Kick-off meetings happen routinely at the start of a new clinical trial.  Often, they fail to offer participants the information they need or to engage project team members in a way that helps them retain key information.  However, with some planning and creativity, a kick-off meeting can have a significant positive impact on the execution of your study. Here are six tips for conducting an effective kick-off meeting that ensures project team members walk away prepared to successfully execute the clinical trial.  While this article focuses primarily on internal kick-off meetings, many of the tips are relevant to kick-off meetings that incorporate all stakeholders.

1. Assign pre-work to get the most out of your time together
   Provide relevant materials in advance. Don’t let your meeting devolve into a group review and re-read of documents, foster collaboration. Set the expectation that team members will review and prepare prior to the meeting to encourage participation.

   Documents I recommend providing in advance include the most current version of the clinical trial protocol, relevant literature, project timelines, budget documents, and any relevant contracts or statement of work (SOW) documents.

2. Getting the most out of protocol review
   Protocol review should not be a regurgitation of the protocol. Make it interactive and keep the focus on key items the team needs to know. Take this time to highlight items that may be obstacles to enrollment or execution.

   For example, at a recent kick-off meeting, I divided the team into groups and each group was assigned a section of the protocol (e.g., inclusion/exclusion criteria, safety, analysis, etc.). Each group was asked to discuss their section and present the most important points to the rest of the team. This encouraged preparation, teamwork, and engagement among the project team members, which is critical from the outset.

3. Ensuring scope, timelines, and budget are understood by all
   The discussion should be more than just a summary of the documents that team members could get by reviewing the documents on their own. Focus on risks (both positive and negative), hand-offs and anything that is out of the ordinary or complex. At Rho, functional leads (e.g. the lead data manager) provide input to timelines, scope, and budget during the proposal process. If changes are needed, make sure you understand what has changed between the proposal and the kick-off meeting.

   Make sure you walk out with as much buy-in from team members as possible. When the team views timeline and budget management as the sole responsibility of the project manager, delays and cost overruns are a likely outcome.

4. Teaching the science behind the study
   This is often overlooked, but making sure everyone has an understanding of the science underlying the clinical trial provides important context for the tasks that will be assigned and decisions that will be made.

   Ask the medical monitor or other appropriate expert to prepare an overview of the therapeutic area and indication, to discuss the specific mechanisms relevant to the product being evaluated, and to talk about previous and competing trials that may provide context to your trial.

5. Setting expectations for communication
   When is it OK to email and when do you need to call? Who needs to know if you are out of the office for a few days? Who should be copied on emails? What are the Sponsor’s preferences? Take the time to set expectations for project communications rather than assuming everyone works the way you do.
6. Laying the groundwork for positive team dynamics
   Get to know each other. Everything will run more smoothly if the recipient on the other end of your email is a person rather than an anonymous entity.

   I try to include something during each kick-off meeting to help the team get comfortable working together, but the specific activity depends on the group. How well do they know each other already? Do they tend to be more or less formal in their interactions? For some groups, ice breaker activities actually can help break the ice. For others, it is an unwelcome distraction and sharing a casual meal together would be better received. Some experimentation may be required to find what works best.