An Introductory Summary Of My Grant Proposal 1 ✓ Solved

An Introductory Summary Of My Grant Proposal1 Do You Have An

Do you have an idea for a project? Is yes, what is it? If no, what area of your specialty interests you the most? My research topic will be, "Avoiding failure in clinical trials." Is your project idea(s) compatible with your organization's current mission and purpose? In what way? Yes, it is compatible with my organization's current mission. This topic is compatible because the organization's main aim is to carry out clinical trials and roll out to the market and ensure minimal failures, including minimizing adverse side effects to the subjects.

Is your project unique? Are there other organizations or groups doing this same work? My project is not unique. For example, Global Development Amgen has outlined what needs to be done to reduce clinical trials' failures. I used the word 'entirely' to mean that there is uniqueness based on how I intend to carry out my research and address unanswered questions despite there being existing topics. Additionally, I plan to share my research with adoption organizations. It is important to maintain a philosophy of continual improvement in clinical trials broadly and specifically to optimize every aspect of the development process (Fogel, 2018).

What need does your idea address? My idea addresses the tendency of researchers to rush to phase 3. This rush is a significant contributor to failures, as it renders researchers unable to review their progress and proactively anticipate any challenges adequately. Rushing studies into phase 3 after successful phase 2 trials may not provide time for reflection on how best to address safety in phase 3 (Fogel, 2018).

How would your idea improve the situation? Upon ensuring there is no rush to phase 3, I will have addressed the need for an exhaustive review of the previous phase, involving the research team and external consultants to audit the project. This will identify and address any unidentified areas, inadvertently skipped objectives, and vital pointers. There will also be a thorough review of the associated costs. By staging investment and optimizing for cost instead of speed, the project can reduce failures in future drug trials (Amgen Science, 2021).

What do you plan to do to improve the situation? To improve the situation, I will study organizations with recorded failures in their previous research to obtain firsthand information on best and worst practices. This information will be shared with all relevant bodies and regulators.

How will you know if your idea worked? To determine if my idea worked, I will evaluate the rate of new drug approvals before and after the implementation of my recommendations. Given that 90 percent of test drugs that enter clinical trials never get approved (Amgen Science, 2021), this evaluation will provide insights on the effectiveness of my approaches. Additionally, I will review the availability of willing future financiers for subsequent phases.

How much will your idea cost? My idea is estimated to cost approximately USD 100,000.00. Is there support within the organization for the project? Yes, the organization is supportive as the project will help address pressing challenges in the industry.

Is there a way in which these services might be funded in the future once the grant money runs out? Yes, the project can be funded by income generated from community-based initiatives developed during the research, and I will continuously search for additional grants.

Paper For Above Instructions

Clinical trials are critical in the development of new drugs, yet many such trials fail or experience significant setbacks. This research proposal discusses the strategies to avoid such failures, particularly the risks associated with rushing patients into phase 3 trials without adequate assessments from prior phases. Currently, it is apparent that the pharmaceutical industry requires a more methodical approach to drug development to enhance the likelihood of success and regulatory approval.

The underlining issue with clinical trials, especially with regard to phase transitions, is primarily the inclination to accelerate processes upon achieving preliminary successes. Researchers often feel pressured to hasten into phase 3 due to the inherent financial investments and timelines associated with drug development. However, this "rush" results in insufficient reflection on the results and safety data from phase 2 trials, which could critically undermine the entire project (Fogel, 2018).

To address this, the proposed research will explore the implementation of a structured review process before transitioning to phase 3. This process will engage the research team alongside external consultants to undertake a comprehensive audit of previous phases. By identifying any objectives missed and ensuring a thorough evaluation of safety measures, researchers can proactively mitigate potential risks moving forward.

In addition, a cost analysis will be incorporated to identify budgetary constraints and potential financial roadblocks which can stall trials midway. The importance of this financial assessment cannot be overstated: failure to secure proper funding tends to lead to cessation of trials before completion (Amgen Science, 2021). By ensuring that phase transitions are accompanied by not only scientific validity but also financial feasibility, the prospect of achieving successful drug approval is vastly improved.

The evaluation of prior clinical trials that have ended in failure will shape the methodological framework of the research. By collaborating with companies that have recorded setbacks in their previous studies, insights regarding what went amiss can be documented, along with actionable solutions that may benefit the industry (Halcomb, 2016). Understanding these failures and the steps taken to remediate them provides a wealth of knowledge that can be shared with regulatory bodies to foster a climate devoted to research integrity.

In measuring the success of this proposed approach, one can compare the rate of new drug approvals before and after the adoption of the outlined methodologies. Drug development is financially exhaustive, with a staggering 90% of drafted medications failing to reach market approval (Amgen Science, 2021). Thus, this proposal aims to contribute positively towards reducing this high failure rate.

Moreover, ensuring transparency and effectiveness throughout this process can encourage investors to continue supporting research endeavors. A successful phase 3 trial can translate to improved confidence from financiers for future projects, ultimately leading to a more robust and resilient pharmaceutical industry.

To conclude, by addressing the common pitfalls present in clinical trials—especially the tendency for researchers to rush critical transition phases—this proposal seeks to enhance not only the success rate of individual trials but also the overall integrity and sustainability of clinical research. Engaging stakeholders at various levels will yield a comprehensive blueprint for success that can serve as a standard approach within the industry, helping mitigate risks while maximizing the probability of delivering effective new therapies to market.

References

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• Halcomb, E. (2016). Measuring Research Success. Nurse Researcher.
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