Clinical Research: Approving Studies Effectively

Our healthcare team were called upon to examine the existing processes for approving any new study at a major hospital trust in the northeast of England.

The studies were to include clinical research trials and were to improve efficiency.

4

days of delays were saved for every study submitted, improving the speed at which trials could start

Significant increase in teamwork between different departments

A of process clarity for all staff involved in workshops

Clinical Research: Approving Studies Effectively

Results

The three-month programme resulted in:
• A transformation of communication between the research admin office and other teams, saving 4 days of delay for every study submitted.
• Clarity for all staff involved in the workshops, who were able to openly discuss and rework the way they viewed their processes.
• Greater teamwork between different departments, which encouraged unity and problem solving.

Clinical Research: Approving Studies Effectively

Observations

The biggest achievement from our observations was that the initial analysis highlighted a range of future measures which would continue to transform the approvals process. The 12 to 18 month programme currently being implemented is:
• Identifying project managers to coach and mentor.
• Developing a dashboard for delivery teams and senior managers to track progress.
• Encouraging weekly meetings to discuss critical process measures.
• Creating a best practice standard tool for all teams to measure themselves by.
• The overall aim is an internal system used by all staff for the long term to continually prioritise and increase high-value applications.

Clinical Research: Approving Studies Effectively

Objectives

• A lack of ownership. Each department was taking a siloed approach without cross departmental coordination, which resulted in lengthy delays.
• Studies were prioritised in sequential order as opposed to their importance, resulting in a loss of high-value applications and deferring income.
• An absence of tracking systems to monitor data, KPI’s, targets or income
• 80% of applications were returned as incomplete and requiring amendment and up to 50% of trials were unnecessarily rejected.

Clinical Research: Approving Studies Effectively

Actions

Working with the teams we embarked on a three-month process:

STAGE 1: Conducted stakeholder meetings and process mapping workshops to determine each part played and encourage open discussion and honest analysis.

STAGE 2: Directed workshop reviews at each step to identify issues affecting the process. Created countermeasures including a local level Programme Management Office which allowed teams to track performance with metrics.

STAGE 3: Prioritised quick wins to introduce in the short term and developed a complex Master Schedule of work to implement over the next 12 months.