Types of Clinical Trials
Clinical trials can be used as a method to study a wide range of interventions, and by a range of individuals or as we keep referring to them – sponsors. Clinical trials can involve investigating new or existing medicines, medical devices and other medical or non-medical interventions. For example, a clinical trial could involve new drugs, medical devices, biologicals, vaccines, surgical and other medical treatments and procedures. Psycho-therapeutic and behavioural therapies help service changes, preventative care strategies and educational interventions are also examples of clinical trials. Researchers might also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
The types of sponsors for clinical trials include:
- Commercial Sponsor
- Disease or condition specific networks of researchers.
- Collaborative research sponsors.
- An individual institution, such as an university or public hospital.
- An individual researcher can also be considered the sponsor of the clinical trial particularly in private sector research.
Non-commercially clinic trials are also referred to as academic investigator initiative clinical trials.
What are the differences between non-commercially sponsored clinic trails and commercially sponsored clinical trials?
Well there are some differences compared to how some commercially clinical trial starts up compared to a non-commercially sponsored clinical trial commences. Many of the obligations on institutional staff remain the same. For example all clinical trials require the approval of Human Resource Ethics Committee established in accordance to the National Statement on Ethical Conduct in Human Research.
Some clinical trials for example those involve new medicines must also be reported to the Australian Therapeutic Goods Administration or the TGA. We will learn more about regulation later in this module.
In this module we will focus on clinical trials involving new therapeutic goods particularly medicine. But the information generally applies to most of the forms of clinical trials.
In Australia the term Therapeutic Goods comes from new medicines and a range of technical devices. Clinical trials for new medicines in Australia are intended to establish quality. What is the drug prepared according to recognized standard for manufacturing, for example, the good manufacturing factor guidelines and does it only contain the ingredients listed.
Safety: Does the drug contains toxic materials? And is the known side effects justified by the therapeutic benefit of the medicine
Efficacy: If the drug is clinically affective. In other words, does it do what it promises?
Clinical trials in medicine are usually conducted in phases
Phase 1: "first in man" study which test safety and toxicity.
Phase 2: which establishes safety and efficacy.
Phase 3: which proves clinical effectiveness.
Phase 4: which looks at new combinations or post marketing surveillance.
Let's look at these phases more closely.
Clinical trials of medical devices can also go through trial phases, but the phases are different from those used in drug trials.
This module will not address medical devices in detail. However, it is important to note that monitoring participants in trials involve medical devices and this must continue throughout the life of the device. These are maintaining records for trial protocols indefinitely.