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Compliance In Focus
Posted by John Lehmann on Wed, Oct 19, 2016

Drug and Medical Device Clinical Trials 101

Most medical professionals enjoy being on the forefront of new clinical treatments, techniquesClinical_101.jpg and products. Drug and device research trials are a great opportunity for those in the healthcare field to learn about and assist in the development of revolutionary ways to treat patients, before they’re introduced to the public. These studies can provide invaluable information and learning experiences to everyone involved.

The responsibility for running a clinical trial is immense, so learning as much as possible about the process is essential for clinical research professionals to effectively contribute. Read on to discover the who, what, why and how of drug and device clinical trials.


Clinical trials for drugs are divided into four phases.

  • Phase I - The drug is tested on a small group of healthy individuals. This phase is used to determine the appropriate dosing, how humans react to the drug and possible side effects.
  • Phase II - In Phase II, the drug is administered to a larger group of people, usually divided into two groups—one which receives the experimental drug and one which receives a placebo. This part of the study allows researchers to determine the relative safety and effectiveness of the drug.
  • Phase III - Phase III involves testing the drug on a larger population (between several hundred and several thousand individuals) to confirm its effectiveness, its benefits, how it compares to other treatments and possible adverse reactions. When Phase III is complete, pharmaceutical companies can request FDA approval to introduce the drug to the market.
  • Phase IV - Often referred to as Post-Marketing Surveillance Trials, Phase IV studies are conducted after the drug has received permission from the FDA to be sold. In this phase, pharmaceutical companies can compare their drug to other drugs in the market and monitor the drug’s long-term efficacy.

Medical device clinical trials are different from drug trials in that only patients with the condition which the device is designed to treat are involved. They are traditionally comprised of three different types of studies.

  1. Exploratory or Feasibility Study - Exploratory studies (also known as feasibility studies) are conducted in the early stages of device development. They are used to establish preliminary safety and effectiveness of the device and design the next stage of the trial, the pivotal study.
  2. Pivotal Study - Pivotal studies are performed to demonstrate the device is safe and effective for a specific use within a defined patient population. The results of a pivotal study are used to gain regulatory approval to market the device.
  3. Postmarket Study - Run either as a condition of approval to meet a business objective, post-market studies are similar to Phase IV of clinical drug trials since the goal is to better understand long-term effectiveness of the device and potential adverse events associated with the use of the device.

Being familiar with the specifications and format of drug and medical device clinical trials can help all participants (including medical professionals, clinical staff and patients) ensure the trials run as smoothly and efficiently as possible.

Conducting Global Clinical Trials  

John Lehmann is the director of business development of IMARC Research, a clinical research organization (CRO) that specializes in medical device trials. IMARC Research assists study sponsors with clinical monitoring, auditing, training, consulting, project management and more. To learn more, visit imarcresearch.com.

Topics: Medical Devices


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