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Project: Avoiding failure in clinical trials.

Project: Avoiding failure in clinical trials.

An Introductory Summary of My Grant Proposal

1. Do you have an idea for a project? Is yes, what is it? If no, what area of your specialty interests you the most?

Yes. My research topic will be, “Avoiding failure in clinical trials.”

2. Is your project idea(s) compatible with your organization’s current mission and purpose? In what way? If no, can the idea be revised to better fit the organization’s current mission and purpose?

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.

3. Is your project unique? Are there other organizations or groups doing this same work? Is there a way to revise the project idea to make it more unique?

My project is not unique. For example, Global Development Amgen-a biotechnology company focused on clinical research-has outlined what needs to be done to reduce clinical trials’ failures. I, however, 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).

4. What need does your idea address? (The answer to this question will become the framework for the proposal’s need statement).

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).

5. How would your idea improve the situation? (This answer will become the basis of the proposal’s goals and objectives).

Upon ensuring there is no rush to phase 3, I will have addressed the need for an exhaustive review of the previous phase. This will involve not only the research team but also external consultants to audit the project. As a result, any unidentified areas, inadvertently skipped objectives, tests, and other vital pointers will be identified and addressed proactively.

To boot, there will be a thorough review of the associated costs and any anticipated costs. Through this, necessary trials will not stall in the future due to funds exhaustion midway. Optimizing for cost by staging investment also slows down, while optimizing for speed tends to drive up the cost (Amgen Science, 2021). This means that a rush to phase 3 may achieve speed but yield more costs upon failure. Further, on successful completion of phase 3 because of a meticulously executed phase 2, there will be an increased likelihood of financiers’ willingness to fund future projects, hence creating a more successful research industry.

6. What do you plan to do to improve the situation? (This answer will become the basis of the proposal methodology).

To improve the situation, I will conduct a study of organizations with recorded failures in their previous research to obtain first-hand information on best and worst practices, consequences, and solutions, which I will share with all relevant bodies and regulators.

7. How will you know if your idea worked? (This answer will become the basis of the evaluation section of the proposal).

To know if my idea worked, I will evaluate the organizations’ and industry’s rate of new drugs’ approval before and after the implementation of my recommendations. The cost of success is so enormous because of all the money invested in drugs that fail: 90 percent of test drugs that enter clinical trials never get approved (Amgen Science, 2021). Into the bargain, I will review the availability of willing future financiers for the next phases, to determine the project’s potential for future advancement and industry-players’ support. Each researcher’s reputation and future grant funding depend on the success of each project (Halcomb, 2016).

8. How much will your idea cost? (This answer will become the basis of the budget). My idea is estimated to cost approximately USD. 100,000.00

9. Is there support within the organization for the project? Consider if the idea might need internal support of organization leadership/administration or perhaps external support from community leaders, school board, or church leaders.

Yes, the organization is supportive as the project will help address some of the industry’s most pressing challenges and reduce the rejection of new drugs’ rollouts. I am seeking approval from the local community and church leaders and local governments, as some of the data collection and trials may fall within their jurisdiction or violate individual rights given religious or traditional beliefs.

10. Is there a way in which these services might be funded in the future once the grant money runs out? (Think sustainability).

Yes, if the grant money runs out, the project can be funded by income generated from community-based initiatives that will be developed in the course of the research. Secondly, once the project has started, I will continuously search for additional grants by sharing our progress and success milestones to have new partners on board for emergencies.

References

Amgen Science. (2021). A Strategy for Making Clinical Trials More Successful. https://www.amgenscience.com/features/a-strategy-for-making-clinical-trials-more-successful/

Fogel, D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemporary clinical trials communications, 11, 156-164.

Halcomb, E. (2016). Measuring research success. Nurse Researcher.

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