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Clinical Trial Information
Our clinical study center is providing you with some information relating to clinical trials. Let us give you first of all offer you information regarding the history. The concepts behind clinical trials are ancient. The Book of Daniel chapter 1, verses 12 through 15, for instance, describes a planned experiment with both baseline and follow-up observations of two groups who either partook of, or did not partake of, "the King's meat" over a trial period of ten days. Persian physician Avicenna, in The Canon of Medicine (1025) gave similar advice for determining the efficacy of medical drugs and substances. Although early medical experimentation was often performed, the use of a control group to provide an accurate comparison for the demonstration of the intervention's efficacy was generally lacking. For instance, Lady Mary Wortley Montagu, who campaigned for the introduction of inoculation (then called variolation) to prevent smallpox, arranged for seven prisoners who had been sentenced to death to undergo variolation in exchange for their life. Although they survived and did not contract smallpox, there was no control group to assess whether this result was due to the inoculation or some other factor. Similar experiments performed by Edward Jenner over his smallpox vaccine were equally conceptually flawed. The first proper clinical trial was conducted by the physician James Lind. The disease scurvy, now known to be caused by a Vitamin C deficiency, would often have terrible effects on the welfare of the crew of long distance voyages. In 1740, the catastrophic result of Anson's circumnavigation attracted much attention in Europe; out of 1900 men, 1400 had died, most of them allegedly from having contracted scurvy. John Woodall, an English military surgeon of the British East India Company, had recommended the consumption of citrus fruit (it has an anti-scorbutic effect) from the 17th century, but their use did not become widespread.
Lind conducted the first systematic clinical trial in 1747. He included a dietary supplement of an acidic quality in the experiment after two months at sea, when the ship was already afflicted with scurvy. He divided twelve scorbutic sailors into six groups of two. They all received the same diet but, in addition, group one was given a quart of cider daily, group two twenty-five drops of elixir of vitriol (sulfuric acid), group three six spoonfuls of vinegar, group four half a pint of seawater, group five received two oranges and one lemon, and the last group a spicy paste plus a drink of barley water. The treatment of group five stopped after six days when they ran out of fruit, but by that time one sailor was fit for duty while the other had almost recovered. Apart from that, only group one also showed some effect of its treatment. After 1750 the discipline began to take its modern shape. John Haygarth demonstrated the importance of a control group for the correct identification of the placebo effect in his celebrated study of the ineffective remedy called Perkin's tractors. Further work in that direction was carried out by the eminent physician Sir William Gull, 1st Baronet in the 1860s. Frederick Akbar Mahomed (d. 1884), who worked at Guy's Hospital in London, made substantial contributions to the process of trials, where "he separated chronic nephritis with secondary hypertension from what we now term essential hypertension. He also founded the Collective Investigation Record for the British Medical Association; this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials." Modern trials: Sir Ronald A. Fisher, while working for the Rothamsted experimental station in the field of agriculture, developed his Principles of experimental design in the 1920s as an accurate methodology for the proper design of experiments. Among his major ideas, was the importance of randomization-the random assignment of individuals to different groups for the experiment; replication-to reduce uncertainty, measurements should be repeated and experiments replicated to identify sources of variation; blocking - to arrange experimental units into groups of units that are similar to each other, and thus reducing irrelevant sources of variation; use of factorial experiments - efficient at evaluating the effects and possible interactions of several independent factors. The British Medical Research Council officially recognized the importance of clinical trials from the 1930s. The Council established the Therapeutic Trials Committee to advise and assist in the arrangement of properly controlled clinical trials on new products that seem likely on experimental grounds to have value in the treatment of disease.
The first randomized curative trial was carried out at the MRC Tuberculosis Research Unit by Sir Geoffrey Marshall (1887–1982). The trial, carried out between 1946-1947, aimed to test the efficacy of the chemical streptomycin for curing pulmonary tuberculosis. The trial was both double-blind and placebo-controlled. The methodology of clinical trials was further developed by Sir Austin Bradford Hill, who had been involved in the streptomycin trials. From the 1920s, Hill applied statistics to medicine, attending the lectures of renowned mathematician Karl Pearson, amongst others. He became famous for a landmark study carried out in collaboration with Richard Doll on the correlation between smoking and lung cancer. They carried out a case-control study in 1950, which compared lung cancer patients with matched control and also began a sustained long-term prospective study into the broader issue of smoking and health, which involved studying the smoking habits and health of over 30,000 doctors over a period of several years. His certificate for election to the Royal Society called him "...the leader in the development in medicine of the precise experimental methods now used nationally and internationally in the evaluation of new therapeutic and prophylactic agents."
