Forum

Notifications
Clear all

WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?

43 Posts
40 Users
2 Reactions
3,058 Views
(@amd29)
Posts: 31
Eminent Member
Topic starter
 

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.

 
Posted : 26/10/2018 12:07 am
(@lurongyang)
Posts: 33
Eminent Member
 

It is very important to make sure that every pharmaceutical drugs should go through the clinical trials multiple multiple times with sampling subjects more and more extensively before they are put into the market. This is because every drugs has its specific effectiveness and toxicity functions to its dose. If we don't do clinical test, we will never know how that curve will show on the human body. Doctors will never prescript those drugs before they know their adverse effects, effective dose, and contradictions because they will be the one responsible for the aftermath of a likely medical malpractice. Besides, a drug that can be bought on the market must be proved to be apparently more effective than the placebo group to relieve the major symptoms, or to counter the known cause of a disease. But cure rate is a different story because almost every disease can be classified into many subtypes according their pathologic properties and causes. Like in leukemia, you can call it incurable as a whole, but there is a "curable" type called acute promyelocytic leukemia that can be eradicated by using arsenical and all-trans retinoic acid.

 
Posted : 26/10/2018 8:46 pm
(@mem42)
Posts: 40
Eminent Member
 

Clinical testing of pharmaceutical drugs is highly important. Drugs should undergo clinical trials to investigate their effect in the subjects, as well as any other changes such as secondary effects or healing curve. Even if you have the idea that pharmaceutical drugs won't improve your condition, would you want to take it not knowing secondary effects? or in what another way it could affect you?
The clinical testing is key to demonstrate this so that customers are aware of what they are ingesting. For doctors, it can be very helpful to determine if a patient should take certain drugs or not because through the testing the professional will know if the patient can be helped or should avoid because of certain side effects.

 
Posted : 27/10/2018 2:08 pm
(@mattie718)
Posts: 61
Trusted Member
 

Personally, I do not agree with either statement made above. First, I am sure there are medical devices which have failed to improve human well-being or have even backfired and caused unintentional harm during clinical trials. Perhaps the metal being used in an implant elicited a reaction from the body and the immune system rejected the foreign body. Medical devices may be simpler in the possible reactions and side effects which can occur, but can still be dangerous. Meanwhile in terms of pharmaceutical drugs, I think the whole basis of western medicine is heavily reliant on the use of drugs to combat illnesses and improve human well-being. There wouldn't be any market for these drugs if patients did not receive some sort of benefit. Everything from vaccinations against certain diseases, to anti-inflammatory drugs for simple pain relief, to anti-coagulants for preventing blood clotting, are all examples of simple to complex benefits from drugs. Now if a company believes they have an effective drug solution they still need to test extensively on humans, since we can have very different reactions and tolerances than animals. The trials will help identify any side-effects and determine the effective dosage to produce the optimal effect.

 
Posted : 28/10/2018 11:45 am
(@krp67)
Posts: 76
Trusted Member
 

I notice that one critical step was missed this discussion was taking place. FDA demands animal testing prior to even having clinical trials being a thought. Data collection of the drugs on animals has to be analyzed for efficacy, toxicity, viability, etc.. Then after many trials on animals , next is testing the drug on humans during clinical trials.
Advil, penicillin, chicken pox vaccines, the list can go on they have indeed help to actually receive their normal health back, whatever that may be. So we cannot say “all drugs” have not helped the well-being of people. You have to take the bad with the good. The body is complex we really do not understand all the biologic pathways that get changed when taking a drug. When just naming some of the drugs structures that are listed don those pill bottles you realize how complicated and complex those names are. You change the 1,4 linkage to a 1,3 linkage in some drug that get altered somehow, it could have drastic effects on the human body. That’s why these drugs need to be tested on animals first before humans.

