Clinical Trials: Risky Business

In the world of startups, entrepreneurs take risks daily. Taking a leap and starting your own business is one of the most daunting tasks anyone could ever do. But when does the risk outweigh the reward? And more importantly, what steps should you be taking to mitigate risk or avoid risk altogether?

Clinical trials are a delicate, tedious, and lengthy process that can be derailed at any given moment for any number of reasons. For example, some companies assume their study will enroll faster than previous studies because they have an exciting, innovative product. Others might not be strategic enough when it comes to selecting their patient population, objectives, or endpoints. Ultimately, clinical trials involve people from patients to health care works to study team members, and people are often unpredictable. Addressing known risks in your study upfront and being prepared to address new risks as they arise, can help set your trial up for success. At Proxima Clinical Research, our clinical project managers have the experience needed and are here to help you foresee the potential risks in your study to avoid them as well as help you address them when they do arise. Below are just a few common examples of risk mitigation that can help you streamline your upcoming clinical trial.

 

Product Considerations      

Product Availability: Beginning a trial when your investigational product is not available, can cause delays in subject enrollment by months at a time. This may create a chain reaction of delays requiring additional in site training, timeline adjustments, and other costs. Make sure that your product has been cleared for clinical trials and enough supply is available before opening the trial to enrollment.

Product Training: Inadequate product training can cause subjects to be treated incorrectly, therefore, making your data null and void. This will then prompt you to add additional subjects, requiring a protocol amendment as well as extra time and budget to complete enrollment. Having all users of your product correctly trained before the trial start date will help offset this potential risk. This is especially true with a device and digital product but cannot be overlooked with drug and biologic products either. 

 

Subject Enrollment

Delayed Enrollment: Delaying your enrollment process, even at just one site, can cause a delay for your entire trial. Negotiations are one of the biggest causes of delayed enrollment. By knowing your site's start up process and streamlining negotiations, you can eliminate the possibility of derailing your start time.

Slow Enrollment: No one ever wants to over-promise and then under-deliver, but over-commitment is one of the most common issues with enrollment. On one particular study, a Sponsor relied too heavily on their most significant key opinion leader to get one-third of their subjects, which fell flat. This resulted in having to add four more sites to contribute to enrollment, causing a seven-month delay. You can avoid this by setting realistic expectations with your sites and making sure you keep enrollment competitive. Key opinion leaders (KOLs) are great and extremely helpful, but make sure you're not relying on them too heavily, especially if they are KOLs for multiple companies or have a lot of other obligations.

Rapid Enrollment: Lastly, make sure your study team and sites have the resources and flexibility need to manage enrolling subjects quicker than planned. This can be a fantastic problem to have, but make sure your sites and team are agile enough to pivot with the needs of the subjects and study to handle clinical monitoring and data management to ensure site compliance and manage data cleaning activities properly.

Have questions regarding your upcoming clinical trial? Check out our areas of expertise to see if we can be of service to you!

The clinical trial process can seem overwhelming, but companies like Proxima are here to take the stress off of you and your team by handling the coordinating and project management headaches for you. Delayed timelines and cutting corners make neither you, your KOLs, nor investors happy. By taking steps early on to avoid the risks mentioned above, and the many others not said, you can keep your product on track and make your stakeholders proud.

Read More >>