Insights for Clinical Management

Insights for Clinical Management

In Clinical, Preclinical, Regulatory, Toxicology by Anney Majewski and Nicole Feist

Extending your reach back to the earlier design stages, at least as far as preclinical testing for example, may provide unanticipated benefits in your product development efforts – leading to speedier and more efficient progress toward your ultimate goal of delivering safe and beneficial products to patients.

The basic structural differences between human, in vivo and in vitro models can result in different outcomes in the safety and performance of a medical device. Preclinical studies, which involve in vivo and in vitro models, are executed to develop and assess new medical device technologies and evaluate the potential safety and efficacy of the devices. Clearly, what you learn in early studies can help you know what to look for in later studies; that is a primary reason such studies are required. However, with planning, more can be gained from the preclinical studies to aid in the design and development of human clinical trials, whether pre- or post-market.

The purpose of conducting clinical studies is to evaluate the safety and performance, or effectiveness, of the device in humans; feasibility or pilot trials can provide information to further refine the device as well as increase the efficiency of the development process. It is important to conduct preclinical studies as they can offer insight to problems that may occur during clinical studies and help to identify potential risks that could be mitigated prior to the human trial. Sometimes a product appears to work well in bench models, but when you test the device in an in vivo model, other issues are discovered. Receiving and understanding this input can prevent unpleasant discoveries during clinical trials, especially when the cost of the discovery is significant to patients and the cost in terms of time and money is at its highest. In addition to improving the device and study design, uncovering these types of issues early can also provide information on how to and how much training Principal Investigators are going to need to use the product correctly.

Bringing together preclinical staff and clinical trial managers at the beginning of the preclinical studies offers multiple benefits and is worth the extra investment as product development proceeds. The following are just a few areas where efficiencies can make a big difference:

Case Report Form (CRF) design – Leverage the data collection form used for the preclinical study into the clinical trial by getting input from the clinical manager on how the data should be gathered. The clinical manager should also provide input into what data collection points could be collected that may be vital to the clinical trial. An additional benefit is that completing the data collection could be more efficient for the preclinical study director.

Database preparation – Electronic data capture in clinical trials is becoming the norm. We have found value in developing a database for our preclinical studies using the same or compatible data management systems and then using that building block for designing the clinical trial database. The preclinical trial can expose awkward data entry as well as reduce the cost of the clinical database development.

Adverse events and technical failures– Evaluate all adverse events identified during either bench or preclinical testing for risk mitigation. What can be designed out? What should be changed in the clinical protocol? What additional or different training of investigators could reduce the risks?

A vital step in the “benchtop to bedside” process model is the move from research and preclinical testing to “first-in-human” (FIH) studies. Several US-based companies choose to conduct FIH studies in EU member countries since the approval process there is fairly straightforward. Selecting a European “Authorized Representative” is a critical part of planning an FIH study in Europe.

To read the next blog in this series, The Need for an Authorized Representative for Clinical Trials in the EUclick here.

Authors:

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.

Nicole Feist, BA (nfeist@namsa.com) is a Medical Research Manager with NAMSA. Before joining NAMSA, Nicole held senior-level clinical positions at medical device organizations and contract research organizations. She specializes in helping companies create strategic clinical pathways for adoption of new technologies by developing and managing first-in-human, IDE, and postmarket clinical trials for US and outside-US approval.