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Clinical Studies

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 su65
(@su65)
Posts: 40
Eminent Member
 

Advantages and disadvantages are associated with clinical trials. Performing a clinical study is important for the drug/ device to be tested for its effectiveness, safety and risks and to come into market. If a drug or device can save thousands of lives, then doing clinical trials to test it is worth enough considering its risks and benefits. Sometimes it is necessary to conclude a reasonable trade off between risks and benefits when considering the drug/ device is very much helpful to market.

 
Posted : 29/10/2017 9:32 am
(@akashranpura)
Posts: 39
Eminent Member
 

When looking at the benefits of clinical studies, it is hard not to look at the potential risks of such studies. In clinical trials where the patient’s life is at risk there are always measures taken to warn the patient and provide him/her with ample information. Also most patients that participate in such trials are facing some form of imminent death and they are looking to these medical trials as a last resort. It is important to understand and realize that there have been times where patients’ lives have been saved because of medical trials.

 
Posted : 29/10/2017 10:07 am
 hv42
(@hv42)
Posts: 42
Eminent Member
 

Every Coin has two sides of it in the same way every clinical trials has advantages and disadvantages:-

Advantages :-
1. You may gain access during and after the clinical trial to new treatments that are not yet available to the general population
2. You may obtain medical care free of charge
3. You will be closely monitored for possible adverse events
4. You are contributing to medical research that may result in the advancement of medicine and healthcare in general thereby helping other fellow human beings
5. Participating in clinical trials is not a source of primary or additional income. However almost all sponsors reimburse persons that participate in trials for all reasonable expenses related to participating in the trial, including travel expenses, food, medical care and compensation for provable and insured adverse events that are related to the trial.

Disadvantages:-
1. You may need to set aside time for trial related activities like visiting the trial site
2. You may not use certain medications including traditional medications without the approval of your trial doctor
3. Your personal private or social life may be affected, e.g. sexual activity, reproductive functioning, consumption of alcohol, tobacco or other drugs of abuse, etc.
4. You may have to consult your usual healthcare provider for all your other illnesses that are not related to the trial, but still you have to inform your provider that you are part of a trial and that certain medications or treatment options may not be compatible with your trial protocol
5. Your employer, medical aid, personal insurance and/or Commissioner for Compensation for Occupational Injuries may not pay for claims that are related to events due to your participation in clinical trials; it is therefore extremely important that you verify that the sponsor of the trial has an appropriate comprehensive insurance cover for you.

 
Posted : 29/10/2017 10:59 am
(@alexandrabuga)
Posts: 149
Estimable Member
 

I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have mentioned the patients understand the risks of entering a clinical trial, but especially in the oncology field, many do no have options and are eager to participate in clinical trials. Immunotherapy is really interesting field with the idea of using yourself to heal yourself. Car-T cell therapy engineers a patient's immune cells to treat their cancers. Car-T cell clinical trials are very popular and have seen success. For example as the NCI has stated- in ALL-one of these earlier trials, used CD19-targeted CAR T cells, all signs of cancer disappeared in 27 of the 30 patients treated in the study, with many of these patients continuing to show no signs of recurrence long after the treatment.These early successes laid the foundation for a larger trial of a CD19-targeted CAR T-cell therapy, called tisagenlecleucel (Kymriah), for children and adolescents with ALL. Many of the patients who participated in the trial, funded by Novartis, had complete and long-lasting remissions. Based on the clinical trial results, the FDA approved tisagenlecleucel in August 2017. ALL is the most common cancer in children, so this is really a break through. Creating treatments to provide patients with options where there haven't been is really remarkable. However, all clinical trials have risks and there are side effects and the potential of not making it trough. For example in two Juno trials, the FDA had to stop a study after three patients died of cerebral edema. As article in stat news " Juno maintained that the problem was not with its product — an infusion of genetically engineered cells — but rather with a cocktail of chemotherapies used to treat patients before they got the experimental therapy. The company removed one of those chemo drugs, called fludarabine, from the cocktail, and the FDA quickly gave Juno the green light to resume the study.". Overall, as many have mentioned clinical trials are important to provide patient's new treatments, but they do come with risks. Since the patients are aware of the risks involved in the clinical trial and voluntarily opt-in to them, I believe that clinical trials are necessary. We learn a lot from clinical trials even if they don't go as expected.

