What does complete remission mean?
The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.
What is the difference between aliquot and subsample?
See Subsample . Aliquot: a subsample derived by a divisor that divides a sample into a number of equal parts and leaves no remainder; a subsample resulting from such a division. In analytical chemistry the term aliquot is generally used to define any representative portion of the sample.
What is seamless design in clinical trials?
There is also growing interest in developing a type of continuous trial process by “connecting” different trial phases, especially from Phase II to Phase III, called seamless design. Scientists combine the learning stage of Phase II trials and confirmatory stage of Phase III trials.
What is the process of investigating new treatments?
In order to sequentially investigate safety and then efficacy and effectiveness issues in a manner that protects human subjects from harm, the process of investigating new treatments typically goes through a phased series of clinical trials.
What is treatment randomization?
Clinical trial randomization is the process of assigning patients by chance to groups that receive different treatments. In the simplest trial design, the investigational group receives the new treatment and the control group receives standard therapy.
What is treatment in CRD?
A completely randomized design (CRD) is one where the treatments are assigned completely at random so that each experimental unit has the same chance of receiving any one treatment. For the CRD, any difference among experimental units receiving the same treatment is considered as experimental error.
What is treatment allocation?
Treatment allocation in a clinical trial can be randomized or nonrandomized. Nonrandomized schemes, such as investigator-selected treatment assignments, are susceptible to large biases. Even nonrandomized schemes that are systematic, such as alternating treatments, are susceptible to discovery and could lead to bias.
What is treatment and replication?
Randomisation: the random allocation of treatments to the experimental units. Randomize to avoid confounding between treatment effects and other unknown effects. Replication: the repetition of a treatment within an experiment allows: To quantify the natural variation between experimental units.
What is CRD and RBD?
In CRD the treatments are assigned completely and randomly so that the experimental unit get the same chance of receiving any one treatment. In CRD there is no Local control. RBD is the pressure of blocks of equal size which contain all the treatments. There is Replication, Randomization and Local Control.
What is CRD model?
Description of the Design. -Simplest design to use. -Design can be used when experimental units are essentially homogeneous. -Because of the homogeneity requirement, it may be difficult to use this design for field experiments.
What does allocation mean in a clinical trial?
Allocation methods, such as the ones described above, are used to assign participants to two or more study groups (e.g., treatment and control groups).
What is allocation in a clinical trial?
Allocation sequence - A list of intervention groups, randomly ordered, used to assign sequentially enrolled participants to intervention groups. Also termed the "assignment schedule", "randomization schedule", or "randomization list".
What is the difference between blinding and allocation concealment?
The key difference is that allocation concealment is done before/along with randomisation, while blinding is usually happened after randomisation.
What is a treatment in an experiment?
In an experiment, the factor (also called an independent variable) is an explanatory variable manipulated by the experimenter. Each factor has two or more levels, i.e., different values of the factor. Combinations of factor levels are called treatments.
What is treatment structure?
◆ Treatment Structure. ⇨ Consists of the set of treatments, treatment. combinations or populations the experimenter has. selected to study and/or compare.
What is the best definition of replication?
1 : the action or process of reproducing or duplicating replication of DNA. 2 : performance of an experiment or procedure more than once.
What is an environmental sample?
Environmental sample: a sample of any material that is collected from an environmental source. Environmentally related measurement: any assessment of environmental concern generated through or for field, laboratory, or modelling processes; the value obtained from such an assessment.
What is the absolute method?
Absolute method: a body of procedures and techniques for which measurement is based entirely on physically defined, fundamental quantities. Acceptable quality level: a limit above which quality is considered satisfactory and below which it is not.
What is split body trial?
Randomization by body halves or paired organs (Split Body trials) – This is a scenario most often used in dermatology and ophthalmic practice where one intervention is administered to one half of the body and the comparator intervention is assigned to other half of the body.
What is controlled trial?
Controlled trials allow discrimination of the patient outcome from an outcome caused by other factors (such as natural history or observer or patient expectation). Choosing a right control at the right dose and right frequency is pivotal to trial success. The controls which can be used are:
What is the purpose of clinical trial design?
Clinical trial design is an important aspect of interventional trials that serves to optimize, ergonomise and economize the clinical trial conduct. The purpose of the clinical trial is assessment of efficacy, safety, or risk benefit ratio. Goal may be superiority, non-inferiority, or equivalence.
Is there a definitive trial design for every research question?
It is imperative to understand that same research question may be tackled through alternative designs and that there is no definitive trial design for every research question.
Is immunotherapy for warts self-resolving?
In immunotherapy in warts, it is imperative to avoid an uncontrolled study. Warts can be self-resolving and hence the efficacy of immunotherapy as opposed to the self-resolution compromises the validity of the results.
