Treatment Be Considered In Clinical Trials Essay

Clinical trials, according to National Cancer Institute (2010), are researches and studies on prevention and treatment of a particular disease that involve human. The main purpose of clinical trials is to test the safety and efficacy of new drug, medical instrument or treatment. It can be a new route of administration of a marketed drug too. Since it involve human, it is strictly regulated to benefit volunteers and study participants so that their safety is protected. There are two types of studies under clinical trials, the interventional studies and the observational studies. Interventional study involves the specific alteration of therapeutic or diagnosis options among subjects, which can be randomly or not randomly assigned by investigator (Clinical trials.gov 2012).Treatment Be Considered In Clinical Trials Essay. Observational study is biomedical research on human being that outcome of interventions are being observed and accessed compared to a controlled group (Clinical trials.gov 2012). Results or outcome measures of clinical studies are differing with the disease being studied. However, there are few concerns regarding the patient’s view and perspective of treatment in the study. As patients are the subjects of the research, their point of view is important to be considered into clinical research study so as a respect of patient right and improvement of research outcome.

A brief introduction to clinical trials

According to National Institute of Health (2012), clinical trials are studies conducted to test the safety and efficacy of new drug or treatment by measurements. Clinical trials can be start 30 days after Investigational New Drug (IND) application (FDA 2011). There are four main phases in the study, namely phase I, II, III and IV (Chow and Shao 2002). In phase I studies, healthy volunteers will be the subject, except in the drugs with high toxicity, for example anticancer drugs, patient of the disease will be the study subject. At first single ascending dose will be given, followed by multiple doses to test the safety of the drug (Scott 2007). In this phase, pharmacokinetics and pharmacodynamics of the drug will be accessed as well as safe dose and dose frequency for the use of phase II studies (Eller 2001).

ORDER A PLAGIARISM-FREE PAPER NOW

Phase II studies is the study that first included ill patients with particular disease, to test the efficacy of the drug (Scott 2007). In other words, it is to test if the drug helps to cure disease. Usually the design of the study is double-blind to avoid bias (Eller 2001). In the double-blind trial, neither researcher nor patient knows the mode of treatment, either placebo treatment or standard treatment with active pharmaceutical ingredient (Bratman 2004). The later part in the phase, known as phase IIb, specify the best dose and dose range, as well as the bioavailability for different formulation and dosage form (Eller 2001). Short term side effects and associated risks with the drug will be determined as well in this phase.

Researchers study and analyse the data from phase I and phase II before continue phase III studies. Phase III study is conformational study, which confirm the safety and effectiveness of the new drug or treatment (Scott 2007). Besides, special population such as elderly, children, pregnant women and patients with hepatic or renal impaired will be included in the phase (Eller 2001). The last phase, phase IV is an additional phase after drug is manufactured to make market-oriented-comparison, for example, cost-effectiveness and comparison with previously marketed drug (Chow and Shao 2002). Besides, phase IV study includes access of patient’s quality of life (QoL) and chances for additional indications. Treatment Be Considered In Clinical Trials Essay.

Patient’s perspective and clinical trials

Patient is an essential element in clinical studies as the results and outcomes are based on patients’ condition via indication instruments such as glucose concentration in blood, ECG, tumor response, muscle mass et cetera, depending on the patient’s illness and disease. The scores and scales from these monitoring machines will then be compiled and analyzed by researchers. However, researcher should not depend merely on the instruments’ scores as the outcome of the studies. Patient’s feedback and perspective is as well important because they are the one who receive treatment, who if not patient to evaluate the effectiveness of the treatment?

In a recent clinical research done by Portenoy et al (2012), Nabiximols, a cannabinoid novel drug formulation is tested for its effect on relieving pain of advanced cancer patients. In the study, Portenoy et al use Interactive Voice Response System (IVRS) to communicate with patient. Patient is asked to answer questions regarding to the pain they feel each day during the studies, based on visual analogue scale (VAS) (Mckechnie 1993; Chapman 1985), which the intensity of pain is measured on a scale of 1 to 10. The scale is used as primary outcome measure, but other measures are used as well in the study. They are categorized as patient-reported outcome measures (PROMs), such as sets of quality of life questionnaires. In the study, EORTC quality of life and Patient Assessment of Constipation quality of life questionnaires are chosen as secondary outcome (Portenoy et al 2012). In other words, patients’ feelings towards treatment are reflected to researcher as a reference of treatment effectiveness.

