Global Clinicals Incorporated understands the value of your questions regarding clinical research. We’ve provided a summary of answers below to some of the most common and relevant questions related to Clinical Research Organizations.
What is a Blinded Study?
The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. “Blinded” studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known
What is Blinding/Masking?
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s)
What is Chinese Medicine?
A complete medical system that has diagnosed, treated, and prevented illness for over twenty-three centuries. While it can remedy ailments and alter states of mind, Chinese medicine can also enhance recuperative power, immunity, and the capacity for pleasure, work, and creativity. The strategy of Chinese medicine is to restore harmony (health, good weather, good fortune) and it is assumed that the body is whole-each part of it is intimately connected and each organ has a mental as well as a physical function.
What is a Clinical/Principal Investigator?
A medical professional who is overseeing the treatment of the patients in the clinical trial. They are usually doctors, nurses, pharmacists, or other health care professionals.
What is a Clinical Trial?
A carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients.
What is Coding?
In clinical trials, the process of assigning data to categories for analysis.
What is a Comparative Study?
One in which the investigative drug is compared against another product, either active drug or placebo.
What is a Coordinator?
This individual manages the conduct of the clinical trial.
What is a CRF?
A Case Report Form is a record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol.
What is a CRO?
A contract research organization (CRO) is an institution employing anything from one to several thousand people and is involved in performing clinical research on a contract basis for a pharmaceutical company, research organization, or other health organization. CROs are contracted to perform some or all of the duties as Sponsor for a clinical trial; this means it may just be to monitor the trial, perform the statistical analysis, or simply to write the protocol.
What is a Doubled Blinded Randomized Placebo Controlled Study?
A double blind study is one in which neither the patient nor the physician knows whether the patient is receiving the treatment of interest or the control treatment. For example, studies of treatments that consist essentially of taking pills are very easy to do double blind – the patient takes one of two pills of identical size, shape, and color, and neither the patient nor the physician needs to know which is which. A double blind study is the most rigorous clinical research design because, in addition to the randomization of subjects which reduces the risk of bias, it can eliminate the placebo effect which is a further challenge to the validity of a study.
What is the FDA?
Within the Department of Health and Human Services, the Food and Drug Administration (FDA) promotes and protects the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Consumers rely on product labels to know what the product is and how to use it. FDA regulates what’s on these labels to ensure that they are truthful and that they provide useable information that helps consumers make healthy, safe decisions when using the product. In recent years they have redesigned the labeling for foods, over-the-counter medicines, and dietary supplements, making them much more informative and easy to read.
What is the FTC?
The Federal Trade Commission is the governmental body that enforces consumer protection laws. In general, the FTC’s efforts are directed toward stopping actions that threaten consumers’ opportunities to exercise informed choice. FTC regulations stipulate that companies are prohibited from claiming that their products or any food, drug or dietary supplement treats, cures or prevents any disease or disorder, unless they have scientific evidence to support the claim.
What is GCP?
Good Clinical Practice is the international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. It insures that the data reported is credible and accurate, and that subject’s rights and confidentiality are protected.
What is a Human Efficacy Trial?
A clinical trail that uses humans to determine the effectiveness of a drug.
What is a Herb?
Any leafy plant without a woody stem, especially one used as a household remedy, for flavor, or other medicinal purposes. The use of plants as medicine is older than recorded history. There are over 750,000 plants on earth. Relatively speaking, only a very few of the healing herbs have been studied scientifically. Plants used as medicines offer synergistic interactions between ingredients both known and unknown. Generally, herbs fall into two categories: wild-grown and farm-grown. A wild-grown herb is one that grows naturally, without human intervention.
What is Herbal Medicine?
The use of herbs to treat both acute and chronic conditions. Herbs and prepared herbal compounds are available in different forms, each of which has it’s own particular characteristics. A health food store has individual herbs as well as complex herbal formulations, including raw herbs, tinctures, extracts, capsules, tablets, lozenges, and ointments. Some common medicinal herbs are: alfalfa, aloe vera, ginseng, bupleurum, burdock, calendura, carob, chamomile, dill, echinacea, fennel, fenugreek, flax, garlic, ginger, goldenseal, licorice, ma huang (ephedra), marshmallow, papaya, parsley, peppermint, red clover, rosemary, sage, skullcap, slippery elm, thyme, yarrow, and yellowdock.
What is Informed Consent?
A discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients.
What is an Investigational Treatment?
The drug or medical device that is tested during a clinical trial.
What is the IRB?
The Institutional Review Board (IRB) consists of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The board scrutinizes all trail activities including recruitment, advertising, and potential risks. The IRB, the FDA term for an Ethics committee, also makes sure that regulations are being followed in a particular trial.
What is an NDA?
A New Drug Application is the compilation of all non-clinical, clinical, pharmacological, pharmacokinetic, and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S.
What is an OTC?
An over-the-counter drug or remedy that can be acquired without a prescription.
What is Pre-Clinical Testing?
Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe.
What is a Protocol?
A plan that sets guidelines for a trial and usually involves several different trial locations. A protocol is usually designed by the sponsor of a clinical trial.
What is Quality Assurance in Clinical Research?
There is a system of checks and balances in place for the conduct of clinical research. Federal regulations and guidelines make up part of this system. Quality assurance (QA) professionals use these tools as they conduct audits to assess compliance with Good Clinical Practice (GCP).
What is a SOP?
Standard Operating Procedure is an official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.
What is a Sponsor?
The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocol
What are Vitamins?
Vitamins are any of various fat-soluble or water-soluble organic substances essential in minute amounts for normal growth and activity of the body and obtained naturally from plant and animal foods.
Below is a guide:
Vitamin A is necessary for maintenance of healthy skin, eyes, bones, hair, and teeth
Beta Carotene is an antioxidant and can be converted by the body to Vitamin A as needed
Vitamin D assists in the absorption and metabolism of calcium and phosphorus for strong bones and teeth Vitamin E helps protect red blood cells and as an antioxidant, it helps to protect cell membranes, lipoproteins, fats and vitamin A from destructive oxidation
Vitamin K is needed for proper blood clotting Vitamin C enhances iron absorption and red blood cell formation. It is important for maintenance of bones, teeth, collagen and blood vessels and as an antioxidant, it inhibits the formation of nitrosamines
Vitamin B-1 (Thiamine) releases energy from foods and is needed for normal appetite and for functioning of the nervous system
Vitamin B-2 (Riboflavin) releases energy from foods and is necessary for healthy skin and eyes
Vitamin B-6 (Pyridoxine) releases energy from foods, plays a role in protein and fat metabolism, and is essential for function of red blood cells and hemoglobin synthesis
Vitamin B-12 (Cobalamin) prevents pernicious anemia, is involved in synthesis of genetic material, and is necessary for a health nervous system
Biotin releases energy from foods, plays a role in metabolism of amino acids, and is needed for normal hair production and growth
Pantothenic Acid releases energy from foods, is involved in synthesis of acetycholine (an excitatory neurotransmitter), and is needed for normal functioning of the adrenal glands
Folic Acid is necessary for proper blood cell formation, plays a role in the metabolism of fats, amino acids, DNA, and RNA, and is a precursor to acetylcholine (a major neurotransmitter in the brain)
Inositol is involved in calcium mobilization