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A

Adjuvant therapy: Treatment given in addition to the main treatment (for example, chemotherapy as well as surgery).

Adverse drug reaction (ADR): An unintended reaction to a medicinal product, where there is the least possibility of the medicinal product causing the reaction.

Alternative therapies: Treatments which patients may opt for outside of standard orthodox treatments.

Antibodies: Blood proteins that are produced by white blood cells when the body recognises that something unfamiliar – for example, infecting bacteria. The antibodies attach themselves to the invading bacteria or viruses, which are then destroyed.

Antiemetic: An anti-sickness drug.

Antioxidants: Substances that prevent chemical reactions (oxidation) that damage body cells and may lead them to become cancerous.

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B

Benign: Not cancerous.

Best supportive care: Care is aimed at relieving symptoms of disease when there is no standard treatment.

Biopsy: A piece of body tissue taken so that the cells can be examined under a microscope.

Blinding: When one or more parties (patient and/or doctor) are kept unaware of the treatment that has been assigned in a trial so that person preference cannot influence results. Single blinding usually means the participant is unaware, while double blinding means that the participant and research team are all unaware.

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Caldicott Guardian: Caldicott Guardians are responsible for agreeing and reviewing internal protocols governing the protection and use of patient-identifiable information by the staff of their Trust. (4)

Clinical trial: Clinical trials are research studies involving patients which compare a different type of medical care with the best treatment or treatments currently available.

Combination therapy: The use of two or more types of treatment.

Common toxicity criteria (NCI-CTC): Guidelines for grading side effects that participants in trials may experience.

Complementary therapies: Supportive therapies that can be used alongside conventional treatment.

Compliance: How closely patients follow the study protocol.

Controlled trial: Involving a comparison of at least two treatment regimens one of which is termed a control.

Crossover design: A study where each subject receives (in a random sequence) each study medication. After receiving treatment A they are ‘crossed over’ to receive treatment B (or vice versa).

Cross-sectional study: The observation of a defined population at a single point in time or time interval. Exposure and outcome are determined simultaneously.

Cytotoxic: Cytotoxic treatments are those that are directly toxic to cells, preventing their reproduction or growth. Cytotoxic agents can, as a side effect, damage healthy, noncancerous tissues or organs which have a high proportion of actively dividing cells, for example, bone marrow and hair follicles. These side effects limit the amount and frequency of drug administration.

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D

DNA: Deoxyribonucleic acid. Genes are made of DNA. DNA is the ‘genetic code’ that controls how cells behave by controlling the type of protein they make.

Dose response: The amount of the investigated treatment needed to estimate the correct dose required of experimental treatment to give the desired effect to the patient.

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Efficacy: Refers to whether the intervention worked or not in those patients who received it.

Endpoint: The issue being looked at to measure which treatment is the most effective, e.g. survival, time to progression.

Ethics committees: A group of professional and consumer experts that review the ethical considerations of research involving human participants. All clinical research must be submitted to this committee and approval sought before the research can begin.

Exclusion criteria: Specified restrictive controls on the recruitment of particular patient sub-groups that are not eligible to participate in the study.

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Factorial design: A study that compares two (or more) different sets of interventions. The simplest design uses Drug A versus Placebo A and Drug B versus Placebo B. Subjects are randomised to one of four groups: Placebo A + Placebo B, Drug A + Placebo B, Placebo A + Drug A or Drug A + Drug B. This is a very efficient type of study because it not only allows assessment of Drug A and Drug B in one study instead of two but also allows us to investigate the question of whether drugs A and B show any interaction.

Feasibility study: A small preliminary study to assess the practicalities of doing a larger study. Also called a Pilot Study.

First line treatment: The preferred therapy for a given condition.

Follow-up data: Information collected after patients have been entered into a trial.

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G

Good Clinical Practice (GCP): A systematically developed statement designed to assist practitioner and patient make decisions about appropriate health care in specific clinical circumstances. The development of these guidelines is based on the World Medical Association Declaration of Helsinki.

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H

Historical controls: Groups of patients treated in the past that are used as comparisons in the present.

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I

ICH-Good Clinical Practice (GCP): International Conference on Harmonisation-Good Clinical Practice is an international ethical and scientific quality standard for designing , conduction, recording and reporting trials that involve the participation of human subjects. 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. See http://www.doh.gov.uk/research/document/gcpguide.pdf (4)

Inclusion criteria: Inclusion criteria define the particular patient sub groups who are eligible to take part in the study.

Independent Data Monitoring Committee (IDMC): A committee that meets at intervals looks at the progress of a trial, the safety data and endpoints. It can recommend whether the trial should be continued, modified or stopped.

Informed consent: The process that enables patients to make a choice or state a preference about the treatment on offer.

Interaction: When one variable affects other variables differently (for example, the effects of a drug may be different in males and females).

