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Compliance In Focus
Posted by John Lehmann on Wed, Oct 25, 2017

Drug and Medical Device Clinical Trials 101

Most medical professionals enjoy being on the forefront of new clinical treatments, techniques Drugs and Medical Devices.jpgand 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. IMARC has published a whitepaper on this important topic.

Before deciding to participate, it’s a good idea to learn as much as possible about the process. Well-informed participants are able to not only effectively contribute to the success of the study but also reap the full professional benefits. Read on to discover the who, what, why and how of drug and device clinical trials.

Drugs

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.
 
Devices

Medical device clinical trials are different from drug trials in that only patients with the condition which the device treats 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.
  3. Postmarket Study - This study is 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.

Download Drugs vs. Devices

 

photo credit: US Army Africa Shoulder to shoulder, sharing medical practices: American and Cameroonian military medical professionals partner, develop relationship through MEDRETE 17-5 via photopin (license)

Topics: medical device clinical trials

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