Clinical Trial Management System Capability Analysis

A Clinical Trial Management System Capability Analysis is a System Capability Analysis for a CTMS.

• See: Clinical Trial Process Model.

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References

2018

• (Fogel, 2018) ⇒ David B. Fogel. (2018). “Factors Associated with Clinical Trials That Fail and Opportunities for Improving the Likelihood of Success: A Review.” In: Contemporary Clinical Trials Communications, 11.

Table 1. A list of factors associated with problems or challenges when preparing for or executing a clinical trial, along with the opportunities for artificial intelligence to help alleviate these issues. Abbreviation: NLP = natural language processing.

Factor	Opportunity	Role for Artificial Intelligence
Poor study design	More complete literature review
	Appropriate endpoints
	Inappropriate eligibility criteria
	Appropriate statistical analysis
	Determination of appropriate sample size
	Reducing likelihood of amendments
	Inconsistencies in protocol
Ineffective site selection
Poor recruitment	Improved use of funds
	Ensuring appropriate eligibility criteria
	Facilitating locating eligible patients
	Enrolling patients who are likely to complete the trial
Patient burden/safety
	Minimize out-of-pocket expenses
	Minimize possibility of contraindicated medicines/procedures
	Increase likelihood of feeling respected
Poor trial execution
	Preparing data and reporting for write-up
	Lack of general awareness
Overall	Factor analysis to improve trade-offs based on budget and other constraints

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