Main glossary
Special | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | ALL
A |
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Adverse reactionAn
unwanted or harmful reaction which occurs after administration of a drug | ||
AIArtificial intelligence (AI) is the simulation of human intelligence processes by machines | ||
Amino acidAmino acids are the building blocks to forming
proteins: they are the acids formed from the coding of a triplet of bases in
the DNA. There are 20 amino acids, and most have several triplets which code
for them. | |
AnecdotalEvidence based on personal accounts rather than facts or research | ||
Animal modelAn animal model utilises a non-human species to be studied to understand particular biological phenomena, to provide insight into the workings of other organisms. | |
AssentThe expression of agreement | |
Audit trailA record of the changes that have been made to a database or a file | |
B |
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Baseline dataThis is data that is collected on patients at the beginning of the clinical trial. | |
Big dataExtremely large data sets that may be analysed computationally to reveal patterns, trends and associations | |
BiobankA
biobank is a place that stores biological samples for use in research | |
BiochemicalRelating to the chemical processes and
substances that occur within living organisms | |
BioinformaticsAn interdisciplinary field of science that
combines biology, computer science, information engineering, mathematics and statistics
to analyse data | |
Biological sampleAny sample or specimen of material derived from
an organism | |
Biomarker | |
BiotechnologyThe area of biology involving living systems and organisms used to develop a product | |
BlindingBlinding means setting up a trial in a way which prevents anyone from knowing which participants are in the control group and which are in the treatment group. | |
Boilerplate paragraphIt is the small section at the end of the press release that provides some background information about the organisation or group, including what the group does, its mission and past accomplishments. It comes under the “Notes to Editor” section along with relevant links to the website and social media channels. | |
Bowed legsWhen the leg curves outward at the knee | |
BrandedDrugs that have been given a name by a company
for the purpose of advertising | |
Budget impactThe change in levels of spending because of a
decision | |
C |
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CandidateA drug that has been identified as having strong
therapeutic potential and will be taken into clinical trials | |
CarrierA person who is generally not affected with the condition (at that moment), but carries one faulty copy of a gene. | |
Clinical researchClinical research is any research that requires human participation. This could include giving biological samples (e.g. blood or tissue), answering health questionnaires, giving researchers access to medical records, or taking part in a clinical trial. | |
Clinical trialA clinical trial is any research study that assigns human participants to health-related interventions to evaluate the effects on health outcomes. | ||
ClinicianA medical professional that has direct contact
with patients | |
Co-morbidityThe presence of more than one disorder in the
same patient | |
Coding region | |
CohortA group of people with a shared characteristic | |
ComparatorThe alternative to the proposed treatment or
strategy | |
ComparatorsThe alternatives to the proposed treatment or
strategy. | |
Compound rescue | |
ConsentProviding permission for something to happen or
agreement to do something | |
Contract research organisationAny organisation that provides services relating
to clinical research, such as the development of medicines, clinical trials and
commercialisation | |
Control groupA control group in a clinical trial is given either an existing standard treatment or a placebo, to serve as a base line for the new medicine's effects to be tested against. | ||
Corporate Social ResponsibilityCorporate Social Responsibility (CSR) is the voluntary activities undertaken by a company to operate in an economic, social, and environmentally sustainable manner. | |
Cost of illness | |
Cost-consequence modelA model that details the costs and outcomes of
an intervention separately, without combining the two elements | |
Cost-effectivenessA measure of the value a new treatment provides by looking at the costs per unit of benefit. | |
Cost-effectivenessA measure of the value a new treatment provides by looking at the costs per unit of benefit. | |
Cost-effectiveness modelA model that compares the costs and benefits of two or more interventions | ||
Cost-utility modelA model type that measures health benefits in a
preference-based measure, such as quality-adjusted life years (QALYs) | |
CrowdfundingA way of raising funds by asking a large number
of people each for money | |
CrowdsourcingObtaining information or input into a
task/project by enlisting the help of a large number of people | |
D |
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Data integrityThe maintenance and assurance of the accuracy and consistency of data over its entire life cycle. | |
