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Glossary- Clinical Trials Terminology – Q to S
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Glossary- Clinical Trials Terminology – Q to S
Q
quality assurance (QA) 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 good clinical practice (GCP) and the applicable regulatory requirement(s)
quality control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trialrelated activities have been fulfilled
R
random allocation Assignment of subjects to treatment (or control) groups in an unpredictable way. Assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience
randomization 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
raw data Records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations
recruitment (subjects) Process used by investigators to enroll appropriate subjects into a clinical study, i.e., those selected on the basis of the protocol’s inclusion and exclusion criteria.
recruitment period Time period during which investigators must complete enrollment of their quota of subjects for a trial.
recruitment target Number of subjects that must be recruited into a study to meet the requirements of the study protocol. In multicenter studies, each investigator has a recruitment target.
regulatory authorities Bodies having the power to regulate. In the ICH GCP guideline the expression “regulatory authorities” includes the authorities that review submitted clinical data and those that conduct inspections. These
bodies are sometimes referred to as competent authorities
risk In clinical trials, the probability of harm or discomfort for subjects. Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of side effects. However, unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
S
safety Relative freedom from harm; in clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects
serious adverse event (SAE) or serious adverse drug reaction (serious ADR) Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
single-blind study One in which subjects do not know whether they are receiving the active drug or a placebo.
source data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies)
source documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
statistical significance State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say “significant at the 5% level.”
This implies that a level of significance has been applied such that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it and/or that the observed result has led to rejection of the null hypothesis.
subject/trial subject An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control
USFDA approves first Clinical Trial on Zika Vaccine
The US Food and Drug Administration (FDA) has approved the first human tests of an experimental Zika virus vaccine, the makers of the drug announced on Monday.
Called GLS–5700, the medication will be used in a clinical trial involving 40 healthy people, and represents the first major step towards ultimately immunising people against Zika – which was declared a global public health emergency by the World Health Organisation (WHO) in February.
“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” said J. Joseph Kim, president and CEO of US-based Inovio Pharmaceuticals, which is developing the vaccine with South Korean partner, GeneOne Life Science. “We plan to dose our first subjects in the next weeks and expect to report phase 1 interim results later this year.”
GLS–5700 works by stimulating the body’s immune system to defend itself against Zika. Synthetic fragments of viral DNA are injected into the skin, prompting the immune system’s T cells to generate antibodies to fight the infection.
The news of the vaccine trial comes two months after the US Centres for Disease Control and Prevention (CDC) confirmed the causative link between the infection and birth defects such as microcephaly, and represents the culmination of an intense nine months of vaccine development, during which global fears over Zika’s spread have only grown.
“As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus,” said Kim. “[T]he incidences of viral infection and medical conditions caused by the virus are expanding, not contracting.”
It’s worth pointing out that just because GLS–5700 has reached human testing, there’s no guarantee it will turn out to safely immunise people against Zika. The vaccine has been tested successfully in small and large animal models, but clinical trials in humans could take several years to demonstrate that the treatment is safe, and there’s no guarantee it will ultimately prove effective or make it through subsequent testing phases.
But fortunately, GLS–5700 isn’t the only Zika vaccine candidate currently in development. An Indian company called Bharat Biotech is researching Zika vaccine development in animals, while French pharmaceutical company Sanofi SA is expected to begin human trials with one of its drugs later this year.
In the US, the National Institute of Allergy and Infectious Diseases (NIAID) says it’s expecting to shortly receive FDA approval to trial a separate vaccine candidate it developed itself, which would mean we could have two vaccines in human testing in a matter of weeks.
Earlier in the month, scientists from the University of Texas Medical Centre published findings on how a protein called interferon-induced protein 3 could help reduce Zika’s ability to infect brain cells – although clinical trials may be a while away for that particular treatment.
Even though there’s a huge amount of hurdles and potential roadblocks facing all of these vaccine trials, there’s reason to have hope.
“Always, the first vaccine to go into clinical trial is important,” epidemiologist Anna Durbin from Johns Hopkins University, who is involved with the NIAID vaccine effort, told Jessica Glenza at The Guardian.
“It means the FDA has reviewed it, and I’m sure is formulating questions and getting ready for additional candidates to submit their investigational drug applications,” she added. “It shows progress and momentum, and we just need to keep momentum going.”
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Types of Clinical Trials – Based on Study Design
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Types of Clinical Trials – Based on Study Design
CASE-CONTROL STUDY:
This type of study identifies people with a disease (or another variable of interest) and compares them with an appropriate control group which does not have the disease.
An examination is made, comparing the frequency of exposure to this or other factors between the cases and the controls.
It is an analytical observational study which enables the cause-effect relationship to be followed.
