A comprehensive review of various clinical trial data showed that the probability of success for a therapy to go from Phase I testing to approval by the Food and Drug Administration was only 13.8%. With the increasing complexity of clinical trial management tools and processes, there is no shortage of pitfalls biotech sponsors must steer clear of to ensure the success of their study. Read on to discover the top 5 mistakes sponsors make when planning a clinical trial and how you can avoid them.
Mistake #1: Inadequate Recruitment Plans
Ineffective recruitment and retention plans for patient enrollment are some of the pervasive underlying causes of clinical trials failing to meet their endpoints. These challenges are especially prevalent when sponsors fail to design their study so that common pain points, such as time-consuming visits or a lack of information, are adequately addressed. Biotech companies can avoid these pitfalls by taking a diversified approach to recruitment. Enrollment delays can be minimized proactively using numerous strategies, from using various marketing materials to utilizing local providers and support groups to share information. Providing simplified study materials and options for remote visits can also improve subject retention rates over time. Furthermore, working with a trusted partner such as a contract research organization (CRO) can alleviate the stress and hassle of recruitment. Many CROs will have resources that sites may not have to recruit efficiently.
Mistake #2: Improper Site Selection
Site selection is a phase of the clinical trial start-up that needs adequate time to establish a successful sponsor-site partnership. If site selection is rushed, it could lead to unfavorable results. The quality and success of a study ultimately relies on its enrolled patients, and site staff are primarily responsible for bringing in the right ones. Therefore, sponsors can avoid choosing sites that are not the right fit for their trial by starting early enough that they can thoroughly vet each potential location. If using a CRO for trial management, many CROs will have vetted site networks that can provide sponsors with appropriate options.
From assessing staff capabilities and principal investigator expertise to recognizing facility or patient population limitations, there are many considerations to be made during this selection phase. Sponsors must also ensure that they are not swayed solely by the prestige of sites. The PI’s affiliations provide no guarantee that their site will be adequately aligned with a sponsor’s study goals in terms of relevant experience, effective data collection, or the inclusion of appropriate participants. All in all, a simple step to avoiding this common mistake is conducting thorough research when selecting a site for your trial.
Mistake #3: Unrealistic Timelines
Timeline estimates are essential for creating a clearer picture of how costly an upcoming clinical trial may be for sponsors. Establishing unattainable timelines can quickly become an expensive mistake for sponsors when common obstacles appear, and their team has no backup strategies to fall back on. Avoid this pitfall by taking advantage of knowledge from experienced CROs, site staff members, and previous clinical trials to learn how to adjust your project to accommodate common challenges conservatively. As paradoxical as it may be, the more time that is devoted upfront to planning each Phase of a clinical study, the quicker and more smoothly it progresses later on.
Mistake #4: Failing to Stay Current
Standard methods of information dissemination used in the past are slowly becoming obsolete as potential patients are replacing radios with music streaming services and forgoing newspaper advertisements for those found online. The clinical trial technologies sponsors have available to them today are significantly more advanced than what existed ten years ago. Therefore, to avoid the mistake of falling behind more tech-innovative companies, sponsors can upgrade their clinical trials by launching social media marketing campaigns, forgoing paper-based methods for electronic clinical trial management systems, and streamlining screening processes with the use of highly trained central call centers to review eligibility criteria. Furthermore, when selecting a CRO, ensure they use modern technology such as eSource, EDC, and ePRO.
Mistake #5: Not Asking for Help
Starting up and running a successful clinical trial is no small feat. Of all the pitfalls listed here that sponsors must become aware of, the most critical mistake is not recognizing when to ask for help. Clinical research is entirely team-based. Sponsors set themselves up for the best chance of success when they incorporate the innovative resources of contract research organizations (CROs) like Vial CRO and take advantage of valuable networks of local healthcare providers or recruitment organizations.
Conclusion
The difficulties of clinical trial management are unavoidable, but sponsors have a valuable trove of information to draw from when preparing their studies against these five common pitfalls. By starting startup processes early, sponsors have more time to incorporate patient-centric approaches, develop informative study materials, and establish partnerships with third-party organizations to deliver the most current and innovative study tools. Vial is a next-generation, tech-enabled CRO with a proven track record of streamlining the trial management process for sponsors. Connect with us today to learn more about how we can help your study circumvent the most common clinical trial mistakes.
