Research in industry can be volatile due to time and money constraints. Sometimes, corners need to be cut in order to meet deadlines or cut down costs. What do you believe is the deciding factor between a viable study and poor study when cutting down on resources or speeding up results? Should results be compromised to meet deadlines?
Pitfalls such as time crunches, budget loss, and delays can all result from pre-clinical research. Ways to overcome these pitfalls include reducing the study size, using alternate models, and removing experimental roots. However, it is important to think carefully when removing/eliminating groups or models because it could make the science less valid or rigorous. When cutting down on resources or speeding up results, there are different factors that contribute to a viable study and poor study when cutting down on resources. For example, reducing the study size to n = 1 or 2 might seriously invalidate results because there would not be enough data generated to show reproducibility. In this case, the sample size would be the deciding factor between a viable study and a poor study. However, choosing an alternate model may not necessarily be the deciding factor between a viable study and poor study in some cases. For example, when using animal models if using rats are significantly cheaper than using guinea pigs, depending on the intent of the study this may not make a significant difference in the outcome of the results. Therefore, animal model would not be a deciding factor between a viable study and poor study when reducing cost. What are some ways to overcome the pitfalls that may arise in the industry without invalidating study results?
I believe it would incredibly dangerous to cut corners in research and then use poor results to then sell a product. It is counter-intuitive to comprise the integrity of your results to meet a deadline becase in doing so you're missing the whole point of doing the research: good results that prove a point. Of course, the medical device industry is incredibly competitive and with the pressure to make money people may feel inclined to manipulate results to keep the ball moving. Luckily, there are agencies like the FDA which strictly monitor the safety and efficacy of medical devices sold in the United States. FDA monitoring should be the last line of defense against faulty medical devices.
Ultimately, a company needs to show a product is safe and effective which is often done through the use of statistics. Do you feel that using statistics as a metric for safety is enough due diligence for medical device companies?
@anthonynjit I think that statistics are not a sure way to determine safety as it is completely dependent on how the study is set up that the data is being extracted from. If the study is not robust, the data can tell a very different story than the reality. For example, if the preclinical testing of a metal hip implant is assessing the degradation of the metal and the study design is limited to 30 days post implantation due to time constraints, the data may show that there is no metal degradation and rationale may be written comparing the device to predicate devices to get it approved. However, since the long term effects were not evaluated, metallosis (a type of metal poisoning) may occur years after implantation. While I do not know the specifics of the study designs done by hip implant manufacturers that faced recalls due to metal poisoning in the patients, it may be due to unreliable statistics.
I do not think results should be compromised to meet deadlines, however, I do believe that cutting corners is essential to meeting deadlines. I think the deciding factor between a viable and poor study comes down to what the customer wants and what they NEED. what makes any product ever different than the other? All the different quirks and variations of gadgets that are designed to appeal to a targetted audience. For example in the car industry, there are two very big names, Honda and BMW. Within the same time that honda manufactures 1000 steering wheels, BMW spends the same amount of time on a third of those. Does this mean Honda is cutting corners? or does this mean that their steering wheels are worse than BMW's? Cutting corners yes, but they are meeting the deadline and the steering wheel is doing its job that the customer needs. Now is the quality the same? No. BMW spends more time crafting the wheel for a higher quality appeal. They both get the job done even though some corners were cut.
@cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain in the body for large portions of times. The problem with cutting budget and removing samples to save time is that it seriously affects the amount of variation within your sample. This may cause the pre-clinical trial to give results that prove absolutely nothing about the test. For example, If your sample size originally includes male and female mice, but male mice are cheaper so you are told to only use males, your trial may be ineffective because it may effect female mice differently. If this occurs in the pharmaceutical field, female mice have more hormones than male mice, meaning the device could effect them differently. This could lead to side effects that cause harm to women that may not have been caught because of this lapse in variation during pre-clinical studies. Cutting corners in research may seem like a good idea, but the consequences could be more impactful and end up costing the company more money in the future.
@cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain in the body for large portions of times. The problem with cutting budget and removing samples to save time is that it seriously affects the amount of variation within your sample. This may cause the pre-clinical trial to give results that prove absolutely nothing about the test. For example, If your sample size originally includes male and female mice, but male mice are cheaper so you are told to only use males, your trial may be ineffective because it may effect female mice differently. If this occurs in the pharmaceutical field, female mice have more hormones than male mice, meaning the device could effect them differently. This could lead to side effects that cause harm to women that may not have been caught because of this lapse in variation during pre-clinical studies. Cutting corners in research may seem like a good idea, but the consequences could be more impactful and end up costing the company more money in the future.
I believe cutting corners in any regulated research field should strictly be prohibited and avoided at all costs. A perfect example of this would be the covid vaccine that was released by Pfizer, Moderna, and Johnson and Johnson. Starting from the time when the covid vaccine was announced, an immense amount of speculation was going around and the whole pharmaceutical industry was under micro scrutiny. Many advocate groups had a wide variety of different opinions and because of this each respective company must have understood that everything that must be done must be done properly and without any shortcuts to be taken. As any fault that may have occurred in the reporting of data could have very disastrous consequences for the company and frankly for whoever may have taken the medicine.
