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Medical Device Clinical Trials vs Drug Trials

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(@tulikadasp)
Posts: 39
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Topic starter
 

Clinical trials for medical devices have many similarities to drug trials, there are some necessary
differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required. Clinical trial for drug trials has three phases  - phase I, phase II, phase III and sometimes phase IV. Whereas the phases for the clinical trial of medical devices are pilot, pivotal and post-approval study. They are highly related yet different processes. Can you point out the differences between them? 

 

 
Posted : 03/11/2019 5:31 pm
(@rv395)
Posts: 36
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Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and then in population with the disease or condition indicated for treatment. And in devices, trials are initially conducted in a smaller “pilot” population with the disease or condition being studied, and then moving into the larger “pivotal” population.

The difference in their trials is that even slight modifications in the chemical composition of a new drug can result in unanticipated effects in healthy subjects. However, for medical devices, which involve a surgical implant, it can't be inserted into healthy subjects. So usually there are lesser trials in Medical devices than drug trials.

 
Posted : 07/11/2020 8:21 pm
(@mduru)
Posts: 24
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They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood typing machines, aren't chemical compounds made to react a certain way in the body. There are fewer things in play with medical devices compared to drugs so a much less likely of material interactions and other complications due to different body chemistries. Drugs tend to see different reactions from the body than do medical devices so I think it's more important to perform more testing with drugs than with devices.

 
Posted : 08/11/2020 11:41 pm
(@shereenmurrah)
Posts: 39
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For trial periods, drugs are conducted in four phases (I,II,II and IV). The first three trials test for safety, effectiveness, dosage, and side effects, while phase IV is a continuation in testing after the FDA approves the drug. For devices, the trials are called pilot and pivotal trials, with a post trial similar to the drug process, which is a trial called post approval studies, for a continuation of the process after the device has been approved. To explain the pilot trials, they are used for preliminary safety and effectiveness before heading to the next trial. Pivotal trials are conducted to gain regulatory approval to have the device on the market. And the post market study oversees the longterm effectiveness of the device and any potential events that happened with the use of the device.

 
Posted : 09/11/2020 12:20 am
(@delany)
Posts: 45
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While drug trials and medical device trials are similar in a few ways, they are also different in just about the same number of ways. First of all, they have vastly different routes to assist and/or alleviate pain. With drugs, the have chemical makeups that must agree with our bodily functions and follow proper Absorption, Distribution, Metabolize, Excretion (ADME) procedures. Medical devices, on the other hand, are not usually consumed and digested so their trials are less strenuous and more direct. This leads me to my next point. Because drugs can potentially affect multiple body systems due to the route it takes once inside the body, they must be tested for a wide variety of environments, as opposed to medical devices. The devices are usually specific to an area of the body or particular ailment. This allows for specific testing instead of multiple. 

 
Posted : 07/06/2021 8:47 pm
(@djwhitemsm-edu)
Posts: 48
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Posted by: @tulikadasp

Clinical trials for medical devices have many similarities to drug trials, there are some necessary
differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required. Clinical trial for drug trials has three phases  - phase I, phase II, phase III and sometimes phase IV. Whereas the phases for the clinical trial of medical devices are pilot, pivotal and post-approval study. They are highly related yet different processes. Can you point out the differences between them? 

 

Both of these processes are integral for the overview and regulation of medical devices and medicines. However there are distinct differences between the clinical trial phases of the two areas. For instance the general requirements for devices and drugs are significantly different. the trials for drugs can have regulations so strict that they tend to take 10 more years to finish compared to medical devices. This is largely due to the fact that drug candidates have to be successful on a larger scale compared to medical devices. 

https://www.clinicaltrialsarena.com/news/outlining-the-key-differences-between-medical-device-and-drug-trials-to-determine-how-device-trials-can-best-be-run-effectively-4644599-2/

 
Posted : 08/06/2021 12:31 pm
(@nuran-kavakli)
Posts: 39
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The differences in the process of Drug versus Medical Device Clinical trials have various reasons. The main one is that two have different roles when entering the body. Drugs that are chemical-based have a direct effect on the human body systems. On the other hand, Medical devices do not have a chemical reaction, so the testing on them is not as detailed. Clinical trials for medical devices test the safety and the performance of the device while drug trials work on the chemical interactions and tolerability of the drug in the body. Drug trials are more precise and detailed because of what it aims at and how it aims. Drug trials could happen worldwide while medical devices need a smaller number of patients.

