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 have involved in the human research study were we worked on the TBI and ADHD subjects and the research was related to attention. I see the pros and cons of the human research study to be an equal one. Introducing a medical device or drug to a group of humans of course would be a better option to estimate the success rate of the product. But eveything happening here is measured by the probability and not by reality. Reality is only known when it is completely utilized by the population. If the discovery would be creating a good venture in the history or if it has benefits a higher level then small scale of effects can be acceptable.So depending upon the probability of the future effects the clinical studies should be done. Even though it has credible risks in order to enhance the well being of the people clinical studies are done.
The most obvious advantage of a clinical trial is that you have access to a new treatment that you wouldn't have otherwise. People are likely to go through regular testing which is in most cases very beneficial to the patient. The risk always involves that the treatment may not work and instead have side effects. Sometimes the side effects can be even worse than the current treatment. Patients usually may not like the uncertainty of not knowing whether you are taking an active new drug, the standard treatment, or a placebo. The biggest factor is that insurance company may not cover the costs of this new treatment. This very reason can be discouraging for most people for taking a part in clinical trials.
Nothing in this world is perfect, anything has to have pros and cons, but we have to put the most effort to make more pros than cons. In this case the pros of clinical research are: you may get promising new treatment methods that you cannot get outside clinical research, the new method may have less side effects than the usual care, you may be the first to benefit from the new method, you are helping others with the same disease, both now and in the future, and you play an active role in your own health care. Also the cons are very clear: new drugs or methods are not always better than the normal treatment, new methods may have side effects or risks that doctors do not expect or are worse than those from the normal treatment, if you are in a randomized study you will not be able to choose the treatment you receive, your health insurance may not cover all costs, you may need to make more visits to the hospital or clinic, and even if a new treatment has benefits, it may not work for you.
Clearly, we need clinical studies for a better future, using better and more reliable treatment. A good thing that makes people do it would be the FDA guidance documents and if the process is approved by the FDA, it is going to be safe. However, some types of clinical studies like randomized is a bit risky to people.
It's important to have clinical trials. I agree with Mark and @reshamn on this point.
I also want to point out that before going on clinical trials. The drug and medical devices being tested must have been tested intensively in many different models in vivo, vitro to assure the safeness and efficacy.
I think the point of clinical trials is to bring a better treatment for most people/society for generations to come. In the Belmont Report, it stated 3 principles essential for research with humans which are respect for the persons, beneficence, and justice. The last point justice has two parts:" Fair procedures and outcomes are used to select research participants, and there is a fair distribution of benefits and burdens to populations who participate in research". So the benefit of a successful clinical trial can benefit a lot of people in the present and future.
Furthermore, many people are suffering from incurable diseases or at the later stages of some deadly diseases. In those cases, sometimes, clinical trial for a new treatment had offered a new hope to them.
With that said, all the steps/tests before going into clinical trial be done thoroughly and correctly to minimize risks and the study design needs to be ethical and maximize benefit...
Reference for Belmont Report: https://phrp.nihtraining.com/index.php
Hi All,
Please read below the pros and cons of clinical studies.
Pros
1. You may get promising new treatment methods that you can’t get outside clinical research.
2. The new method may have less side effects than the usual care.
3. You may be the first to benefit from the new method.
4. You are helping others with the same disease, both now and in the future.
5. You play an active role in your own health care.
Cons
1. New drugs or methods are not always better than the normal treatment.
2. New methods may have side effects or risks that doctors do not expect or are worse than those from the normal treatment.
3. If you are in a randomized study you will not be able to choose the treatment you receive.
4. Your health insurance may not cover all costs.
5. You may need to make more visits to the hospital or clinic.
6. Even if a new treatment has benefits, it may not work for you
Advantages of clinical studies includes the following: access to new treatments that work, improvement of future treatments and medical knowledge and discovery of fewer side effects compared to the standard treatment.
Disadvantages of clinical studies includes; new discover treatment may not be any better than your current treatment, high risk that the new treatment may not work for you and may bring more side effects compared to the standard treatment.
In addition to the valid pros reshanm and ppp23 made, I would like to highlight that in a lot of cases, the patient volunteering to undergo clinical trials does not have to pay much (if any) out for their own pocket. It is true that insurance companies mostly will not pay for these experimental clinical trials, however, the organization itself often times sponsors their ‘test subjects’ and may even compensate them for their time. This sponsorship is due to the high demand for these volunteers because, without them, the clinical trials would not occur which would significantly delay and decrease the chances the new drug candidate ever reaches market. This free of charge care (although not always guaranteed to work) becomes a final hope to many individuals who need lifesaving care yet simply cannot afford the conventional proven drugs on the market. Finally, this means that the biggest hardship for those who want to undergo clinical trials would be the regular commute to the testing facility. Typically these facilities are very specialized centers and patients may have to travel great lengths (at regular testing intervals) to receive this experimental care. This could cause an inconvenience in the patient’s normal work and social life and priorities must be decided upon before such a commitment is made.
https://www.spribrooklyn.com/weighing-potential-pros-cons-participating-clinical-research-trial/
I would agree with most of the pointers that are mentioned above. When it comes to the discussion of clinical trials are ethically correct, one should also consider that for most people that are in unique situations where a new study for a solution is the only chance they have to get a cure/improvement in their overall health is substantial and at the same time their data can be used to further help humanity. The downside with clinical testing is that you have the risk of experiencing no improvement or can obtain additional unwanted side effects. This is where the informed consent is important to inform the patient with all information needed to make their decision. The other downside would be that health insurance will not cover side effects obtained from the study because it was essentially almost intentional. As mentioned before, all these tests have statistical supporting data to obtain probability of success and need to be approved by the IRB first. It all comes down of equivalent exchange and also playing with probability. With some patients this might be their only solution.