Data protectionAll personal information is protected in the UK by the Data Protection Act (1998). This means that researchers have to put in all the necessary safeguards to protect the confidentiality of the information they collect about research participants. They should explain the patient information sheet:
| |
Data Protection ActThe
Data Protection Act 2018 is the UK's implementation of EU General Data
Protection Regulation (GDPR), that controls how personal information is used by
organisations. | ||
De novo | |
Decision trees | |
DegenerativeCharacterised by progressive deterioration and loss of function in the organs or tissues | |
DemographicA particular sector of the population. | |
DiseaseA disorder of structure of function in an
organism | |
DNAA chemical substance which makes up the genes, and which contains the information needed for the body to work. | |
DosageThe amount of or frequency that a drug is given
in | |
DrugAny substance that causes a change in an
organism | |
Drug reformulation | |
Drug repositioning | |
Drug reprofiling | |
Drug repurposing | |
Drug target | |
DuplicationThe act or process of making an exact copy of something | |
E |
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EfficacyEfficacy refers to the ability of a medicine to provide a beneficial effect (a positive benefit/risk ratio) when studied in a clinical trial. When talking in terms of efficacy vs. effectiveness, effectiveness relates to how well a treatment works in the real world practice of medicine, as opposed to efficacy, which measures how well a treatment works in clinical trials or laboratory studies. | |
End of lifeTypes of terminal medical conditions that have become advanced, progressive and incurable. The criteria required to meet this description differ between decision makers across the different regions. | |
Endoplasmic reticulumA network of membranes within animal cells used to facilitate reactions | |
EndpointAn outcome relating to a change in biological
processes, sometimes measured to determine the effectiveness of an intervention | |
EthicsEthics is the name given to the code of practice based on a set of decent, fair, and moral principles and guidelines that researchers should abide by when conducting research. Any research that will seek to gain personal confidential information or to test a new intervention or treatment on people must get ethical approval from a Research Ethics Committee. | |
European Medicines AgencyThe body in the European Union that regulates the use of medicines across all EU states. | ||
European Reference NetworksVirtual
networks of healthcare providers across Europe that aim to facilitate
discussions on complex or rare conditions | ||
ExclusionNot everyone is applicable to take part in a clinical trial. Volunteers can be excluded for a number of reasons such as age, gender, type of condition, and other symptoms. | |
Expert testimonyTestimony about a scientific, technical, or professional issue given by a person qualified to testify because of familiarity with the subject or special training in the field. | |
ExtrapolateTo make a prediction about the future, using
existing trends. | |
G |
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GeneInformation needed for the body to work, stored in chemical form (DNA). | ||
Generic | |
GenomeAn organisms complete set of DNA | |
Genotyping | |
H |
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Health statea comprehensive description of an individual’s
health, including their quality of life and likely outcome of their condition
(known as a prognosis) | |
HeterogeneityHaving different characteristics and qualities | |
HeterogeneousA state of having different characteristics and qualities. | |
High-throughputThe automation of research such that experiments
can be conducted on a large scale with repetition | |
I |
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in silicoPerformed on computer or via computer simulation | |
in vitroWhen a study is performed with microorganisms,
cells or molecules outside of their normal biological context | |
in vivoWhen a study tests the effect of drugs on
whole, living organisms | |
InclusionNot everyone is applicable to take part in a clinical trial. Volunteers can be included for a number of reasons such as age, gender, type of condition, and other symptoms. | |
Incremental cost-effectiveness ratioA measure of the economic value of an intervention, in terms of costs and health benefits, compared with an alternative (comparator). It is usually the main output or result of an economic evaluation. | ||
Indication | |
Informed consentInformed consent requires trial participants to be provided with a clear explanation of the trial and associated risks and benefits to make a fully informed decision about participating. | |
Intellectual propertyDenotes ownership of an idea and can include
copyrights, patents and trademarks | |
InterventionA treatment option such as a drug, type of
surgery, or medical device. | |
InterventionA treatment option such as a drug, type of
surgery, or medical device | |
Inverted pyramid structureThe inverted pyramid is a writing style used by journalists which follows a standard format. In this pattern, the most important facts are presented at the beginning followed by additional information in the subsequent paragraphs. The opening paragraph answers the 5 W’s and 1 H: who, what, when, where, why, and how. | |
