This paper is aimed at deriving a framework for a study budget. According to the protocol (2008), it is a randomized, placebo-controlled trial of asthma drug in acute severe asthma in children. In particular, it is necessary to do the following tasks: 1) to identify types of costs associated with this research; 2) to point out different categories of effort which can give rise to expenses; 3) to estimate the resource requirements and translate them into personnel hours. This analysis can assist in developing a budget of the clinical research. It has to be admitted that this protocol does not contain all the relevant information, and some details, for instance, the cost of medication or the wages of research personnel, are lacking. Nonetheless, this assignment still remains beneficial to that extent that it can provide deep insights into the principles of clinical research budgeting. On the whole, this stage of the research is both time-and-energy consuming, it demands foresight, precision and proficiency in several disciplines, like accounting or even HR management. This and other questions will be addressed in the following sections.
Clinical trial: types of costs and procedures for estimating the budget
At first, it is vital to mark out the types of expenses involved in clinical trials. According to John Neal, such studies entail direct, indirect (or overhead) and opportunity costs (2009, p 2). Direct costs are those expenses, incurred by the researcher if he/she does not resort to the help of any other research facility and works independently. In turn, overhead costs normally arise when the study requires the use of infrastructure, research utilities, personnel, insurance services, legal consultant etc (Neal, 2009, p 2). The third category is opportunity costs; they can be defined as the profit which the organization (hospital, research center) could have gained it had invested capital differently (Neal, 2009, p 2). Judging from this discussion we can argue that this protocol does not provide exhaustive information about the overall expenses. As a matter of fact, we can speak only about direct and overhead costs, incurred by the investigators and the organizations that assist them in this project.
At present, there is no universal pattern for determining the budget. As a rule, this procedure consists of such steps as identification of research-related tasks, estimating staff and non-staff costs, and determining the cost of each study visit (Neil, 2009, 3). Naturally, these are the most general guidelines but they lay the basis of a well-planned budget. Unfortunately, we can identify only study-related procedures as well as the resources required for them but we cannot give the most precise estimation because the given protocol does not specify several important points like the staffing costs.
Categories of effort, which give rise to costs
Hypothetically, this study includes a great number of procedures, which are associated with extra expenses. One of them is the recruitment of the participants. According to the protocol, the sample population will be five hundred children, which means that the investigators will need to receive the consent of parents or legal guardians, who may be willing or unwilling to take part in this experiment (2009, p 16). This task is extremely time-and-resource consuming, and it cannot be performed without volunteers or part-time employees. Therefore, the head of the group should determine the number of people who will see this problem. Furthermore, he/she must determine their daily pay. These people will need to explain the rationale for the research and explain how the patients can benefit by it. It is essential that they overcome their parents apprehension.
Another important part is screening or eligibility assessment. The investigators must ascertain whether the child may be treated with asthma drug 1 or not. This assessment will be made by nurses who work in a certain institution and it automatically leads to extra workload that must be compensated. The problem is that we are not sure whether the study will be carried out by a separate group of scientists or it will involve the personnel of the hospital. But given the fact that the study will be undertaken in more than twenty hospitals and there will be approximately 500 hundred subjects, we can presume that the researchers will be unable to do this on their own. So, screening is most likely to entail extra expenses. Nevertheless, we need to know whether the traditional screening method used in hospitals is different from that one proposed by the authors of this clinical trial. If they are similar to one another, this part of the study will not be too costly. Thus, we may say that the researcher must first and foremost estimate the approximate amount of time spent by the nurses on screening. Having these data, it will be possible to calculate the sum of compensation that he/she should receive.
As it has been pointed out before, the research will be conducted in more than twenty medical institutions. Hence, while developing the budget one must also consider travel expenses, which include transportation and sometimes lodging costs (Penson & Wei, 2006, p 55). This is why it is of crucial importance to estimate the total number of visits made by each member of the team. David Fenson and John Wei urge the researchers not to forget about the fees, charged for retrieving medical records, phone calls, photocopying, office supplies etc (2006, p 56).
