Skip to main content

Different Types of Clinical Trials

BayBiotech.NET
We often think of clinical trials as a principle method of studying new drugs, but there are many different types of trials that are designed to answer different questions related to health care and well beings of the human subject. Understanding the objective of your clinical trial and the entire process is the first step taken towards determining the regulatory pathways that will apply to a particular study. Depending on the end-goal different types of clinical trials are as under:
Prevention trials – Prevention trials look at substances and lifestyle factors that may raise or lower the risk of developing a clinical condition. e.g. effect of a particular type of food or exercise on preventing Diabetes.
Screening trials – Screening trials are designed to diagnose a condition in its early stages when it is often more curable. e.g. a newly developed imaging technique if used to screen breast cancer occurrence.
Diagnostic trials – Diagnostic trials are aimed to evaluate the methods to detect a clinical condition or to accurately measure the levels of a biomarker associated with the condition. E.g. various trials to test a newly developed kit for HIV.
Treatment trials – Treatment trials evaluate the ability of drugs, radiation, surgery, or other measures to treat a medical condition. These are the most conventional type of clinical trials and most tedious ones in terms of usage of times as well as resources.
Supportive care trials – Supportive care trials are also called quality-of-life trials. They study the ability of a drug or procedure to lessen the symptoms related to a condition. These trials are mainly designed around device developments.
Out of all the abovementioned trials, Treatment Trials are the most conventional types and referred while mentioning the clinical trials.
References: ClinicalTrials.gov & Medpedia.com

Comments

Popular posts from this blog

Available Total Quality Management Tools

BayBiotech.NET Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment. Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams. Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice...

A Facility Inspection Checklist

BayBiotech.NET Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility: 1.General information (a) name of establishment inspected (b) date of inspection (c) name(s) of the inspector(s) (d) date of last inspection. 2.Type of inspection Comprehensive, concise, follow-up, special, investigative, announced, and unannounced. 3.Licensing (a) licensing of premises (b) person with supervisory role in establishments (c) adherence to licensing provisions. 4. Activities undertaken on premises manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes. 5. Adequacy and suitability of pre...

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...