CLINICAL DATA MANAGEMENT
A Clinical Data Management System or CDMS is used in clinical research for managing the data of a clinical trials. The clinical trial data collected at the researchers location from the Case Report Form are stored in the CDMS. A clinical trial is a test compared with a medication, other medical treatment (a medical device), versus a placebo, or standard medical treatment for a patient's condition. The clinical trail answers specific questions regarding vaccines, new therapies, new method and ways of known treatments, which is used to determine new drugs and treatments safely and effectively. Once researcher test new therapies or procedure in laboratory in the animal and get promising results, they begin planning phase I clinical trails in human.
TYPES OF CLINICAL TRIALS
PREVENTIONAL TRIAL
Prevention trials test new approaches, such as medications, vitamins, or other supplements, that doctors believe may lower the risk of developing a certain type of cancer. Most prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had cancer and want to prevent recurrence (return of cancer), or reduce the chance of developing a new type of cancer.
SCREENING TRAIL
Screening trials study ways to detect cancer earlier. They are often conducted to determine whether finding cancer before it causes symptoms decreases the chance of dying from the disease. These trials involve people who do not have any symptoms of cancer.
DIAGNOSTIC TRIAL
Diagnostic trials study tests or procedures that could be used to identify cancer more accurately. Diagnostic trials usually include people who have signs or symptoms of cancer.
TREATMENT TRIAL
Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.
QUALITY-OF-LIFE TRIAL
Quality-of-life trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from cancer or its treatment.
GENETIC STUDIES
Genetic studies are sometimes part of another cancer clinical trial. The genetics component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to cancer treatment.In these studies, researchers look at tissue or blood samples, generally from families or large groups of people, to find genetic changes that are associated with cancer. People who participate in genetics studies may or may not have cancer, depending on the study. The goal of these study helps to understand the role of genes in the development of cancer.
TRAILS PHASES
Clinical trials are usually conducted in a series of steps, called phases. However, screening, prevention, diagnostic, and quality-of-life studies do not always have a phase. Genetics clinical trials generally do not have a phase.
Phase I
Phase I trials are the first step in testing a new approach in people. In these studies, researchers evaluate what dose is safe, how a new agent should be given (oral or parenteral), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The dose of the new therapy or technique is increased a little at a time. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing.
Phase II
Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body.Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients.
Phase III
Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Participants are randomly assigned to the standard group or the new group, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study’s results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials often include large numbers of people across the country.
Phase IV
Phase IV trials are conducted to further evaluate the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use. Several hundred to several thousand people may take part in a phase IV study. These studies are less common than phase I, II, or III trials.
CONTROL GROUP
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
PARTICIPATING IN CLINICAL TRAILS
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
PARTICIPANT
All clinical trials have guidelines about who can participate. Using inclusion or exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
IMPORTANCE
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress against, cancer. They also receive up-to-date care from experts
ADVANTAGES
Clinical trial volunteers are often suffering with pain, discomfort or inconvenient symptoms that hinder their daily activities. By participating in clinical trials, volunteers are able to: Take advantage of new treatments at no cost before they become available to the public. Have access to top quality medical care from our board certified physicians.Offer valuable new insights into their condition and help future patients. Receive close monitoring of their condition throughout the study.Take a more active role in their health care.
OUTCOMES
Clinical trials are designed to provide information about different types of outcomes. Some studies, particularly those involving pharmaceutical products, are designed to determine what the body does to the product. These are usually called pharmacokinetic (PK) studies. PK studies are usually the first phase of study and are performed to determine proper dosing. Dosing may be different for different populations based on age and genetics (which includes sex, race, and differences in metabolism). Another type of outcome is to examine what the product does to the body. These studies are called pharmacodynamic (PD) studies. PD studies are used to examine the ability, safety, and clinical activity of a drug or device.