By Mary Malloy, Ph.D., and Nikki Cammarata, Halloran Consulting Group
There are many elements that influence a site’s choice to accept a clinical study, particularly when multiple studies are participating and when equally promising treatments in similar patient populations are being studied. Sponsors can influence site choices by creating a positive sponsor-site relationship from the onset, which includes making design decisions that consider the patient perspective and making execution decisions that alleviate common operational challenges, reduce burden on sites and their personnel, avoid protocol amendments, and help to dodge operational surprises.
As with every industry, there is a concern for the value of time in bringing a product to market. However, in clinical research, the value of time has added meaning, particularly for patients with serious diseases where a marketed product can mean a longer life or the potential for a better quality of life. So, taking the time at the beginning of a study to increase the likelihood of success in the end can be a worthwhile trade-off and can often save money in the long run.
Considering Patient Perspectives
To achieve the goal of building more efficient trials, sponsors should strive for meaningful relationships with sites to collaborate and learn about the patient journey with the goal of making trials as simple and easy as possible for the patient to understand, access, and participate in. Additionally, sponsors can engage with patient advocacy groups to review the schedule of events and informed consent form(s) (ICFs) to identify any aspects of the trial that may be significant barriers for patients.
When patients are the driving force in all that sites accomplish, these patient-centric efforts will further nurture the sponsor-site relationship and can also provide patients with confidence when making the decision to join a study.
Initiating Sponsor-Site Relationships
Initiating and nurturing sponsor-site relationships can be a daunting task, especially with the mounting pressure for increased development speed to bring investigational products from bench to bedside and the 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 initiate a warm introduction.
- Lean on your CRO or other vendors who have a strong relationship with sites to provide an introduction and establish trust.
- Whenever possible, utilize site lists from prior trials conducted at your company and reach out directly.
- The cold introduction:
- Reach out directly to site networks.
- Reach out directly to patient advocacy groups.
- Reach out directly to well-known KOLs.
Real-World Examples To Reduce Site Burden & Nurture Meaningful Sponsor-Site Relationships
Operationalizing trials more effectively not only strengthens relationships with sites but also helps sponsors to spend less money and time throughout the course of the study. In addition to obtaining patient perspectives on a study, it is also valuable to receive site input on the draft protocol. By speaking with KOLs and study coordinators in advance of protocol finalization, sponsors can confirm the study is operationally feasible. Planning for this step in the timeline for protocol finalization and first patient in (FPI) can allow sponsors to avoid unnecessary protocol amendments. Protocol amendments cost sites and sponsors time, money, focus, and momentum – all of which cause additional site burden and may lead to a negative perception of the sponsor or decreased likelihood of success or timely completion of the study.
Reducing burden on sites and minimizing operational surprises are some productive ways to foster meaningful sponsor-site relationships. Specific examples are outlined below. Although some of these suggestions may seem minor, the amount of time that is saved and the acknowledgement that site staff time is valuable will be appreciated.
- Utilizing industry standard platforms that are familiar to sites, such as a common electronic data capture (EDC) system, will save the site team time and energy on training and managing data entry.
- Reducing training burden and repetition can also be accomplished by working with vendors to shorten training modules to focus on what is novel and important, making basic function training optional for experienced staff, timing training to occur when it is most useful and relevant, and providing dynamic hands-on training rather than reading slides during initiation visits.
- Allowing sites to use their own processes and forms frees them to operate most efficiently and consistently. As an example, sites may have their own templates for the Delegation of Authority log or their own process for training and training documentation that is different from the sponsor’s or clinical research organization’s (CRO’s) standards but is sufficient to satisfy good clinical practice (GCP). When sponsors refrain from imposing unnecessary requirements, they not only save sites time, but they also acknowledge the sites’ expertise.
- Avoiding protocol amendments whenever possible is a major way to minimize operational surprises and burden on sites. A frequently cited study1 published by Tufts in 2016 found that 45% of substantial amendments were deemed “avoidable.” Sponsors should take the time for a thorough quality check prior to finalizing the protocol to ensure there are no redundancies or minor discrepancies. Such quality checks can help decrease site questions and confusion and help increase site confidence in the sponsor.
- Maximizing administrative efficiencies will also be welcomed, such as streamlining payment processes and reconciliation and coordinating contracts and documents from the sponsor, CRO, and vendors to the site.
It’s best to think long-term when discussing nurturing site connections. While each trial will have its own complexities along with common challenges, site connections can be navigated with ease when sponsors are prepared to address issues and resolutions. Sites will be more likely to choose sponsors who view them as partners and take time to discuss challenges with them and implement mitigation strategies.
Value connections with investigators, including and beyond KOLs:
- Gather feedback from principal investigators (PIs) who have not been identified as KOLs, as this will also enable sponsors to obtain varied perspectives and build a larger network.
- Map out your KOLs to provide different perspectives; sometimes the same KOLs used over and over can act as an echo chamber and lack diversity in opinion.
- Clearly communicate to a site when and why they were not chosen to participate on a trial, as this builds rapport and may help the site to improve and better focus their efforts in the future.
Ultimately, the early effort a company puts into site relationship building and maintenance can set the sponsor up for success and helps differentiate them to the site amongst competitors. As a sponsor, if you come to the initial site connection with a willingness to understand the site and patient journeys, and to make accommodations accordingly, you can set yourself apart and generate a positive first impression and strong foundation for the sponsor-site relationship.
- The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Ther InnovRegulSci. 2016 Jul;50(4):436-441. doi: 10.1177/2168479016632271.
About The Authors:
Mary Malloy, Ph.D., is a consultant at Halloran Consulting Group. She is a FINRA-registered investment banker with more than eight years of experience in life science-based corporate transactions and cross-functional project management. Her doctoral research encompassed investigating protein matrix interactions in the neurodegeneration space. She also has experience in strategic advisory for emerging biotech companies, agnostic of therapeutic area or modality. Her consulting experience has been focused on scientific due diligence, market landscape analysis, and primary research with key stakeholders, and she frequently operations as the nexus of several functional heads of a life science start-up as a program manager.
Nikki Cammarata is consultant at Halloran Consulting Group. She has more than seven years of experience in conducting early- and late-phase clinical trials. She uses her experience within clinical operations and clinical systems to act as a clinical trial manager for global studies and to lead CTMS and eTMF implementations.