We should also take into account the fact that the initial plan includes follow-up-assessment as well. So, the investigators will send questionnaires to each of the participants. In case, if parents of the child do not return the questionnaire, an attempt will be made to contact them. (Protocol, 2009, p 15). Therefore, it will result in mail and phone call costs.
The most blatant mistake that an inexperienced researcher can make is to neglect some aspects of the study that seem to be minor, for example, paperwork or administrative fees. Yet, in the long run these minor activities may require considerable investment. Ironically, lack of office accessories can occasionally put the whole process of research to a standstill. This is why, it is crucial that the investigator accurately predicts resource requirements.
One should not forget about the regulatory issues, which can also be rather cumbersome. First of all, people, who are going to carry out this clinical trial, must obtain permission from the IRB (internal review board) of the hospital that must decide whether this investigation meets ethical and safety standards (Gallin & Ognibene, 2007, p 345). It should be pointed out that the fees charged by IRBs of various medical institutions differ from one another. This is why these expenses should be incorporated into a budget plan. In this case, the investigators will need to receive permission from more than twenty IBSs, and this effort subsequently entails many administrative fees.
Furthermore, it is important for us to know the price of asthmadrug 1, itself. As it has been stated in the protocol, it is unlicensed medical product; especially we are speaking about the treatment of asthma. However, it has already been used for other indications. So, the question arises, whether the supply of this drug to the hospital will be organized at the expense of the manufactures that might be interested in this research; or the hospital will rely on its own funds. If their will be not support from the manufacturer, the researchers will need to calculate purchasing costs. This will be one of the most challenging tasks, because the dosage of alpha drugs varies according to the age of the patient. But at this point one cannot precisely estimate the age variances among the participants. Additionally, the researchers must estimate the exact quantity of asthma drug that should be procured and its distribution among hospitals.
An important element of any clinical is the collection and analysis of data. The investigators will need to gain access to various sources of information such as patient records, appointment books, laboratory reports and so forth. Obviously, they will need to scan and copy them, and this is not for free. Apart from that, data analysis requires the use of sophisticated software, and this item should also be included into the budget. One should not disregard the importance of hardware like printers, copiers, or facsimile machines (Gallin & Ognibene, 2007, p 344). Although this point is not included into the protocol, these items constitute a considerable part of the budget because without them it would be rather difficult to gather and process statistical data.
In this section, we have tried to summarize those procedures of this research that will give rise to costs. These are the most time-and-resource consuming parts of the study and they need to be included into the budgeting plan. Judging from this discussion, we can argue that the development of a study budget is a significant part of the research itself, because it is supposed to include virtually each step that the scholars are going to take. Moreover, it requires proficiency in accounting, HR management, logistics and other disciplines, which are in no way related with medicine or pharmacology. This is one of the reasons why it presents so many challenges to the researchers. A scholar is usually limited in his/her financial resources, and he or she must always be realistic in his estimations, otherwise the study will not receive any support. To crown it all, the investigator is strictly accountable for every item put on the budget list, and each of the purchasing decisions must be well-grounded. Besides, every bill or receipt must be provided to the organization that invested capital in the research, failure to do so may end in a legal conflict. This evidence eloquently proves the complicated nature of budget development.
Estimation of the resource requirements
Judging from the aforesaid procedures, we can estimate staffing and resource requirements. The team will consist of the following members: the principal investigator, or investigators, who proposed the idea of the study. These people will work according to a regular 8-hour schedule. The second group will comprise research nurses or coordinators, who will be responsible for screening, administration of the drug and assessment of the patient’s health as well as collection of data. At this point we can presume that there will be more than fifty of them, especially if we consider the number of institutions in which the trial will be held. It is most preferable that they will work in day and night shits. The thing is that patients with severe asthma can be admitted to the hospital at any time of the day. This may significantly accelerate the whole process of investigation and the data can be collected within a shorter period of time.
Data manager will occupy an important position in this team; his/her main function will be the collection and analysis of information. This person will process/documents, questionnaires, medical records in order to find regularities among them. Data manager has to bring regular updates to the findings, visualize statistical data and make presentations. Although this individual is directly subordinate to the main investigator, his contribution should not be underestimated because the validity of the study will heavily depend on his accuracy and attentiveness. Most likely, the data manager will work approximately 8 hours per day. But, in his/her case the schedule can be more flexible but the new information can come at irregular intervals. As we have said before, recruiting is an inseparable part of this study. Therefore, it is vital to hire a group of assistants who will be knowledgeable enough in this area of study. Most importantly, these people must be able to convince parents or legal guardians that administration of asthma drug 1 will in no way imperil the life of the child.
