The interdependence of time and budget in clinical research trials has far-reaching consequences on the research protocol. Missed or delayed appointments due to lack of patient transportation or reimbursement can not only affect the study schedule but also raise questions about the reliability of the data.
It is critical to have a timely negotiation and agreement on the budget and contract to expedite the selection of clinical research sites, patient recruitment, and staff hiring.
Investigator Budget Considerations for Clinical Trials
To keep clinical research projects on budget and on time, there are no one-size-fits-all recommendations or assumptions. Instead, sponsors, CROs, and lead investigators must work together to create a sound investigator budget, accounting for the reasonable and hidden costs associated with clinical trials.
The budgeting team should include medical staff, regulatory agencies, sponsoring institutions, and outside independent reviewers. The team should also consider costs such as the cost per patient, medical staff training, reimbursement for travel, and startup fees at the site location.
Schedulers must also consider the impact of budgeting on timing, and timing on budget, as well as the acceptable level of compromise on the research protocol. Delays in recruitment and regulatory approvals, conflicts with the clinic or hospital’s schedule, and site accessibility are some factors that can affect scheduling.
To find reasonable and hidden costs the budget team must ask:
- What is the cost per patient? Any budget for a clinical research study begins with basic calculations such as the cost per patient, which is then multiplied by the number of expected enrollees.
- What is the cost for the medical staff? For example, the staff may need training in standard operating procedures, translations of documents, reimbursement for travel to and from the site, and salary increases if the global clinical trial takes years to complete.
- Which budget items will be reimbursed? For example, startup fees at the site location if the clinical research study is unable to continue, and which will not be reimbursed, for example, costs not identified in the budget?
- What effect will the study site have on the budget? Such as the need to provide security, importing and exporting costs for drugs and equipment, and access to specialized equipment (for example, extremely low-temperature refrigeration)? Once the site is set up with that specialized equipment, will it be suitable for future studies by the sponsor?
Scheduling Considerations for Clinical Trials
The sponsor, CRO, and lead investigator must be clear about the impact of budgeting on timing, of timing on budget, and of both on the research protocol, and the acceptable level of compromise.
Schedulers should ask:
- What effect will the protocol have on the time available to recruit patients and staff? Taking into account the frequency of patient visits, documentation, outside and internal reviews, and other tasks.
- Will clinical research staff and investigators need time during the clinical trial to run their regular practice or meet conflicting institutional demands?
- How will scheduling delays be handled, including delays in recruitment and regulatory approvals? Some delays can cause regulatory agencies to shut down a trial before it even starts.
- What effect will the site have upon scheduling? For example, if patients are being seen in a hospital or clinic, the study’s schedule (and access to resources) can be complicated by conflicts with the clinic or hospital’s schedule. If the site is hard to access, patients may need more time between scheduled visits.
Where Confidence Pharmaceutical Research Fits In
Confidence Pharmaceutical Research understands the unique nature of each clinical trial and will use its decades of experience to create a budget and schedule that supports the specific protocol, accounting for local knowledge and expertise.
The use of CROs is expanding in the pharmaceutical industry, and sponsors need to evaluate the CRO based on various factors before choosing the right one for their clinical trials. Clear communication, a defined management style, and an evaluation of CROs based on various factors are crucial for a successful sponsor or CRO relationship. For more information about our methods and capabilities, please contact us today.