Framework for Budget of Asthma Drug Study Protocol - Assignment Example

?FRAMEWORK FOR BUDGET OF ASTHMA DRUG1 STUDY PROTOCOL Asthma drug1 Study Protocol is a randomized, placebo controlled study of acute severe asthma in children. The entire study will be executed at 20 – 25 sites with study population of 500 children. The details of the entire study is outlined in the study protocol. In this section, the resources (Human resources, financial resources) required for execution of the study protocol has been analysed in detail. TABLE 1 List of expenditure incurring resources Sr. No. Details of resources required in study protocol Justification 1. Human Resources Sample population Patients of two age groups have been considered i. Children aged 2-5 years ii. Children aged 6 years and above Chief Investigator, Local Investigator, DCC To take ultimate responsibility for the design, conduct, analyses and reporting of a clinical study. The DCC will have primary responsibility for data management and analysis for Network research Trial Manager, Trial Co-ordinator Ensure sites have sufficient supplies of medications from recommended manufacturer Medical and Nursing staff Provide information about trial to eligible patients Trial screening assessment Obtain written informed consent from eligible patients Administration of randomized therapy at 20, 40, 60, 120, 180 and 240mins post randomisation Monitoring patients while in hospital Monitoring patients post trial ( after 1 month) Support staff Appropriate temperature monitoring of medicines 2. Medications Treatment kits, additional salbutamol administrations, medications for intravenous bronchodilator treatment, additional medications to treat adverse events. 3. Documents Case Report Form, Withdrawal CRF Consent Form Follow up Questionaire Study design – dosing schedule Randomistion Log where details of randomized patients are entered and filed in Study Site File Accountability Log kept with supply of trial medication Confirmation Sheet which documents correct no. of treatment kits received Sheet for appropriate temperature monitoring after receipt of kits Change of Address card Unblinding envelopes Unblinding CRF Statistical Analysis Plan Central Protocol Deviation Log Monitoring Report Data Management System Delegation of Responsibilities Log 4. Committees Trial Steering Committee Independent Data and Safety monitoring committee 5. Infrastructure Hospital Emergency department Paediatric intensive care unit The above table includes all direct and any applicable indirect costs for one clinical group and not for the entire network (Taggart 2009). COMPONENTS OF STUDY BUDGET In developing budgets for clinical research, the first step is to list all the required resources and then categorize into direct costs, modified direct costs, indirect costs and total costs. Direct Costs is defined as costs in a grant or contract that support a project/program including personnel, equipment, supplies, patient care costs. Modified Direct Costs is used to calculate the indirect costs and excludes items from the direct costs such as: some equipment, student tuition, research patient care costs, and some subcontract costs (Children’s Hospital Clinical Research Program – RPG 2010). Indirect Costs are costs associated with the general operation of an institution and conduct of its research activities like facilities and administrative costs; calculated by applying a specified rate to the modified direct costs. Facilities &Administrative (F&A) costs should not be paid on any cost component representing the cost of research patient care activities. Research patient care rates (routine and ancillary) include F&A costs related to "hospital-type" employees (nurses, medical technicians, and similar personnel) supported as a direct cost under a grant. Therefore, to preclude over-recoveries of costs similar to these F&A costs, salaries and wages of all "hospital-type" employees working on the grant must be excluded from the salary and wage (S&W) base used to claim F&A costs. Related fringe benefits also should be excluded if such costs are part of the S&W base. If a "total-direct-costs" base is used to compute and claim F&A costs, the above-mentioned "hospital-type" salaries also must be excluded from the base as well as any other base costs chargeable to the grant through the application of a research patient care rate (Children’s Hospital Clinical Research Program – RPG 2010). If the grant or a consortium agreement/contract under a grant provides funding exclusively for research patient care activities, no F&A costs normally will be allowed as a separate cost element since all allocable F&A costs will be accounted for in the routine or ancillary activity costs contained in research patient care rates (Taggart 2009). Total costs: Total allowed costs, both direct and indirect, incurred by a grantee to carry out a project or activity (NIH Grants Policy Statement 2010). The budget does not need to include Data Co-ordination Center Costs ( Eg: for drug distribution, forms development, co-ordinator training and data collection). The protocol budget should include all per – patient costs associated with the conduct of the proposed study (recruitment, procedures for enrollment, randomization and follow up visits, participant reimbursement, drugs supplies and any laboratory tests). For equipment, it can be assumed that the equipment necessary to perform prescribed tests are already available and do not need to be included in the proposed protocol budget (Taggart 2009). The budget for Asthma drug1 study protocol