Why clinical trials fail: Common pitfalls and how to avoid them

Key reasons clinical trials fail

1. Insufficient preclinical data

Incomplete or inadequate preclinical studies can derail clinical trials before they even begin. Without robust data on safety, toxicity, and pharmacokinetics, unexpected challenges may emerge during later phases.

• Impact: Trials may need to be paused or terminated due to unforeseen safety risks.
• Prevention: Conduct thorough preclinical testing to establish a strong foundation for clinical success.

2. Flawed study design

A poorly designed trial can fail to yield meaningful results. Common issues include selecting unsuitable patient cohorts, insufficient dose optimization, and endpoints that do not adequately assess the drug’s efficacy.

• Impact: Non-significant results or safety concerns that could result in trial discontinuation.
• Prevention: Collaborate with experienced researchers to design robust trials and conduct pilot studies to refine the approach.

3. The role of packaging: ensuring stability and accuracy

Choosing the right primary packaging is often overlooked, yet it is vital to trial success. Packaging that is incompatible with the drug can lead to chemical interactions that can cause pH shifts or contamination by particle creation, compromising both stability and results.

Key risks include:

• Leachables: Elements from the container’s material can lead to pH shifts and destabilize sensitive drugs such as proteins.
• Delamination: Glass flakes detaching from the container’s inner surface can cause significant safety issues.
• Adsorption: Adhesion of proteins to the glass surface can result in conformational changes, denaturation, aggregation, and loss of biological activity.

Prevention: Choose pre-tested, high-quality packaging solutions that ensure compatibility and stability. This minimizes the risk of errors during critical development phases.

4. Data integrity challenges

Inconsistent or incomplete data can undermine the validity of a trial. Poor data collection methods, missing points, and lack of standardization are frequent sources.

• Impact: Trials may be deemed unreliable or invalid, leading to additional costs and delays.
• Prevention: Implement robust data management systems and train teams to ensure accuracy and consistency throughout the trial.

EVERIC® pure: A packaging solution that reduces risk and accelerates development

EVERIC® pure by SCHOTT Pharma offers unmatched vial excellence. It provides a reliable foundation for successful clinical trials. Its pure borosilicate glass composition and advanced production processes address a number of key challenges in drug stability and compatibility, leading to:

• Minimized risks: Exceptional resistance to delamination and ultra-low leachable levels protect the drug’s integrity.
• Accelerated timelines: Pre-tested compatibility broadens formulation options and reduces delays caused by reformulations.
• Seamless integration: Standardized dimensions ensure smooth fill-and-finish operations.

By choosing EVERIC® pure from the outset, pharmaceutical companies can streamline drug development and focus on delivering safe and effective treatments. With unmatched excellence, EVERIC® pure is designed to provide peace of mind.

Learn more about EVERIC® pure.

SCHOTT Pharma’s PartnerLab: Pharmaceutical testing for regulatory submission

SCHOTT Pharma’s PartnerLab provides extensive analytical testing services to meet the stringent requirements of drug product packaging and interaction testing during clinical trials. It enhances the testing process, accelerates market submission, and ensures the quality and safety of drug products.

SCHOTT Pharma’s accredited, FDA-registered state-of-the-art laboratory is staffed by highly experienced professionals who simplify and streamline this critical process. By entrusting PartnerLab with the complexities of testing and compliance, the core strengths of pharmaceutical companies can be prioritized, with the assurance that performance testing is expertly managed. Learn more about PartnerLab.

Conclusion

The failure of clinical trials often stems from preventable issues such as flawed design, insufficient data, or poor packaging choices. By proactively addressing these challenges, pharmaceutical companies can significantly reduce risks, save time, and increase the likelihood of a successful market launch.

High-quality packaging solutions such as EVERIC® pure provide a foundation for stability, safety, and efficiency throughout the trial process. Sensitive drugs such as large molecules and lyophilized applications may require more specific solutions, where inner coatings could be applied. Comprehensive analytical testing services such as SCHOTT Pharma’s PartnerLab ensure compliance with the stringent requirements of drug product packaging and interaction testing during clinical trials to streamline the drug submission preparation process.