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Decision Making: To do or Not to Do?

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(@amin-sadig)
Posts: 37
Eminent Member
Topic starter
 

I was thinking about the mock simulation that was done in the in person class on Friday and wanted to hear the thoughts of others on the decision making mechanism those of you with years of industry experience have with regards to the scenario presented where two antibacterial coatings of similar cost and availability were tested in an animal model. Four of the rats died for coating A but the autopsy indicated that it was due to stress. Coating A, however, showed higher results sooner than coating B although the final results were not statistically significantly different. The decision as to which coating to use was to be made.

Some methods say that we should plan for failure and always have a plan B whereas others say that spend the time you would on making plan B on perfecting plan A.
Research shows that project failure can be due to the lack of understanding of the scope of the project or an over optimistic estimate of resources required (time and money).

In class a decision had to be made with a justification for the choice.

Because there can be complications with Coating B later on resulting in failing in later tests, I thought the coatings should undergo the other system tests before coming to the conclusion since there is no evidence indicating the deaths of the rats was related to the coating. Since if we choose a coating now and that coating fails a test later on, we will have to go back to square one.
The caveat is that if it passes all the tests we save resources, time included.

I tend to lean towards the always having a Plan B, planning for failure, where we continue through with all the other planned tests like coating adhesion to the device before making the decision since it has been narrowed down to coating A and B. What do you think? What if there were more coatings?

 
Posted : 21/01/2018 3:31 pm
(@ak977)
Posts: 41
Eminent Member
 

If there were more coatings then there might be more options to what the clear choice may have been. Perhaps coating C could have garnered quicker results, such as coating A, but without the stress deaths, such as coating B. The merging of those two qualities would have allowed the choice to be made clearer. However, dependent on the number of resources and competition, companies often try to push products through as quickly as possible and therefore, running extra tests would mean more money and more time.
In addition, although the autopsy for the rats did say that the 4 deaths were due to stress, could it have been that the stress was exasperated due to the coating, that it perhaps heightened it? But even doing that testing might be time-consuming.

But I do agree with you -- it is better to be thorough and know the ins and outs of why issues happened vs. just making quick decisions.

 
Posted : 21/01/2018 3:40 pm
 cs22
(@cs22)
Posts: 27
Eminent Member
 

I feel that, for adding more coatings to test, it becomes a balancing act between finding an ideal antibiotic and the increased time and resources of a larger study. In these situations I think it’s important to properly research beforehand on established coating and protocols to minimize the chance that any mishaps were due to factors that are not being examined by the lab test. For the example given in class, the two drugs are established as being safe for use in humans, so there is very little chance that the drugs themselves would pose a risk to humans. If by some chance the adverse stress effects were due to the drug itself in the rats, there is still very little reason to rule out its use in humans if there is no published evidence that these drugs have had similar results in human testing. The purpose of the test was to examine the antibiotic effectiveness of the coatings since they were already deemed safe for use.

 
Posted : 21/01/2018 6:09 pm
(@cdj24)
Posts: 40
Eminent Member
 

I do agree with and if there were unlimited resources would like to run all the tests I could since its better to be safe than sorry. In our scenario that was not the case, so I think even though coating A gave better results earlier on both coatings got the job done. So without being able to run all the tests we would like, none of the rats died with coating B so that would be the better option. Someone mentioned before that the stress that killed the rats could have been exacerbated from the coating. I do think that should be studied more to further rule out A or see if it was random. As for more coatings, I am assuming that enough research was done to conclude that A or B were the better options to go onto the implant. I believe in class we also mentioned that there would be further testing possibly on dogs and that the plan B would be to go back and do more work with coating A.

 
Posted : 22/01/2018 12:14 pm
(@mdp57)
Posts: 3
New Member
 

From the in-class discussion, we came to a conclusion that, we do not have sufficient data to rule any of the coatings out of the testing phase. Yes, coating A had few rat deaths due to rat stress. Also, coating B eventually produced the same result. The deaths in coating A made all the students lean towards a safer choice B. However, what if with further testing, choice B develops some complications? I believe, we would know more if we go back to the literature and find any indication that could have been overlooked at first. Yes, this would have been much easier from an analytical point of view to have a third choice. However, it is not the case here. I agree with Amin to do more clinical trials maybe on different animals. After more clinical trial data, it would make the choice easier in eliminating one over the other. The data would also convince management in picking the better of the two. Having more clinical trials on different test subject would be planning for a failure, and staying on the timeline for product development.

 
Posted : 23/01/2018 7:48 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

Based off of the discussion in class, the two coatings will have to undergo another round of testing to come to a decision. However, time, money and resources are always an important thing to consider. Possible test that could be run is trial that will prove whether or not the rats died because of stress induced by the coating or if it was some other cause. We can also run the exact same test again to see if the results change. However, if we were supposed to make a decision right away I would have to go with coating B. No one will want to buy a product where 25% of the subjects died. Even if they cant prove that it was directly from the coating, individuals would not wanna take that risk on a coating that did not prove to be significantly different from the other coating. Therefore, because more test would have to be done, with most likely different animals that are more expensive, and more money would have to be spent to pay the workers for their time, and now there is more time being spent learning about the product when the product can be closer to the market where it will make money, I would have to go with coating B.
Given that there are more coatings, I would have to push for more testing though because now there can be a product better than the ones we just tested. Also, I do think that more research should be done on how the drug affects humans since it could have different outcomes from rats. Safety of the individual is primary concern, but testing may come to the point where we have to end up just testing the product on human subjects. However, we can not test a potentially lethal product on humans, and we may never know until it is tested on humans, which is why it is best to have more coatings so that we are not stuck with only these two options. That way we can find a safe alternative without spending more money on testing different animals.

 
Posted : 23/01/2018 11:02 am
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