Let us now give some information with regard to classification of clinical trials. One way of classifying trials is by the way the researchers behave. (1) In a clinical observational study, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study. 2) In an interventional study, the investigators give the research subjects a particular medicine or other intervention. Usually, they compare the treated subjects to subjects who receive no treatment or standard treatment. Then the researchers measure how the subjects' health changes. Another way of classifying trials is by their purpose. The U.S. National Institutes of Health (NIH) organizes trials into five different types. (A) Prevention trials look for 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. (B) Screening trials test the best way to detect certain diseases or health conditions. (C) Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. (D) Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. (E) Quality of life trials (supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. (F) Compassionate use trials or expanded access trials provide partially tested, unapproved therapeutics to a small number of patients who have no other realistic options. Usually, this involves a disease for which no effective therapy has been approved, or a patient who has already failed all standard treatments and whose health is too compromised to qualify for participation in randomized clinical trials. Usually, case-by-case approval must be granted by both the FDA and the pharmaceutical company for such exceptions. (3) A third classification is whether the trial design allows changes based on data accumulated during the trial. (A) Fixed trials consider existing data only during the trial's design, do not modify the trial after it begins and do not assess the results until the study is complete. (B) Adaptive clinical trials use existing data to design the trial, and then use interim results to modify the trial 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. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained. The aim is to more quickly identify drugs that have a therapeutic effect and to zero in on patient populations for whom the drug is appropriate.
4) Finally, a common way of distinguishing trials is by phase, which in simple terms, relates to how close the drug is to being clinically proven both effective for its stated purpose and accepted by the regulatory authorities for use for that purpose. A) Adaptive clinical trial: An adaptive clinical trial is a trial that evaluates patients' reactions to a drug beginning early in a clinical trial and modifies the trial in accord with those findings. The adaptation process continues throughout the trial. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained. The aim is to more quickly identify drugs that have a therapeutic effect and to zero in on patient populations for whom the drug is appropriate. A key modification is to adjust dosing levels. Traditionally, non-adverse patient reactions are not considered until a trial is completed. B) Bayesian designs: According to FDA guidelines, an adaptive Bayesian clinical trial can involve: Interim looks to stop or to adjust patient accrual; Interim looks to assess stopping the trial early either for success, futility or harm; Reversing the hypothesis of non-inferiority to superiority or vice versa; Dropping arms or doses or adjusting doses; Modification of the randomization rate to increase the probability that a patient is allocated to the most appropriate arm. C) Abandoned drugs: Research groups are partnering with companies to take over research on abandoned compounds. The concept is that the value of some drugs was obscured by conventional trial protocols. Companies have begun sharing results on failed drugs, with the aim of figuring out whether the too-small number of patients who benefited from the drug can be characterized, leading to a targeted therapy for such patients.
Phases: Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 0, 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population. Before pharmaceutical companies start clinical trials on a drug, they will also have conducted extensive preclinical studies. Each phase has a different purpose and helps scientists answer a different question.
Trial design: A fundamental distinction in evidence-based practice is between observational studies and randomized controlled trials. Types of observational studies in epidemiology, such as the cohort study and the case-control study provide less compelling evidence than the randomized controlled trial. In observational studies, the investigators only observe associations (correlations) between the treatments experienced by participants and their health status. However, under certain conditions, causal effects can be inferred from observational studies. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. Currently, some Phase 2 and most Phase 3 drug trials are designed as randomized, double-blind, and placebo-controlled. (a) Randomized: Each study subject is randomly assigned to receive either the study treatment or a placebo. (b) Blind: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment a subject receives. This intent is to prevent researchers from treating the two groups differently. A form of double-blind study called a "double-dummy" design allows additional insurance against bias. In this kind of study, all patients are given both placebo and active doses in alternating periods. (c) Placebo-controlled: The use of a placebo (fake treatment) allows the researchers to isolate the effect of the study treatment from the placebo effect. Although the term "clinical trials" is most commonly associated with the large, randomized studies typical of Phase 3, many clinical trials are small. They may be "sponsored" by single researchers or a small group of researchers, and are designed to test simple questions. In the field of rare diseases, sometimes the number of patients is the limiting factor for the size of a clinical trial.
Randomized controlled trial: A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment, where the people being studied are randomly allocated one or other of the different treatments under study. The RCT is often considered the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention and may provide information about adverse effects, such as drug reactions. Random assignment of intervention is done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, and follow-up calls, should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. The terms "RCT" and randomized trial are sometimes used synonymously, but the methodologically sound practice is to reserve the "RCT" name only for trials that contain control groups, in which groups receiving the experimental treatment are compared with control groups receiving no treatment (a placebo-controlled study) or a previously tested treatment (a positive-control study). The term "randomized trials" omits mention of controls and can describe studies that compare multiple treatment groups with each other (in the absence of a control group). Similarly, although the "RCT" name is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", the methodologically sound practice, to avoid ambiguity in the scientific literature, is to retain "control" in the definition of "RCT" and thus reserve that name only for trials that contain controls. Not all randomized trials are randomized controlled trials (and some of them could never be, in cases where controls would be impractical or unethical to institute). The term randomized controlled trials is a methodologically sound alternate expansion for "RCT" in RCTs that concern clinical research; however, RCTs are also employed in other research areas, including many of the social sciences. Classifications of RCTs: By study design: One way to classify RCTs is by study design. From most to least common in the healthcare literature, the major categories of RCT study designs are: 1) Parallel-group – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention. 2) Crossover – over time, each participant receives (or does not receive) an intervention in a random sequence. 3) Cluster – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention. 4) Factorial – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y). An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. By outcome of interest (efficacy vs. effectiveness): RCTs can be classified as "explanatory" or "pragmatic." Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can "inform decisions about practice." By hypothesis (superiority vs. non-inferiority vs. equivalence): Another classification of RCTs categorizes them as "superiority trials," "non -inferiority trials," and "equivalence trials," which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are non-inferiority trials "to determine whether a new treatment is no worse than a reference treatment." Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.
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