During the startup phase, around 75% of clinical trials are expected to face a one-month delay. This postponement can lead to losses ranging from US$600,000 to US$8M per day for sponsors. Stakeholders know that starting promptly reduces timeline delays and unforeseen expenses. Despite potential obstacles, there exist several strategies within reach of companies in the biotech industry. To tackle five common hurdles encountered during clinical trial initiations, we offer some solutions below.
Timelines for Regulatory Submissions
Essential documents must be submitted and approved by the appropriate regulatory bodies before commencing a clinical trial in the drug development pipeline. The length of time it takes for these decisions to be made is dependent on the specific Institutional Review Board (IRB). Yet, sponsors have three key strategies they can utilize to expedite this process.
Hire an exceptional team to produce the requisite documents; investing more time in the initial submission expedites its review process.
In your study, consider opting for a technology-based approach rather than slower paper-based methods without any hesitation.
To prevent unforeseen regulatory delays in the future, acquaint yourself with the differing IRB prerequisites of various nations.
Strategic Site Selection: A Crucial Factor in Clinical Trial Success
The ultimate revenue and success of a clinical trial hinge upon the quality of each site involved. As such, expert selection is paramount in ensuring that this phase does not lead to delays or setbacks. Finding the right balance requires sponsors to closely examine multiple sites during qualification while maintaining an acceptable timeline for startup.
To achieve optimal results, sponsors should begin reviewing potential sites as early as possible and weigh important considerations like investigator experience with past trials, staff workload capacity, patient access availability among other determinants affecting project outcomes before making any selection decisions. It’s advisable they devote ample time screening all options available since these attributes dictate how successful their study can be – choose wisely!
Negotiation of Contract and Budget
After selecting a site, the next crucial step involves engaging in contract and budget negotiations. However, this can prove to be an arduous and time-consuming process particularly if there are inexperienced staff or insufficient templates for budgets or legal reviews that take longer than expected.
These issues may lead to delays in starting the study, but sponsors can overcome them by partnering with highly skilled Contract Research Organizations (CROs) experienced in negotiating with sites. CROs who have previously worked with particular sites will also help streamline this stage of the trial since they already possess approved contracts and budgets which saves on additional work from sponsors allowing less seasoned teams receive professional guidance from third-party negotiators.
Coordination in Optimizing Site Activation
It is unfortunately common for some sites to find themselves in a situation where they have been selected for a clinical trial, completed the necessary regulatory steps and lined up patients for screenings but still cannot begin recruiting due to poor coordination with study vendors. Delays in receiving items such as lab kits, electronic devices or the study drug can significantly slow down site activation and enrollment.
To prevent these delays from occurring, sponsors need to ensure effective communication with their vendors while also collecting estimates on product timelines. This will allow them to establish vendor availability before planning out their entire startup timeline. Failing this could lead to initiating sites too early which would mean potential subjects having an increased wait time resulting potentially losing interest in participating altogether.
Overcoming Patient Recruitment Challenges
One of the primary factors causing clinical trial failures is delayed patient recruitment. This phase often encounters difficulties in sticking to predetermined schedules because of impractical timelines and misguided planning assumptions. To avert pricey delays at this stage, sponsors need to invest resources upfront in anticipation of inevitable recruitment hurdles.
The starting point should be an accurate comprehension of the target patient demographic when designing study protocols and selecting suitable sites with adequate resources. Additionally, realistic enrollment plans incorporating conservative forecasts based on multi-channel marketing techniques accompanied by innovative CRO technology are vital for success.
Concluded remarks
It is inevitable that clinical trial startup will present a range of intricacies. Between regulatory submissions, site selection and active recruitment, potential complications are plentiful for studies to contend with. Nevertheless, taking early planning measures, encouraging constant communication, and obtaining suitable assistance can significantly reduce or eliminate such challenges altogether.
As an innovative CRO renowned for simplifying the startup process on behalf of sponsors, Eclevar Medtech welcomes you to connect with us today about how we may expedite your study’s launch.