I 100% believe clinical studies are important but in my experience, I have learned that a lot of mistakes happen. Either it is human study or animal study. Frankly, animal study more often than human, may be because no animal can sue. But that's sad and disheartening. Biggest disadvantage is losing a life whether it is human or animal. In one of the previous post of mine, I had mention how the study I was working on all of sudden got cancelled because scientist overdosed male monkey since he messed up on the calculations of dosage. This one small mistake of a scientist cost a living being to give up his life. I believe that rather than animal study, it is better to test directly on humans since scientist will be more careful and attentive. But I know it is not possible and some studies or drugs or devices have to be tested on animal and then on human. The obvious advantage is we get brand new drug or device, or revised and better version of it.
A clinical trial has various advantages depending on which side of the fence you one may stand. It may serve as an additional source of income for doctors and nurses. At the same time physicians and nurses may be delighted to provide patients with the latest and newest treatments available. It may also be the only hope a patient may have if this is a life-threatening disease and they have exhausted all the available treatment options. Signing up for a clinical trial may help prolong one’s life while providing some sort of income to the ill.
The disadvantages of clinical trials may include treatments being harmful and toxic, the discovery of side effects that were not predicted and other drawbacks that may include additional trips to the hospital.
I do understand that if a clinical trial goes bad it might cost the well-being of a person but what if all goes well….
I think the advantage of a clinical trial is being about to actually see the product of years and years worth of research. To get to a clinical trial means that there was a lot of data that got it there and this is the climax. This is where we actually get to see if that research paid off and if we are actually going to get to help people. The disadvantage to me is that clinical trials can be influenced by companies. I know that there are regulations in place to make sure this doesn’t happen but if you do a clinical trial at a pharmaceutical company, I believe it could be influenced. What I’m taking about is providing drugs and making more available just to make more available. The drug might not be better than treatment that already exists but the goal of the trial is to just give a product that has therapeutic effects and is safe. Just because a drug is safe doesn’t mean it doesn’t have side effects. Most drugs have side effects because it’s nearly impossible to target just one pathway because everything in the body is dependent on another aspect of the body. Those side effects might mean that a different treatment approach might be better (not drugs) but it doesn’t matter. The goal is just to output the drug that is safe and therapeutic. We are just going to ignore that it might not be the best treatment and has more side effects and the pharmaceutical company is profiting off of this.
I agree with most of the participants in the forum that clinical studies/trial comes with a risk and a side effects. However, it is crucial for the researchers and doctors to perform these clinical trials to determine the effectiveness of the new drug or medical device. As we learned from this week lecture, that prior to signing up for the clinical trials, there are consent forms and clinical protocol that the doctor or researcher must review with the patient. It is understood that patient might feel the side effects and it can sometime be severe. Many patients are reluctant to participate after looking at the side effects, but it may not always occur. Prior to carrying out the clinical trials, the researcher adheres to the FDA guidance and prepares the protocol to make sure it is going to be safe. All in all, clinical trials and studies can bring new and reliable treatment to the market in curing various health problems.
Clinical research allows for the growth of the research being done. Essentially, it includes humans as subjects to determine the effectiveness of the product. One major aspect that needs to be considered is the risk factor. If something goes on with the research, someone’s, or multiple people’s, life is on the line. It could result in further damage to the person being tested on. A beneficial side to clinical research being done on humans, the researchers can make note as to how much of the product can be used when it is on the market. This will allow for accuracy in the usage of the product, and can prevent future users from being in harm. Although animals may be seen as an alternative, they will not provide the results needed for humans.
I think with every new procedure being introduce or proposed it always has its adv and disadvantage, but i think in case of medicine something which has proven itself in clinical trial show how safe the procedure is, Even in cases when any adverse effects or any risk are shown setps can be taken to avoid those duringfg treatment. But from what I believe Something is invented when people think either its not available or the current treatment is too risky with very less successful outcomes.
Advantages:
You may have access to new treatments that work.
There may be fewer side effects compared to the standard treatment.
You may have more regular tests, which some people find reassuring.
You may help to improve future cancer treatments and medical knowledge.
Possible disadvantages
The new treatment may not be any better than your current treatment.
There is a risk that the new treatment may not work for you.
There may be more side effects compared to the standard treatment.
The trial may not be available at a location that is convenient to you.
You may have to go to hospital more often for tests and treatment, which can be inconvenient.
You may not like the uncertainty of not knowing whether you are taking an active new drug, the standard treatment, or a placebo.
With all said most disadvantages are to the patients who participate to be in the trial since the procedure has never been used on humans before but with this said they sign the consent form only when they believe that this there short worth trying or with they believe that it gonna work. So I think no one as certain are facing all advantages or disadvantage.