Clinical trials are a vital step in the route to market for medical devices, providing data for the approval process, as well as information for sales and marketing teams, and for post-market surveillance. There are some similarities and differences between clinical trials for drugs and devices, and understanding these can be important, especially when developing a hybrid device, such as a drug in a delivery system.
There are some similarities and differences between clinical trials for drugs and devices, and understanding these can be important, especially when developing a hybrid device, such as a drug in a delivery system.
This white paper explores the differences between drugs and medical devices, and how these differences shape and streamline the clinical development process for medical devices and clinical research organizations (CROs).
The differences between drugs and medical devices
The differences between the mechanism of action of a drug and device, their application and their development pathway, influence how they are studied in clinical trials.
DIFFERENT MECHANISMS OF ACTION AND APPLICATIONS
Drugs are small molecules and biologics that act by targeting disease mechanisms, from cells down to subcellular processes, including gene expression. Therapeutic medical devices are not physiologically active and can act from the cell level up, from tissue grafts, to prostheses, and can include digital devices and apps. Diagnostics use genes and cells to diagnose and track disease progression, both in vitro and in vivo. The breadth of mechanisms and applications for medical devices means that the methods used to evaluate safety, performance and clinical benefit, including patient outcomes, must be broader, and may be less quantitative (and therefore, less precise). For example, the evaluation of an implantable spinal cord stimulator used to treat chronic pain may include semiquantitative pain scores, and qualitative quality of life scores, rather than the precision biomarkers that can be used in drug evaluation.
DIFFERENT DEVELOPMENT PATHWAYS
Drug development often begins with identification and characterization of biochemical pathways in complex biological systems in a laboratory. The researcher identifies a target along the pathway, and finds compounds that modify the target using technologies such as high-throughput combinatorial chemistry. Medicinal chemists and pharmacologists then step in to optimize the molecules by enhancing their activity and specificity, minimizing side effects, and drug delivery systems. The drugs then move into clinical trials, and two drugs that treat the same disease may have trials that are similar in terms of trial site requirements, design, size and timelines.
Devices are designed and engineered to address problems identified in a much broader variety of environments, such as in a clinical, community or home setting, and can have hardware, software and/or medicinal components that must work together to make the device both safe and effective.