Clinical studies do come with risks but they are an important part of drug and medical device development processes. After getting favorable results from pre-clinical trials, companies need to further their studies and go into clinical trials to prove their products' safety and effectiveness to the FDA. Just as there are healthy people who are enrolling with the purpose of helping to move science forward, there are also sick people who participate in these trials with the hope that the treatment they receive will help their disease and others who suffer from the same condition. People are given a consent form where they are made aware of all the risks associated with the studies so it is really up to them to decide whether it is worth it or not.
Clinical research are the fastest way to find effective treatments, improve standards of care, and identify methods to improve health care. Participating in clinical research is essential for the development of new medications and new treatments. Participants volunteer to gain access to new medicine, therapies, and/or medical devices before they are available to the public. They are given an additional treatment option that may not otherwise exist. Patients receive medications, devices, supplies, medical exams, and laboratory and diagnostic tests at no cost. Patients may also receive compensation for their time and travel.
The risks for clinical trials depends on the type and purpose of trials. Let's talk about advantages first: YOu many gain access during or after the trials which are not available to general population in outside world. Obtaining medical fair in free. If any adverse events occurred you will be monitored closely for them. You have greater risk as you are working on medical and healthcare advancement for humans. Clinical trials is not a primary source of income but company will provide money for everything from failed results trials to transportation and food.
Now looking disadvantages: You need to assign time for visiting trial sites and work. You can't use traditional medications without the approval of a doctor. Your personal and social life might get affected like consumption of alcohol, productivity , sex etc. While going to a doctor you have to inform them that you are under trial and so van't use certain medications. Major drawback is you insurance companies won't pay for the claims related to the participation pf clinical trials.
An advantage to clinical testing is being able to come up with a breakthrough medical device/technique that treats many patients to unique illnesses while of course, being lucrative. A disadvantage is risking a high-cost study that yields adverse results with several ill/dead patients. It's true that there's only so much that laws and controls can do regarding the safety and efficacy of clinical trials, however these trials have also undergone many milestones of their own, a lot of which aim to proceed away from compromising the health of the patient. For example there was a study involving the culturing of hepatocytes on 3D constructs that were administered fialuridine for treating hepatitis B (1). Fialuridine however, was toxic in that it can result in liver failure (and has resulted in clinical losses in the past). The cultured hepatocytes however, were able to express the hep B infection that went undetected in preclinical studies, preventing any potential harm to patients who would have undergone the trials had the 3D technology not been available. Even cosmetic companies such as Loreal use either skin from organ donors or 3D tissue-engineered skin for testing their products for cytotoxicity, sensitivity, carcinogenicity, etc.
On the contrary, studies done in the U.K. have attempted to treat rheumatoid arthritis and leukemia with a drug (TGN1412), which instead caused chronic inflammation and organ failure in its patients, so sometimes great attempts lead to drastic failures. Could the advancements in medical technology today be achieved without applying what we know now from human clinical trials? Are there any other studies done that foresees the testing on humans as obsolete? How risky do human trials need be to justify achieving an effective product for a particular condition such as skin irritation? What about type I diabetes or Alzheimer's?
Reference:
(1) Ng, Soon Seng et al. "Long-Term Culture of Human Liver Tissue with Advanced Hepatic Functions" JCI Insight, June 2017
Clinical studies is medical research involving people. Clinical studies are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment like a new drug or medical device is safe and effective in people. Before the FDA approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy safety and efficacy. If these studies show good result, the FDA gives approval for the intervention to be tested in humans.
Clinical trials are risky but it is necessary regardless of how many preclinical trials are performed. Testing a subject (individual) is not that good but however helping for the mass of humankind would be beneficial for all. The most practical way of testing in humans is human testing. The subjects would be informed of the risks. The disadvantages include that there is no surety of the outcomes, there may be more side effects compared to the standard treatment, the trial would not be given at a convenient location and the uncertainty of not knowing whether you are taking a new drug or standard treatment.