So, what is quality of life? Based on the definition given by World Health Organization, quality of life is “individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.”(WHO 1997) There are different types of quality of life questionnaires available from different organization such as World Health Organization (WHO) (Sexena et al 2001), European Organization for Research and Treatment of Cancer (EORTC) (Urdaniz et al 2008), and Short Form health survey 36 (Ware 2012). Survey questions vary from physical health, mental health, general health and well being, social function and vitality, depending on the patient’s disease and treatment received (Ware 2012).

Why are patient-reported outcome measures important? This can be answered using the result of the study conducted by Slevin et al in 1988. The study compared questionnaires about quality of life, anxiety and depression completed by both doctor and patient simultaneously; and the result had proved that doctor cannot precisely know the patient feelings, thus cannot determine the quality of life (Slevin et al 1988).Treatment Be Considered In Clinical Trials Essay.  Slevin et al concluded that patients should measure their quality of life as they know the feelings better. This inferred the importance of patient-reported outcome measures in clinical research and care of patient.

Next, another major reason why should patients’ view of treatment be considered in clinical trials is its ability to improve patients’ compliance. Patients’ compliance can be defined as the willingness of patient to follow doctor’s advice on treatment and complete it (Aronson 2007). How can it help with patient compliance? It is a simple theory. If patient’s opinions are to be listened and considered, they will feel respected and able to contribute to medical science as well as future patient, thus they will follow full course of treatment and increase compliance. It is an easy approach, just by a better relationship with patient due to respect and communication. Compared to many suggested ways to increase compliance such as the measure of compliance by tablet count, therapeutic drug assays in blood or urine et cetera (Pullar et al 1989). Besides, Austin Regional Clinic, TX (1994) suggested that patient education and clear instruction able to help in patient compliance problems. This is one of the major concerns in research because poor compliance may be an obstacle in clinical trials as it can researcher misjudge drug’s efficacy and draw a negative conclusion (Schechtman and Gordon 1994).

Conclusion

Clinical trial and study is an important process in drug development of drug and medical instrument in order to treat patient who are suffering from diseases. Some participating patient feels the trial is a hope for a cure in their desperation (Ellis 2000). Unlike pre-clinical in-vivo studies, clinical trial involve human who is able to express feelings and opinion. It is immoral to view patient as a subject to study without consider their opinion and perspective of the treatment at the first place. Moreover, there are advantages in taking patient perspective and feedbacks into consideration; improve patient’s quality of life and their illness as well as compliance, thus better and accurate result can be obtain. By then accident such as Thalidomide incident can be avoid. Also, good clinical practice should be apply besides consider patient perspective to achieve the aim of clinical study, that is, to prove the effectiveness and safety of drug in human body. Treatment Be Considered In Clinical Trials Essay.

The clinical drug test is a drug examination to judge whether the result can treat the disease. In other words, a clinical drug test is conducted to determine the efficacy of the drug. Clinical drug trials are ethical as scientists are trying to treat hope to find hope and take over the lives of people. Chase with a vulnerable X syndrome shows that the drug minocycline he took in clinical trials did well when it began to develop the ability to understand things and react to others.

Pharmaceutical (pharmaceutical) companies often do clinical trials of their drugs so that qualified participants can obtain drugs that are not approved or are not widely used. In clinical trials, we will test aspects of the safety, efficacy, quality, etc. of drugs in the human body. Clinical trials have eligibility criteria, and often the number of people who can participate is limited. If you are interested in participating in clinical trials, please discuss with your doctor about this possibility. If you are participating in a clinical trial, be sure to understand and sign the informed consent form before entering the exam. This table outlines the test conditions, in particular related risks. Try to discuss whether the medicine is right for you, you can continue to use it after the exam is over until you can pass your medicine plan

Clinical trials involve exposing new inventions to humans, so it is an important stage in clinical research for new drugs and treatments. Do not misunderstand clinical trials as normal treatment. It takes 5 to 10 years to legally produce new clinical research products. All clinical research studies need FDA approval before human clinical trials and all results should be updated with FDA clinical research database.

