Humanized content about engagement strategies with sites and investigators.
The Study Start Up (SSU) phase of clinical trials always feels very chaotic when you are in the “thick of it” with feasibility, site list finalization, regulatory body submissions, essential record templates, Client meetings, etc.To help the noise fall into the background and stay focused and streamlined to achieve activation timelines, ProPharma implemented the following strategies.
Internal Alignment between SSU, Clinical, & Project Management Team
During the SSU phase of a trial, the SSU Team and Clinical Team should act as an integrated unit rather than as separate departments, simply “handing over” a site. The disconnection between the SSU Team and Clinical Team quickly becomes evident to sites. For example, duplicated requests for documents, contacts, addresses etc., are easily identifiable by sites and project an unprofessional reflection on ProPharma and the clients we represent. Internal team alignment is critical from the start and throughout the SSU phase. To ensure the team continues to work cohesively, weekly scheduled check-in meetings are recommended between SSU, Clinical, & Project Management. These meetings are a great opportunity to bring progress and the current challenges you are facing to the group for discussion and to agree on an action plan. Open & effective decision-making is key to a successful internal team, enabling quick action to assist sites and move forward toward activation.
Personalized Start Up Strategy Call with Site Staff and ProPharma
The number one driver of a faster start-up is open and collaborative communication with Investigators and site staff. The best way to start the conversation is to hold a Start Up Strategy Call between the Investigator Site Team and ProPharma regional representatives, with Clients optionally attending. During the alignment phase of SSU a targeted set of questions is developed in preparation for the Start Up Strategy call. The list of questions should be distributed to the site prior to the Start Up Strategy call for consideration. Quick engagement after selection is key to getting sites interested and excited about participating in our clinical trial. If a site cannot start immediately, keep them engaged through regular study updates. Never leave site emails or calls unanswered, even if their questions require further investigation on your part; it is important when building a strong relationship with sites and to acknowledge them in real time. During the Start Up Strategy Call, be open with the site on study timelines and expectations, and build your mutual understanding of each other and the Client. Establish the site’s preferred communication method and the expected number of touchpoints per week during the SSU phase. This trick goes a long way toward not overwhelming staff and keeping exchange channels open. All parties should leave the Start Up Strategy Call with positive attitudes towards what was discussed and full, clear understanding of the immediate next steps and overall pathway to activation. There should be no assumptions around key target dates that all parties are working toward. The SSU representative leading the call provides a summary to the Site, Client, & wider ProPharma Team. All efforts should be made over the next 3 business days to make any adjustments to the timeline or “blueprint” presented by all contributors. Once agreed and the plan is in place, any deviations from the established delivery dates should immediately cause concern for the project team, opening a conversation with the site, if not already done. The teams should have a direct conversation about what is happening and the best way to course-correct the site’s SSU process to stay on target for activation. We all know something will inevitably go “wrong” during the SSU process, but you will be valued for how you recover and move forward. So, stay calm, be confident, and move to Plan B.
Our process at work
After implementing the Start Up Strategy Call and consistently checking in with sites to help stay on course, we have seen improved Site and Client relations as well as overall faster activations. Because timelines and expectations were clearly set from the beginning, sites reported not feeling “caught off guard” by the study team's requests. Additionally, feedback is commonly positive about communicating how the site prefers. For example, we worked with a site that wanted only one person to contact them for all SSU/Clinical requests. This was a difficult request and required willingness from the identified team member, precision, clarity, & support between SSU and Clinical, and overall team readiness to be flexible for the site. The flexibility paid off and we were able to achieve activation 3 weeks earlier than initially expected.
Start Up Strategy Call Questions
Here are some key items and areas of concentration to be thinking about and help target your next conversation in a Start Up Strategy Call.
Regulatory Approval Pathway
- What type of Regulatory body does the site utilize? Does the approval process allow parallel review or require sequential submissions? Establish an expected date to receive ICF edits for review. What translations does the site require? Discuss required document collection and timelines.
CTA/Budget
- How long will it take to receive redlines of the CTA and budget feedback from the receipt of the template? Does the site need any additional documents or manuals to start its review process? Is Regulatory Approval required before CTA can be executed?
- Are there any pre-review committees that will need to take place prior to Regulatory submission/budget review/CTA review? On average, what is the site’s CTA execution timeline? Is there a specific process for signing contracts? What is the typical turnaround time? Can the site use DocuSign? Who are the signatories?
Clinical Trainings
- Request shipping contacts and addresses for all study vendors and materials. Confirm if vendor equipment can be shipped to the site prior to a fully executed CTA. Clarify training process for study equipment and establish training timeline around equipment receipt.
Site Initiation Visit (SIV)
- Does the site require Regulatory approval, or a Fully Executed CTA, prior to an SIV being scheduled or completed? When is the best time to begin to set up the SIV with a CRA?
General
- Key considerations or potential study challenges.
- Are there any staffing issues or resourcing restrictions that may impact study start-up? Any staff vacations or scheduled office shutdowns?
- What is a reasonable projection for activation, considering all the items discussed during the call?
- Contingency plans for missed meetings, approval dates, and other delays. What are the backup plans for any missed targets?
Author