 
Posted : 08/11/2021 12:24 am
(@jadebowale)
Posts: 25
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There are some key differences between Medical Device and Drug Clinical Trials. In most drug trials, therapies are tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects with the condition for which the trial is designed. In a medical device trial, the person administering the device is typically the principal investigator while the patient or caregiver will be dispensing medication. Th responsibility of implementing medical device trials maybe place on physicians while for drug trials it may fall more on patients. Lastly the approval process for new drugs is typically longer (~ 10-12 years) than the approval process for medical devices(~ 3-7 years) to bring a new product to market. Both drug and device trials follow the same requirements when it comes to protecting human subjects, maintaining records and disclosing financial relationships including: 

  • 21 CFR 11 - Electronic medical records.
  • 21 CFR 50 - Human subject protection.
  • 21 CFR 54 - Financial disclosure.
  • 21 CFR 56 - Institutional Review Board (IRB) requirements.

While exclusively drug trials are exclusively required to follow 21 CFR 312, and medical devices trials by 21 CFR 812.

 

Sarac, T. P. (2020). Steps in Device and Drug Pathway Development: Clinical Trials, Similarities, and Differences. In Clinical Trials (pp. 87-99). Springer, Cham.

 
Posted : 09/04/2022 3:49 pm
(@justinmb)
Posts: 22
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As you said, both have many similarities however there are some differences. Drug trials are testing for safety and tolerability along with pharmacokinetics; medical device trials are mainly checking for the safety and the performance of the device so therefore have a much more patient focused outcomes. This is probably due to the fact that drugs can affect people differently, so they only have to work on efficacy and amounts to ensure a safe amount is administered for treatment. Whereas a device is for a specific use and the patients survival can be dependent on the devices reliability to perform its duty 

 
Posted : 09/04/2022 9:38 pm
(@justinwilliams)
Posts: 21
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Medical device trials and drug trials share certain commonalities but also differ significantly. Medical device trials primarily check for the safety and performance of the device and, as a result, have far more patient-focused outcomes than drug studies, which also test for tolerance and pharmacokinetics. Though they may take place abroad, device studies tend to be far smaller in scope than drug trials, which frequently involve many locations spread across multiple nations. In addition to the usual regulatory and ethical permission needed for medication and device trials, they also have a substantially longer follow-up duration (up to 10 years).

 
Posted : 31/07/2022 9:31 pm
(@atharva)
Posts: 39
Eminent Member
 

Medical devices do not have a placebo; unlike in drug trials, a specific group receives a placebo. Drug trials can be conducted in a single-blind, double-blind, or triple bind, but that is not possible with devices if that is class 3 devices since they are implantables. Dosing measures need to be adhered to and are strict for drugs, but for medical device trials changing parameters come with low risks and can be safely varied

 
Posted : 05/11/2022 10:40 am
 jj52
(@jj52)
Posts: 75
Estimable Member
 

Device trials are different in several ways when compared to drug trials such as:

1) medical device trials are usually smaller than drug trials.

2) Physician technique or bias is a larger role in drug trials.

3) medical devices modifications may occur during clinical trials.

4) Endpoints of both trials are usually not similar.

 

Because of these differences the overall FDA approval process, training requirements, patients who participate, and those who admininster devices or drugs will vary as well.

 
Posted : 11/11/2023 12:01 am
(@noahyoussef)
Posts: 63
Trusted Member
 

In general, clinical trials for both medical devices and drugs have the same end goal, to prove the safety and efficacy of these products for their given purposes. However, as many indicated above, the process of proving the safety and efficacy of the products is different. For clinical trials of pharmaceutical products, there is much more data and analysis needed to fully understand the chemical reactions such as pharmacokinetics and pharmacodynamics of the product. Because of this, the early stages of clinical trials are usually much longer and much more involved. For medical devices, safety is not as complicated as the risks are much more straightforward/predictable. In terms of the actual trials themselves, the clinical trial protocols for pharmaceutical companies tend to be more complicated, often using placebos as control groups. Placebos and control groups are not usually used in medical device trials as a means of proving efficacy. Rather, efficacy is shown by improvement of patient outcomes in both short-term and long-term settings.

 
Posted : 12/11/2023 10:38 pm
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