Types of Clinical Trials and its importance.
Target this keyword at the end of blog : Clinical Research Reviews
Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.
Types of Classifications:
In one way of classification it is based on the behavior of researches: clinical observational study: The investigators observe the subjects and measure their outcomes. They don't actively manage the study.
Intervention study: The investigators give the research subjects a particular medicine
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It provides partially tested, unapproved therapeutics to a small number of patients who have lost all realistic options. Usually this involves disease for which no effective therapy has been yet approved.
A third classification is whether the trial design allows changes based on data accumulated during the trial.
Fixed trials : It considers existing data only during the trial's design, and does not modify the trial after it begins and even not assess the results until the study is complete.
Adaptive clinical trials: This use existing data to design the trial and then use inferred results to modify the trials as it proceeds. Modifications include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. Adaptive trials often employ a Bayesian experimental design to assess the trial's progress.
Phases of clinical trials
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
Phase
Aim
Notes
Phase 0
Pharmacodynamics and pharmacokinetics in humans first-in-human
This systematic review conducted by Takeda A, Taylor SJC, Taylor RS, Khan F, Krum H, Underwood M, (2012) sourced twenty-five trials, and the overall number of people of the collective trials included was 5,942. Interventions were classified and assessed using the following headings.-
It is essential that when using evidence-based practice guidelines to choose a treatment, that variety of research methods are applied so that the best relevant data can be produced. Such methods include qualitative/quantitative research, randomised controlled trials and systematic reviews. Both qualitative and quantative methods produce valuable data. Quantative research produces numeric evidence that is necessary for practice and can be measured and qualitative research produces descriptive data about the subject by using patients views etc. which can also be applied to clinical practice (Broeder et al, 2010)
With the high degree of variations in health care, patients can be under or over treated or even treated with the wrong treatment for their illness. These unwarranted care techniques can be categorized into three different situations. The first category of unwarranted care is the use of evidence or lack thereof, based on other medical care. The way to explain this category is that a care plan for a patient is proven effective without any proof as to why. The example given by Kongstvedt (2007) is the use of beta blockers post heart attack. Beta blockers prove to be effective in nearly one h...
...s little information about the possible benefits of the study or the side effects. The side effects proved to be significant (gastrointestinal complains, headache, and an elevation of alanine aminotransferase), while the benefits were minimal. This situation emphasizes the need for a balanced approach when it comes to drug clinical trials.
Methodological quality was independently assessed by using the Maastricht-Amsterdam Criteria List. The qualitative and quantitative characteristics of the selected trials were independently extracted by using a standardized data extraction form. Levels of evidence were used to determine the strength of the evidence available. It was not possible to perform meta-analyses because of the heterogeneity of the selected studies. Standard operating procedures were adopted for data collection and assimilation. The report is based on the DAP, SOAP and BIRP notes collected while preliminary studies and treatment methodology.
As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b...
trials of investigation medical products. The FDA also has to review and approve in a
Randomized Controlled Trials can be used to in several types of evaluations, including new therapies (i.e. Cognitive behavioral therapy versus emotionally focused therapy when treating couples), community interventions, and diagnostic techniques (O'Brien, 2013). The RCT study design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups is the outcome variable being studied (O'Brien, 2013).
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
A career in clinical research can begin at any of the different stages of clinical research. An aspirant in the clinical research field usually begins as a clinical research associate or as a clinical research scientist or as a clinical research coordinator. There are other entry positions, but these three are the most common entry route to a career in clinical research. A clinical research associate is the most common position an aspirant can choose to enter the clinical research field.
Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Second is an observational study in which individuals are observed and their outcomes are measured by the investigators.
Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints, a control group, randomly allocated subjects into a treatment group and a control group, blinded both subject groups and investigators, sufficient sample size, and an approved independent ethics committee and monitoring by data safety and monitor board to have stronger the scientific validity on the clinical trials (Brody, 1997). The use of placebos will enable to have more scientifically reliable outcome. However, unnecessarily or ineffectiveness of placebo use is also claimed therefore considering appropriate conditions and suitable cases would be needed for placebo use.
The key area of decision-making on direct patient care is intervention effectiveness, picking an intervention
Therapy is the most commonly used treatment for symptoms. A variety of therapy treatments are offered for patients based on their specific characteristics and what th...
Research is systematic way to find out facts and knowledge as Kothari (2006) has analyzed that research is the pursuit of truth with the help of study, observation, comparison and experiment; the search for knowledge through objective and systematic method of finding solutions to a problem. However there are two types of researches one is by Purpose and other is by method. The type by purpose falls into three categorize such as Basic, Applied and Action Research.