Clinical trials are meant to find new ways to detect, prevent, treat diseases or make an improvement to an existing drug or device. New methods/procedures are not possible without clinical trials. The pros of clinical trials are that the patients are the first to receive the treatment of it's kind for the first time. The patients are helpful in finding if the clinical trial will be useful for the future and the patients have added benefits such as access to highly qualified medical professionals. The clinical trials help have more understanding of the treatment and the disease while performing the study. However, there will be disadvantages associated with any new idea, product or a process and so is the case with clinical trials, they may the study/trial may not always be a success and may result in some patients having a side-effect. As a patient one may be a part of the placebo controlled study and may not be as effective as the patients in the control group. Apart from that if the study duration is long then considerable amount of time may be demanded for the study.
Before clinical trial a drug or medical device cannot go into the market. Clinical trial has unavoidable moral conflict which cannot be solved permanently. Without clinical trial we won't know the good or bad effects of the drug or device. Here we have look at the bigger picture. Patients are volunteering for the trial and they are made aware of all risks related to the procedure. If they still goes on with the study we have to count that sacrifice and make sure we do our best to keep them alive while trying to produce a successful drug or device which can save lives of thousand others.
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.
In order to release a product to the public, clinical trials are absolutely necessary to understand the potential effects of the product on the human body. The disadvantages are obviously that there can be negative effects on the patient, but that is why pre-clinical studies are performed to try and identify those side effects prior to exposing any humans to the product. Also, anyone who signs up for a clinical trial would have signed a waiver and recognized that potential side effects may occur, so they should know and understand what they are getting themselves into. On the plus side, the advantage of clinical studies is that the effects of a product can be understood and quantified during the trial period, prior to the general public being exposed to them. If improvements in the product need to be made during the trial period, that is much better than if things go wrong one the product has already been released to the public. At that point, far more people would be exposed and affected, the company would need to potentially recall the product, and would most likely have to deal with lawsuits from people affected by their product.
There is no complete correspondence between animal testing and humans.
Doing tests on tissue apart from a live person is not always possible.
So there is no way to get conclusive results wi
I personally think that clinical studies are necessary as we need to test it on humans to actually know what the results could be on human, because the other way would be not to have a trial at all and then if something goes wrong it would affect a lot number of people compared to clinical trials. Also while doing clinical trials several measures are taken to ensure the safety of the people involved in the trial.
The ethical implementation of clinical studies is extremely important me. The prerequisite of pre-clinical research with animal subjects diffuses some of my concerns about the safety of human in clinical studies or trials. Every study must have a plan for protecting its human subjects and written procedures for if an adverse event occurs. It cannot be understated that clinical studies are critical to finding better ways of treatment and demonstrating that a product meets minimal safety standards before being released into the consumer market. When done right, clinical studies can contribute to a better quality life or improved patient well-being. Moreover, there are situations with exploratory drugs or devices where terminal patient subjects are on the verge of death and the new unproven treatment may yet offer promise. For that reason alone, I firmly believe that clinical studies are worth affirming and expanding.
Clinical research is of great importance for emerging technological diagnosis and treatment. But like everything else, this comes with its pros and cons.
Pros being that the individual may get promising new treatment methods that are not currently available outside clinical research and can be among the first few to benefit from it. The new method may have fewer side effects than the usual care. If this does work for that person, it is likely to work for others suffering from the same ailment at the same time and in the future.
Cons include that the new drugs or methods being tested may not always be better than the normal treatment. They may lead to side effects or prolonged risks which are not predicted by the doctor. If it is a randomized study, the individual will not be able to choose the treatment they receive. Repeated visits may be required and even if this method or drug does prove a good enough new treatment, it may not work on the individual participating in the trial. If anything goes wrong, health insurance may not cover all costs, and getting treated for any new ailment would turn out expensive.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
There are lot of important points to consider during clinical trials .There may be fewer side effects compared to the standard treatment. But You may have access to new treatments. There are always pros and cons in a clinical trail ,most of the time people who volunteer for this kind of trails are people who are suffering from the disease or sometimes in the last stages.
As have been said before there is different Pros and cons for clinical studies, one of the cons that come up to my mind is long term side effect. Some side effects appears several years later even after clinical trials ends. From some volunteers perspective, one Of the pros would be getting money from the organization which considered a common practice.