If the frequency of exposure or the cause is greater in the group of cases with the disease than in the control group, we can say that there is an association between the cause and effect.
The measurement of the association which quantifies this association is called the “odds ratio“(OR).
In medicine, a case-control study is a cross-sectional type of study which is used to research the etiology of a disease or a given result.
Study in which people with a certain disease or symptom (cases) are compared with others who do not present the disease or symptom under study (controls), with regard to prior exposure to risk factors.
This has been incorrectly called Retrospective Study.
In a case-control study, a single disease but various risk factors or exposures are examined.
COHORT STUDY:
Epidemiology adopted this term to refer to the idea of a simultaneous advancement, in time, of a group of individuals defined for possessing a common characteristic or group of characteristics.
The common characteristic is usually exposure to a factor (environmental, pharmacological, occupational, etc).
The term “cohort” is used to designate a group of subjects with a common characteristic or group of characteristics who are monitored over a period of time.
It is an observational, analytical and longitudinal study in which two cohorts differing with regard to the exposure to the factor under study are compared in order to assess a possible cause-effect relationship.
Study in which people subjected to a certain exposure or treatment are compared with people who are not subjected or exposed.
LONGITUDINAL STUDIES:
These are studies in which there is a time lapse between the different variables, so that a time sequence can be established between them.
They can be both descriptive and analytical.
In analytical studies, it should be taken into account whether the time sequence is from the cause to the outcome (experimental studies and cohort studies), or from the outcome to the cause (case-control studies).
Any study not focused on an alleged cause-effect relationship, but whose data is used for purely descriptive purposes is considered descriptive.
This type of study is useful for generating etiological hypotheses which should subsequently be contrasted with analytical studies.
Any study which evaluates an alleged cause-effect relationship is considered analytical.
The alleged causal agent may be a factor which is suspected of being able to lead etiologically to a disease or a treatment to prevent or improve a clinical situation.
CROSS-SECTIONAL STUDIES:
These are studies in which the data of each subject represents essentially a moment of time.
This data may correspond to the presence, absence or different degrees of a characteristic or disease.
It consists of examining the relationship between different variables in a defined population at a specific moment in time.
These designs do not permit the study of an alleged cause-effect relationship.
Cross-sectional studies are descriptive by definition.
Epidemiological strategy in which observations of numerous factors at the same time are recorded and then a comparison is made between them.
The presence or absence of a disease or other variables (or, if they are quantitative, their level) are determined in each subject.
The analysis of the results can be made in two senses: by comparing all the variables in the individuals who suffer from the disease being studied, comparing them with those who do not suffer from it, or by comparing the prevalence of the disease in different subgroups of the population.
Types of Clinical Research – Based on Investigational Product
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Types of Clinical Trials – Based on Investigational Product.
Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
In simple terms – Investigational Product or IP is the medicine/treatment on which a clinical trial is conducted. Based on what Investigational Product is used, clinical trials can be classified as follows.
Chemical Entity Clinical Trials.
These are clinical trials conducted on Allopathy medicines. Chemical Entities can be NCE (New Chemical Entity) which means a newly discovered Allopathy medicine. They can also be FDC (Fixed Dose Combination) i.e. combinations of various drugs in one tablet – multiaction tablets.
Medical Devices Clinical Trials.
As per CDSCO, Medical Devices can be classified as follows based on risk.
Class A: Low Risk: Eg: Thermometers, Tongue depressors.
Class B: Low-Moderate Risk: Eg: Hypodermic needles.
Class C: Moderate -High Risk: Eg: Bone fixation Plate
Class D: High Risk: Eg: Heart Valves, Defibrillators, Stents.
Clinical trials on medical devices are predominantly conducted for BIOCOMPATABILITY – how the human body reacts or accepts a foreign body which is intending to diagnose, treat or manage a disease or disorder.
AYUSH Clinical Trials:
Clinical trials on Ayurveda, Siddha, Homeopathy, Naturopathy, can be done on both medicines, cosmetics and even supplements.
Vaccine Clinical Trials:
Vaccine clinical trials can be of two types.
Prophylactic: Developing a new vaccine and doing clinical trial on the vaccine to verify if it prevents a disease or disorder.
Therapeutic: Sometimes attentuated vaccines maybe given as a way of boosting the body’s immune system against a particular disease.
Biologics Clinical Trials:
Clinical trials on medicines or treatments that are derived from biological sources. Eg: Stem cells, Monoclonal antibodies, gene therapy etc.
Clinical Trials on Treatment Systems:
Clinical trials may be done to verify the efficacy and safety of a change in a particular treatment modality. Eg: A new surgical methodology development, cross interaction treatments between different systems of medicine or even developing new treatment systems such as acupressure, acupuncture etc.
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