Clinical trials and your clinical trial are part of clinical research and are the core of all medical progress. In clinical trials, new methods to prevent, detect and treat diseases are being studied. Treatment is a new way to use new drugs and new drug combinations, new surgical procedures and instruments, or existing treatments. All clinical trials have special requirements for matching with potential subjects’ studies, such as age group and other acceptable conditions / drugs. For details on participation in clinical trials, please visit www.nih.gov / health / clinicaltrials / index.htm and use search terms such as “senile depression” or “depression and elderly people”.

The clinical drug test is a drug examination to judge whether the result can treat the disease. In other words, a clinical drug test is conducted to determine the efficacy of the drug. Clinical drug trials are ethical as scientists are trying to treat hope to find hope and take over the lives of people. Chase with a vulnerable X syndrome shows that the drug minocycline he took in clinical trials did well when it began to develop the ability to understand things and react to others.

Pharmaceutical (pharmaceutical) companies often do clinical trials of their drugs so that qualified participants can obtain drugs that are not approved or are not widely used. In clinical trials, we will test aspects of the safety, efficacy, quality, etc. of drugs in the human body. Clinical trials have eligibility criteria, and often the number of people who can participate is limited. If you are interested in participating in clinical trials, please discuss with your doctor about this possibility. Treatment Be Considered In Clinical Trials Essay.If you are participating in a clinical trial, be sure to understand and sign the informed consent form before entering the exam. This table outlines the test conditions, in particular related risks. Try to discuss whether the medicine is right for you, you can continue to use it after the exam is over until you can pass your medicine plan

Clinical trials involve exposing new inventions to humans, so it is an important stage in clinical research for new drugs and treatments. Do not misunderstand clinical trials as normal treatment. It takes 5 to 10 years to legally produce new clinical research products. All clinical research studies need FDA approval before human clinical trials and all results should be updated with FDA clinical research database.

Clinical trials and your clinical trial are part of clinical research and are the core of all medical progress. In clinical trials, new methods to prevent, detect and treat diseases are being studied. Treatment is a new way to use new drugs and new drug combinations, new surgical procedures and instruments, or existing treatments. All clinical trials have special requirements for matching with potential subjects’ studies, such as age group and other acceptable conditions / drugs. For details on participation in clinical trials, please visit www.nih.gov / health / clinicaltrials / index.htm and use search terms such as “senile depression” or “depression and elderly people”.

clinical Trials Information for Patients In cancer research, a clinical trial is an organized study conducted in people with cancer to answer specific questions about a new treatment or a new way of using a known treatment. Each study tries to increase medical knowledge and to find new and better ways to help cancer patients. Besides studying new anticancer drugs, clinical trials study new combinations of drugs already used in cancer treatment, new ways of giving treatment, and how changes in lifestyle can help cancer patients or prevent cancer from occurring. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces more cures and causes fewer side effects than the other. Before a new treatment is tested in patients, it is carefully studied in the laboratory.

First, a drug is considered because it changes cells or parts of cells in a way that suggests it will destroy cancer or help the body to deal with the side effects of cancer treatment. Then, the new treatment is tested in animals to learn what it does in the body. But this early research cannot predict exactly how a new treatment will work in people or define all the side effects that might occur. Clinical trials are designed to help us find out how to give a new treatment safely and effectively to people. Each patient who participates in a clinical trial provides information on the effectiveness and risks of the new treatment. Advances in medicine and science are the result of new ideas and approaches developed through research.  Treatment Be Considered In Clinical Trials Essay.

New cancer treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made available to all patients. Treatments now being used (standard treatments) are the base for building new, hopefully better, treatments. Many standard treatments were first shown to be effective in clinical trials. Clinical trials show researchers which therapies are more effective than others. This is the best way to identify an effective new treatment. New therapies are designed to take advantage of what has worked in the past and to improve on this base.

