The value of clinical studies in my opinion, looks at the larger picture of society. We would all probably agree that if a product, medical device or drug were developed and approved without a definitive plan and set of criteria, the impact could be significant. Clinical studies with an approach with limit such as with Phase I, II and III where testing increases incremental patient populations is a balance of risk. By stepping through the stages, learning and understanding the impact (good or bad) to the patient is warranted to minimize unwanted results.
We must also remember that design, simulation, pre-clinical work with animals can only take us so far today. At this point in time, clinical studies are needed not just from a regulatory perspective but also to validate our medical devices and drugs do what we set out to do.
If a company invests in developing a new drug/device, then they should follow all the regulations to have an effective product. Clinical trials aid in the success of every drug or device in the market. Anything that humans will use or consume should go through a clinical study even if clinical studies encounter disadvantages. Clinical studies teach us what we do not know about the human body, and that is what makes us invent more and more for the wellbeing of humans. Clinical trials help scientists determine the right dosage of drugs and how ADME process of the drug/device works in the human body. How will the product work on humans if not tested on them. Human bodies are very complex and testing on animals is not enough in determining the safety and efficacy of the product. Humans who participate in clinical trials have the advantage of receiving new treatments that are not yet available, and they are the ones that help the rest of the population by participating. Although, they may encounter side effects or their bodies might encounter unexpected reactions, they still would be of a great help in determining these reactions as well. Without clinical trials, the developments we make will not reach far in improving the wellbeing or treatment of people.
I agree with the last statement that clinical studies are necessary for discovery, although I am conflicted with risking human lives for such advancements. It would not be possible to administer a treatment and have an understanding of its effects over a large population of people if a clinical trail has not been done to prove the safety and efficacy of the drug/device. However, it is also concerning that if a study were to go wrong, people's lives are at stake. Well, this is most likely where the pre-clinical trails and results obtained from such data would play a large role in determining if this treatment has proven to be safe enough, or work well enough at its intended function, to begin testing in humans. It should also be considered that with this, any person involved in a clinical trial must provide informed consent, and therefore is joining the study on their own free will. This does weigh on trust between a doctor, or clinical trail investigator, and the patient to decide if going this route is really right for them. Sometimes, a patient can meet all of the inclusion criteria to be in the clinical trial, but would not be a good candidate for reason x,y, or z. This is where it is really up to the medical professional working closest to this patient to provide some guidance. But overall, it is up to that individual who must be made aware of all risks associated with the trail to decide if they would like to move forward and participate. And as of now, there are no other ways to test treatments on large populations of people, well, without the people.
Clinical trials are essential for testing new drugs, devices, and vaccines in development. People have signed up over many years to be subject of the test in clinical trials. While I understand the concern of the side effects that the patients could have from the trial. It is on the person's responsibility to figure out if they trust the company that produced the drug and if the company had a good reputation before participating in the trial. Those people who participate in the study help researchers and scientists move forward with their products to be able to produce it and help millions of people around the world.
With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are the advantages and disadvantages of clinical studies?
I think that clinical studies are necessary for discovery, but I am conflicted when it comes to the risk of the people. If a study goes bad, it can cost the well-being of a person.
Clinical studies have different advantages and disadvantages in different topics. Thus, some areas must be used, and there are areas that an alternative way must be sued to perfect the method before getting approved to be used on humans or any other living being.
Common advantages:
1) A new treatment method could be introduced
2) A better treatment method could be introduced
3) It could be the only method that can be introduced
Common disadvantages:
1) It might do more hard than benefit
2) It could be an inferior method to the existing treatment option(s)
3) It might prove to be a waste of time
In my belief, Clinical studies should only be used on patients that have no other option. Although this would decrease the speed of clinical findings and new treatment methods, it is the ethical thing to do. Furthermore, no one can tell the clinical study won't have any long-lasting effects, thus having more harm than good. To give an example, one of the areas that clinical studies can be used is Cancer. Especially the ones that cannot be operated.
In terms of advantages, clinical trials help to see if treatments are effective and are sometimes for novel treatment options. In terms of disadvantages, the treatment from the clinical trial could have adverse effects on the patients as the effect of a treatment is not completely known sometimes. Obviously, research is done to minimize the harm that can be done, but at the end of the day, not everything can be accounted for sometimes. In my opinion clinical trails are necessary and can be justified by the fact that they are voluntary. In almost all cases, clinical trials are for patients who want to try a treatment or drug and these patients are aware that it could have adverse effects. Similarly, a patient could drop out of a clinical trial at any time. For these reasons, I think having clinical studies can be justified.
Clinical studies are necessary for the advancement of medical technology and medication. Assuming the application of the product provides ideal results, the primary advantage of a clinical trial is simply the access to this particular treatment over other common treatments. Being a participant in a clinical trial can provide you with treatment that has never been explored before, which can potentially provide results in which no other treatment offers. Unfortunately, clinical studies don’t always produce the results they intend and patients may suffer adverse effects.
Clinical studies are dangerous for some drugs but they are a necessary process of drug development. the benefits are that through the use of clinical studies drugs can be finely developed for a larger group of patients. However, this may be accompanied by several side effects. I think the way to conquer this is to choose test subjects who are healthy and fully aware of the risk. In addition to this more testing using body-on-a-chip technology could help shape the future of drug development and prevent any harm from testing drugs initially in humans.
