Discussion Topic: Beyond experimental design issues

Home Forums Medical Device Development Pre-clinical Device Development Discussion Topic: Beyond experimental design issues

This topic contains 25 replies, has 22 voices, and was last updated by  cy268 6 months, 4 weeks ago.

  • Author
    Posts
  • #885

    Josh
    Course Facilitator

    Take the scenario where an animal study has been designed and as near as you can tell, the design is not flawed. That is to say, you think the design will give you no problems.

    Your company outsources this animal study to a university located about 1000 mi (1600 km) away where one of the members of your research team has a lot of connections because she went to school there.

    What issues or pitfalls should you guard against in a situation like this? What precautions should you take in this situation?

  • #3702

    bb254
    Participant

    With any type of animal testing the main pitfall stems from delays. The process of ordering animals is time consuming and also limited. If you are completing an animal test on a specific animal then you would need to find multiple suppliers to purchase from because animal suppliers can run out of animals. If the animal testing is now being completed 1600 km away then it would be a wise decision to locate different suppliers in that area in advance. Build in time for delays within your testing schedule so that your study does not get overdue. Open the study to more than one type of animal testing so that you have an alternate option to complete the tests. Lastly, take into account the cost of the number of animal test that need to be conducted along with cost of transportation and maintenance while discussing the budget of the study due to the new testing location.

    • #3843

      jlw23
      Participant

      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.

  • #3704

    asimbana
    Participant

    Animal testing procedures can encounter many pitfalls in the course of it’s phase just as many other testing procedures such as clinical trials. Considering in this scenario that the company is using a university located 1000 mi away since a research member has connections can be helpful but also problematic if no contingency plan is established. To further elaborate on this contingency plan, I refer to time constraints, lack of communication and shortage on specific animals availability. To prevent any delays in the animal testing phase, a good approach would be to establish a list of possible animal suppliers in the area as a backup and gather a price list to compare. Suppliers can encounter shortages based on high demand and also can vary in price due to their scarcity. By creating a backup plan, this would help in preventing delays in the phase, another issue would be the cost of shipment, the larger to supply, the longer the distance, the more expensive the shipment can be overall. This can affect the overall project budget, as a company, it is best to ensure to pay attention to expenses, it is wise to gather quotes early on for comparison.

  • #3708

    srg36
    Participant

    First of all, I think that the decision to outsource to this university just because a team member has connections there is a poor decision. In a best case scenario (which is probably what was assumed when making this decision), the team member will have more leverage with the lab to make sure they run the test exactly as planned and on time. However, this can also work in the other direction, since there is a conflict of interest. If something does go wrong, such as an unexpected result in the test, or a delay in the test, what may happen during the resolution of the problem is more of “how do I smooth this over to maintain a good relationship with this lab, since they are my former colleagues,” instead of “what exactly went wrong, who is responsible, how can it be resolved and how will it impact the project?” So in the case of something going wrong in the test, which is probably a more likely situation than everything running exactly as planned, it can lead to compromises being made by the company since the team member feels bad for his colleagues, and in general it can lead to a messy situation where it is difficult to reach a resolution due to the conflict of interest. However, if this lab was selected not only because of connections, but because of having a good reputation and past history, and reasonable pricing and timing, a precaution that a company can take to avoid this situation is to not have the team member who has the connection to be leading this effort, and to keep his involvement in the interactions with this lab to a minimum.

  • #3714

    alexandrabuga
    Participant

    I work at a non-profit. If a company outsources a study to a university there would need to be a formal contract in place (collaboration agreement, sponsored research, or service agreement) to cover the scope of the what university will be doing, budget, payment terms, IP terms, etc. This process is handled by our contracts/legal department and this could take several weeks (at best) just to get executed. Once the agreement is executed then the animals can be ordered and the project to take place. As @bb240 mentions there are pitfalls due to the distance that could also create delays. There are protocols used for animal studies and other SOPs required and this would be required to preform the research for the company. The budget needs to be defined, how many animals, how many days (when will they be sacrificed) etc.

    Overall, it takes awhile to set up a collaboration/service agreement for a university to perform studies for a company. It might seem cheaper to use a university than a CRO, but in fact there are IDC rates in place which for my institution are about 73% IDC rate since we are in NYC- the overhead is high. So you would have the direct costs of how much the pre-clinical study would cost and then you would take 73% of that and add it to it! So it can become very expensive.

    To avoid these pitfalls, the company should reach out to the Tech Transfer office at the university and start putting in place the formal agreement that will cover this project. The lab should make preparations for ordering the animals and making sure the proper protocols are up and ready for this particular project. There has to be communication with the company and the tech transfer office, the company and the lab, and the lab and the tech transfer office. Having a clearly defined study/budget and the appropriate approvals are necessary to even contemplate having a successful pre-clinical study done at a university.

  • #3720

    zbw2
    Participant

    assuming the university to which the study was outsourced to is competent to properly complete the task, as alexandrabuga stated, explicit instructions are vital for proper execution of the animal study. as bb254 stated, because of the distance of the university time delays are imminent, but can be mediated. to minimize delays, frequent phone or video meetings should take place to maintain continuous communication about the status of the study. the distance also introduces potential pitfalls in securing the data. minimizing data loss can be achieved by ensuring the data, when collected, is uploaded and stored on local servers and saved by both parties until the project is completed.

    depending on the value/importance of the study, a staff member can be sent to the university to either oversee the study to visit periodically as another form of contact.

    also as Alexandrabuga stated preparations for ordering the animals should, ensuring there is no issue with delivery quality and shipping times from an appropriate vendor.

    • This reply was modified 7 months ago by  zbw2.
  • #3725

    Josh
    Course Facilitator

    Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound business decisions are not clear-cut either.