 
Posted : 28/10/2018 12:15 pm
(@ap499)
Posts: 72
Trusted Member
 

Like you have mentioned, clinical tests takes place to evaluate the safety for human well being. Similarly, Pharmaceutical companies conduct clinical test to evaluate the safety and efficacy of their drugs. This tests are an important requirement to obtain regulatory approval so the drugs can be provided to patients. The test consists of a series of phases to ensure the product is safe and effective to treat the disease for what it is meant for. The stages of clinical trials starts with pre-clinical research and process through phase I, phase II, and phase III. Pre-clinical research is where it is tested by the manufacturer on cell cultures and on animal methods for toxicity to discover if unknown results are shown. From there, phases I to III takes place which gives pharmaceuticals companies authority to go next level which is phase IV to research more on information about the side effects and safety of the drug. Just like medical devices, drugs also progress though stages of tests/studies, only difference is in order to cure certain diseases those research still needs more work.

 
Posted : 28/10/2018 4:37 pm
(@pv223)
Posts: 76
Trusted Member
 

The purpose of clinical testing on pharmaceutical drugs is to see how well the drug accomplishes its intended purpose as well as identify any and all side effects that the drug can cause so that they can be listed for the patients that do take the medication. Without this testing, there is no way to see if the drug that is being produced is even safe for humans to take, let alone effective. If a drug were to ever be used as a medication without any testing done on it beforehand and it has an adverse effect on a patient, no one would know what to do because no one actually knows anything about the drug itself. With the clinical testing, companies are able to see how effective the drug is at doing its job, what side effects can occur, how it interacts with other drugs, etc. All of this knowledge is essential to know so that the patients who use this drug are taking it as safely as possible, and it can only be obtained through clinical testing.

 
Posted : 28/10/2018 6:10 pm
(@jmeghai)
Posts: 79
Trusted Member
 

Clinical Trials are very essential both on medical devices and on drugs. The main purpose isn't to find the cure to all diseases. The main purpose of a clinical trial is to see how well the device or drugs performs on a certain group of peoples; while studying the side effects, the dose required and how compatible it is in the human biological system.

Drugs are made to mitigate and control any disease to the extent where the patient can be able to live everyday life with little or no pain. Just as drugs don't cure diseases, also, medical devices don't cure all diseases as well. So clinical trials on Pharmaceutical drugs is to find ways to more effectively prevent, diagnose, or treat disease. During the clinical trial on drugs, preventive trials are carried out to see how well the drugs can prevent disease from occurring and mitigate it as well. Clinical trials on drugs also determines the dose to be administered and what dose will be effective to the disease it is meant to treat. 

 
Posted : 21/10/2020 5:58 am
Jafar reacted
(@nikhil-nagarjun)
Posts: 78
Trusted Member
 

The point about curing might be true in most of the cases .But clinical trials are not just about  curing ,it is also about the safety of using the drug .In most cases it may not do the magic ,but it is important to test for human safety or for  human use .It is very important to understand about curing a disease is that it is a  process where pharmaceutical drugs are the part of the process or treatment . Pharmaceutical drugs are never considered to be the cure in any case.

 
Posted : 21/10/2020 11:20 am
Jafar reacted
(@jafar)
Posts: 75
Trusted Member
 

In my opinion clinical trials doesn’t differ either testing a drug or a device it is a way of improving the overall wellbeing of humans. In pharmaceutical drugs the testing has 5 phases from preclinical trials to approval by FDA. So when a new drug or vaccine is introduced Clinical trials plays a major role in determining the dosing, efficacy, possible side effects. For example, diabetic drugs such as metformin or Insulin made a huge difference in those patient lives. It decreased both morbidity and mortality in those patients. Nowadays, we can see how all pharmaceutical companies doing there best to come with COVID-19 vaccine which all of us waiting for the approval without clinical trials of pharmaceutical drugs it wouldn’t be there. Nonetheless, sometimes those pharmaceutical drugs can help in patient relive without improving the wellbeing of humans. In my opinion pharmaceutical drugs clinical trials has same phase of medical devices trials with both making our life better and leading to a better human wellbeing.