With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are the advantages and disadvantages of clinical studies?
I think that clinical studies are necessary for discovery, but I am conflicted when it comes to the risk of the people. If a study goes bad, it can cost the well-being of a person.
You are correct, there is a lot of risk that is inherent with drug trials. At present, the proper explanation and consent from the participant seems the best policy. Unfortunately, if a study is approved and still goes badly, it is the risk that the participant decided to accept. For lack of a better example, it reminds me of those who have fought in wars and never made it back home. Whether in war or in a clinical trial, all participants realize the risk (even if that is death or maiming) in engaging. It is very unfortunate, but part of the agreement. No one wants to go to war or sign up for a trial hoping to die or become maimed, but it certainly a risk that they were willing to take. I think as long as they can make informed decisions and they are of sound mind, they should be able to make that decision for themselves. Those running the studies should respect and appropriately care for those participants.
A few of the advantages as it comes to clinical studies are the marketing and the treatment. The marketing side comes from the word of mouth distribution coming from the subjects regarding their results and experiences. The treatment can pose as an advantage from the possible help offered by the product in testing. Disadvantages are innumerous, as risk is a large factor that usually sways people to or from participation. Harm is always a disadvantage.
The advantages of clinical studies include discovery of new medications, devices and treatments. This could include fewer problems or side effects of current treatments. A new medication may also work stronger and faster than a previous medication as well. Finding treatments for life threatening diseases such as cancer, and HIV could change so many lives and allow people to live longer. However, some of the disadvantages may cause some of the subjects to lose there lives while participating in the trials. Others may develop life altering changes in there bodies. I believe if the disadvantages outweigh the advantages then the clinical study should not be conducting, because the new development is not worth the subject to lose their life.
With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are the advantages and disadvantages of clinical studies?
I think that clinical studies are necessary for discovery, but I am conflicted when it comes to the risk of the people. If a study goes bad, it can cost the well-being of a person.
I agree with you, I think clinical trials are necessary for discovering if a drug/biologic/device is safe and effective but sometimes they hold some risk of things going wrong.
I think the biggest advantage of clinical trials is that you get the most relevant data: How does the drug/biologic/device work in humans. I work in creating relevant bench top models for determining the efficacy of medical devices, and although it provides useful information there is no substitute for the real thing. One professor I had during my undergrad had a saying "All models are wrong, but some are useful". A model, like the ones I develop at work or the pre-clinical studies can possibly give an idea of how it will work in humans. However, the best way to figure out what happens, for good or for bad, is to see what happens on humans.
With that being said, I would argue that that is also its biggest disadvantage: The unknown. Trials can go wrong, medical devices/drugs/biologics might not work and in some cases, could even be detrimental to a participant's health. That is why patient consent and informed consent is crucial. Prior testing and pre-clinical studies can give indications of possible risks but there isn't any guarantee that all risks are addressed. I think that's also just one of the risks with doing science.
Does anyone else share any similar opinions on human testing being the best way for understanding how drugs/biologics/medical devices affect humans?
Thanks,
Matt
Definitely clinical studies are necessary in order for a drug/product to be approved by the FDA. It is true that people who are participating in the trials can get affected if the study goes wrong or the drug/medical device doesn’t show the result as expected. But at least the scientists would get to know the cons before it gets at a point where mass people get affected. Therefore, in my opinion it is important to make the best use of the research on animals before a product gets approved for clinical studies.
While there are risks to participating in a clinical study for new drugs, treatments, or medical devices, they are necessary to ensure that products being released to market are safe and effective for human use. It is important to note that participation in these studies is voluntary and that patients are able to withdraw from the studies at any time. Patients who choose to be a part of these studies, regardless of the risks, do so in the hopes that the new drug/treatment could improve their health or quality of life. There are protocols in place to make sure that patients are informed of how the clinical trials will progress and what is expected from the treatment and drugs as well as follow-up appointments. So, while the obvious disadvantages are the possible health impairments that can result from the new drug/treatment, the biggest advantage is that in proving the safety and efficacy of the novel drug/treatment, there is the opportunity to treat thousands to millions of people with the same condition/illness.
The benefit of a clinical trial, in my opinion, is being able to witness the result of years of study. To get to a clinical study, a lot of data has to be gathered, and this is where it all comes together. This is where we will see if our study was worthwhile and if we will be able to assist individuals. Clinical studies can be influenced by businesses, which is a disadvantage to me. Although there are procedures in place to ensure that this does not occur, I feel that a clinical study conducted by a pharmaceutical corporation might be affected. What I'm referring to is the provision of pharmaceuticals and the expansion of their availability just for the purpose of expanding their availability. Although the medicine may not be superior to existing treatments, the trial's objective is to provide a product that is both therapeutic and safe. A drug's safety does not imply that it is without adverse effects. Because everything in the body is reliant on another component of the body, it's practically hard to target just one route with most medications. Those adverse effects may indicate that an alternative therapeutic technique is preferable, but it makes no difference. The only objective is to produce a medicine that is both safe and effective. We'll simply disregard the fact that it's probably not the greatest therapy and has additional side effects, and that the pharmaceutical corporation is benefitting from it.
