By Mary Malloy, Ph.D., and Nikki Cammarata, Halloran Consulting Group
Many factors influence the choice of a site to accept a clinical study, particularly when multiple studies are involved and when equally promising treatments in similar patient populations are being investigated. Sponsors can influence site choices by creating a positive sponsor-site relationship from the start, which includes making design decisions that consider the patient’s perspective and making execution decisions that mitigate challenges operational routines, reduce the load on sites and their staff, avoid protocol changes and help avoid operational surprises.
As in all industries, there is concern about the value of the time it takes to bring a product to market. However, in clinical research, the value of time has additional meaning, particularly for patients with serious illnesses where a marketed product may mean a longer lifespan or the potential for a better quality of life. So taking the time at the start of a study to increase the chances of success at the end can be a worthwhile trade-off and can often save money in the long run.
Consider patient perspectives
To achieve the goal of building more effective trials, sponsors should strive to build meaningful relationships with sites to collaborate and learn more about the patient journey with the goal of making trials as simple and easy as possible. possible for the patient to understand, access and participate in. Additionally, sponsors can engage with patient advocacy groups to review the timeline of events and informed consent forms (ICFs) to identify any aspects of the trial that may pose significant barriers to sponsors. patients.
When patients are the driving force behind everything sites do, these patient-centered efforts will further strengthen the sponsor-site relationship and can also give patients confidence when making the decision to participate in a study.
Initiate sponsor-site relationships
Initiating and maintaining sponsor-site relationships can be a daunting task, especially with the growing pressure for increased development speed to bring experimental products from bench to bedside and increased competition within the clinical space.
Here are some ways to initiate site connections:
- The warm introduction:
- Leverage your professional network, including sites you’ve worked with and key opinion leaders (KOLs) you know, and connect directly with colleagues to kick off a warm introduction.
- Lean on your CRO or other vendors who have a strong relationship with the sites to introduce yourself and build trust.
- Where possible, use site lists from previous trials conducted at your company and contact directly.
- The cold introduction:
- Contact site networks directly.
- Communicate directly with patient advocacy groups.
- Contact well-known KOLs directly.
Real-world examples to reduce site load and nurture meaningful sponsor-site relationships
Operationalizing trials more efficiently not only strengthens relationships with sites, but also helps sponsors spend less money and time throughout the study. In addition to obtaining patient views on a study, it is also helpful to receive site feedback on the draft protocol. By talking with KOLs and study coordinators prior to protocol finalization, sponsors can confirm that the study is operationally feasible. Planning for this step in the protocol and first patient completion (FPI) timeline can help sponsors avoid unnecessary protocol changes. Protocol changes cost venues and sponsors time, money, focus and momentum – which places additional load on the venue and can lead to negative sponsor perception or reduced likelihood success or timely completion of the study.
Reducing the load on venues and minimizing operational surprises are productive ways to foster meaningful sponsor-site relationships. Specific examples are shown below. Although some of these suggestions may seem minor, the time saved and the recognition that site staff time is valuable will be appreciated.
- Using industry standard platforms familiar to sites, such as a common Electronic Data Capture (EDC) system, will save the site team time and effort for training and data entry management.
- Reducing training burden and repetition can also be accomplished by working with vendors to shorten training modules to focus on what is new and important, making training in basic functions optional for staff experienced, scheduling training when it is most useful and relevant and providing dynamic training. hands-on training rather than reading slides during introductory visits.
- Allowing sites to use their own processes and forms allows them to operate more efficiently and consistently. For example, sites may have their own templates for the delegation of authority log or their own training and training documentation process that is different from sponsor or clinical research organization (CRO) standards, but is sufficient to satisfy good clinical practice (GCP). When sponsors refrain from imposing unnecessary requirements, they not only save venues time, but also recognize venues’ expertise.
- Avoiding protocol changes whenever possible is a major way to minimize operational surprises and site load. An oft-cited study1 published by Tufts in 2016 found that 45% of substantial modifications were considered “avoidable”. Sponsors should take the time to conduct thorough quality control before finalizing the protocol to ensure that there are no minor redundancies or discrepancies. These quality checks can help reduce questions and confusion on the site and increase the site’s trust in the sponsor.
- Maximizing administrative efficiencies will also be welcome, such as streamlining payment processes and reconciling and coordinating contracts and documents from sponsor, CRO and vendors on site.
It’s best to think long-term when it comes to nurturing site connections. While each trial has its own complexities as well as common challenges, site connections can be easily navigated when sponsors are ready to troubleshoot and fix them. Sites will be more likely to choose sponsors who see them as partners and take the time to discuss challenges with them and implement mitigation strategies.
Value relationships with investigators, including and beyond KOLs:
- Collect feedback from principal investigators (PIs) who have not been identified as KOLs, as this will also allow sponsors to gain varied perspectives and build a wider network.
- Map your KOLs to provide different perspectives; sometimes the same KOLs used repeatedly can act as an echo chamber and lack diversity of opinion.
- Communicate clearly to a site when and why they weren’t chosen to participate in a trial, as this builds rapport and can help the site improve and better focus their efforts in the future.
Ultimately, the early effort a company puts into relationship building and site maintenance can set the sponsor up for success and help them differentiate the site among competitors. As a sponsor, if you come to the initial login to the site with a willingness to understand the site and patient journeys, and make accommodations accordingly, you can stand out and generate a positive first impression and a strong foundation for the sponsor-site relationship.
- The impact of protocol changes on the performance and cost of clinical trials. The InnovRegulSci. 2016 Jul;50(4):436-441. doi: 10.1177/2168479016632271.
About the authors:
Mary Malloy, Ph.D., is a consultant with Halloran Consulting Group. She is a FINRA-registered investment banker with over eight years of experience in life science-based corporate transactions and cross-functional project management. His doctoral research encompassed the study of protein matrix interactions in the space of neurodegeneration. She also has a background in strategic consulting for emerging, domain or therapeutic modality agnostic biotechnology companies. Her consulting experience has focused on scientific due diligence, market landscape analysis, and primary research with key stakeholders, and she frequently operates as a liaison between multiple functional heads of a startup life sciences as program manager.
Nikki Cammarata is a consultant at Halloran Consulting Group. She has over seven years of experience conducting early and late phase clinical trials. She uses her experience in clinical operations and clinical systems to act as clinical trial manager for global studies and to lead CTMS and eTMF implementations.