Classification of Drugs and Medical Devices in Clinical Trials
Drugs and Medical Devices play important and crucial role in Health care System. Drugs are intended for the treatment of Diseases and also to sustain health of human beings, where as Medical Devices are considered to be crucial for the services offered in prevention, diagnosis, treatment and rehabilitation of illness and disease.
Before to use of Drugs and Medical Devices approval by the regulatory authorities is a must considering the safety and effectiveness of the product. Hence Clinical trials should be conducted. To safeguard the research participants while bringing safe and effective products to the market as quickly as possible. Understanding the similarities and appreciating the differences of both Drug and Medical Devices is important for clinical researchers who are involved in trials.
In case of Drugs, clinical trials are always required, however not all Medical Devices will need to undergo clinical trials. It depends on risk stratification; Minimal risk Medical Devices would not require a clinical trial, whereas some intermediate risk Medical Devices and all substantial risk Medical Devices will require a clinical trial. Currently, the FDA is considering providing additional guidance to assist researchers in determining whether a particular Class II device would require a clinical trial.
Medical Devices classified into three classes Class I, Class II, ClassIII.
Class I: Least risk and general controls adequate medical devices comes under this and these devices do not require clinical trials.
Class II: Intermediate risk and Special Controls(510K) needed Medical devices comes in Class II and they may require clinical trials.
Class III: Substantial Risk and premarket approval needed Medical Devices comes into this class and they mandatorily require clinical trials.
Drug trials are conducted in different phases as shown in below table, all new Drugs require clinical trials where safety and tolerance in Phase I, Safety and efficacy in Phase II and III trials are checked. Phase III trials require large population group to determine how the chemical interaction affects the human body and how it potentially interferes with the metabolism of the other drugs.
Phase I:
Normal healthy volunteers needed to determine metabolism and pharmacologic actions, safety and tolerance.
Phase II:
This Phase requires small population; they are patients with the disease or condition. In this safety and effectiveness of the drug checked.
Phase III:
The safety and efficacy of the drug is checked in phase III clinical trial. It requires large amount patients with the disease or condition.
Medical Devices has no phase I clinical trials equivalent to Drugs. Medical Devices may be studied in terms of pilot studies which might involve a smaller number of patients with the disease being studied and pivotal studies which would include a larger sample size of patients with the disease. Often pilot study data are eventually combined with pivotal study data for analysis purposes.
In clinical trials the Investigational product will be provided free of charge to the investigative sites and patients .Medical Devices can be expensive to produce and depending on the Device, Patient has to bear the costs.
Coming to the regulations, the regulatory requirements for conducting a clinical trial are exactly the same for Drugs and Medical Devices. Drugs and medical devices need Electronic medical records (21 CFR 11), human subject protection (21 CFR 50), financial disclosure (21 CFR 54), and IRB requirements (21 CFR 56) regulatory requirements. The differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812). The regulation investigational new drug regulations (21 CFR 312) are required for drugs only. The investigational device exemption regulations (21 CFR 812) are required for devices only.
Still there is lot to be known about Drugs and Medical Devices. In this article we tried to explain basic knowledge about what are drug and medical device, Classification, Regulatory requirements and approvals.
Before to use of Drugs and Medical Devices approval by the regulatory authorities is a must considering the safety and effectiveness of the product. Hence Clinical trials should be conducted. To safeguard the research participants while bringing safe and effective products to the market as quickly as possible. Understanding the similarities and appreciating the differences of both Drug and Medical Devices is important for clinical researchers who are involved in trials.
In case of Drugs, clinical trials are always required, however not all Medical Devices will need to undergo clinical trials. It depends on risk stratification; Minimal risk Medical Devices would not require a clinical trial, whereas some intermediate risk Medical Devices and all substantial risk Medical Devices will require a clinical trial. Currently, the FDA is considering providing additional guidance to assist researchers in determining whether a particular Class II device would require a clinical trial.
Medical Devices classified into three classes Class I, Class II, ClassIII.
Class I: Least risk and general controls adequate medical devices comes under this and these devices do not require clinical trials.
Class II: Intermediate risk and Special Controls(510K) needed Medical devices comes in Class II and they may require clinical trials.
Class III: Substantial Risk and premarket approval needed Medical Devices comes into this class and they mandatorily require clinical trials.
Drug trials are conducted in different phases as shown in below table, all new Drugs require clinical trials where safety and tolerance in Phase I, Safety and efficacy in Phase II and III trials are checked. Phase III trials require large population group to determine how the chemical interaction affects the human body and how it potentially interferes with the metabolism of the other drugs.
Phase I:
Normal healthy volunteers needed to determine metabolism and pharmacologic actions, safety and tolerance.
Phase II:
This Phase requires small population; they are patients with the disease or condition. In this safety and effectiveness of the drug checked.
Phase III:
The safety and efficacy of the drug is checked in phase III clinical trial. It requires large amount patients with the disease or condition.
Medical Devices has no phase I clinical trials equivalent to Drugs. Medical Devices may be studied in terms of pilot studies which might involve a smaller number of patients with the disease being studied and pivotal studies which would include a larger sample size of patients with the disease. Often pilot study data are eventually combined with pivotal study data for analysis purposes.
In clinical trials the Investigational product will be provided free of charge to the investigative sites and patients .Medical Devices can be expensive to produce and depending on the Device, Patient has to bear the costs.
Coming to the regulations, the regulatory requirements for conducting a clinical trial are exactly the same for Drugs and Medical Devices. Drugs and medical devices need Electronic medical records (21 CFR 11), human subject protection (21 CFR 50), financial disclosure (21 CFR 54), and IRB requirements (21 CFR 56) regulatory requirements. The differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812). The regulation investigational new drug regulations (21 CFR 312) are required for drugs only. The investigational device exemption regulations (21 CFR 812) are required for devices only.
Still there is lot to be known about Drugs and Medical Devices. In this article we tried to explain basic knowledge about what are drug and medical device, Classification, Regulatory requirements and approvals.
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