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Terms Abbrv. Definition Remarks
Matched-pair Design A type of parallel trial design in which investigators identify pairs of subjects who are “identical” with respect to relevant factors, then randomize them so that one receives Treatment A and the other Treatment B.
Medical Research Ethics Committee MREC Conducts scientific and ethical assessment of all health research conducted by the MOH, researchers and non-MOH researchers utilizing facilities and resources of MOH.2 It is responsible to operate under the authority of the Deputy General of Health Malaysia and operates in accordance to ICH GCP guidelines.
Mega Trials Massive randomized clinical trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects. Synonym: large sample trials.
Meta-analysis Systematic methods that use statistical techniques for combining results from similar studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This type of analysis is typically hypothesis generating
Minimal Risk The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or physiological examinations or tests.
Ministry of Health MOH Ministry of Health Malaysia
Monitor Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor’s duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study. See also CRA.
Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedure (SOPs) Good Clinical Practice(GCP), and the applicable regulatory requirement(s)
Monitoring Report A written report form the monitor to the sponsor after each site visit and/or other trial related communication according to the sponsor’s SOPs.
Multicentre Trial Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
Multiple Project Assurance Permit given to institution for multiple federally funded research grants for a specified period of time. States institution retains responsibility for all research involving humans and that the institution must have an established IRB.
Multiple-rising dose study See Dose-Ranging Study
National Committee for Clinical Research NCCR A committee established for the purpose of coordinating and promoting clinical research in Malaysia, chaired by the Deputy Director of Health (Research & Technical Support), Ministry of Health (MOH)
National Institute of Health NIH Agency within the Department of Health and Human Services that funds research, conducts studies, and funds multicenter national studies. Malaysia?
New Drug Application NDA An application submitted by a sponsor to the FDA for approval to market a new drug (a new, non-biological molecular entity) for human use in interstate commerce in the United States. Malaysia?
n-of-1 Study A trial in which an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment’s effect in that person, often with the order of experimental and control treatments randomized.
Non-clinical Study Biomedical studies not performed on human subjects
Nuremberg Code As a result of the medical experimentation conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.
Objective Measurement A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment.
Observational Study An epidemiologic study that does not involve any intervention, experimental or otherwise. Such a study may be one in which nature is allowed to take its course, with changes in one characteristic being studied in relation to changes in other characteristics. Analytical epidemiologic methods, such as case-control and cohort study designs, are properly called observational epidemiology because the investigator is observing without intervention other than to record, classify, count, and statistically analyze results.
Off-Label Use A drug prescribed for conditions other than those approved by a country’s regulatory agency.
Open-Label Trial A clinical trial in which doctors and participants know which drug or vaccine is being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies.
Opinion The judgment and/or the advice provided by an Independent Ethics Committee (IEC)
Original Medical Record See Source Documents
Orphan Drugs A drug category that refers to medications used to treat rare diseases and conditions. Orphan drug status, provides a manufacturer specific incentives (i.e. tax advantages and extended marketing exclusivity) to develop and bring such treatments to market.
Outcomes Trial/Study An outcomes trial evaluates the effect of a treatment on patients. Treatments may include medications or other therapies and outcomes may include changes in disease status, morbidity or mortality.
Over-the-Counter OTC Drugs available for purchase without a physician’s prescription.
Parallel Study A parallel designed clinical trial compares the results of a treatment on two separate groups of patients. The sample size calculated for a parallel design can be used for any study where two groups are being compared.
Patient Individual seeking medical care
Patient file One that contains demographic, medical, and treatment information about a patient or subject. It may be paper-based or a mixture of computer and paper records.
Patient Reported Outcome PRO Report coming directly from patients or subjects through interviews or self completed questionnaires or other data capture tools such as diaries about their life, health condition(s) and treatment. NOTE: PROs are used to assess outcomes involving the patients’/subjects’ perceptions, symptoms, satisfaction with treatment, adherence to prescribed regimens. Historically observations on patients have been made by observers, which has produced scientific records lacking high quality data on subjective symptom intensity, perceived benefit, etc. PROs include outcomes recorded by interviewers transcribing the views expressed by the patient, but the term does not apply to outcomes recorded by observers who rely on their own judgment.