Finally, according to worldwide standards, established for clinical trials, the research team must include a person or a group of person, who will be occupied solely with monitoring (Gallin & Ognibene, 2007). He/she is to ensure that every procedure is consistent with ethical and safety norms. It is rather difficult to determine the exact number of such supervisors, because an experienced researcher can monitor more than one clinical trial (Gallin & Ognibene, 2007, p 136). Overall, it seems prudent to employ at least ten such onlookers. But much will depend upon the distance between the hospitals. If they are located in proximity to each other, it will be permissible to hire even fewer supervisors. However, these details have not been provided in the study protocol.
The resource requirements cannot be limited only to the personnel, because the research team will also need some equipment: PCs with appropriate software for data processing, office accessories, paper, scanner and other gadgets that facilitate the collection of data and its dissemination. Consequently, the team has to include at least one person, who will purchase these things. In addition, a research team always closely collaborates with subcontractors, who deliver the drugs to the hospitals, provided that the institution does not possess a sufficient supply of asthmadrug1. So, the cost of delivery should be incorporated into the budgeting plan. In this part of the paper we have attempted to describe the staffing of this team and determine the working hours for each member. Having these data, the researchers may be able to draw up a budget.
The information, required for the development of line budget
This protocol lacks some information, which is of crucial importance for the development of a study budget. Namely, it should tell the total number of research personnel, and identify the role of each participant in the team as well as the salary which he/she expects (Cluster & Powers, 2005, p 201). The model presented in the previous section is purely hypothetical and full version of the protocol is needed. It should be noted that the scholar must justify his/her staffing decisions. In other words, he or she must explain why he or she hired a certain number of assistants or why he allocated the duties in this or that way. This is by far the most vital component of the budgeting plan. This type of information is not easy to find especially on the Internet. So, the scholar, who is not experienced in study budgeting, should examine various books and articles dedicated to this question. But the most prudent decision will be to refer to the administration of the research facility, specializing in clinical trials. These people can share valuable guidelines about personnel management as they have already conducted many clinical trials and solved such problems before.
There is another factor, which must not be neglected by the scholars, when they develop a study budget and it is wage variances. This trial will take place in more than twenty institutions, but it is not specified in the protocol whether these will be public or private organizations. The status of the hospital significantly affects the salaries of the employees and the amount of reimbursement that must be paid to them. Again, we have to emphasize an idea that these data are seldom published on the Web. For this purpose, one should directly contact the administration of the hospital. At the very beginning, we mentioned the so-called opportunity costs or the profits that would be lost due this experiment. This information can be obtained only from hospital administration.
An effective budget cannot be created without the careful examination of subcontractors. Procurement of medicaments is one of the greatest concerns for many healthcare organizations and the ultimate supplier must offer the best price-quality ratio. The information about suppliers can be obtained either via the Internet or by calling them directly. The most optimal solution will be to contact local healthcare departments, which can help to select the best procurement route. The point is that these agencies can derive no benefit from this venture, and their opinion is unbiased. This is the true criterion of reliability. Thus, we can maintain that the creation of the study budget requires in-depth research because the information about suppliers and partners is not readily available.
The development of the financial plan for a clinical research can be regarded as a set of activities that include search for the information about partners, estimation of HR needs and selection of contractors. In this paper, we have tried to identify those activities which give rise to costs. Moreover, we have described the staffing decisions of the manager. To create a financial plan, the scholar must be well-aware of every procedure that will be carried out in the course of the clinical trial otherwise the group may have to incur unexpected expenditures. At this point we can single out several activities that are normally line item budget costs: they are as follows 1) personnel; 2) procurement of equipment; 2) delivery of the products; 3) interactions with IRBs and other public organizations; 4) phone calls, travel and lodgings. These items are normally put on the budget list.
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