Assignment: Properties to Prioritize in An Optimization Program Questions

Part 1.

Choose three properties that you would prioritize if you were running a lead optimization program and explain the primary reasons for you choices. ( 1 paragraph 10-11 sentences)

Read the referenced article and provide your comments as the contents applies to clinical trial design. ( 1 paragraph 10-11 sentences)

Part 2

1.) Using the referenced file, if putting together a clinical research study budget is nothing more involved than creating a MS Excel spreadsheet, why do we find researchers, authors, and even consultants dedicated to the subject?- 1 page

2.) What are the differences between descriptive, comparative, and inferential statistics?

sorry for the delay I know have question 3:  In 2005, 72,007 men and 69,398 women were diagnosed with colorectal cancer. Assume that you are the statistician designing a clinical trial for a new drug that purports to cure this disease. Using the referenced website, what would your recommended sample size be, given a 5% margin of error and a 95% confidence level?http://www.raosoft.com/samplesize.htmlThe DeGoey et al., paper describes numerous clinically effective drugs that have one or more properties “beyond” Lipinski’s Rule of 5.  Is it time to replace Lipinski’s rules with a more current set of rules based on recent experience?  If so, what parameters would these new rules include?  Would they be applied to every program?  Would they be applied at the very beginning of the program? 7-9 SENTENCES

In 2005, 72,007 men and 69,398 women were diagnosed with colorectal cancer. Assume that you are the statistician designing a clinical trial for a new drug that purports to cure this disease. Using the referenced website, what would your recommended sample size be, given a 5% margin of error and a 95% confidence level?http://www.raosoft.com/samplesize.html

Clinical Research Developing an Investigator Site Budget for Clinical Trials The Center for Cancer Care and Research (TCCCR) of St Louis, Missouri, is a Clinical Trial Award–winning practice and a member of the US Oncology Network (Houston, Texas) and participates in clinical research through US Oncology Research. The practice also participated directly with pharmaceutical sponsors, and it is a member of the Heartland Cancer Research Community Clinical Oncology Program (St Louis, Missouri). TCCCR has found that developing a site budget that captures all of the costs associated with the trial and using the budget to negotiate expense coverage with the sponsor is critical to ensuring the appropriate funding support for a trial. Sponsors must provide funding for protocol requirements that exceed the standard of care.1,2 These procedures may include additional lab testing, extra radiology procedures to confirm response at predetermined intervals, and tests for specific toxicities expected with the study drug. During the budget development process, it is important to identify these protocol-specific testing requirements.

In addition, determine what routine patient care costs Medicare or private insurance carriers in your state will cover, and set up appropriate billing processes for the nonroutine patient care costs. Most sponsors pay these costs through an invoicing process, but the cost must be determined prospectively and negotiated. The optimal conduct of clinical research in any setting requires dedicated research staff. Having such staff increases the likelihood of success adhering to protocols and providing the best patient care. When budgeting for staff time, consider the time required for all tasks integral to coordinating the trial: screening patients, obtaining informed consent, conducting patient visits, completing accurate source documents and case report forms, maintaining regulatory documents, and communicating with the sponsor and contract research organization. Reimbursement for those costs should be included in a budget. TCCCR has designed an Excel template that reflects the true cost of conducting research by including these so-called hidden costs in the budget request (Table 1). The template takes into consideration fees for research personnel at all levels, including the principal investigator, site manager, clinical research coordinators, and regulatory coordinators.

Important information for writing discussion questions and participation

Welcome to class

Hello class and welcome to the class and I will be your instructor for this course. This is a -week course and requires a lot of time commitment, organization, and a high level of dedication. Please use the class syllabus to guide you through all the assignments required for the course. I have also attached the classroom policies to this announcement to know your expectations for this course. Please review this document carefully and ask me any questions if you do. You could email me at any time or send me a message via the “message” icon in halo if you need to contact me. I check my email regularly, so you should get a response within 24 hours. If you have not heard from me within 24 hours and need to contact me urgently, please send a follow up text to

I strongly encourage that you do not wait until the very last minute to complete your assignments. Your assignments in weeks 4 and 5 require early planning as you would need to present a teaching plan and interview a community health provider. I advise you look at the requirements for these assignments at the beginning of the course and plan accordingly. I have posted the YouTube link that explains all the class assignments in detail. It is required that you watch this 32-minute video as the assignments from week 3 through 5 require that you follow the instructions to the letter to succeed. Failure to complete these assignments according to instructions might lead to a zero. After watching the video, please schedule a one-on-one with me to discuss your topic for your project by the second week of class. Use this link to schedule a 15-minute session. Please, call me at the time of your appointment on my number. Please note that I will NOT call you.

Please, be advised I do NOT accept any assignments by email. If you are having technical issues with uploading an assignment, contact the technical department and inform me of the issue. If you have any issues that would prevent you from getting your assignments to me by the deadline, please inform me to request a possible extension. Note that working fulltime or overtime is no excuse for late assignments. There is a 5%-point deduction for every day your assignment is late. This only applies to approved extensions. Late assignments will not be accepted.

If you think you would be needing accommodations due to any reasons, please contact the appropriate department to request accommodations.

Plagiarism is highly prohibited. Please ensure you are citing your sources correctly using APA 7th edition. All assignments including discussion posts should be formatted in APA with the appropriate spacing, font, margin, and indents. Any papers not well formatted would be returned back to you, hence, I advise you review APA formatting style. I have attached a sample paper in APA format and will also post sample discussion responses in subsequent announcements.

Your initial discussion post should be a minimum of 200 words and response posts should be a minimum of 150 words. Be advised that I grade based on quality and not necessarily the number of words you post. A minimum of TWO references should be used for your initial post. For your response post, you do not need references as personal experiences would count as response posts. If you however cite anything from the literature for your response post, it is required that you cite your reference. You should include a minimum of THREE references for papers in this course. Please note that references should be no more than 5 years old except recommended as a resource for the class. Furthermore, for each discussion board question, you need ONE initial substantive response and TWO substantive responses to either your classmates or your instructor for a total of THREE responses. There are TWO discussion questions each week, hence, you need a total minimum of SIX discussion posts for each week. I usually post a discussion question each week. You could also respond to these as it would count towards your required SIX discussion posts for the week.

I understand this is a lot of information to cover in 5 weeks, however, the Bible says in Philippians 4:13 that we can do all things through Christ that strengthens us. Even in times like this, we are encouraged by God’s word that we have that ability in us to succeed with His strength. I pray that each and every one of you receives strength for this course and life generally as we navigate through this pandemic that is shaking our world today. Relax and enjoy the course!

Hi Class,

Please read through the following information on writing a Discussion question response and participation posts.

Contact me if you have any questions.

Important information on Writing a Discussion Question

• Your response needs to be a minimum of 150 words (not including your list of references)
• There needs to be at least TWO references with ONE being a peer reviewed professional journal article.
• Include in-text citations in your response
• Do not include quotes—instead summarize and paraphrase the information
• Follow APA-7th edition
• Points will be deducted if the above is not followed

Participation –replies to your classmates or instructor

• A minimum of 6 responses per week, on at least 3 days of the week.
• Each response needs at least ONE reference with citations—best if it is a peer reviewed journal article
• Each response needs to be at least 75 words in length (does not include your list of references)
• Responses need to be substantive by bringing information to the discussion or further enhance the discussion. Responses of “I agree” or “great post” does not count for the word count.
• Follow APA 7th edition
• Points will be deducted if the above is not followed

• Remember to use and follow APA-7th edition for all weekly assignments, discussion questions, and participation points.
• Here are some helpful links
• The is a great resource