Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and drug clinical research relates to the requirements that go into the studies. While a clinical trial is mandatory in the case of drug clinical research; it need not be so in the case of medical device research. A drug clinical without clinical trials is akin to an automobile without an engine. It is simply unthinkable. In the case of medical devices, depending on the class of the medical device; a clinical trial is not an absolute must.
The size of the population that is being studied and the method of administration:
The sample size is a major factor in clinical trials. They usually run into thousands, and many a time, a product may have to be administered into even healthy individuals. This is not the case with medical devices. Not only is the sample population relatively much smaller; it is impossible to think of a medical device being inserted into a healthy individual who has no need for it.
Classification:
The ways in which these trials are classified are another area of difference between medical device and drug clinical research. Clinical drug studies are classified into Phase I, Phase II, Phase III and Phase IV; while trials for medical devices are classified into Pilot, Pivotal and Post-Approval stages.
Regulatory requirements:
By far, the most important differences between medical device and drug clinical research relate to the regulatory requirements. A number of often confusing differences exist between the regulations between medical device and clinical drug trials.
Clinical trial sponsors have to submit an Investigational New Drug Application (IND) as part of 21 CFR Part 312. Medical device researchers are not required to do this, but they are subject to 21 CFR Part 812, which deals with Investigational Device Exemptions (IDE). The IDE makes training for the staff an important requirement, as the efficacy of the medical devices could vary from user to user. While the IND requires all adverse events to be reported; the same is not required on the part of an IDE, because of the reason stated above: the difference in the method of usage of the medical device, which could impact its effectiveness.
Full understanding of the differences from the expert
A complete understanding of the major and minor differences between medical device and drug clinical research will be offered at a highly interesting and absorbing webinar that is being organized by MentorHealth, a leading provider of professional trainings for all the areas of healthcare.
At this webinar, Sarah Fowler-Dixon, an Education Specialist and instructor with Washington University School of Medicine, who has developed a comprehensive education program for human subject research which has served as a model for other institutions; will explain the differences between the areas of medical device and drug clinical research.
Want to expand your understanding of the differences between medical device and drug clinical research? Then, please register for this webinar
Emphasis on the differences in the regulations
Sarah will stress the regulatory aspect of the differences between medical device and drug clinical research. She will clear the various confusions and complexities between the two and familiarize participants with the nuances in them. An understanding of the way in which medical device and drug clinical research is regulated is necessary for researchers and students, and will go a long way in helping them overcome the challenges associated with them.
She will help participants sift through the tomes of information available about the two areas at many sources. While there is an abundance of information; it is often a case of information overload, which leads to more confusion than clarity. The speaker at this webinar will highlight these aspects. She will seek to instill the following learning objectives:
- Define Drug Research
- Define Device Research
- Explore the Differences Between the Two
- Describe Requirements when Drugs and Devices are combined in One Study
Sarah will cover the following areas at this webinar:
- Defining Drug Research
- FDA approved drugs
- Investigational drugs
- Compassionate use
- Defining Device Research
- FDA approved devices
- 510 K devices
- Humanitarian Device Exemptions
- Invitro Diagnostic Devices
- Investigational Devices
- Federal regulations governing drugs and devices
- Guidance governing drugs and devices
- Combining devices and drugs into one study
- What are the requirements?
- What are the regulations and guidance?
- How these studies are reviewed.
To do all this, a healthcare practice, business or organization needs to have a good grasp of the fundamentals of what it takes to protect PHI. It also needs to make sure that its current safeguards are sufficient to withstand government scrutiny. Another reason for the need for understanding what requirements need to be met to safeguard PHI is that there has been a substantial increase in HIPAA data breaches
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