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Discussion Topic: Beyond experimental design issues

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(@ao242)
Posts: 43
Eminent Member
 

Issues that would need to guard against when outsourcing an animal study to a university located about 1000 mi (1600 km) away from the company are as follow; Poor study design, time management, not enough money, communication and inappropriate bond between a member of the company and the university.
The study model can fail, if this happens it will affect the deadline of the vitro. For this reason, the company should make sure design study is well put together. A very good communication means need to be put in place, for example, if something goes wrong and their is no exchange of information between both parties, this could lead to the study's pitfall. A conference call twice a day and a monthly visit at least by a member of the company to the university. With a member from both the company and university knowing each other, if extreme care is not taking improper suggestion might come up and end up putting to try in the design study that can also cause series of problem to the success of the animal study. Laws should be in place that prohibited the company workers from discussing work related projects with contractors.

 
Posted : 21/09/2017 8:17 pm
(@krp76)
Posts: 76
Trusted Member
 

While working in industry I did come across a situation very similar to this, in which our company was conducting animal studies for a product under development. The constraint that we had was we had to conduct the trial at a specific test center that was pre-approved by the company and had a non-disclosure assigned. The test center was in Ohio and the main contingency that we took to ensure a properly conducted study is proper communication. First off we created a detailed protocol and went back and forth to ensure that the study and its' parameters were properly understood by the lead investigator at the facility and there was no ambiguity in the procedure. Moreover, we also decided it was best to arrange the study so that we can send two employees during the initial testing phase of the animal trial to ensure the first round was conducted properly and work out any issues that the lab may have.

In the scenario presented above I would advise that the individual who chose the lab not be heavily involved further on so that it removes any bias from the study. Moreover, proper communication is key in ensuring that the study requirements are met, and if possible a site visit would be the best way in negating any issues.

 
Posted : 22/09/2017 4:42 am
 hv42
(@hv42)
Posts: 42
Eminent Member
 

The first thing I want to point out is, I would never do such a study whee I know a lot of people and specially university because that relation of knowing people can definitely delay the our project purpose and we are here to do business not making friends and the only think I care is my experiment data on time, I don't care if you will not invite me on dinner. The second thing is at the university the work flow is slow peace so their is two things you can do, Increase those time lap in your project schedule and extend the project date. The second thing you can do is don't give this project to the university simple! I said that because at the university the post grad, grad and undergrad do all the work they really don't specific have a time line for a project and beside that they also have million other things to do that you project so their is pretty good chance they can delay your project and might mess up and report you a wrong data which they don't know about it either. On the other hand if you give this project to the company it will be less expensive, you can trust the data and most important you can rely on them and can able to finish your project on time.

 
Posted : 23/09/2017 6:26 am
 hv42
(@hv42)
Posts: 42
Eminent Member
 

At university professor more care about their research what I mean by that is they would like to perform studies on as much as different animals they can because they would perform some other studies on that for their research for which your company will pay the money which ultimately result into more budget for your project. They really care about the money because they get paid from the university but along with that if they find something interesting from your studies by doing more experiment than they can definitely get grants for that so at at university that is the motivation. Also let see if the professor is not tenure and if get the opportunity like this what he or she will do is they will perform more studies and try to find some thing different along with your studies and hope for the grant, the good thing for them in this is they are not paying for the animals so they are performing their studies for free. The motivation for them is if they get more grants then they can be eligible for tenure. Also in this scenario the professor save a lot of money for the studies of a PHD and the the motivation for PHD form this is if they get more publication by doing more experiment on different animals then they it's good for their career. One example let see if I am doing research on the rat then I can use the same rat for my other experiment too like I can take that rat tail and extract the collagen and use in my other experiment or I can use that dead animals for the undergrad course work studies which will ultimate save money to the university or to the me.

 
Posted : 23/09/2017 6:56 am
(@akashranpura)
Posts: 39
Eminent Member
 

When outsourcing animal studies to other institutions there are several pitfalls that need to be addressed and looked into. One of the first ones is the distance between the university and the company. It is critical to ensure that if any transportation of proteins or biomolecules is needed, it is done by proper procedures to prevent denaturation or contamination. Also because the animal testing is done at a different location, communication of the protocol to perform the study needs to be detailed and to the point. Also the delays that will most likely accompany this study need to be accounted for and prepared for well in advance. Also animal studies may take more time to work out because of lack of animals and it is vital to plan for such a pitfall. And another important thing to point out is that just because the employee has connections there it does not mean it is the best for the study. Risks should be weighed against the benefits before making such a decision.