https://www.statnews.com/2016/11/23/juno-cancer-immunotherapy-deaths-2/

 
Posted : 29/10/2017 11:22 am
(@rachelpatel1796)
Posts: 43
Eminent Member
 

I believe that clinical studies are necessary in order to determine the best possible treatment for a disease or other pathology. There are some advantages to the participant as well, being monetary compensation and follow up check-ups for a potential treatment that may help their disease. It may also be an advantage to some since they are contributing to medical research that can become a medical advancement for the rest of the population. The participant may also obtain medical care free of charge. Some of the disadvantages include that the participant may have serious adverse events that are related to the treatment and their lives may be ruined if something does go wrong. In the long run, it seems like an individual decision to make to be a "human guinea-pig."

 
Posted : 29/10/2017 1:05 pm
(@jad73)
Posts: 30
Eminent Member
 

I agree with your stand regarding clinical trials. It is necessary for discovery but comes with greater risk in the form of a negative impact on the well-being of the subject when the experiment goes awry. I think that human subjects are necessary in clinical trials however its still ways a way before we can completely eliminate this method because modeling the human body is too complex that computer simulations or animal testing are simply not enough. This is an example of the Trolley Problem where you choose between saving one life and kill more than one on another track when you pull the lever; or you let one person suffer/die for the good of the many. Clinical trials do carry this risk however I think its minimal because Human Subjects are usually towards the last phase of clinical trials where rigorous studies and experiments have been done prior to this stage.

 
Posted : 29/10/2017 3:14 pm
(@woolynn)
Posts: 36
Eminent Member
 

For clinical studies, there are both advantages and drawbacks.

Advantages are like: may get a new treatment that works, that could not get outside the trial; could be helping to improve cancer treatment for future patients; may have more blood tests, CT scans or other cancer tests; have check-ups more often and for longer than usual with your doctor or research nurse.

Disadvantages are in several aspects:
Possible risks. There is some risk that an experimental treatment could harm patients. The research team may not know a great deal about the new treatment yet. They will keep a close eye on patients and will stop the treatment if necessary. Even in phase 1 or 2 trials, the treatment has been carefully researched in the laboratory before it is given to patients. With phase 3 trials, more is known about the new treatment so there is less risk that there could be a harmful side effect.

Side effects. There is a chance patients will get side effects that they (and their doctors) weren't expecting. If patients are in a phase 1 trial, the researchers may not be able to tell them much about side effects. They will tell you everything they do know before patients agree to take part in the trial. Patients will be asked to report all their side effects to their doctors or nurses. They may ask you to keep a diary at home or fill in questionnaires about side effects, such as feeling sick or tiredness.

There are other drawbacks. Patients may have to make more trips to the hospital. They may also find this increases your worry about cancer. They may also have to do some paperwork. If they need more check-ups and tests, they will spend more time at the hospital. This will cost them time and money. Patients can ask if there is money available to cover your fares. Trials can go on for a long time and fares can add up.

 
Posted : 29/10/2017 4:39 pm
(@puneet)
Posts: 80
Trusted Member
 

There are positives and negatives about clinical trials, but I think that clinical research is important and needed in medicine and treatments. The biggest negative on clinical trials is the possibility that something goes wrong and one of the subjects experience serious adverse effects. There have been cases were people have been greatly injured and there is a risk when it comes to participating in a clinical trial. The likelihood of something going very wrong isn't very high, but improvements could always be possible. With clinical trials there is strong regulation and getting approval to conduct them is in place to make sure that a product or treatment is tested for safety as much as possible before testing on human subjects. The positive side of clinical trials is that they offer a hope for a future treatment possibilities that don't yet exist.

 
Posted : 29/10/2017 5:07 pm
(@williamzembricki)
Posts: 64
Trusted Member
 

I understand that it is normal to worry about the life of another human being but it is a moment where the livelihood of the masses matters more than the individual. One thing that is not often mentioned is that the studies are voluntary. Due to the policies on correct treatment of patients the patient has to be aware of the risks of the study they are involved in. If a patient is aware of the risk and they are willing to do the study still the clinical research should continue. The biggest concern is making sure the study is worth occurring in the first place. If the there is no proof of the likelihood of success than the study should be seen as unethical.

