The overall cost of clinical trials is rising due to several factors, including escalating trial complexities and increased travel expenses for conferences, instructional material, and oversight. While some of these considerations are fixed, costs can be managed by concentrating on parameters over which the financiers and research platforms have much control.
A large portion of that attention should be placed on factors that can result in errors, which can significantly lengthen the time needed to finish a clinical trial, necessitate repeating work, and require remedial steps, such as staff additional training, which also raises expenses.
Errors can significantly increase the cost of a clinical trial by necessitating additional labor when the errors are severe enough to jeopardize the reliability of the data collected. However, there are easy tips clinical researchers can do to avoid medication errors. The objective is to concentrate on the phases of clinical trial planning and execution with a tremendous potential to influence significant cost-increase determinants.
- Implement Decision-Support Technologies
Decision-support resources can be designed in tandem with a computation-based training course to give investigators references to use once a clinical trial is started. Devices to assist research supervisors and analysts in patient screening, for instance, might incorporate inclusion and exclusion parameters; the availability of essential lists of this type may serve to reawaken the muscle memory produced through simulations incorporated into training.
Checklists and graphics could also support intriguing or challenging procedures for a particular protocol. Staff members could use brief animations in electronic decision-support resources to reaffirm the proper approach to complete operations.
For example, new technology has helped them shift from traditional paper case report forms (CRFs) to more efficient and safe ways of assessing clinical products. While most organizations have tried embracing this evolution, there are tips overcoming CRF form issues.
Checklists, diagrams, and flashcards are examples of hard-copy tools for supporting decisions. Electronic decision support tools can be obtained via a mobile device or the facility’s computer infrastructure.
- Utilize All Available Resources
Marketing and publicity are crucial if you want your clinical study to be successful. Sponsors can, however, stay within their budgets by cultivating and upholding connections with nonprofit organizations that can assist in reaching a wider audience. Local collaborators in a specified area, such as healthcare facilities, charitable organizations, or advocacy groups, are precious since they frequently have proximity to people who fulfill the demographic being studied for a research project.
Sponsors can increase their confidence that the information being distributed will reach the patient category they seek by adding more cost-effective options to their advertising campaign.
- Leverage Technology To Streamline Trial Operations
The sponsors and research institutions agree that it can be challenging to manage a clinical trial. Thus, if you are unprepared, this is an additional component that could result in unexpected costs. Sponsors may reduce costs by encouraging greater use of automation in their data gathering and maintenance processes.
Validation of data sources can cost as much as 25% of a research’s budget, but enabling participants’ or institutions’ staff members to enter the data directly into the research system can significantly reduce that cost. This tactic reduces sponsor labor expenses for comparing transcribed case data with original information, as is frequently found in decentralized clinical trials.
- Develop Clear Written Protocols
Pay close attention to the procedure to ensure it is stated understandably and straightforwardly. Experts have identified the ever-growing complexity of clinical trials as one of the leading causes of protocol violations or errors. A more significant number of endpoints and unique procedures that deviate from the standard of care can make a protocol more error-prone. It can be ensured that protocols are written in a form understandable to all employees by involving the staff early in the protocol development process.
When creating a protocol, it’s also essential to consider facility resources and expertise. Not all research facilities will have access to the same materials and equipment or equivalent knowledge.
For example, integrating genetic testing into the trial may require specialized equipment and trained personnel. To ensure smooth operations, sponsors should collaborate with facilities that have experience in handling genetic testing or provide adequate resources and training for the staff.
- Provide Comprehensive Training for Consistency
The following step is to provide extensive, efficient training to guarantee that every staff member thoroughly comprehends how to do their duties following the procedure. This can be difficult to accomplish with a conventional lecture- or slide-based training course.
For instance, a mismatch between the protocol and the patients can result from improper application of any criteria during the screening process. The final effect of this will probably be the time and money spent gathering information that cannot be included in an application to authorize a new product. This enables sponsors to swiftly and effortlessly identify underperforming facilities and people while also focusing on any vulnerabilities. Before a prospective individual enrolls in a trial, this allows more specialized guidance and assistance, which helps to prevent mistakes and related costs.
Conclusion
One of the main things that increase the length and cost of a clinical trial is errors and procedural violations. Like many other issues, proactively spotting and fixing possible faults is more efficient and cost-effective than waiting for a mistake.
Sponsors can help ensure they deal with possible errors upfront and decrease the probability of deviations. Doing this will boost the time and money required to complete their clinical trials by prioritizing composing a specific and understandable protocol and offering practical training and