IsomerMolecules with identical formulas but distinct
structures | |
L |
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Lay (person)The term 'lay' means non-professional. In research, it refers to the people who are neither academic researchers nor health or social care professionals. | |
Licence | |
LicensedWhen a product has been given a marketing
authorisation (product licence) by a medicines regulator, meaning it can be
placed on the market | |
Literature reviewA comprehensive summary of previous research on a topic. | |
M |
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Market ExclusivityA fixed period of time during which similar
medicines for the same indication as the drug granted market exclusivity,
cannot be placed on the market. The EMA grant market exclusivity for a 10-year
period after the marketing authorisation of an orphan drug | |
Marketing authorisationThe approval to market a medicine in one,
several or all of the European Union Member States | |
Markov modelsA type of model that assumes that patients move between different health states through the course of their disease. These health states are associated with particular costs and quality of life levels, and the time spent in these health states determines the overall costs and benefits experienced by the patients. | |
MetaboliteAn intermediate or end product of metabolism | |
MiningLiterature mining is the process of extracting facts/data
from text in the scientific literature. Literature mining can generate new
hypotheses by scrutinising large numbers of publications | |
ModelA biological or computational system used to
simulate a disease or biological process, on which tests are done to describe
and explain phenomena that cannot be experienced directly | |
MoleculeA group of two or more atoms held together by
chemical bonds | |
Monotherapy | ||
Multi-omics | |
MutationA change in a gene. | |
N |
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National Institute for Health and Care ExcellencePublic organisation that develops medical guidelines
for health and care in England | ||
Natural historyA natural history study is a medical study of people who have, or are at risk of developing, a specific condition over an extended period of time. | |
NefariousTypically of an action or activity- wicked or criminal | |
NutriceuticalPharmaceutical alternative which claims physiological benefits | |
O |
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Off-labelOff-label use is when a drug is used for something other than for what it was approved. | |
On-label | |
Opportunity costThe cost in terms of the value of the treatment compared to the best alternative option that was not chosen. For example, if the NHS decided to spend
money on a new treatment for a rare disease, an opportunity cost would be that
the money spent on this new treatment could not be spent on anything else. | |
OrphanConditions that only affect a small group of patients. In the European Union (EU), the European Medicines Agency (EMA) defines this as a condition affecting fewer than 1 in 2,000 individuals (European Medicines Agency, 2015). | |
Orphan diseaseAnother term for rare disease. They are conditions that only affect a small group of patients. In the European Union (EU), the European Medicines Agency (EMA) defines this as a condition affecting fewer than 1 in 2,000 individuals (European Medicines Agency, 2015) | |
Orphan drugA medicine developed for a rare disease. | |
OrphanetAn online portal containing information related to rare diseases, orphan drugs, patient organisations, professionals and institutions, research projects, clinical trials, biobanks and expert centres. | |
OutcomeA broad term often used to describe a variety of
results from trials | |
Outcome measuresOutcomes measures are measurements of the effects of a treatment or service. They might include physical measurements - for example measuring blood pressure - or psychological measurements - for example measuring people's sense of well-being. So if someone takes part in research, they may be asked questions or may be asked to have extra tests to assess how well the treatment or service has worked. | |
OutcomesA broad term often used to describe a variety of results from trials | |
P |
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PaediatricThe branch of medicine that involves the care of
infants, children and adolescents | |
ParticipantA participant is someone who takes part in a research project. Sometimes participants are referred to as research "subjects". | |
Participatory researchThis is a type of research where researchers and people who use services or carers are partners in a research project. The research addresses an issue of importance to service users or carers, who are involved in the design and conduct of the research, and the way the findings are made available. The aim of the research is to improve people's lives. This is not a research method - it's an approach to research, a philosophy. | |
PatentA form of intellectual property that gives the
producer of a drug the legal right to exclude others from making, using or