will be presented in direct costs only; no administrative costs will be included. DIRECT COSTS INCURRED TO CONDUCT RESEARCH IN ASTHMA STUDY PROTOCOL ARE AS FOLLOWS: 1.) Personnel effort : Salary for Chief Investigator, Local investigator, Trial manager, Trial co-ordinator, Statisticians and data entry staff, Trained medical and nursing staff. The determination of the budget including effort for each staff person should be made by those most familiar with the scope of work of the project, usually the PI (principal investigator) in collaboration with the Project Director/Manager. Direct costs incurred on payments of trained Personnel is determined on the basis of Personnel efforts described as Full Time Equivalents (F.T.E.’s). Full time equivalent is a unit to measure employed persons/students in a way that makes them comparable although they may work different number of hours per week (Study Link 2011). Typically, a daily FTE is 8 hrs and yearly FTE is 2080 hrs (40 hrs per week for 52 weeks or 8.66 working months in 12 months). 2.) Medications : Medications such as nebulised salbutamol, treatment kits containing combinations of asthmadrug 1 or placebo with mixture of salbutamol and ipratropium bromide. Additional prescribing may give rise to requirement of more medicines. 3.) Lab tests and procedures: Lab tests, MRI’s, X-rays, echocardiograms, etc, that are budgeted are allowable direct costs as defined by the sponsor guidelines. Many sponsors, such as NIH, limit the amount of money that can be budgeted for these expenses. 4.) Printing : Printing costs may be budgeted for manuals, case report forms, recruitment materials justified by number of pages and cost per page. 5.) Patient Care Costs : Costs for patient care such as admission to a paediatric intensive care unit, intravenous bronchodilator treatment (if required), inpatient room charges. Research patient care costs do not include: (1) the otherwise allowable items of personal expense reimbursement, such as patient travel or subsistence, consulting physician fees, or any other direct payments related to all classes of individuals, including inpatients, outpatients, subjects, volunteers, and donors, (2) costs of ancillary tests performed in facilities outside the hospital on a fee-for-service basis (e.g., in an independent, privately owned laboratory) or laboratory tests performed at a medical school/university not associated with a hospital routine or ancillary service , (3) recruitment or retention fees or (4) the data management or statistical analysis of clinical research results. 6.) Patient incentives and Patient reimbursements: Reimbursements for patient costs for travel, lodging and parking, especially when it is expected subjects will be travelling any extended distance for participation in the study. Incentives should be modest to avoid any issue of human subject protections, they should commensurate with the time and effort study participants are being asked to give (Relman n.d.). CALCULATION OF PERSONNEL HOURS For NIH grants, personnel efforts are described as percent efforts also termed as Full Time Equivalents (FTE) or calendar months. The amount of effort to be budgeted for each person is carefully matched to the responsibilities of individuals and scope of work of the study (Lawrence 1997). In the below table, personnel efforts starting from screening of patients, randomization, post randomization and follow up period have been quantitated in number of hours required for each patient. TABLE 2 Personnel efforts in FTE is calculated for asthma drug1 study protocol Personnel Efforts Hours / patient Hrs /250 patients FTE % efforts %efforts x 12months Screening patients 1 250 0.12 12 1.44 Obtaining consent Performing assessments 0.25 62.5 0.03 3 0.36 Randomisation (Treatment initiated) 4 1000 0.48 48 5.76 Completion of study outcomes, Discharge of patients 0.5 125 0.060 6 0.72 1 month follow up by post 0.25 62.5 0.03 3 0.36 Total 6 1500 0.72 72 8.64 months The above table portrays percentage efforts on a yearly basis. As mentioned in the study protocol, the entire study with 500 patients over 20-25 sites is anticipated for completion in two years. Therefore, calculations are done based on the assumption that approximately 250 patients will be assessed on a yearly basis. Full Time Equivalent for each personnel effort is calculated by dividing hours/250 patients with 2080 hours (yearly FTE). When converting percent effort in a year to calendar months per year, percent effort is multiplied by 12. This type of calculation aids in projecting budget costs for personnel effort. In addition, investigators should be aware of and adhere to any salary caps or effort minimums or maximums that must be followed for various sponsors or funding mechanisms. For example, NIH has a maximum salary that must be used for senior investigators whose salary may exceed this amount, and this amount is announced on a yearly basis (We Make Lives Better UT Health Science Center 2011). ASSESSMENT OF RELIABILITY OF BUDGET Factors affecting direct and indirect costs will depend on whether it is industry sponsored or NIH/foundation supported (We Make Lives Better UT Health Science Center 2011). a.) Industry sponsored trial is characterized by the below mentioned features : testing of a drug, device, diagnostic, treatment, intervention, or preventive measures including testing for an unapproved indication or Data collection, or review of data generated or acquired in a clinical setting, to increase knowledge that would lead to enhanced safety and efficacy of a drug or device. The study