NCRN has increased involvement and recruitment into trials through the creation of 34 regional Cancer Research Networks across England, closely aligned to cancer service networks. NCRN funding is allocated to networks to appoint research staff, such as research nurses, data managers and medical staff sessions and to access pharmacy, pathology, radiology and other areas of support, such as information systems and training, all of which are integral to high quality research. Each network is required to appoint a clinical and administrative lead (Clinical Lead for Research and Research Network Manager) with responsibility for the overall leadership and management of the local networks.
Case histories include the case report forms and supporting data, eg, signed and dated informed consent forms, any medical records. Case histories document patient informed consent obtained prior to participation in the study.
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or effectiveness for the development of medicines. This includes medical devices and other investigational products for which clinical data are required for approval to market.
CTA (CLINICAL TRIAL AUTHORISATION):
Regulations came into force on 1 May 2004 introducing new procedures for the authorisation of clinical trials.
Clinical Trial Certificate.
DECLARATION OF HELSINKI:
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. It was first adopted by the 18th WMA General Assembly in Helsinki, Finland, June 1964. It has since been amended 5 times at a succession of WMA General Assembly meetings, the latest of which the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Also there have been two notes of clarification provided since 2000.
The molecular modelling of a broad spectrum of drugs followed by chemical and biological screening of the best products.
The program for advancing a drug compound generally from the pre-clinical decision to recommend a single compound in a research program through its approval for marketing by regulatory agencies.
The European Medicines Evaluation Agency.
FDA (FOOD AND DRUG ADMINISTRATION USA):
FDA is the federal agency within the USA responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.
GCP (GOOD CLINICAL PRACTICE):
See ICH-GOOD CLINICAL PRACTICE.
Once a licence has been granted by the MHRA, a pharmaceutical company can then market a medicine under a brand name. The company then has exclusive rights to market the medicine for the licensed uses for a certain period of time, usually about 10 to 12 years. This is known as a patent and allows the company to recoup the costs of research and development of the new medicine, before other drug companies are allowed to produce it at a cheaper rate, because the R & D has already been done. Once a patent expires, other companies then have the right to manufacture and market the drug but must market it under a different brand name, or under a generic name.
GMP (GOOD MANUFACTURING PRACTICE):
GMP refers to principles and specifications for good manufacturing of medicinal products that are set by the Federal Therapeutic Goods Administration (FTGA), in accordance with international standards (known as Codes of GMP). These are the standards manufacturers must comply with to provide safe and reliable products for consumers.
HTA (HEALTH TECHNOLOGY ASSESSMENT):
HTA is one of the three main national programmes funded from the NHS R&D levy, the others being New and Emerging Applications of Technology (NEAT) and Service Delivery and Organisation (SDO). The purpose of the HTA programme is to ensure that high quality research information on the cost, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. “Health technologies” include all devices, equipment, drugs and procedures across all sectors of healthcare and is not confined to new drugs or pieces of sophisticated equipment.
ICH-GOOD CLINICAL PRACTICE (GCP):
International Conference on Harmonization Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights integrity and confidentiality of trial subjects are protected. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trial data are credible.
INSTITUTE OF CLINICAL RESEARCH (ICR):
The Institute of Clinical Research (formerly ACRPI) has been in existence since 1978. The Institute encourages communication between all its members by supporting the various subcommittees and special interest groups and continues to fulfil its original goal of providing a forum for education and sharing of best practice amongst clinical research professionals.
MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY):
The MHRA is the Executive Agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. The MHRA was formed from a merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) on 1 April 2003.
The act of overseeing a clinical trial, and of ensuring that it is conducted, documented and reported in accordance with the protocol, standard operating procedures (SOP’s), GCP and the applicable regulatory requirement(s).
MRC (MEDICAL RESEARCH COUNCIL):
The MRC is a national organisation funded by the UK Government. It promotes research into all areas of medical and related science and is independent in its choice of which research to support, though it does work in close partnership with Health Departments, other Research Councils, industry and others to identify and respond to current and future health needs.
NICE (NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE):
NICE was set up as a Special Health Authority for England and Wales on 1 April 1999. It is part of the NHS, and its role is to provide patients, health professionals and the public with authoritative, robust and reliable guidance on current “best practice”. The guidance will cover both individual health technologies (including medicines, medical devices, diagnostic techniques, and procedures) and the clinical management of specific conditions.
An orphan drug is any drug developed under the 1983 U.S. Orphan Drug Act, which concerns drugs for rare diseases such as those affecting less than 200,000 people in the US. This has been adopted as a subclause of the FDA. Developing a drug for these small groups would be financially unsound. Therefore, development of drugs for such diseases is rewarded by tax reductions and a monopoly for that drug for a limited time (7 years).
Pharmacovigilance is defined as watchfulness in guarding against danger from drugs or providing for safety of drugs. It can also be a dedicated department whose role is to monitor toxicity and safety of drugs both in the developmental phase and post marketing.
A generic term used to describe the products a pharmaceutical company has in development at any one time.
Investigator held primarily responsible for the clinical conduct of a study carried-out under his/her supervision.
Quality Assurance (QA) ensures that All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s).
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
Many geopolitical entities have established agencies/authority responsible for regulating products used in healthcare. The agencies are collectively referred to as regulatory agencies or authorities.
SERIOUS ADVERSE EVENT:
Any adverse event occurring at any dose that results in any of the following outcomes: death, a life- threatening adverse experience, inpatient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalisation may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardise the patient or subject and may require medical or surgical intervention to prevent one.
An assistant to the Principal Investigator in a clinical study.