    * University overhead can make an animal study nearly twice as expensive as doing it at a CRO
    * Personal relationships can make problem solving a little more nuanced.
    * University contracting and Tech Transfer departments are extremely slow. (Why wouldn’t these same departments be as slow at a CRO?)

    • #3874

      cy268
      Participant

      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.

  • #3727

    reshamn
    Participant

    Why wouldn’t these same departments be as as slow at a CRO? -Josh

    According to Pharmamodels, “When evaluating the growth of CROs, the statistics show it all. Seven years ago, the biotech and pharmaceutical industry spent $60 billion of which $15 billion was outsourced. This means that CROs accounted for 25 percent of the market seven years ago, a number which has probably increased since then. The partnerships made between sponsors and CROs continue to grow, and there are now numerous networking websites that help connect CROs and Pharmaceutical companies connect”.

    This statement indicates that the CRO’s provide efficiency for pre clinical research. This is a major benefit for pharma companies due to their strict deadlines and allocated budgets. CRO’s help reduce the cost for biopharmaceuticals by relieving the overheads spending for the required trials. To answer the question, if CRO’s are rapidly growing or even being outsourced which indicate that their process cannot be slow otherwise companies would not pursue them. Even Forbes magazine show that there is much greater interest in CRO’s than even before due to low costs. A CRO would be providing the exact service and expertise required for the job and since it is an established company, there are professionals doing the work. Therefore, the attitude cannot be lax if the company’s deadline has to be met.

  • #3731

    Josh
    Course Facilitator

    Right, so the underlying message there is that CRO’s are businesses that want to maximize their turnover. The more studies they do, the more money they make.

    How is the situation different in a university? Obviously they also want to make money, but in this specific case of animal studies, that’s not the main motivating factor. What is?

    • #3737

      Scott
      Participant

      The main motivating factor, in terms of animal studies, is conducting the study on these animals and seeing what the results are. The results will demonstrate if the research for the university is worth pursuing and these type of studies help identify for professors and doctors in the school if they should continue some of their research interest. Outside of that, I would speculate the motivation outside money for a university to conduct clinical research trails would be to bring prestige and a reputation to the school.

  • #3732

    mark abdelshahed
    Participant

    Looking at this situation presented here, there is a lot of pitfalls that you should put into consideration. First, you have to check the study design so that you don’t discover any missing points and make sure everything is clear enough to start the project. Then you have to consider any delays caused by the distance to the lab or the time spent by the supplier to supply the animals. Just the fact that the university is 1000 mi away, that is a sign to prepare for any delay caused by commuting there and back. To make yourself more prepared, you can contact more than one animal supplier just in case one of them runs out of animals. The last thing is to be sure that there is enough money to cover the expenses.

  • #3739

    aaq2
    Participant

    The pitfall to awarding the trial to this university could bring about ethical issues. With so many ties to the university one could assume possible manipulation of data to favor the clinical trial. Also, the risk of kickbacks associated with awarding the contract to alma mater.
    Depending on the location of this lab the preclinical trials may not be conducted to specific guidelines. In certain countries animal rights may differ from that of the U.S. It is known that stressed rats develop chronic inflammatory conditions that can affect the overall data collected.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594046/
    The location of the site may also be an extra expense when traveling is involved. On the other hand the location might be very cheap but remember you always get what you pay for.

  • #3744

    alexandrabuga
    Participant

    The University is interested in making connections with Industry-some investigators are in hopes to build a relationship in which the company will fund more research and be a source of funding for the lab. Others are doing it not only for the money, but in certain cases (as the contracts will determine) the ability to publish on the research. A PI always loves to add another publication to the books.

    If you do a service agreement for a company, they may provide something to in the future. For example, maybe provide material (a drug) for internal research purposes under a Material Transfer Agreement or collaboration agreement. In this situation the lab would not have to pay for the material, they essentially get it for free but as everyone knows company’s don’t just give things for free. Industry material transfer agreements/ collaborations include strict restrictions and basically want the university to assign all of the rights away to any invention that arises in relation to the drug. This is why Tech Transfer Offices are crucial in reviewing/negotiating Industry contracts in order to protect the university’s IP.

  • #3746

    hm243
    Participant

    There are many pitfalls to consider with the animal study being doing so far away. The most important factor to consider is that the design of the study is thought out thoroughly and there are no missing aspects. In addition, there needs to be a guarantee that there is enough animal supply in that area for the study. Another factor to consider is that there will be importance given to the research. When doing research yourself, you give more importance to making sure that it gets done. However, when the research is being done at a different, distant location, the research may be given lower priority. Maybe one of the researchers on the team who designed the animal study should be present when the study is being completed. This way someone who has knowledge of the background as to why and how the study is being done will be able to oversee that the study is being done as needed. It would probably be better to have the animal study done at a closer location, to ensure that there will not be any delay in the research.

  • #3751

    myton
    Participant

    I think that the biggest problem that this type of situation can encounter may include communication. Because of the distance, regular in-house check ups may not be possible which may cause problems in the progress of the project. There will always be always be some sort of miscommunication when people do not talk and meet face to face. There will also be the issue of different understandings of the concept. This may need a different experimental design based on the different environment at which the lab is. Observing the procedures of the experiments may also cause trouble since there is distance.

  • #3762

    ao242
    Participant

    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.

  • #3765

    krp76
    Participant

    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.

  • #3784

    hv42
    Participant

    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.

  • #3787

    hv42
    Participant

    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.

  • #3793

    akashranpura
    Participant

    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.

  • #3816

    Ibraheem Shaikh
    Participant

    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.

  • #3822

    rd389
    Participant

    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.

  • #3862

    sahitya.sadineni
    Participant

    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.

  • #3864

    hruship101
    Participant

    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.

You must be logged in to reply to this topic.