Clinical studies are expensive, time-consuming, and frequently stressful for patients. Numerous factors might cause clinical studies to fail. Pharmaceutical and medical device clinical trials present numerous chances for failure. Failures can result from a lack of efficacy, safety concerns, or a lack of funds to finish a study, as well as from other factors such as failing to uphold proper manufacturing processes, disobeying FDA directives, or having difficulty with patient recruiting, enrollment, and retention. At every stage of the clinical trial process, it's crucial to produce reliable and sufficient results to decide whether or not it makes sense to keep on.
Cutting corners in research can be risky and unethical in certain cases. I don’t think results should ever be compromised to meet deadlines. However, I do think that, if available, simpler methods can be implemented in completing certain tasks as long as those methods are proven to be reliable. I’ve learned as a PhD student that for anything I do, whether it be using software for calculations, or applying a new method for data processing, I need to have sufficient information backing up my decision. The same should be true for research in industry. When the term “cutting corners” is used in this context, I think of it more as a way of simplifying the process and using what’s already known, instead of trying to innovate every step of the procedure. To simplify the process, a researcher needs to use reliable methods to ensure that the information collected and displayed to the public post-study is correct. Cutting important steps from a study with the argument that deadlines are approaching, or there aren’t enough funds should never be the case. Any “researcher”, whether they be in industry or academia, that knowingly puts others at risk due to their decision to not follow important steps in their project should not be in the field. What are your thoughts on this?
As discussed in this weeks lecture, a common pitfall faced in industry is lack of time. Consequently, you may be tempted to cut corners to appease management or to meet deadlines. However, in doing so you may be jeopardizing the quality of your work. In which case it is important to communicate with management the risks of an over ambitious deadline. Potential ways to reduce time in research studies include decreasing sample size or the number of tests being conducted as well as using easier to obtain materials/resources, but that is with the risk of inaccurately representing your research and receiving push back later on from regulatory bodies when questioned about safety and efficacy. Other, ineffective yet common attempts to cut corners to make up time include rushed documentation or poor design controls/defined variables. Therefore, for new product development that requires pre-clinical research it is important to consult regulatory agents to gain a better understanding of expectations before creating a project timeline and being transparent with management about said pitfall.
The key difference between a poor study and a rushed study is the quality of the results. Just because there was a tight deadline and some corners had to be cut does not automatically mean the study was done poorly and the results should not be considered. There are many instances where a company might need to minimize some resources or allocate them somewhere different but once this starts affecting the quality of the study, choices need to be made. It is known that businesses act on efficiency and try to make money in every avenue possible. There is a fine line where results should be somewhat compromised due to time constraints. Cutting too many corners to the point where the results become unviable will just mean the whole study was a large waste of time and that is a very inefficient route to take. Likewise, not cutting any corners at all and allowing the study to go way over the deadline will most likely start cutting into the profits and thus lead to a lot of money lost. Having the right balance of knowing where to cut some costs while not sacrificing the quality of the results will help lead the company to greater profits and closer to the goal at hand.
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?
In the industry, if one is running low on time, I don't think they should cut corners because that leads to sloppy and unfinished work. What they should do is work overtime and try to ask for an extension if possible. This is because if you have more time, you should have better results, and would you rather have better results or okay results? Results in no case should be compromised to meet deadlines, especially in products that are in biologics, because it can lead to severe complications with people's bodies. If you are running low on time, the best option would be to ask for an extension or work over time to create the best product.
As others have mentioned, cutting corners in a clinical study introduces more risk, and might make the results less robust. However, regulatory bodies exist to mitigate a lot of potential harm to the general public that poor studies might cause. If too many corners were cut, the FDA will inevitably conclude that the data is insufficient to warrant approving the proposed medical device, and the company will have to go back to the drawing board. In the end, companies should be very careful when making compromises in research, because often it will end up just hurting the company. It's better to take a little longer to ensure you have strong results the first time around, rather than having to face the FDA repeatedly due to poor studies.
In a way though, the time and budget restraints imposed by management when it comes to study design can actually be helpful, because it forces the person writing the protocol to really examine what sort of data is really critical and which isn't. As long as the sample size is still large enough to be statistically significant, and it passes the scrutiny of the regulatory organization, then narrowing a study down to its essential components might be ok.
I personally feel as though corners should NEVER be cut in research for any reason. One of the biggest downfall in industry is the time constraints companies put on their employees to get their projects done. This could lead to a variety of faults in their research and device developments. I couldn't even count the many research studies ive read which had faults in the results. Budget cuts are also one of the main reasons corners could be cut. Honestly, cutting corners is never right in my opinion.
