Nearly three-quarters of all clinical trials will run one month behind during their startup phase, and in that time, sponsors can lose anywhere from US$600,000 to US$8M in revenue for every day of the delay. Stakeholders are well-aware that the more prompt the startup, the fewer timeline delays and unexpected expenses occur. Although these projects face no shortage of pitfalls, there are many strategies widely available for sponsors to employ. Here are five of the most common challenges biotech companies face during the clinical trial startup phase and what solutions can be used to overcome them.
1. Regulatory Submission Timelines
Before a clinical trial can begin through the drug development pipeline, essential documents must be submitted and approved by the right regulatory bodies. These decisions can take months, depending on the Institutional Review Board (IRB) in question. However, sponsors can apply three key strategies.
- Employ a top-notch team when creating the required documents; the more time spent on the initial submission, the faster it will get through review.
- Don’t hesitate to choose a technology-enabled approach compared to a slower, paper-based one
sin your study. - Become familiarized with variations in IRB requirements across different countries to avoid unexpected regulatory delays down the road.
2. Careful Site Selection
The success of a clinical trial and the resulting revenue for sponsors ultimately comes down to the quality of each site involved. This makes site selection one of the most important phases of a clinical trial startup, one with the potential to sink the entire ship if rushed too quickly. This is where the challenge appears; sponsors must strike a balance between thoroughly vetting sites during qualification, but the process must not be so lengthy that startup timelines are delayed. The clear solution for sponsors is to start reviewing sites as early as possible. During their review, sponsors should consider site characteristics, such as the investigator’s past trial experience, staff workload, and their patient population access. These attributes will have the largest impact on how successful your project is; take the time to choose carefully.
3. Contract and Budget Negotiation
Once a site is selected, the next step is for contract and budget negotiations to take place. This can be a tedious, time-consuming task, especially if the site staff are inexperienced, the budget templates are inadequate, or if the legal review is prolonged. These factors can contribute to study startup delays, but one way for sponsors to circumvent them is by utilizing a contract research organization (CRO) that is experienced in site negotiations. Skilled CROs may have already worked with a site before, which can shorten this stage of the trial by adopting a previously approved contract and budget. This removes extra work from the sponsor’s hands and allows more inexperienced sites to receive guidance from the expertise of third-party negotiators.
4. External Vendor Coordination
Here’s a scenario that is unfortunately not unfamiliar to some sites: they’ve been selected for a clinical trial, the initial regulatory steps have been completed, and they have patients lined up for screening. However, the site cannot begin recruiting because of poor coordination with the study vendors. Whether it’s lab kits, the study drug, or electronic devices, any delays in shipment will inevitably slow site activation and enrollment. In order to minimize these issues, sponsors can ensure clear communication and coordination, gather estimates on their vendors’ product timelines, and begin establishing vendor availability before working their study startup timeline around this information. If the two are not harmonized and sites are initiated too early, potential subjects may have to wait longer for screening, which can increase the chances they will lose interest in participating.
5. Unrealistic Recruitment Planning
Last, but certainly not least, one of the key reasons clinical trials will not succeed is due to patient recruitment delays. Oftentimes, this phase struggles to run on schedule due to unrealistic timelines and misinformed expectations when planning. Therefore, to avoid costly delays on this front, sponsors should ensure they devote resources from the beginning to prevent inevitable recruitment challenges. This starts by properly understanding the target patient population when designing the study and choosing the best-equipped sites accordingly. The recruitment plan itself also must be realistic by using conservative estimates, multi-channel marketing, and enlisting the help of advanced CRO technology.
Conclusion
The complexities of clinical trial startup are unavoidable. From regulatory submissions, through site selection, to active recruitment, there is no shortage of pitfalls for studies to encounter. However, these challenges can be minimized or circumvented entirely by implementing early planning, employing consistent communication, and enlisting the right help. Vial is a forward-thinking CRO with a proven track record of streamlining the startup process for sponsors. Connect with us today to learn more about how Vial can help you get your study off the ground faster.