selling the drug | ||
Pathways | |
Patient groupAn organisation set up to represent the views of
patients and families around all issues relating to a condition, from
diagnosis, care and management, and treatment. | |
Patient information sheetResearchers must provide a patient information sheet to everyone they invite to take part in a research study, to ensure people can make an informed decision about this. The sheet explains what taking part will involve and should include details about:
| |
Patient registryA
patient registry is a centralised database that systematically collects
information about people who are affected by a particular condition or have
specific interactions with a health service. | ||
Patient reported outcomeA
health outcome directly reported by the patient who experienced it | ||
Peer reviewPeer reviewing is where a research proposal or a report of research is read and commented on by people with similar interests and expertise to those who wrote the proposal or report. Peer reviewers might be members of the public, researchers, or other professionals. Peer review helps to check the quality of a report or research proposal. Members of the public who act as peer reviewers may choose to comment on:
| |
PerspectiveThe point of view that an analysis is conducted
from. | |
Pharmaceutical companyA pharmaceutical company is a company that develops, produces, and markets drugs for use as medications. | |
PharmacoepidemiologyThe
study of the use and effect of drugs in a well-defined, large population | |
PharmacokineticsThe study of how a drug enters, moves through
and leaves the body. This can include its absorption, distribution, breakdown
and excretion | ||
PharmacovigilanceThe
practice of monitoring the effects of medical drugs after they have been
licensed to identify previously unreported adverse reactions | |
PhaseClinical trial programmes are divided into
different stages, called phases. There are three main phases where Phase I
trials typically involve testing a drug on a small number of healthy volunteers
to assess safety, Phase II trials are testing on a small number of patients to
assess the efficacy and Phase III allow this to be scaled up to much larger
numbers | |
PhenotypeThe set of observable characteristics in a living organism | |
PhenotypingThe full set of an individual's observable characteristics reflecting genetic inheritance, genetic mutations, and environmental influences. Phenotypic data can include the results of clinical tests, scans, and descriptions. | |
Pilot studyA small scale preliminary study to evaluate the
feasibility, duration, cost and side effects prior to embarking on a full-scale
research project | |
PlaceboA placebo is an inactive medicine which has no treatment value. | |
Pre-clinical researchPre-clinical research is essentially all medical research that does not require human participation. To name but a few methods, researchers can use bacteria, yeast, animal models, and computational models to investigate human health. | |
PreclinicalA stage of research that begins before a
first-in-man clinical study, during which feasibility and drug safety data are
collected. Preclinical studies are required before clinical trials can be
started | |
Predatory price hikesWhen marketing authorisation has not been
secured for a drug by a company, it is possible for another organisation to buy
the drug and drastically increase the price at which it is sold | |
PreferencesA greater liking for one option over another | |
Press releaseA press release is an essential communication tool that is used to get your message across to the media in one fell swoop. It follows the structure of a typical news story including relevant quotes and 5 Ws and 1 H (who? what? Where? When? Why? and how?). Whether you want to announce a fundraising event, launching an awareness campaign, promoting an accomplishment or engaging in any clinical trial/research programme, a press release can be used to get the right publicity. | |
PrevalenceThe proportion of a chosen population that are
affected by a single disease. | |
Pro-drugA biologically inactive compound which can be
metabolised in the body to produce a drug | |
Product registryRegistries set up to collect information related to pharmacovigilance. They are different to patient registries as they only include people taking the medicine in question and only collect information on the drug’s effects. | |
ProductivityThe extent to which an individual can work
effectively. | |
ProliferativeTo increase or spread at a rapid rate | |
ProtocolA protocol is the plan for a piece of research. It usually includes information about:
A protocol describes in great detail what the researchers will do during the research. Usually, it cannot be changed without going back to a research ethics committee for approval. | |
PseudonymisedPseudonymisation is a process that removes or replaces information that identifies an individual within a data set. This may involve replacing names or other identifiers with a less easily recognisable reference number. | |
PsychosomaticA condition caused or aggravated by a mental factor such as internal conflict or stress | |
Q |
