When conducting a clinical trial, the main goal is reliable and clean data
to support the investigational product effectively and safely. Did you know?
Up to 30% of data collection is not used for data analysis due to ineffective
protocol design.
Approximately 25% of procedures in protocol are not associated with any
key endpoints (primary, secondary, treatment or exploratory). Better Design: - Clearly define the endpoints and measures – Straight-forward and intuitive endpoints, will save time and money.
- Simple endpoints are more effective for marketing purposes and prevent regulator confusion. Clearly written protocol minimizes work and time efforts and enable faster patient enrollment.
- Focus on the Essential procedures, Collect only necessary data, to draw conclusions about study hypothesis by “Connecting” the procedures to the study objectives.
- Reducing complexity and unnecessary procedures, lowers the risk of deviation/non-compliance by the site.
- An efficient study design may require fewer subjects while providing the same results (sufficient power to demonstrate an effective and safe drug or device). Smaller sample size – > less Data to collect – > less resources.
- Clearly define the eligibility criteria to avoid screening and enrollment errors.
- Clearly define the standard of care and match it to the Protocol. Ensure all investigators are aware of it.
- Avoid multiple secondary objectives to reduce site burden.
Better planning:
Improving the efficiency of monitoring is one of the largest
cost control drivers in clinical research today. - Remote monitoring is an alternative approach to maintain trial participant follow-up during the study, keeping all clinical monitoring, and communication with sites on track, while reducing on-site visits.
- A risk assessment remote monitoring plan should be prepared before applying the remote monitoring, in order to maintain study and patients’ safety.
- Sponsor should consider combining “remote follow-ups” visits using advanced platforms such as:
* eICF
* e-Pro
*Video visits (webEx, Zoom,TCs, etc.)
* Home nursing | 
