Many stakeholders + different costs = complex clinical trial (Part 2)
In part 1 of the article, we presented the top cost drivers of clinical trial expenditures across study phases and the largest barriers to conducting clinical research. In this article, we’ll focus on a special aspect of the process – the clinical trial payments to patients and the role of the CTMS in managing the budget and financial flows.
Clinical trial payments to patients
Clinical trial payments are not something unusual, although there are some trials that do not envisage such costs. If provided they could vary from $50-300 per day or visit, depending on numerous factors, as Clinicaltrialsarena.com states. Here could be mentioned: the length of the time required, the procedures performed, the number of in-person or phone visits required, the necessity of symptom tracking, the patient burden, the condition being studied, and the phase of the study, as earlier phase studies typically involve more risks, say the experts from Meridian Clinical Research. It could be perceived as compensation for the time and efforts of the participants in the trial, or even be used as a motivation for enrolment, although there are some voices that oppose this trend.
Reimbursement expenses usually are incurred as a result of participation in a clinical trial. The amount and the conditions of the payment are documented before the start of the trial. They could include travel, meal and accommodation expenses, and compensation for loss of income.
Payment Compensations for participants
Here are included the monetary benefits the participants received. As already mentioned, they could vary and depend strongly on the sponsor. In the USA, for example, the National Institutes of Health have a standard tariff for participation. In Europe, the situation is a little bit different. “The legislation and practice regarding compensation in Europe vary widely. Some countries exclude compensation entirely, but the most common practice requires that any compensation is reviewed and approved by the respective Ethics Committee”, as explained on the Toolbox Eupati website. All the legal requirements are described in the EU Clinical Trial Directive (2001/20/EC) and the Regulation (536/214). According to the legal framework, no incentives or financial inducements are given to incapacitated participants or minors, or to pregnant women, except for compensation for expenses and loss of earnings directly related to participation in the clinical trial.
Compensations for harm
The compensation for harm resembles obligatory insurance, covering the risks incurred during the trial. According to the regulation, clinical trials do not always pose additional risks to the participants over normal clinical treatment. In such cases, no specific damage compensation will be required.
Clinicubes and the proper budget management
The proper management of the expenditure and revenue allocations is a must for every clinical trial site and could be done by our clinical trial management system – Clinicubes.
Clinicubes CTMS allows precise automated reporting of the clinical trial budget. The system covers all these different types of payments. It provides detailed information like budget allocation for each visit divided by different procedures. As a result, financial tracking is much easier for everyone, involved in the process – from the clinical staff members to the hospital CFO. The system also gives detailed information about the invoices that have already been issued or need to be issued. Moreover, Clinicubes CTMS automatically creates payment-tracking records when subject visits are marked as completed.
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