Peer Review Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.
Period Effect An apparent or real effect of passing through a period of time designated during the course of a trial in which subjects are observed and no treatment is administered.
Pharmacokinetics The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
Pharmacology The study of how drugs interact with living organisms to produce a change in function. Pharmacology deals with how drugs interact within biological systems to affect function.
Pharmacovigilance The science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identify new information about hazards associated with medicines and preventing harm to patients
Phase 1 Clinical Trial Sometimes called dosing studies, these trials may test methods of administering the treatment (e.g. by mouth, injection, etc.) and how often, as well as the safety of the treatment. These trials usually involve a small number of healthy participants (20-80).
Phase 2 Clinical Trial These trials continue to test the safety of the treatment and evaluate how well the treatment works. Phase 2 studies usually evaluate the treatment in a specific condition. These trials usually involve 100-300 patients.
Phase 3 Clinical Trial These trials compare the new treatment to the current standard of treatment for a specific condition, establishing both efficacy and adverse events. Participants are usually assigned to either receive the new treatment or the current standard. Phase 3 trials typically enroll large numbers of patients (1,000-3,000 or many more) and may be carried out at hospitals and doctors’ offices nationwide
Phase 4 Clinical Trial Post-marketing studies to gain a greater understanding of the treatment, including its risks, benefits, and optimal use.
Pivotal Study A study, usually Phase 3, which presents the data used by regulatory agencies to decide whether to approve a drug. A pivotal study will generally be well controlled, randomized, and whenever possible, double-blind.
Placebo A placebo is an inactive pill, liquid or powder that has no treatment value. In clinical trials, a placebo is administered instead of an active drug or experimental treatment to assess the experimental treatment’s effectiveness.
Placebo Controlled Study A method of drug investigation in which an inactive substance (a placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective than the placebo in treating the condition.
Placebo Effect A physical or emotional change, occurring after an inactive substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance
Planned Emergency Research Use Research conducted in a setting in which an inability to obtain informed consent can be anticipated, such as research conducted In a trauma unit.
Preclinical Studies/ Preclinical Testing Experiments performed in the laboratory and in animals to study a drug before it is tested in humans. Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe.
Prevention Trials Conducted to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Principal Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator who is the responsible leader of the team may be called the principal investigator.
Prospective Study A prospective study identifies subjects, applies a treatment and follows them over time to measure their progress/outcomes relative to a predetermined set of criteria or endpoints.
Protection of Pupil Rights Amendment PPRA Department of Education regulation that states that surveys, questionnaires and instructional materials for school children must be inspected by parents/guardians.
Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol and protocol amendments / A protocol is the study plan on which a clinical trial is based. Each trial is carefully designed to safeguard the health of participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications, dosages, and length of the study.
Protocol Amendment A written description of a change(s) to or formal clarification of a protocol.
Proxy A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures.
Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO) directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. Proxy outcomes seem to be part of the outcomes literature with a consistent meaning.
Psychometric The science of assessing the measurement characteristics of scales that assess human psychological characteristics.
Psychometric validation The specialized process of validating questionnaires used in outcomes
research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, face validity means that an assessment instrument appears by inspection and consideration of the semantic content of items in it to be measuring what it is supposed to measure. Construct validity means that a scale based on one or more items measures an unobservable psychological construct (e.g., “distress”) that it is proposed to measure. Construct validity is usually tested by measuring the correlation in assessments obtained from several scales purported to measure the same construct.
P-value A p-value demonstrates the likelihood that sample data do not adequately represent the population from which they were drawn. The accepted standard for a statistically significant p-value is <0.05, meaning that the likelihood that the result could occur by random chance is less than 5 in a hundred.