Believing that every clinical trial has the same procedure is a common misconception. Specifically research between drugs and devices has a significant difference.
When new drugs are developed, a clinical trials is absolutely necessary. But, for medical devices, a clinical trial might not be required.
Drugs are studied carefully in different phases. Usually it starts with a Phase I trial, which involves a study with a small number of healthy volunteers (20-100 subjects). Phase II trials are conducted with a small population (around 50-200) with the specific condition or disease and Phase III trials test the drug in a larger setting (100s to 1,000s of subjects), usually with people that live with the disease or condition. Phase IV trials test the long-term effects of a specific drug.
Medical Device trials are divided in: Pilot, Pivotal and Post-Approval-Study. Similar to the drug trials, the initial Pilot study is conducted with a smaller group, but who live with the disease or conduction (10-30 subjects). The Pivotal study is conducted with a larger number of individuals who live with the condition or disease (150-300). Similar to drug research, The Post-Approval study exists to learn about long-term effects.
Clinical Trial Design involves randomization as well as blinding. As regards randomization, this is all about being assigned to either the placebo, or control arm, or, being selected for the actual study arm. With reference to blinding, there is the single blind, which means that the researcher knows who gets the placebo and who gets the actual drug; and double blind means that the researcher also doesn’t know who receives the placebo and who receives the actual therapy/drug.
The differences in trial design are enormous between drug and medical device research:
For drug research, randomization is very common, and there is an ability to blind and double-blind the trial.
For medical device research, there is often no randomization, placebos are rarely used and blinding the research is very difficult.
Despite all these differences, drug and device research have one thing in common: patient recruitment.
If you want to talk patient recruitment with CitrusLabs, please get in touch.