In the words of Heraclitus, the Greek philosopher, “Change is the only constant in life.”
In my experience, the fear of change is similarly inevitable. This is especially true in clinical research.
Change takes many forms in clinical research
- Changes to form design, e.g., a change in eligibility requirements or new data required per protocol
- Changes to workflow, e.g., a change in trial parameters results in gaps or overlaps in tasks
- Changes in site membership, e.g., adding new virtual or decentralized trial sites
- Technology updates, e.g., a new application, updating/modifying an existing one or building integrations across systems
- Regulatory compliances changes, e.g., HIPAA, GDPR, ICH, GCP, FDA and MHRA
- Data loss due to unexpected failures in hardware, IT networks, hacker, software bugs, etc.
- Recruitment issues
Mid-Study Changes Are All But Certain
Given its many forms, it’s all but inevitable that there will be mid-study changes.
A survey of 194 global drug discovery companies conducted by the Tufts Center for the Study of Drug Development (CSDD) found that mid-study updates delay trials by about a month. Smaller companies say the delays run an average of 25 days and larger companies take 35 to 40 days to resume a clinical trial after a planned or unplanned mid-study update. “Companies report an average of four such disruptions per clinical trial.”
That’s why clinical trial researchers and staff are advised to prepare for change rather than fear it. A framework for successful change management anticipates possible changes and leverages capable systems and well-designed processes to address unintended consequences.
This kind of change management framework starts with stakeholder recognition. As we wrote in the white paper, Managing Change in Clinical Trials, “start by identifying each stakeholder, their role in the study, and what they need.”
Key stakeholders include:
- Clinical Research Coordinators (CRCs)
- Investigators who sign-off on the data
- Patients
- Data Scientists
- Data Managers
- Study Programmers
- Monitors
- IT Personnel
“Working with stakeholders early to understand their requirements and get feedback increases your chances of a successful study start. Throughout the study, practice frequent communication, solicit feedback and adjust expectations as necessary.”
For insight into the ways common types of change in clinical trials can be effectively managed and the kind of data-specific standard operating procedures (SOPs) that enable compliance and speed change management, download our white paper, Managing Change in Clinical Trials, visit: https://www.openclinica.com/managing-change-in-clinical-trials/