It’s Still All About Relationships: Why Sponsors, CROs, Patients, and Study Sites Are Key to Improving Performance
Throughout the clinical trial industry, stakeholders are embracing the value of patient centricity in the execution of drug development research and in understanding real-world marketability. Recognizing the role of sites and investigators in supporting patient-focused studies, Jeff Zucker identifies six areas in which CROs might nurture site relations.
Even in our current times when world events are affecting our lives and work, the relationships between sponsors, clinical research organizations (CROs), and study sites represent the lifeblood of a successful trial. The patient comes into play significantly when ensuring we are meeting the needs not only for success of the trial but also for the understanding of patient needs in our current environment.
With the increasing trend toward patient-centric trials, sites and investigators have been somewhat forgotten in the process. We are now re-engaging sites to include the patients. Relationships are increasingly being created virtually via email, videoconferencing, etc. Although technology has clear benefits in terms of both time and cost efficiencies, today’s researchers can still learn a lot from the time when communication and processes weren’t electronic. It is important that the industry continue with its patient-focused activity. However, it is also crucial for sponsors and CROs to balance this patient focus with increased site engagement, forging and maintaining strong relationships with site study teams on the ground, as well as between the patients and sites. An engaged site can serve as a key advocate at every level, nurturing an engaged and retained patient.
Ultimately, CROs and sponsors should want to make it easier for sites to work with them, as they are the ones carrying out the work and therefore can provide valuable input to support effective protocol development. The majority of sites that Worldwide works with relish the opportunity to be more involved. They can offer insights on operational issues before, during, and after a trial, which, if used effectively, can improve protocol assessment, study start-up, patient recruitment, and data quality. Ultimately, a collaborative design process will benefit all involved. The same holds true for patients – we want to make it easy for them to be involved in a clinical trial. The COVID pandemic has driven us to a more virtualized study conduct, but the site/patient connection needs to remain for some indications.
We have identified six key areas for CROs to examine as they seek to nurture successful partnerships with sites and patients.
1. Managing Site Relationship Processes
Building and maintaining site relationships needs to be a structured process.
A. It starts with engaging site leaders early. A solicitation meeting should take place as soon as possible, at which a mutual confidential disclosure agreement (CDA) can be put in place so information can be shared back and forth freely. When possible, a face-to-face meeting should also be set up with the main study coordinators, including the principal investigator at which lines of communication will be agreed upon. This meeting should also discuss potential pain points for the sites, sponsor, and CRO and how these could be addressed. When not possible to meet face to face, a videoconference should be used.
B. Next, high-level processes need to be agreed on for the following :
- Pre-award input: How is the sponsor/CRO going to reach out to get a site’s input on protocols, rather than just issuing a survey?
- Site identification: How is the site going to become one of the sponsor/CRO’s preferred sites and vice versa?
- Issue escalation: How will this be handled (by all parties) without undercutting the CRA?
- Communication: Frequency is key, but it should also be with purpose, so how will this be managed? To create effective processes, collaboration at all levels is vital.
2. Increasing Sponsor and CRO Interaction
CROs and sponsors will benefit from working very closely together when interacting with study sites. When possible, they should attend meetings together to set up relationships, even when there is an existing relationship, and maintain this throughout the trial. Ultimately, better site engagement and strong relationships come from great communication. Being proactive in communication can not only improve site commitment but also avoid delays in responses, which can result in strained relationships; accelerate the consultation and the start-up processes; and achieve higher-quality outcomes. With recent developments, it is more important than ever to maintain that line of communication, and occasional videoconferencing is a great facilitator in times of limited travel.
3. Delivering Site Benefits
For sites, fostering strong relationships with sponsors and CROs also has its benefits. Early and frequent engagement with protocol design and program development will result in a clinical study that is easier to execute. Consequently, most sites will thrive off the opportunity to contribute both at the start and throughout the study. Being involved in planning will mean clinical study sites know what to expect and are aware of exactly what they should be looking for when it comes to patient recruitment, allowing them to be proactive and optimize start-up in a tailored fashion, giving the study the best chance of retention .
4. Engaging Physicians
As well as engaging sites from an operational point of view, it is also important for sponsors and CROs to seek advice on clinical excellence. There is potential for give and take between the CRO team and medical practitioners, all of which has the potential to improve clinical trial performance. CRO teams can learn about developments in medical care and practice by reading articles or consulting with professionals. Conferences and seminars are ideal spaces to build relationships that may lead to consultancy opportunities. The Center for Information and Study on Clinical Research (CISCRP) is a great resource for bridging the information gap between patients and research professionals. The Association of Clinical Research Professionals ( ACRP) provides researchers excellent opportunities for professional development. Model Agreements & Guidelines International ( MAGI) is a group where stakeholders in the clinical trial industry come together to identify solutions for improving clinical trial efficiencies and compliance. Patient advocacy groups are becoming increasingly important resources for CROs to receive vital patient-focused guidance; they also have the potential to become supportive allies in the shared goal of bringing important therapies to the patients who need them.
5. Communicating with Purpose
While we can talk about the importance of regular communication, it is also incredibly important that sponsors and CROs manage the frequency and nature of our follow-ups to avoid becoming a burden, which could result in the opposite desired effect. Visiting sites shows dedication, and face-to-face interaction is essential; however, this should be balanced with phone calls, video meetings, and emails, etc., to ensure communication is time- and cost-effective.
The partnerships of CROs and sponsors with sites and patients are symbiotic in nature, each bringing value to the other. Likewise, your communications with sites and patients will ideally be carried out in this same spirit of mutual benefit. While communication is typically initiated in the service of the clinical trial with the aim of maintaining or correcting protocol compliance, such efforts bring value to both parties. Rather than taking a top-down approach to communication, it can be more effective to take an attitude of collaboration.
By improving communication and setting clear expectations and goals, sponsors and CROs can make it easier for sites to conduct clinical trials and improve commitment. However, to achieve this, they must consider sites as true partners throughout and beyond the study.
6. Facilitating Patient Engagement
Patient-centric has been a buzzword we associate with concern for the patient’s experience as a clinical trial participant, specifically with the goal of alleviating patient burden. During the COVID-19 pandemic, many safety measures we’ve been forced to incorporate into our processes have proven to have positive impacts on the patient experience. Remote trials have reduced the need for patients to travel for site visits, with teleconferencing and EDC-enabled tools and apps filling the gap when in-person engagement was not advisable. Home health nursing services have been another means by which patients can undergo assessment and evaluation without leaving their homes. Any modalities that support a decentralized approach to clinical trial conduct can vary and require deliberate decision-making for each study. That said, now that these approaches have proven effective during the pandemic, we can envision a future where the associated side benefit of easing patient participation burden might become a reasonable standard for optimizing patient compliance.
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