Clinical trials are key to developing new drugs, medical devices, and therapies, but many never even make it off the ground. Consider the fact that 90% of new drug candidates fail and 80% of clinical trials are unable to recruit enough patients.
There’s no way to prevent obstacles entirely, but knowing the industry and doing your research can go a long way. Below, we look at 5 common clinical trial challenges and explain how partnering with a Functional Service Provider (FSP) can help solve them.
1) Increased trial complexity
A clinical trial isn’t a monolith. It has multiple dimensions, including protocol design elements, patient recruitment strategies and data collection requirements.
Making things even more challenging is the pressure to design trials that both stay on budget and attract potential patients. With so many different areas to focus on, many sponsors end up stretching themselves too thin or burning out.
2) Managing Multiple Trial Sites
Over the last decade, many biopharmas have begun conducting trials across multiple sites. While more sites make it easier to recruit diverse patients, it increases the number of vendors and steps involved.
It’s crucial to coordinate communication and record-collection efforts between trial sites. Doing so can reduce headaches, keep data consistent, and ensure compliance with regulatory authorities.
3) Difficulty recruiting patients
As we previously mentioned, 80% of clinical trials never even being, because sponsors encounter issues with patient recruitment. There are various reasons for this, including:
- Poor patient recruitment strategy
- Strict eligibility criteria
- Competing clinical trials
- Lack of information
To address these and other similar issues, many sponsors now emphasize the benefits of participation and offer monetary or similar compensation. Moreover, an FSP can help you develop an effective plan for patient enlistment and retention.
4) Rising costs
Clinical trials have a median cost of $19 million, with some studies costing upwards of $90 million. As research becomes more complex and decentralized, those expenses will only continue to rise.
Designing a strict budget and monitoring your financial resources throughout each and every phase of the trial can prevent surprises later on.
5) Coordinating with Vendors
Many sponsors rely on more than one vendor to carry out their trial protocols. Regardless of a trial’s scope, it’s vital to establish expectations with your vendors right away. Clinical Trials Arena recommends:
- Communicating clear standards
- Setting firm timelines
- Telling your vendors what you need upfront
- Being flexible
That last point is particularly important. Sometimes, the unexpected happens. If you’re flexible and ready for anything, it’s easier to adapt.
How A Functional Service Provider (FSP) Can Help
Clinical trials are more complex and expensive than ever before. Unfortunately, these challenges often result in wasted time or poor data quality.
Why take the risk when you can partner with a Functional Service Provider (FSP)? At Harbor Clinical, our focus is on compliance and GxP Auditing, but we offer a full suite of services, including:
- Clinical operations
- Regulatory affairs
- Strategic development
- Biometrics
Our commitment to integrity and slow but steady growth has helped us build an excellent reputation within the industry.
Because no two trials are exactly the same, we never take a one-size-fits-all approach. To learn more or to set up a meeting, call (781) 775-0342 or fill out an online contact form.