 
Posted : 23/09/2017 10:24 am
(@ibraheem-shaikh)
Posts: 40
Eminent Member
 

Very generally speaking, the distance of the institute conducting the research is not a huge concern in the face of modern communication technology and shipping availability. The most important factor in this particular decision is whether the university chosen was the best one for this particular job. It is possible, albeit seemingly unlikely, that this university was chosen because of its expertise in a particular area of animal research. To detect issues such as these, it is essential that decision makers in these scenarios declare any potential conflicts of interest before they commit to a choice.

There can be a number of reasons free of any cronyism-related accusations why such a university may be chosen. For example, the researcher's contacts at said university may have resulted in the company's ability to obtain the animal research at a lower cost. But this information, and the reasoning behind the decision, should be well documented to avoid both a conflict of interest and even the illusion of conflict of interest. After all, if rumours spread that the company is mismanaging its funds through favoritism in its contracts, this may result in investors pulling out, causing severe financial damage to the company.

As for choosing a university vs a CRO, the advantages of a CRO are that the study would be done more cheaply and faster (due to less overhead and specific procedures in place for normal business). However, a university may be likely to produce more accurate results by being more careful, because a university is more affected by the loss of prestige that results from publishing results that later are proven false.

 
Posted : 24/09/2017 10:46 am
(@rd389)
Posts: 46
Eminent Member
 

I think the most important precaution would be shipping of those samples and making sure that there is stability of those samples after whatever time it takes to travel. Also, I think it would be also necessary to check before hand samples stability as in temperature and pressure wise. Sometimes these samples are stable in -70*C while not in room temperature or need to be on dry ice or wet ice. Also, just because of the employee has connections that doesnt mean university will do great job. It would be necessary to make sure FDA regulations or GLP regulations if applied are taken into consideration. All the paperwork are according to SOP of the company or standardize FDA rules.

 
Posted : 24/09/2017 11:18 am
(@jlw23)
Posts: 50
Trusted Member
 

I do not have any personal experience working with a company where the study itself was outsourced but I do have experience seeing a vital part of the company being outsourced. At my first job the Help desk was outsourced to India to save money. I can speak to that experience. Outsourcing the Helpdesk to India did hurt the company. Our clients were not happy with the service or the quality anymore, it was harder to manage a team working so far away and in a different time zone. There was always a delay in communication and hence decision making. From that experience, I would say outsourcing the study would not be the best choice for the company. As many of my peers have stated, lack of communicated would be a huge pitfall in my opinion. Another pitfall to look out for is the compromise of the data and results of the study.

 
Posted : 24/09/2017 3:54 pm
(@sahitya-sadineni)
Posts: 69
Trusted Member
 

There are many issues when having a lab do the experiments from long distance. The main difficulty would getting everything done in time. Many factors play into this when outsourcing. You must keep in mind the holidays observed if the university is in a different country and also the laws there. Another main issue is that this lab may have other companies have to its testing there. If they get a bigger project than yours, they will push it aside to the bigger one. Another factor would be cost. It maybe cheaper to get it done elsewhere but it will take longer. If it is done closer to the company, they can keep an eye on the university and make sure everything is done on time. The quicker the labs are done, the faster the product can be in the market.

 
Posted : 24/09/2017 5:03 pm
(@hruship101)
Posts: 76
Trusted Member
 

One of the major pitfalls that may arise in animal study is the delay in testing and the time the specimen is received from the supplier. Due to the demand for animals for many pre-clinical trials, it is important to have multiple animal suppliers. Also, outsourcing an animal study 1000 miles away involves transportation cost. One must allocate the shipping and receiving time of the animals. It is not always wise to outsource the animal study because there are lot of connections working there. One must factor in the cost of the study, shipping and receiving cost and the lead time prior to making the final decision. Also, expand the testing to be done on multiple animals so that there is an alternate option to finish the tests.

