Major Components and Definitions in Clinical Trials

Clinical trials aimed to improve health and quality of life are the cornerstone of progress in medicine. Support comes from academic medical centers, philanthropy, the National Institutes of Health (NIH), industry, or combinations thereof. Medical research should always be patient-centered; thus, the patient is seated on the model chair of clinical research. The medical team comprises the first leg in the clinical research paradigm. It is typically composed of compassionate individuals focused on the needs of an individual patient. They include basic research scientists and clinicians organized into translational and clinical research teams—all with a focus on the disease from which the patient suffers. Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking steps necessary to safeguard the people taking part. Every new treatment is usually tested in three phases of clinical trials before regulatory agencies consider it safe and effective. Trials are also conducted according to Good Clinical Practice (GCP) guidelines that regulators require in order to protect patient safety. The more tightly this disease group is linked, the quicker the research is translated to the patient. These team members know best the unmet needs of patients and the issues related to their disease. Medical teams are typically more mission than business oriented, given their training background. However, they, too, must consider the financial impact of trial design. Clinical trials need to be hypothesis-driven and address an unmet need. Successful trials require teams of physicians, scientists, and statisticians. After researchers test investigational new therapies or procedures in the laboratory and in animal studies, those with the most promising possibilities are moved into human clinical trials. Clinical trials are broken down into different phases. During a trial, more and more information is gained about the potential treatment, its risks and how well it may or may not work, along with aspects related to quality of life.

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The medical drug and device industries are also vital for the success of the clinical research enterprise, as they invest in new products for the medical team to test. From a financial standpoint, the medical team is risk averse; the drug and device developers must take that risk with the goal of profit and benefit for patients and stockholders/investors. Clinical research is an important tool to help develop solutions that will benefit people all over  the world. Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.

Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.

Clinical research includes:

• Medical and behavioral research involving volunteer participants

• Investigations that are carefully developed and conducted with clinical outcomes recorded

• Identification of better ways to prevent, diagnose, treat, and understand human disease

• Trials that test new treatments, clinical management and clinical outcomes, and long–term studies

• Strict scientific guidelines

• Ethical principles to protect participants

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Clinical Research is important because:

• Clinical trials test how well new approaches and interventions work in people

• These approaches can be medical, behavioral, or management

• Each study answers scientific questions. People who take part in clinical trials contribute to the knowledge of how a disease progresses.

• Each study helps scientists prevent, screen for, diagnose, manage, and treat a disease .

Some benefits of taking part in a clinical trial are:

• Participants have access to promising new approaches often not available outside the clinical trial setting

• The drug, vaccine or other intervention being studied may be more effective and/or

efficacious than the standard approach (although there is no guarantee that participants will receive the experimental drug, vaccine, or other intervention)

• Participants receive careful medical attention from a research team of doctors and other health professionals

• Participants may be the first to benefit from the study

• Results from the study may help others in the future

Some risks of taking part in a clinical trial are:

• New vaccines, microbicides, and other strategies under study are not always better than the standard care to which they are being compared

• New treatments may have unexpected side effects or risks that are worse than those resulting from standard care

• Health insurance and managed care providers may or may not cover all participant care costs in a study

• Participants may be required to make more visits to the doctor than they would if not in the clinical trial

• Participants in randomized trials are not able to choose the kind of intervention they will receive

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