Drug versus device: How clinical trials differ.

People might assume that all clinical trials follow the same rules and regulations put forth by the Federal Drug Administration (FDA). But the truth is, that’s not always the case. This is especially true when you compare the processes of drug trials and medical device trials, like the fact that device trials are not required in some cases, like with Class I devices, such as bandages and stethoscopes.

Similarities certainly exist between drug and device trials, but the differences are far more numerous – from phases and pivotal trials to randomization and dosing schedules. Read on to get a better sense of how the two types stack up.

Trial periods.

Drug trial – Conducted in four phases; phases I, II, and III test for safety, effectiveness, dosage, and side effects, and phase IV continues testing following FDA approval of the drug

Device trial – Conducted in pilot and pivotal trials, with post-approval studies continuing the process once the device is approved

Control.

Drug trial – Has a control arm, in which a group of patients receive placebo, or a comparative arm, in which a group of patients receive a specific treatment considered to be effective at treating the indication being studied

Device trial – Does not have a placebo arm because there is no ethical way to generate a mock device (i.e., every patient receives the medical device)

Randomization.

Drug trial – Randomization occurs over several phases, meaning that participants are randomly assigned to an experimental arm or to the placebo arm of the study

Device trial – When randomization is implemented, participants are randomly assigned to the device arm or to the standard of care arm of the study

Blinding.

Drug trial – Generally conducted in a blinded fashion, whether single blind (researchers know which participants are receiving the study drug versus placebo but the participants don’t know) or double blind (neither the researchers nor the participants know who is receiving the study drug versus placebo)

Device trial – Blinding is difficult because many of the devices have to be surgically implanted in trial participants

Dosing and implantation.

Drug trial – Utilizes a dosing schedule for the investigative drug; drug dosage must adhere to the established dosing escalation schedule with no changes to that schedule permitted during a trial

Device trial – The medical device is usually used and/or implanted one time; modifications to the device may be permitted during a trial to make the device safer, more effective or easier to use

At Praxis, we understand these differences well, and that assists us in creating tailored approaches to recruitment and retention that are as unique as each trial we work on. If you’re looking for some recruitment or retention assistance, write us a note. We’d be happy to talk it over!

Any questions? Want to know more?

Contact us today.