 
Posted : 24/09/2017 5:15 pm
(@cy268)
Posts: 30
Eminent Member
 

In a university setting, a university sets aside funds for an entire year for all the projects going on in the university irrespective of the type of financial need each department has in terms of research. For example, electronic parts are much cheaper and research is much easier to conduct than to buy material for say a wet lab or research that involves animal studies. Research pertaining to biological sciences are comparatively much more expensive than research in any other field. It is due to the level of safety that needs to be maintained and the direct impact it has on people and healthcare. As the committees in the university need to strictly regulate the budget allotted to each department while also not compromising on the quality of research, university contracting might be a slow process. Whereas CROs are dedicated centers that carry out these trials with trained leaders and employees and the capital is exclusively used for clinical research. Therefore these same departments at a CRO (with skilled and experienced people) are far more faster and efficient than research crew at a university.

 
Posted : 24/09/2017 5:46 pm
(@dsk35)
Posts: 38
Eminent Member
 

Outsourcing, in general, gives you less control over the final results. You have no way of directly observing how the study is being conducted. Also, if the university really is 1000 miles away, it would be too far to monitor what is going on, even on, let's say, a monthly basis. Even communication and/or transportation of materials can be delayed because of this long distance. As people have stated already, having personal connections with someone at the university is not a definitive way of ensuring that the university will effectively complete the study as intended. That personal relationship can make it challenging if difficult business decisions are to be made.

With that being said, if proper research is done regarding the university's resources and qualifications for completing this study, and there is a solid business/professional relationship with that university, outsourcing can potentially save some time for the company. Although, there is still the issue of not being directly involved with the study.

 
Posted : 18/09/2018 5:27 am
(@jonathan)
Posts: 39
Eminent Member
 

My biggest concern in that scenario, like many others, would be the quality of the work done at the outsourced lab. While outsourcing always poses a quality issue, the most dubious aspect of this scenario is the reason for outsourcing to that particular lab. It was chosen based on a coworker having connections rather than research and reading reviews. If the coworker went to school there, chances are her connections are past friends. I would be more secure, in a business sense, if the researchers saw the project as just a job that they were getting paid for and not a project they were doing for their friend. Not only would they be more relaxed when faced with setbacks, but they would introduce bias in the experiments. Confirmational bias is real. Also, with a lab that far away, transportation of supplies would pose an issue. You cannot order animals and ship them 1000 miles, some might die, or otherwise become unusable for the experiment, in transition. Also, you cannot fly out there as often to check up on how the experiments are going first hand. You have to rely on hearing it indirectly from the PI.

 
Posted : 18/09/2018 6:21 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

In any situation like this you should guard against pitfalls such as budgeting. With a lab so far away it will cost more money to visit the lab and to meet with the laboratory members for meetings. You should also generally guard against time to make sure that your project will finish before the end date or close to the end date that you have chosen. Based on the fact that the laboratory was chosen by only one of your team members you should have back up sources, universities, and laboratories to use incase this university does not perform the way you had initially intended. An important precaution you should take is developing a very well defined experimental design plan and target dates. Considering the company is far away you should schedule weekly phone calls and progress reports to see that the experiment is on track to finish on time. With animal studies you should prepare for problems such as running out of test animals or having a limited number of test animals in the age requirement that you need. You should have another animal vendor on call that you can use just in case this one does not provide what you are looking for. A well defined risk management plan should be set up, as communication may be slower with a distant company, both groups will need to know the back up so as to not waste any time waiting on communication delays.

 
Posted : 20/09/2018 10:03 am
(@jr377)
Posts: 79
Trusted Member
 

I agree with some points by jz365 but I disagree on other points. For example, the connections and bias aspects I agree with. The rest I disagree. Instead of shipping the animals, you would have some near the particular lab. With the technology of this day and age, you don't have to fly out there or hear it from the PI, all you have to do is have conference video calls with all members to have weekly updates. If you want to see the lab itself, just do a virtual walk-through (video call). One addition I'll make is that the connections can be assumed to be a friendship, and if something sours and your contract is not ironclad, you may have issues with finishing the experiment properly or just having a well run experiment done. Another issue may be university ethics issues, which will be brought up and may stop the entire collaboration. Assuming you're not in another university, there may be industry/academia related issues as well.

 
Posted : 20/09/2018 1:50 pm
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