Potential investors prioritize the initial budget when planning for a new clinical trial. Budgeting often determines the feasibility of the trial. Although stakeholders try their best to budget appropriately, it is not realistic to achieve 100% accuracy. However, this article highlights 4 tips to help you manage a clinical trial budget effectively.
Set Realistic Budget Estimates
A realistic budget estimate is a critical tenet to effective trial budgeting. However, circumstances may change, and such estimates can be adjusted to get a ‘best-fit model for the trial. Such changes may be attributed to the need to transfer the study to other stakeholders or competition for the limited financial resources/grant. On the other hand, CROs may provide inaccurately and overlay optimistic budget estimates to win a potential study.
The overall trial budget may increase unexpectedly due to a disparity between the reality and the initial estimate, an issue attributed to a misunderstanding of roles. It is the role of a good CRO to provide realistic budget estimates based on an accurate and transparent budget grid.
Invest in a Credible Feasibility Research
A realistic budget for a clinical trial hinges on a quality site feasibility study, involving assessment of countries and study sites. Because high-profile sites are not necessarily the best in recruiting subjects, site selection becomes challenging, especially integrating the interest of the marketing department. Consequently, sites and countries with low enrolment rates should be compensated by those with high enrollment rates in critical sites.
There is a need to consider factors that impact the study budget during the site and country selection process, including site establishment and maintenance costs, research grants, patient’s compensation, and CRA travel, local suppliers. Other factors include the cost of non-IMP/specialized equipment, costs of logistics, and import/export permits, and CA/IRB/IEC applications.
There is a need to put emphasis only on the necessary sites to lower the trial costs. Though, stakeholders should review high-quality feasibility data to validate the final list of countries and study sites. Thus, you should prioritize quality assessment to pinpoint potential risks. Such a strategy is essential in controlling the trial budget.
Ensure Seamless Communication
Seamless and transparent communication from the onset of a clinical trial process is vital to its success. A team of experts can help you plan and navigate the trial effortlessly, particularly when they are available from the beginning of the trial. Also, you can control your trial budget by following recommendations provided by the CRO. Although clinical trials are not devoid of challenges, a good CRO will advise you appropriately and help you mitigate the potential risks.
This is one of the clinical trial feasibility services offered by Dokumeds. With more than 25 years in the industry, they have perfected the art of helping pharma companies in selecting and evaluating sites and investigators to ensure clinical trial’s success.
Minimize Unexpected Delays
Unexpected occurrences, including delays and accidents, are inevitable even with the best study plan. The likelihood of such occurrences increases with the duration of the project. Delays often emanate from such inevitable occurrences as witnessed during the COVID-19 pandemic. Nonetheless, effective communication and decision-making are key to mitigating such delays. A sound relationship between the CRO and the client is the cornerstone to addressing such delays and ensuring the success of the clinical trial.
Key Takeaway: Know Your Region and Your Partners
It is better to have an accurate budget than an attractive one. Your partners play a critical role in helping you budget appropriately from the planning stage. An experienced CRO who understands the site will help you plan and budget effectively. Learn more about keeping your clinical trials under budget by contacting Dokumeds’ specialist team today.