My opinion matches that of the majority. I do not believe that in research, corners should ever be cut. I completely understand why companies would do it. Time is money, and every day that a study goes on without the results that the company wants, they lose money. It sucks that this is how they work, and in a perfect world, we would allow studies to take as long as they need to get the best, most accurate results. When corners are cut, let's say by reducing the sample size, the data produced could be less trustworthy. Higher sample sizes decrease variability and allow the data to be normalized. I think that having a small sample size knowing that you need a larger one is reckless. Everything is fine until it isn't, and when dealing with devices that will at some point interact with human patients, I think that all of the precautions should be taken. Another method of cutting costs as mentioned by another commenter is reducing the amount of people working on a project/study. This is also wrong as it creates a lot of pressure on the individuals left and can result in the researcher being overwhelmed. Unfortunately, in these cases, that individual may be inclined to cherry-pick their data to close the study or, in some cases, feel the need to falsify data given previous trends (for example, run 1 and 2 were pretty consistent and instead of fully running run 3, they fill in the numbers).
The deciding factor between a viable study and a poor study when cutting down on resources or speeding up results is the quality of the study's design and execution. A well-designed study with appropriate sample sizes, controls, and rigorous methods is more likely to yield valid results than a poorly designed study with inadequate controls and small sample sizes. However, compromising results to meet deadlines is not acceptable from an ethical or scientific standpoint. The scientific process requires careful planning, execution, and interpretation of data, and cutting corners can compromise the validity and reliability of the results. Additionally, falsifying or manipulating data in order to meet deadlines is scientific misconduct and can damage the credibility of the researcher and the scientific community. Therefore, it is important to prioritize the quality of the study over speed or resource limitations. Researchers should carefully plan and design studies to maximize their scientific validity and rigor, and should not sacrifice quality for the sake of meeting deadlines.
Deadlines are one of the top factors that differentiate industry from academia. Cutting corners in research whether in academia or industry will likely resurface, often times negatively, in some capacity post-market. In industry, once a product is sold commercially, there is a requirement to conduct activities that monitor how the product is performing in the market. This is termed post-market surveillance. If in fact there has been any issues during the development stages that render a recall or a field action of any sort, that could potentially be more costly than the "savings" that occurred during the research.
Overall, attainable prioritization of deadlines, resources, and budgets should be set whether in academia or industry to prevent cutting corners. This also prevents negative impact to patients, employees, and/or company reputation.
One of the main prioritirs for conducting research in industry is to make money and sometimes the scope ane scale of research exceeds its alloted resources. In my opinion certain parameters can be downsized or changed while still maintaining the integrity of the research. For example, researchers may request ten animal models for a study to undergo five trials. This request may be too expensive so alternatives such as using six animal models instead of 10 or conducting 3 trials instead of five could be done to lower cost. Additionally, depending on the type of research, the type of animal model used could be substituted as well. Results and outcomes should never be compromised to meet deadlines as the implications of false or unsubstantiated results could be dire.
It is terrible that research, especially in the industry, can be violated due to confounding variables such as time/ money constraints. The deciding factor between a viable and poor study when cutting down on resources or speeding up results is when a company or organization has a different agenda to push or is backed into a corner by another party, such as investors. Ideally, results should always be maintained to meet a deadline. They should be tested multiple times and reviewed by multiple scientists before ever putting any information out there concerning the general population being easily persuaded and open to vulnerability due to the lack of knowledge. However, this is not the life we live, and as a future scientist and industry, I hope to change the perspective of having to rush results due to short timelines, money, and constraints.
In general with anything in life cutting corners and taking shortcuts 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. A gain in trust is also very important in building great work relationships which leads to better group work. 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. We can comprehend how our activities affect nature as we learn more about it and how it functions. Most significantly, we learn about business, technology, nutrition, and health. Cutting corners in a facility could result in funding reductions or closure. Your career may be impacted by getting fired or having your study stall.
Unfortunately we don’t live in an ideal world and time and cost usually the deciding factors for clinical research in industry. In order to complete a project under time and budget constraints cuts may need to be made like number of participants within a study, length of study, and the type of participants used for the study. The deciding factor when it comes to making cuts is when the study can not be conducted again to reproduce the same significant results. If this occurs then the all the effort time and money spent is for not. Where the constraint placed on the study will becomes its downfall.
Cutting corners in research is never acceptable in my opinion, this is what separates success from failure. The intention is a top priority in experimenting and is in every detail from start to finish. I can understand that no one walks into a new research opportunity knowing that corners will be cut but I would rather miss a deadline than compromise results. I think the fear of knowing that something small like that can make a difference in finding that cure or that new advancement of the matter at hand and is never worth it.