Demand is sometimes so unpredictable. One example would be the demand for covid19 vaccines as mentioned by @sseal98. The hastened rollout has caused many to speculate about the safety of receiving the vaccination. The main concern is ensuring biocompatibility and keeping potential risks at a low. Otherwise, there is no reason to continue with a project if cutting corners will compromise these two factors. Patient/consumer safety is of utmost importance. Excessively adjusting research diminishes its validity. Similarly, cutting corners can be detrimental to product or service outcomes; if factors such as safety are compromised.
Results should not be compromised to meet deadlines. If corners are cut I do believe which corners to be cut is extremely important. Determining factors in corners being are: "if I do this, am I putting someone's life at risk?" I believe the deciding factor between a viable study and a poor study is which corners were cut during this process. If too many processes during the study were grazed over then the study can be deemed compromised and would be an even bigger waste of time and resources.
cutting corner in research I very dangerous in many ways but I feel there should be a zero tolerance to it just like everything else.But the I honestly feel by cutting corner we are losing a greater understanding of what we are studying.For example covid 19 vaccine rollout had many companies making the vials however with lake of understand to the body some was recalled.However some of the public had already taken the vaccine.In a middle of a pandemic we should not rush understanding cause of panic.Therefore if we keep cutting corners in science do you believe it will get us further or could it be a setback?
Clinical trials are time-consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. Clinical trials for pharmaceuticals and medical devices offer many opportunities for failure. Failures can arise from a lack of efficacy, issues with safety, or a lack of funding to complete a trial, as well as other factors such as failing to maintain good manufacturing protocols, failing to follow FDA guidance, or problems with patient recruitment, enrollment, and retention. Generating accurate and sufficient results to determine whether or not there is merit in continuing is important at each stage in the clinical trial process. The investments of resources, time, and funding grow with successive stages, from pre-clinical through phase 3. Thus, the cost of a failed phase 3 trial is not just the cost associated with the trial itself but the cost of all prior trials as well as the cost of lost time pursuing a potentially viable alternative. It is important to maintain a philosophy of continual improvement with respect to clinical trials broadly and specifically with an aim towards optimizing every aspect of the research and development process. A comprehensive survey of all possible points of failure in clinical trials is beyond the scope of this publication. Still, there are many factors associated with failed trials that can be distilled with evidence, along with recommendations for improving the chances of success. Clinical trials also fail with respect to safety. Hwang et al. found that 17% of the failed phase 3 trials examined were due to safety. Safety is addressed in every clinical trial in every phase, but issues with safety may only become apparent with the larger populations associated with phase 3 studies, or at post-approval (phase 4) or post-market. Identifying safety issues is not always straightforward. Patients have individual concerns about various adverse events that may not match what physicians are concerned about. This can influence which adverse events are reported, particularly if they are mild to moderate in severity. Although we might not always like them, deadlines are a necessity to keep projects in check and on track. Of course, every project manager should start out with the desire to do the best job they can. But with a planned schedule to follow and a budget to stick to, there is a need to be mindful of perfectionism to the detriment of the project. Your starting point to meet a project deadline is to establish a clear and attainable schedule with identifiable milestones. However, despite all the best PM courses in the world; there will still come a time when a project has a tight deadline that you will just have to pull out all the stops to try and meet. This could be the result of a legal issue, a promise made that you weren’t told about, or staff absences but at times like this that things can rapidly fall apart if your team is allowed to lose focus or let quality slide. The results should not be compromised by deadlines.
In research, cutting corners can lead to serious consequences. The research process relies on trust, and trust is essential for maintaining research integrity. Having trust in each other's work is imperative, and researchers must also be trusted by society since they provide science that may have a major impact on individual lives. Research is carried out by scientists, but their findings are beneficial to everyone else as well. As we get to know nature and how it works, we are able to understand how our actions impact it. Most importantly, we gain knowledge regarding health, nutrition, technology, and business. A lab that cuts corners may lose funding or be closed down. Getting fired or having your research stalled may affect your career. Due to this, you should avoid cutting corners and compromising your results in order to meet your deadlines.
Research in industry can be volatile due to time and money constraints. Sometimes, corners need to be cut in order to meet deadlines or cut down costs. What do you believe is the deciding factor between a viable study and poor study when cutting down on resources or speeding up results? Should results be compromised to meet deadlines?
Great question and thought provoking. This is one of those difficulty situations where it all depends on the circumstances that you're in. I'm sure the majority of us believe in good ethics and practices; however, sometimes you have to take that risk by WISELY cut corners in order save lives. A good example of this is the making of covid 19 vaccines. Usually, it takes years to develop a vaccine, but with the fast rate of people dying from the coronavirus during the pandemic, scientists had to hastily create a vaccine in order to save lives. With the guidance of Dr. Fauci, corporations like Johnson & Johnson and Pfizer created and release the vaccine within months to hospitals. They had to cut corners because of the situation they were in. In my opinion it was a justifiable action they had to take.
@mayasaunders I absolutely agree with your point of view. There is never a good reason to cut corners in research. If funding is an issue, having a discussion with management or the project manager needs to occur. Maybe instead of making the project fit a particular budget, other sources of revenue can be used. Also, if the data is not going as originally planned, then it's ok to ask for assistance from management to see where things might have gone wrong instead of falsifying the data. Cutting corners can save time & money but the risks outweigh the rewards and can do more harm than good to the researcher and the community.
