Clinical trial budgets are hard to tabulate precisely. Contingencies often occur with trials, ranging from unforeseen expenses to patient-related delays to mounting site management costs. Even when expectations and objectives for a trial are clearly defined, the possibility of scope creep causes potential budget headaches, dissuading participation and putting trial execution in jeopardy.
Clinical trial budgets require more robustness and inventiveness than ever, considering the increasing average costs of new drugs and extensive setup times thanks to the increased emergence of multinational trials. Especially in 2022, when trials are harder to execute than ever because of all-time high costs, budget optimization should be a greater priority for researchers. All involved in trials should expect delays and prepare for the financial impact those delays will have. Here are five useful ways to maximize your clinical trial budget.
Make the Budget Realistic
Too often, scientists undervalue clinical trial costs and don’t prepare enough for the unforeseen circumstances that arise during planning and execution. A decrease in global averages regarding the year-over-year enrolment of patients in recent years means that more flexibility is needed to accommodate unexpected expenses.
Putting large contingencies in place to accommodate issues and variables negatively impacting trials will ensure greater planning and execution. Among these issues and variables are:
- Protocol amendments
- Recruitment problems
- Issues with outsourced vendor management
- Inflation
Paying for Clinical Research Associates (CRAs)
Clinical research associate shortages are profound worldwide, triggering increased demands and wages. Advertisements for CRA roles are in earnest. But, those in charge of clinical trials must be prepared to invest significant resources, with a long-term approach to attract the right staff and strong retention strategies to keep them.
Though trials are paying higher wages for CRAs, those costs are offset by reduced delays and costs cut with more efficient processes. The relationship between CRAs and trial sites is vital to the clinical trial process, with the proper CRAs keeping staff engaged and meeting goals set by clinical research organizations and sponsors. Investing in CRAs now allows for more maximization of clinical trial budgets over an extended period.
Improving Site Identification
With more clinical trial types available, including decentralized virtual clinical trials and hybrid trials, the smart move is to have clinical trial agreements (CTAs) in place, especially as there is increased competition for site locations. As a result, identifying and negotiating sites can be arduous and potentially harm the trial process. With solid CTAs established in tow, it’s easier to approach sites, saving precious funds and improving management efficiency.
However, for the CTA to have any relevance or validity, improved site identification is a must during the trial process. Initiating clinical trial sites costs tens of thousands of dollars, with extensive maintenance costs accompanying the initiation. Additionally, several multi-center trial sites don’t get activated, largely because of costs. Within a clinical research organization, it’s vital to share information within a practice about the most effective sites to help with identifying the best sites to conduct trials.
Having a Proper Data Management System
A clinical trial data management system gives trial researchers control over various data points, improving the conducting of trials. These management systems are crucial to clinical trials because they generate the appropriate clinical research outcomes, as well as compliant submissions. The increase in volume and complexities of clinical trials within the marketplace demand an increased focus on ensuring high data quality.
Additionally, with regulatory bodies like the Food and Drug Administration (FDA) imposing strict regulations to maximize data quality and more modernized technology available, there is no excuse not to have a strong data management setup. Electronic data storage through clinical data management systems eradicate old spreadsheet-based systems and ensure all data meets the latest standards.
Additionally, data management systems improve data verification processes and fast-track a drug’s transition into the marketplace following submission. These systems ensure efficient data entry and transmission processes, ensuring they are controlled and audited, leading to a more standardized data repository.
Plus, clinical data management systems enhance patient experiences, allowing them to share information easily and remotely.
Prioritizing Patient Engagement
Patient engagement is critical to the success or failure of a clinical trial. The advent of decentralized trials and providing more clarity with data are ways that the industry has been trying to improve patient participation in trials.
Investing in more viable communication methods wins trust from patients and obtains the level of informed consent you need to garner patient participation. It’s vital to keep patients engaged as the trial progression, improving retention and reducing attrition rates, reducing recruitment costs. It also helps to get more social, finding more creative ways to discuss trials with patients, including creative (and targeted) advertising, social media, and paid search, extending recruitment reach, and making patients feel comfortable.
Maximizing a clinical trial budget requires modern approaches, more attention to detail, optimizing data, and improving site identification to keep costs down.
