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Or do you work at a sponsor or CRO where you feel sites are making up study budget numbers or are never happy with any budget proposal? For the purpose of this article, a study budget is defined as the total compensation a sponsor or CRO offers to a site for each enrolled patient.
In other words, a study budget is the per-patient grant amount for all protocol-required study visits and procedures.
Understanding how study budgets are created is the foundation of any study budget negotiation. It will give you perspective on what to expect and how to effectively proceed with your negotiations.
Think of this as homework before you take the actual exam. Study Design Can Affect The Per-Patient Study Budget Generally speaking, sponsors will allocate a higher per-patient grant amount for new product approval studies and indication expansions because new products and broader label indications create an opportunity for the sponsor to generate more revenue, assuming the product receives regulatory approval and is then sold commercially.
On the other hand, Negoitiated study studies that are a regulatory requirement for new product or indication approval are funded less adequately. Such studies are generally an additional expense or overhead for the sponsor.
This may be a no-brainer, but there is no point in getting upset with the messenger for not creating a reasonable budget proposal. Senior leadership is responsible for reviewing and approving the average per-patient amount. The reason for this is simple: The cost to enroll patients in a study is approximately one-third the total cost of clinical study.
When study budget parameters are created, i. Furthermore, if any treatments or visits in the protocol are reimbursed by public or private insurance, the sponsor will not want the site to double dip and get paid twice, which would be illegal.
After the sponsor company works out the financial numbers, the total budget available to conduct a clinical study may actually be quite limited.
In such cases, the clinical study team needs to come up with a creative clinical study design, including lowering the amount that gets paid to sites. For most studies, the three biggest costs are site costs, which include the per-patient grant, labor costs, and clinical vendor costs.
This should provide insight on how and where financial resources are spread for a given clinical study. The truth is that FMV is more than a buzzword.
If you think about it, sponsors are selling their medical products to the same physicians or institutions that may also be participating in a clinical study.
If a sponsor is paying a site more money than it can justify for a given clinical study, the sponsor may be inviting some legal trouble. Nobody wants to be in the news for overcompensating sites for a clinical study.
Lastly, there are strict regulations and compliance policies that impact FMV. Most of these strategies are relevant to sites looking to increase their study budget and sponsors or CRO personnel trying to control and manage clinical trial costs.
Then determine the amount of time it will take to complete each of these fields and then multiply the total time by an hourly rate for a research coordinator.
The secret here is be objective about your numbers. It will help your negotiations go much more smoothly and get you closer to your dream budget. Now why not go all in and enroll patients? The first step to successful enrollment is an enrollment plan.
An enrollment plan will allow you to negotiate a higher per-patient grant amount. Even a one-page plan can be your competitive advantage. Very few sites, if any, are actually investing the time to create such a study and a site-specific enrollment plan.Best-In-Class Negotiation Case Studies (Best Alternative To a Negotiated Agreement) Handle uncomfortable topics or tasks in creative, tactful ways that are sensitive to the parties’ relationship; A factual case study based on the disputed Ukrainian presidential election.
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