Intervention: The treatment, therapy or compound under investigation.
Investigational product: The product being tested or used as a reference in a clinical trial.

Investigator brochure: The document produced by the sponsor detailing all of the required pre-clinical information, toxicology, safety and side effects of the drug. This data is collated from previous studies.

Investigator: The person who has overall responsibility for the recruitment and data handling within a centre. This person may be called the principal investigator, chief investigator, lead investigator or local investigator. This may depend on the overall role of the investigator within the trial. The investigator is usually a qualified medical practitioner and has a role that includes a clinical obligation as well as a scientific commitment.

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L

Lost to follow-up: When patients can no longer be followed up for the planned period of time.

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M

Malignant: Cancerous. The opposite of benign.

Marker: A chemical substance produced by a cancer and used to monitor the progress of the disease. Usually measured by a blood test.

Maximum Tolerated Dose (MTD): The largest dose of a medicinal product that has been found, usually from Phase I and II trials to be safe in humans.

Monitoring: The process of overseeing the conduct of a trial, ensuring it complies with Good Clinical Practice (GCP).

Multicentre: When things are done in more than one centre or geographical site.

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O

Outcomes: Measurements of change occurring as a result of an intervention.

Overviews and meta-analyses: These are analyses that bring together the results of a large number of similar studies. In doing this, doctors and researchers can try to get more accurate answers than from individual trials. They may help to clarify the true value of a treatment and they may also help to identify other important questions that need to be answered. Overviews and meta-analyses do not involve more patients: they analyse the information gained from previous trials.

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P

Parallel group design: The most common trial design where participants are allocated, usually randomly, to receive a particular intervention, and the results of the interventions compared.

Pharmacodynamic: The action of a drug in the body over a period of time.

Pharmacokinetic: The way a drug is processed in the body over a period of time.

Pharmacovigilance: The proactive monitoring and reporting on the quality, safety and efficacy of drugs.

Phase I studies: These studies have small numbers of patients. The trials aim to find out how much of a treatment can be given without causing serious side effects.

Phase II studies: These trials look at whether a treatment has any effectiveness and which types of cancer it might be useful for.

Phase III studies: The main aim is to compare the effectiveness and safety of a treatment with current treatments. These trials are large and usually include hundreds or thousands of patients.

Phase IV studies: These studies are carried out after registration of a product. They are often for marketing purposes as well as to gain broader experience with using the new product.

Placebo: In situations where there is no standard treatment to compare with the trial treatment, patients may be given a placebo. The placebo looks like the real drug but is inactive. Placebos can also be used in situations where a therapy is being added to the standard treatment to see whether this gives better results. One group of people will be given the standard treatment plus the trial therapy and one group of people will be given the standard treatment plus a placebo.

Population: The group of people being studied.

Primary endpoint: The most important outcome measure in a study.

Prospective follow-up study: A study where patients with specific characteristics are identified and followed up.

Protocol: A formally written, step-by-step guide to the study. It should include all of the appropriate information for the study. A well designed and written study protocol should provide anyone new reading it with all the operational information to run the study.

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R

Randomisation: The process of assigning trial participants to treatment or control groups using an element of chance, e.g. automated computer programme.

Randomised Controlled Trials (RCT): A trial where a computer randomly allocates patients to one or other of the treatment groups in the trial. A ‘control’ is something with which to compare the treatment being tested. Usually the control will be the standard treatment.

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S

Sample size: The number of patients needed in a study to make a statistically significant result likely in a given period.

Screening: The process of determining if individuals meet certain criteria. This may be done to see if patients are eligible to take part in a study.

Secondary endpoint(s): Other less important outcome measures in a study than the primary endpoint.

Serious Adverse Event (SAE) or serious Adverse Drug Reaction (Serious ADR): Any medical occurrence that requires hospitalisation, is life-threatening, results in a congenital anomaly/birth defect, significant disability/incapacity or death.

Site file: The document used to store all of the material relevant to the trial except patient data.

Source data: Refers to the original recording of data of a patient. This may be part of the patient case records or notes.

Sponsor: An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.

Standard Treatment: The usual treatment given for a specific illness. This will be the control arm of a trial.

Stratification: A means of carrying out the randomisation within demographic strata of the trial population. For example, a separate randomisation list may be kept for male and female patients in order to ensure that there is balance of sexes within the treatment groups.

Study arm: One part of a study. Patients in different arms are randomised to receive different treatments.

Sub-group: A separate part of the study population – for example, all females over 60
years of age.

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T

Therapeutic study: A trial of an intervention that may have clinical benefit.

Toxicity: Refers to the undesired effects of the treatment under investigation, e.g. nausea.

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U

Unblinding: When the treatment assignments of trial participants is revealed to those groups who until that point had been blinded to this information.

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