must involve contact with human subjects or the review of patient care clinical data. The study must be performed primarily in patient care or clinical space. The study must be industry-funded (American College of Chest Physicians n.d.). For industry sponsored trials, the principal investigator works with the Clinical Trials Office (CTO) to determine the correct costs to budget. CTO's primary activities include: Negotiating and managing agreements for clinical trials and basic science research Working with principal investigators to develop budgets for presentation to sponsors Establishing study funds with Research Finance Negotiating sub-contracts with sister institutions where the primary sponsor is industrial Negotiating and managing material transfer agreements (MTA's) on behalf of interested investigators Negotiating confidential disclosure agreements on behalf of investigators Negotiating collaboration agreements b.) NIH supported or foundation supported studies : NIH provides funds for research patient care costs under grants and cooperative agreements. Research patients may receive routine services as inpatients or ancillary services as either inpatient or outpatient subjects/volunteers/donors. In order to receive reimbursement for research patient care costs, any hospital that, as a direct recipient of NIH funds, expects to incur more than $100,000 in patient care costs in any single budget period on a single NIH grant must either have in place or take steps to negotiate a research patient care rate agreement with the cognizant DCA office (Dartmouth-Hitchcock Medical Center n.d.). The principal investigator works with the Office of Sponsored Programs (OSP) to calculate clinical costs. OSP will work in conjunction with CTO to determine the correct costs. OSP's primary activities include: Providing information on funding opportunities for federal and not-for-profit sponsors Providing guidance with preparation of the business sections of a proposal Reviewing and endorsing applications for external funding Negotiating terms and conditions of awards with sponsors Issuing of sub-awards to collaborating institutions Providing information, guidance, and training to the Children's research community regarding sponsor guidelines, regulations, and expectations Assisting investigators transferring to and/or from Children's Problem-solving and issue management c.) Patient Care costs, Lab tests and procedures are budgeted in consultation with CTO or OSP depending on sponsorship (Gundlapalli 2010). d.) Patient incentives and reimbursements are estimated as per specific guidelines found in Committee on Clinical Investigation (CCI) website under guidelines and policies (American College of Chest Physicians n.d.). e.) Guidelines for calculation of indirect costs are stated in Research Finance’s Direct and Indirect Costs Policy (Research Grants and Indirect Costs n.d.). Indirect cost rates vary by funding agency and are determined by the institution. Indirect rates will change over time and therefore must be confirmed and the most current rate used. (Baer 2010). STUDY TIME LINE Tasks Year 01 Year 02 Finalize study protocol Hire and Train Personnel Develop CRFs and study Manuals Develop study database Recruitment and Randomization 1 month Post Trial monitoring Data collection and analysis The randomized, placebo controlled study of asthma drug1 in acute severe asthma in children has been planned to have a sample size of 500 children in order to detect a difference of 0.5 points on the asthma severity score at 5% significant level with 80% power. Based on feasibility study conducted at 20 – 25 sites recruiting children, it is anticipated that is will take 2 yrs to recruit the overall target number number of participants. Based on the nature of the study, it can be assumed that study treatment and data evaluation will be done simultaneously. Based on these assumptions, timeline for the entire study has been portrayed in the above table. REFERENCES 1. Taggart S.V., Smith R. 2009. National Heart Lung and Blood Institute People Science Health. [Online]. Available: http.//www.nhlbi.nih.gov/funding/inits/faq-asthmanet.htm (24 September 2011). 2. 2010. Children’s Hospital Clinical Research Program – Research Practice Guidelines. [Online]. Available: http://www.childrenshospital.org/cfapps/research/data_admin/site2734/Documents/RPG_22_Guideline_for_Developing_a_Clinical_Research_Budget%5 (24 September 2011). 3. 2010. NIH Grants Policy Statement. U.S. Department of Health and Human Services. [Online]. Available: http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch19.htm. (25 September 2011). 4. Relman A. n.d. Cost Control, Doctors ethics and Patient care. [Online]. Available: http://www.issues.org/19.4/updated/relman.pdf. (25 September 2011). 5. 2011. We Make Lives Better UT Health Science Center. San Antonio. [Online]. Available: http://research.uthscsa.edu/osp/clinical.shtml#5. (25 September 2011). 6. Dartmouth-Hitchcock Medical Center. n.d. [Online]. Available: http://www.dhmc.org/webpage.cfm. (25 September 2011). 7. Gundlapalli A., LaSalle B., Bray B., Narus S., Strong M., Paine M. 2010. Clinical Research Informatics Systems Report. University of UTAH Health Sciences. [Online]. Available: http.//humis.bmi.utah.edu/humis/docs/organization. (25 September 2011). 8. American College of CHEST Physicians. n.d. [Online]. Available: http://www.chestnet.org/accp/practice-management/coding-documentation-faq. (25 September 2011). 9. Research Grants and Indirect Costs. n.d. [Online]. 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