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QualitativeMeasured by the quality of something rather than its quantity | |
Qualitative researchQualitative research is used to explore and understand people's beliefs, experiences, attitudes, or behaviours. It asks questions about how and why a "quality" is being measured by the research. Often the term "holistic" is used, meaning that the complexities of human behaviour are preserved in the study. Qualitative research might ask questions about why people want to stop smoking. It would not ask how many people have tried to stop smoking. It does not collect data in the form of numbers. Qualitative researchers use methods like focus groups and interviews. | |
Quality-adjusted life yearA numerical measurement that combines quality of life and life expectancy | ||
Quality-adjusted life yearsa
numerical measurement that combines quality of life and life expectancy | ||
QuantitativeMeasured by the quantity of something rather than its quality | |
Quantitative researchIn quantitative research, researchers collect data in the form of numbers. So they measure things or count things a "quantity" is being measured. Quantitative research might ask a question like how many people visit their GP each year, or what proportion of children have had an MMR vaccine, or whether a new drug lowers blood pressure more than drugs that are usually used. Quantitative researchers use methods like surveys and clinical trials. | |
R |
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RandomisationRandomisation randomly assigns patients to a control group or treatment group in clincial trials. It removed bias from trials, which could make the test unreliable. | |
RapportuerA person who is appointed by an organisation to report on the proceedings of its meetings. | |
Rare diseaseThe EU defines a condition as 'rare' if it affects less than 1 in 2000 people. | |
RegistriesA collection of information about individuals. | |
ReimbursementFollowing regulatory approval, a reimbursement
body will decide whether the manufacturer will be paid the cost of the drug,
based on a cost-effectiveness calculation. In the UK, the National Institute
for Health and Care Excellence (NICE) decide whether a drug will be reimbursed,
i.e. whether the NHS will fund patients' treatments | |
RemissionThe reduction or disappearance of the signs and
symptoms of a disease | |
Research Ethics CommitteeGroups of professionals and service users who review the ethical considerations of research studies. | |
Restricted fundingFunding provided to a charitable organisation with restrictions around its use to a specific project. | |
S |
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Scenarios | |
Sensitive dataUnder General Data Protection Regulation (GDPR),
health data are considered sensitive data and are therefore subject to specific
processing conditions | |
Sensitivity analyses | |
ShelvedA drug for which development has been halted,
sometimes because tests are not successful, but often because pursuing them simply does not present a tangible business opportunity | |
SponsorIn the conduct of a clinical trial, the sponsor
is an individual or organisation that takes responsibility to initiate, manage
or finance the clinical trial, but does not actually conduct the investigation | |
StatureA person's natural height | |
SynthesisThe preparation of a drug/compound from its
chemical components | |
Systematic reviewSystematic reviews aim to bring together the results of all studies addressing a particular research question that have been carried out around the world. They provide a comprehensive and unbiased summary of the research. For example, one clinical trial may not give a clear answer about the effectiveness of a treatment. This might be because the difference between the treatments being tested was very small, or because only a small number of people took part in the trial. So systematic reviews are used to bring the results of a number of similar trials together, to piece together and assess the quality of all the evidence. Combining the results from a number of trials may give a clearer picture. | |
T |
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Time horizonThe length of time that is examined in a model,
typically in terms of years. | |
Translational researchThe process of turning research findings and discoveries into practical applications that are of benefit to patients. | |
Treatment pathwayThe procedures for treatment of an illness. This
will often take the form of a decision tree, which includes all the possible
outcomes for a medical condition and all the appropriate elements of care a
patient would receive at each stage. | |
U |
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Ultra-orphanConditions that only affect an even smaller group of patients than orphan diseases, typically affecting fewer than 1 in 50,000 individuals (All Wales Medicines Strategy Group, 2015). | |
Umbrella RegistryRegistries
that are set up for multiple conditions that a particular rare disease could
fit into | |
Unrestricted fundingFunding provided to a charitable organisation without any restricted around its use. | |
Utility valuesUtilities are used to represent the strength of an individual's preferences for different health states | |
Social networks