When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the device.
In the case of medical devices, the results have always been known to improve human wellbeing.
In the case of pharmaceutical drugs, however, I fail to see the purpose of doing clinical testing. No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing.
So what is the clinical testing of pharmaceutical drugs all about? Please help explain this.
I can understand your point of view on this topic @amd29 but clinical testing for pharmaceutical drugs do aid in the overall treatment or diseases. Clinical testing is a huge part of that process. Clinical trials are mainly used to test and record the efficacy of a drug or therapeutic. This requires several steps because they first must make sure the drug is generally safe and then they have to make sure it works for the select group being treated. Although this process is slow and occasionally arduous the resulting drug will help improve human wellbeing even if it doesn't cure the illness.
When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the device.
In the case of medical devices, the results have always been known to improve human wellbeing.
In the case of pharmaceutical drugs, however, I fail to see the purpose of doing clinical testing. No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing.
So what is the clinical testing of pharmaceutical drugs all about? Please help explain this.
The benefit of having clinical trials for pharmaceuticals is to measure the safety of the drug itself. Researchers can find the safety of the drug in no effects in the patient. In my opinion, no results are better than negative or fatal results when it comes to testing. Not all clinical trials aim to cure disease; sometimes, the goal is to ease a debilitating disease symptom so the patient can live longer or live more comfortably. To see this goal through, there have to be clinical trials to adjust chemical composition that may produce mal effects of a drug or increase the dosage if there is no change to patients' symptoms.
@amd29, I think you're suggesting the multi-billion dollar pharmaceutical industry has little value? Which I would like to agree, but there is strong evidence to suggest otherwise. Pharmaceuticals provide a host of benefits for disastrous conditions of human health - too many to name in this short chat. At the same time, the pharmaceutical industry deserves a "black eye" for some of its tactics to make money. Namely, the opioid epidemic that has caused many individuals to become addicts to prescription medications and to loose their lives in some cases.
Clinical trials help to prove the safety, toxicity, and efficacy of pharmaceutical prescriptions by examining the pharmacokinetics and the pharmacodynamics of pharmaceutical therapies. Pharmacokinetics is the examination of how drugs are absorbed, metabolized, distributed and excreted by the body. Pharmacodynamics is an examination of the effect that a drug has on the body. You should explore these two topics further to help broaden your understanding of clinical trials.
Clinical testing is an important part of the pharmaceutical drug development process. It helps researchers determine if a new treatment or medical device is safe and effective in people. Testing gives better insight into proper dosage, effects throughout the body, and whether it has any adverse affects. You can also find out whether a new treatment is more effective and/or has less harmful side effects than standard treatments.
@amd29, I think you're suggesting the multi-billion dollar pharmaceutical industry has little value? Which I would like to agree, but there is strong evidence to suggest otherwise. Pharmaceuticals provide a host of benefits for disastrous conditions of human health - too many to name in this short chat. At the same time, the pharmaceutical industry deserves a "black eye" for some of its tactics to make money. Namely, the opioid epidemic that has caused many individuals to become addicts to prescription medications and to loose their lives in some cases.
Clinical trials help to prove the safety, toxicity, and efficacy of pharmaceutical prescriptions by examining the pharmacokinetics and the pharmacodynamics of pharmaceutical therapies. Pharmacokinetics is the examination of how drugs are absorbed, metabolized, distributed and excreted by the body. Pharmacodynamics is an examination of the effect that a drug has on the body. You should explore these two topics further to help broaden your understanding of clinical trials.
@kc4310 you made some good points. Pharmacodynamics and pharmacokinetics are useful examinations, as they tell a lot about the effects a drug has on the body. Clinical testing is important, and should be considered before making drugs and medical devices available to consumers. Also, I respect your comments on the pharmaceutical industry and the opioid crisis.
When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the device.
In the case of medical devices, the results have always been known to improve human wellbeing.
In the case of pharmaceutical drugs, however, I fail to see the purpose of doing clinical testing. No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing.
So what is the clinical testing of pharmaceutical drugs all about? Please help explain this.
I disagree with your statement that "pharma drugs have never actually improved the direction of human wellbeing". Clinical trials for medication have been used to better understand the effect of drugs on humans and prove that a drug is at the very least safe and hopefully effective. As great as animal testing is for uncovering crucial data about a given drug and its efficacy, there is no perfect substitute for how a medication will respond within a human. Humans are able to think and explain how they feel and give even more crucial data points about their pain, psychological or not. During clinical trials, they are able to fine tune dosing and identify any red flags or side affects that may be associated with the drug.
Furthermore, one perfect example of a drug that has improved the direction of human wellbeing is the drug that is used to suppress the Aids virus and make it undetectable. This medication had to go through clinical trials to make sure it was effective in humans and not dangerous. Clinical trials are all about proving that a drug is safe for human use.
I also want to highlight that the pharma industry is not perfect and that they should be held accountable for all of their actions.
Does anyone know of any other drugs that have "improved the direction of human wellbeing"?
