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

Post a Comment

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...
1 comment
Read more