Grant Week 7 DB CI

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Nneamaka Ajaero

Dr. Elizabeth Adamson

Grant Watch Public Company

https://www.grantwatch.com/

Avoiding Failure in Clinical Trials

According to current research carried out, about ninety percent of drugs that reach the clinical stage of development never make it to the FDA's commercialization and confirmation. I might think it could be because of the FDA's stringent review process designed to ensure that only products that deliver a good effectiveness and safety profile ever reach customers. Only half of all drugs which are rejected during the process fail because of a lack of effectiveness. The rush to phase 3 is a significant contributor to failure because it renders researchers unable to review their progress and proactively accept any challenges adequately (Query Sample Size Software Team, 2017). The importance of avoiding failure in clinical trials is to ensure that there is no more cost used since when a clinical trial fails, it costs a lot of money, and avoiding it will cut the cost.

Specific Aims

One of the aims of this proposal is to reduce the costs incurred if a clinical trial fails. Upon the clinical trial failure, the company yields more costs. If a clinical trial's failure is avoided, then these costs will be reduced. Another aim is to reduce the risks associated with the collapse of clinical trials. When the loss of a clinical trial is avoided, then these risks can be avoided.

Significance of the Proposal

The clinical trial's impact, mostly in phase III, is significant, with the most affecting being the effect on the financial cost and the human lives. The failure impacts thousands of patients who enroll in clinical studies hoping to find a workable treatment option. When the clinical trial fails, most patients have cancer, cardiopulmonary diseases, or diabetes mellitus. Those patients who participate in these trials mostly have a later stage or difficulty treating conditions with less standard treatment options. Thus, the effect of failed drug trials may be worldwide and may make worse the expectation of the patient, the life quality of the patient, and their emotional well-being.

Thus, if my proposal works well, it will help these patients who suffer due to clinical failure. All these impacts that the clinical negligence has on these patients will be eliminated (Sy Pretorius, 2016). That is one of the essential things for my project. The clinical trial's failure, mostly in phase III, resulting in material financial distress to the organizations, and they are the contributors to low capital productivity. Weighing the trial's extensive financial investment, several new drugs are accepted by the regulators. The financial results of a failed drug development mostly exceed R$D. My project will also be significant to help these organizations from having extensive financial losses.

Relevant Article Summary

The failure of many drug candidates to win approval is a vast concern in pharma organizations, specifically as this drives the entire cost of developing the drug. To prevent failures and set up a secure phase II trial, the organizations should improve their method during the early stage and think of the data. There has been an innovative design that uses data to predict clinical trials' failures and success. This kind of method could aid clinical trials whose failures have significantly risen (IVIDATA, 2020). This tool could prevent drug development failures at the advanced stages in development and allow the stakeholders to readapt the trial strategy to avoid the waste of money and time. This method could be used at the time of post-approval surveillance of drugs.

Innovation

My idea is not new because there have been explanations on what should be done to prevent other people's clinical trial failures. Still, my idea is different from the others since I will carry my research different from what other people do. I will also be addressing some questions that have not been answered by others.

Conclusion

Only half of the new drugs make it to phase III; collaborating more closely with contract research companies and adopting best practices can help ensure success. One of the main reasons for the failure is the rush by manufacturers to phase II once an exciting signal appears at phase II. For the pharmaceutical organizations, this issue has also become very wasteful, though not only for the companies but also for the patients who may waste time participating in the studies they hope will result in new cures for their ailments. Finding ways to try and avoid these clinical failures is a very important thing that people should embrace.

References

IVIDATA. (2020, January 29). How to avoid failures in clinical trials using machine learning. Retrieved from https://medium.com/ividata-et-ses-business-managers/how-to-avoid-failures-in-clinical-trials-using-machine-learning-f8d852e582c2

NQuery Sample Size Software Team. (2017, May 19). Why do phase III clinical trials fail? Retrieved from https://blog.statsols.com/why-do-phase-iii-clinical-trials-fail

Sy Pretorius. (2016, August 1). Phase III trial failures: Costly but preventable. Retrieved from https://www.appliedclinicaltrialsonline.com/view/phase-iii-trial-failures-costly-preventable