Thanks,
Matt
I believe that the majority of the reason for why clinical testing/trials are done for pharmaceutical drugs is to document any potential or inherent side effects that may transpire when taking the drug. If there is documentation of a person experiencing side effects, then the pharmaceutical company developing the drug will be able to list it on their stock bottle or package insert. That way, if its accounted for and listed as a warning, the drug company cannot be liable for litigation involving being sued because a person experienced an adverse reaction while on the medication. In other words, seeing if a person has side effects in a voluntary clinical trial, covers the tracks of the drug company that would otherwise be caught in a legal fight and bad press if someone has a bad reaction to their medication. In a case study of 100, if at least one person experiences an adverse reaction to the medicine being tested in the clinical trial, the drug company legally has to account for it on their product or package insert.
I disagree that doing clinical trials for pharmaceutical companies does not improve the direction of human wellbeing and doing clinical trials only for med devices has that effect. Many if not all drugs have had to go through extensive clinical trials to determine if
a.) if the drug actually has the desired effect. I am sure that there have been many drugs that may not have had the desired outcome and was therefore then scrapped or repurposed
b.) there were any side effects and if the desired outcome resulted in catastrophic failure. This is absolutely necessary to determine because if this step was skipped, it would have disastrous effect on the population who were consuming these products
c.) whats sorts of interaction it has with the body and any long term outcomes.
All these reasons are particularly why it is important to make sure that all drugs that are meant for human consumption go through extensive human experimental trials.
Drugs do not have to claim to cure a disease or illness but drugs have been created to help alleviate symptoms of an illness or prevent flare-ups of a disease. Regardless of the drug’s indication, clinical trials are there to ensure that the drug is safe and effective for human use. While drugs do go through animal testing, human trials are a necessary step to understand the risks and long-term effects of a drug in the human body.
Well first and foremost, the purpose of any clinical study is to ensure the wellbeing of the public. That is the point of the study, you're running trials to make sure it's not detrimental to a person's wellbeing. Now, as for functionality, the purpose of a drug doesn't always need to be to cure a specific disease right? So, depending on the drug's purpose, you want to target a specific symptom or group of symptoms without affecting or harming other areas, otherwise known as side effects. To understand this you need to understand to what age group it can be given, age, size, gender, dosage, and other specific medical conditions. If anything an argument can be made that there are more factors to take into account with pharmaceutical drugs than medical devices. Also, medical devices haven't always been known to improve human wellbeing, at least not right off the bat, otherwise, these trials wouldn't even be necessary.
I believe it can be argued that some pharmaceutical drugs have helped with some certain diseases or to at least control/diminish the severity for a disease. Even something such as Tylenol or aspirin are pharmaceutical drugs but have to be tested extensively and do help regulate certain illnesses in the body.
But it is important to do clinical trials on pharmaceutical drugs because you need to know the toxicity, what amount to be given, and potential side effects. It needs to be listed on the bottles, for the safety of the consumers and also for the companies. Additionally, pharmaceutical drugs need clinical testing to see its limitations and also potential dangers which cannot be seen if they aren’t tested.
The purpose of clinical trials for pharmaceutical drugs are not necessarily to find a cure for illnesses, but to ensure the safety and efficacy of the drug in humans before it reaches the masses. It is also important for identifying effective dosages, side effects, and other things of that nature. I do not think it is fair to say that pharmaceutical drugs have never improved the direction of human wellbeing. Different types of pharmaceutical drugs have made huge improvements to the lives of people dealing with so many different types of illnesses. Some people need medical devices to improve their lives and others need prescribed pharmaceutical drugs. Both are equally as important for the wellbeing of humans worldwide, and both need to be thoroughly tested to ensure that they are improving lives and not causing more problems.
FDA regulations require a clinical trial before a product is set to market. Clinical Trials are very essential both on medical devices and on drugs. After pre-clinical data is approved it is imperative that it be tested in a controlled human population to see how its actual predicted outcome suffices. Efficacy of a drug, biologic, gene therapeutic, and or medical device must be measured to assure patients' and consumers' safety. If you take a look at the history of the FDA and what was going on prior to its establishment as well as the pharmaceutical industry and governing body you realize that without these regulations people were getting sick and dying at alarming rates. In the US food was spoiled and still being sold and any person could sell a healing tonic that was poisonous. For the safety of all clinical trials are necessary.
The main objective of clinical testing is to test and observe how their pharmaceutical drug effects the people it aims to treat. In the end, it is the goal to make sure the drug is doing more harm than good, and is treating the illness wit was primarily intended for. If a drug is not performing as advertised, it will most likely not make it to market or get FDA approval. Clinical testing also allows researchers to observer any side effects that may not have been present in the animal trials, allowing them to reevaluate the performance of this drug they are testing.
Clinical trials measure the risks and benefits of specific medical treatments or interventions, such as new medications or behavioral changes. Essentially, they provide researchers with the first data on whether a new treatment is safe and effective for people, such as a new drug or diet, or medical device. To determine whether a product is safe, lab tests are conducted. After these tests have been conducted, the FDA determines whether or not a human study is safe enough to be done on the treatment.