You may be interested in participating in a trial. You should learn as much as you can about the trial before you make up your mind. What kinds of clinical trials are there? There are many kinds of clinical trials. They range from studies of ways to prevent, detect, diagnose, control, and treat cancer to studies of the psychological impact of the disease and ways to improve the patient’s comfort and quality of life (including pain control).

Cancer clinical trials deal with new approaches to the treatment of cancer. These treatments most often use surgery (cutting out the cancer), radiation therapy (using x-rays, neutrons, or other invisible beams to kill cancer cells), and / or chemotherapy (using cancer-killing drugs) alone or in combination. Surgery, radiation, and chemotherapy have cured many cancer patients and prolonged the lives of many others. A new area of cancer treatment is biological therapy that use substances that help the body to fight cancer. Most clinical trials are carried out in steps called phases. Each phase is designed to find different information.

Patients may be eligible for studies in different phases, depending on their general condition, the type and stage of their cancer, and what therapy, if any, they have already had. Patients are seen regularly to determine the effect of the treatment, and treatment is always stopped if side effects become too severe.Treatment Be Considered In Clinical Trials Essay.  The purpose of a phase I study is to find the best way to give a new treatment and how much of it can be given safely. In a phase I study, a new treatment is given to a small number of patients. For a new drug, the study starts by giving a very low dose of the drug, then the dose is slowly increased as new patients enter the trial.

The dose can be increased by giving more at one time or by giving the same dose more often. Physicians watch patients carefully for any harmful side effects. Although the research treatment has been well tested in laboratory and animal studies, the side effects in patients can not be completely known ahead of time. Phase I studies may involve significant risks for this reason. They are offered only to patients whose cancer cannot be helped by other known treatments.

Phase I treatments may or may not produce anticancer effects, but some patients have been helped by these treatments. Once the best dose is chosen, the drug is studied for its ability to shrink tumors in phase II trials. Phase II studies are designed to find out if the treatment actually kills cancer cells in people. Usually groups of 20 to 50 patients with one type of cancer receive a phase II treatment. For example, patients with breast cancer that no longer responds to accepted therapy (it has become resistant to standard therapy) may be treated on a phase II study. Patients are closely observed for anticancer effect by repeated measurement of tumor size to see if it has shrunk since the beginning of the study.

When the tumor gets a lot smaller and stays smaller for at least a month, the patient is said to have “responded” to the treatment. If at least one-fifth of the patients in the phase II study respond to treatment, the treatment is judged active against their tumor type. In addition to monitoring patients for response, any side effects of the treatment are carefully recorded and assessed. Since larger numbers of patients receive the treatment in phase II studies than in phase I studies, there is more chance to observe unusual side effects. Each new phase of a clinical trial depends on and builds on information from an earlier phase. If a treatment has shown activity against cancer in a phase II study, it becomes part of a phase III study.

ORDER A PLAGIARISM-FREE PAPER NOW

Phase III studies usually compare standard treatments (the treatment most accepted) with treatments that appeared to be good in the small phase II studies. Phase III studies require large numbers of patients; some studies use thousands of patients. Patients are usually randomized, which means they are assigned by chance to one of the treatments being studied. The group that receives the standard treatment is called the “control” group. The researchers know that a certain number of these patients will be helped by the treatment. Another patient group receives the newer therapy to see if it will help the patients more.  Treatment Be Considered In Clinical Trials Essay.

Phase III studies look for longer life, better quality of life, fewer side effects, and fewer cases of the cancer returning. Adjuvant studies are conducted to determine if additional therapy will improve the chance for cure in patients at risk for the cancer coming back after surgical removal of all visible disease. An example is a study for patients with large bowel cancer. The standard therapy for large bowel cancer is surgery. An adjuvant study could be run in which one group of patients with large bowel cancer received surgery and the other group received surgery and then chemotherapy. If the study shows that surgery plus chemotherapy is better than surgery alone, surgery plus chemotherapy will become the new, standard therapy.  Treatment Be Considered In Clinical Trials Essay.