 
Posted : 22/10/2020 1:59 pm
(@shereenmurrah)
Posts: 39
Eminent Member
 

The FDA requires that any device or drug made and will be used to treat humans, should go through a clinical study/trials. Even if these drugs or devices do not improve the overall wellbeing of humans, we still need them to aid us and ease illnesses/operations. There is a huge purpose of doing clinical testing because anything that will be used by humans such as drugs or devices, should be thoroughly tested. Even if the drug/device isn't as effective as planned, it should be tested on humans to make sure that it doesn't harm them, if not benefit them. Now, people have different opinions on whether drugs/devices have made an impact on the wellbeing of humans or not. What would happen to patient with diabetes without insulin, or to a patient with a lung infection such as pneumonia, without antibiotics? Overtime without the required medications, these patients will not survive. There are thousands of other examples of how we rely on drugs/devices to survive and how they helped improve and treat many of the diseases out there. Clinical trials do not come first in the development to make sure that humans do not get harmed in the process. Clinical trials help us determine the right treatment for different people, and the right dosing for certain bodies and diseases. The success that scientists achieved throughout the years with drugs/devices couldn't have been effective without the use of clinical trials.

 
Posted : 23/10/2020 11:34 pm
(@mg482)
Posts: 64
Trusted Member
 

I disagree, pharmaceutical drugs can be used to cure certain diseases. those clinical trials are very essential to test the effectiveness of the drug. for example, medications that are heavily being used nowadays to help treat coronavirus have had great results. those drugs assist the lungs to fight the virus. Without the drug, some patients can not do well on their own, so I would have to disagree drug human trials are essential to confirm the efficacy of the drug and getting it approved to help millions of people around the world. 

 
Posted : 24/10/2020 10:41 pm
(@aohara)
Posts: 38
Eminent Member
 

I would respectfully disagree that only medical devices have been proven to improve human health, and not pharmaceuticals. In addition, a drug does not need to cure a disease in order to be classified as effective or safe. Reducing side effects of a certain disease, or even when just not feeling well, is a common function of many drug treatments. When either a medical device or pharmaceutical drug is clinically tested, it is to prove it is safe for humans. This is incredibly important in both cases of new treatments discovered in the form of either a device or drug, and more recently, can even be a combination of the two. In the same sense that an implant, a type of medical device, must go through clinical testing to understand if there is a risk of adverse effects, so must a vaccine or pain killer pill, which would be considered pharmaceuticals. Because these are mostly synthetic chemicals humans are either injecting or ingesting into their bodies, the outcome, max dosage, and many other factors must be determined before it is alright to give to a large percent of the population. And just as with a medical device, if not properly assessed, can cost the lives of innocent people who put trust in their doctor, or the faith of medicine in general. 

 
Posted : 25/10/2020 3:55 pm
(@sallirab)
Posts: 74
Trusted Member
 

one thing to add is clinical trails for drugs takes at least 10 years to develop new medicine. It take a lot o time for development and getting FDA for approval. I have red and i am quoting "Less than 12% of the candidate medicines that make it into Phase 1 clinical trials will be approved by the FDA." which is considered a small number and that's why we don't usually hear about any new medicine as it take long time, a lot of effort and money to produce.  Clinical trails are very important in pharmaceutical and i agree with what other student said.

 

 
Posted : 25/10/2020 4:54 pm
(@jal58)
Posts: 60
Trusted Member
 
Posted by: @amd29

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.

I think this statement is just false. I guess it depends on what your definition of "cured" is. My definition is that the patient no longer needs the medication for their condition after treatment. In this case, there are countless antibiotics that assist the human body to fight off infections and cure them.

And also "pharmaceutical drugs have never actually improved the direction of human wellbeing" is ridiculous. That's the whole point of medication; to improve the human condition. Although medications may not completely mitigate the condition, they can improve the patient's quality of life and also extend their life expectancy.

The goal of clinical trials on pharmaceutical drugs is to learn how it affects the human body, its adverse effects, and proper dosage.

 
Posted : 01/11/2020 4:51 pm
Page 1 / 3
Share: