What are clinical trials?
Clinical trials are the basics of developing an innovative, investigational product like drugs or medical devices. The pharmaceutical products are found to be safe and effective in bench testing, in-vitro testing, and animal studies but, are not sufficient to show the same results on humans. Hence, clinical trials and clinical studies are used to check the drugs and pharmaceutical device efficiency in humans.
Clinical trials for pharmaceutical devices
New pharma device’s clinical trials are a must. Pharmaceutical devices with little innovation in designs, method, or usage are ordinary. These small modifications are just done to increase safety, comfort level, ease of use, and reliability so they do not require any pre-regulatory approvals. It’s a common practice in the pharmaceutical industry to increase their pharma business. Not much clinical research is required for the same, generally, these modifiers have to pass the bench and animal testing.
Pharma device clinical trials are required only for devices that have high to medium risks. These devices undergo different clinical trials before being used on humans. The sources for a clinical trial for pharmaceutical devices may come from partially controlled clinical studies; clinical studies without matched controls; case histories with full proof documentation; and significant human experience with a marketed device.
Medical devices requiring a surgical implant are not considered to be used on healthy humans. Instead, these trials are done on pilot population (15-20 people) suffering from the disease that is being studied. When positive results are shown the trial being moved to a pivotal (150-300 people) population. Later, a post approval study is done for medical devices that require a long-term data. The steps of clinical trials for pharmaceutical devices are as follows:
- No randomized trials are done, but for some, it may be carried out
- Tested on a Control group
- Tested on Small pilot population. There are no placebos used for medical devices as they may be considered unethical. For example, for the study of artificial hip placebo can’t be used.
- May compare to other approved therapies
- Visualization and documentation for approval
Challenges for pharmaceutical devices clinical trials
Pharmaceutical devices are used for diagnosis and treatment purpose. With the ease of use, there are some challenges when coming to the efficiency of the device. They are as follows:
- Medical devices are generally used by doctors. The outcome of any device depends on two factors: first is the safety and effectiveness of the medical device and second are the effectiveness and experience of the person who is using the device. A device has to be tested on patient directly to understand the efficiency and safety.
- Medical devices are designed in different ways. This is possible especially when the clinical investigator is the same person for treatment and assessment.
- Sometimes trial design has some limitation especially the implanted devices. Such comparative clinical trials are unethical and find difficulty in finding the subject for trials.