 
Posted : 29/10/2017 5:08 pm
(@lianhuajin)
Posts: 39
Eminent Member
 

Clinical trials are risky, but I do not agree to inhibit doing clinical trials, since it is very important for research. In my opinion, a strategy should be required for reducing the risk comes from clinical trials.
For example, participants may do some blood test before clinical trials to make sure they are really suitable for joining the test. Or participants can take very small dose drug first, then do blood test to further assure the participant is safe to take more drug.
Maybe there are other good methods, but my point is a good strategy should be demanded to protect participants' safety not just by signing a paper.

 
Posted : 29/10/2017 6:04 pm
(@manolo)
Posts: 82
Trusted Member
 

Clinical trials are necessary because regardless of the amount of pre-clinical trials you conduct, nothing done pre-clinically will directly transfer over to a clinical observation. In other words, using something similar to humans is not the same as using humans. For example, if you are testing the fibers of the sheep spinal discs because they are similar to human discs you would still need to test human discs. This is because sheep are quadrupeds and their discs impact differently than our bipedal discs.

 
Posted : 24/10/2018 5:26 am
(@jr377)
Posts: 79
Trusted Member
 

One popular quotes that comes to mind is "nothing ventured, nothing gained". This is exactly what clinical trials are for. Of course there is risk, but clinical trials are designed to minimize the risk of patient injury/death. The patients are told of the risks, and the effects that were seen in previous trials on animals and in vitro. Unfortunately there is no better way to test drugs. There is no way to know the effects of a drug on humans without human trials. This is humane testing, unlike that which we've seen done in the past. There is always risk, that's life. Mitigating risk to ensure safety allows drugs to be tested to determine efficacy. Although some patients get harmed, the vast majority are helped. These drugs go on to help improve/save millions of lives.

 
Posted : 24/10/2018 9:11 am
(@mb698)
Posts: 83
Trusted Member
 

Clinical studies is the study of health and illness of the people. It’s a way learn how to prevent, diagnose and treat illness. Clinical studies describe different elements of scientific investigation. It observes people in normal settings. Researcher gather information, group volunteers according to the broad characteristics and compares the changes over time. Researchers can collect data through medical exams, tests or questionnaires. Pros includes, access to the new drugs which are better than the standard treatment. Treatment and progress are monitored closely than the usual treatments. It may have less side effects than the usual care. Cons include, there is no surety of the outcome, new treatments may not be as effective as the standard ones. There is possibility of unexpected, serious life-threatening side effects. There is more frequent hospital visits, more test is required than the standard treatments. So I think clinical studies is necessary to have a better future in medical industry.

 
Posted : 24/10/2018 9:19 am
 Sk90
(@sanam)
Posts: 109
Estimable Member
 

Clinical trials are done for testing of drugs and medical device and advanced treatment that would be available to human in future. Scientists are constantly working to find new and improved treatment for disease and their research can only be tested through clinical trials. People who participate in clinical trials are receiving new treatment , medical care and advanced therapies before it is available to anyone. In order to assure the safety they also receive medical follow up . Clinical trials plays an important role in evaluating drugs and diagnostic tools to bring discovery into clinical practice and influence health laws and funding for health services . Clinical trials have drawbacks like uncertainty of new drug or treatment which can cause death of volunteers .Patients have to stick to trail schedule and spending money for travelling to clinical trial sites . Many clinical trials are failed either lesser number of patient involved or due to patient's death or serious factors costs millions of dollars to industry .

 
Posted : 24/10/2018 3:03 pm
(@dsk35)
Posts: 38
Eminent Member
 

Clinical trials are necessary in order to further advance the final product. As Professor Simon stated in his lecture, you can't assume that because something works in a mouse or rabbit, it will work the same way in a human. This is why clinical trials are needed. Also, these trials are never done without the consent of the patient. Thus, they should be fully aware of any risks and/or complications that may arise. If consent is not given, the trials cannot be conducted on that patient. The people that participate in these trials are given enough information that will allow them to make the decision of whether or not they want to participate. Obviously, the disadvantages of doing clinical trials are that there is no guarantee that it will work as was intended. Otherwise, there are a lot of things that are gained from doing clinical trials and the more trials, the better.

 
Posted : 25/10/2018 2:35 pm
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