When promising drug candidates are identified for further investigation in clinical trials, sponsor companies are usually optimistic about outcomes.
But there are times, when after years of sunk effort and resources, clinical trials fail to bring a viable drug to market. Frequently, a drug fails for safety or efficacy reasons that are beyond a sponsor’s control. However, to some degree, sponsors can control:
- The speed with which they identify which drugs are viable vs not, and –
- Of those viable drugs, the speed with which they are developed
When drug development moves slower than expected, this isn’t just disappointing for sponsors, but also has costly implications for future trials, current resources, and competitive advantages.
High costs and lengthy study timelines are some of the major obstacles impeding clinical trial conduct in the United States:
- It costs between $314 million and $2.8 billion to bring a new drug to market
- It takes an average of 7.5 years from the start of clinical testing to marketing a new product
- Longer studies are needed to assess safety if the drug is to be taken long-term to manage chronic disease. This leads to longer timelines that increase costs and decrease revenue.
- Patient recruitment requires a substantial investment of time and money. Failure to recruit can also cause costly delays or trial cancellation – wasting resources.
Successfully completing clinical trials in less time (while maintaining high quality) is important for not just individual sponsors, but also for promoting innovation in the pharma space.
But improving efficiencies in the clinical trial process requires a comprehensive review of current standard practices.
Better, faster clinical trials start with efficient clinical operations
Many processes that drive clinical trial speed fall within the clinical operations function. There is therefore, an urgency to improve them. The clinical operations function tends to be labor and resource intensive and also inefficient. This leads to slow trial conduct and prolonged timelines.
Improvements that sponsors have recently identified as requiring serious intervention:
- Reducing protocol amendments
- Spending less time verifying source data
- Use of newer, more specialized technologies
- Efficient startup processes: site identification, selection, and activation
After all, a site’s start-up process lasts 5-6 months on average, and can even last up to one year!
Interestingly, it’s been found that CROs are likely to initiate study startups 6-11 weeks faster than sponsor companies. This is likely due to the unstandardized strategies and technologies that sponsor companies tend to use.
How clinical operations technology can unleash trial speed
Expediting clinical trial startup and conduct at sponsor companies requires the clinical trial function to evolve. Clinical operations teams must be less burdened and be able to more smoothly execute their workflows to meet and even exceed study milestones, particularly:
- Milestones that drive clinical trial speed, e.g. site activation and patient recruitment
- Milestones that support go/no-go decisions, e.g. interim analyses
This can be accomplished by using technology to centralize actionable study data and streamline processes. Many trial stakeholders agree that having a cloud-based database that’s accessible to the entire study team is a good place to start. However, in order to really change the status quo, the platform must:
- Be designed around the end user’s workflows and needs
- An intuitive interface that all trial stakeholders can understand (with minimal to no training)
- Access for all stakeholders within the scope of their responsibilities and that inserts itself seamlessly into their existing workflows
- Allow data entry, import, retrieval, validation, and visualization for complete trial oversight
- Allow users to easily identify and correct emerging risks, trends, and missing information that can affect timeline milestones
- This is especially important in large, complex trials such as those in oncology, where multiple data sources/vendors are used, many global sites are used, numerous processes/documents/timelines are tracked, and where incomplete information can lead to poor decisions that upend the overall study timeline.
- Enable a flexible user experience
- Facilitate bidirectional collaboration among stakeholders such that tasks are done on time and not duplicated
- Configured to a specific trial protocol and study management model
- Interoperable with other regularly used data sources and allows for automated data refresh
- Be secure
- Compliant with industry guidelines and standards (GAMP-5, HIPAA, GDPR, CCPA, SOC, etc.)
- Allow different levels of access and permissions according to the scope of each user’s role that maintains confidentiality
Having access to such a platform would improve efficiencies and compress clinical trial timelines. And this can help sponsors get novel and effective products to market faster, reduce study costs, and streamline team workflows to free their time for other work, or, more effective work
ClinOps Pro is a Clinical Operations Workflow Automation Platform that can unlock clinical trial speed. Having the attributes mentioned above, ClinOps Pro innovatively consolidates study data, streamlines clinical operations workflows, and eliminates repetitive tasks.
Sources
- ASPE (2014). Examination of Clinical Trial Costs and Barriers for Drug Development. Retrieved from: https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0
- Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement DOI: 10.1200/OP.20.00821 JCO Oncology Practice 17, no. 1 (January 01, 2021) 41-51. Published online January 06, 2021.
- Lamberti, M.J., Wilkinson, M., Harper, B. et al. Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations. Ther Innov Regul Sci 52, 572–578 (2018). https://doi.org/10.1177/2168479017751403
- Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020 Mar 3;323(9):844-853. doi: 10.1001/jama.2020.1166. PMID: 32125404; PMCID: PMC7054832.
