While much of the conversations about improving clinical trials has been around patient centricity, we at Paragon have noticed that there are actually three stakeholder groups where there has been focused effort to improve interactions - patients, partners and sites. What are the trends impacting these stakeholder groups?
Attracting and retaining patients to clinical trials continues to be a key challenge for pharmaceutical clients. There are four main areas where we see technology providing significant value to clinical trials.
Patient Recruitment: It is becoming more and more challenging to find patients for a clinical trial due to increasingly complex protocols which are narrowing the pool of available patients by enforcing complex inclusion/exclusion criteria. To battle this, we need to follow the lead of other industries by taking advantage of technology to increase awareness. Clinical trials need to make it easier for patients to find more information about clinical trials that may deliver them hope via social media (Facebook, Twitter), patient communities (Patients like me) and Online Trial Registries. We can then support preliminary self-screening through online surveys and apps that allow a patient to provide their information and help reduce the number of patients who fail screening.
Patient Enrollment: Once a site has identified potential participants, they still face the onerous process of enrolling them and gaining consent, which has been made more challenging due to the increasingly complex protocols and other demands on the patient. One way to improve the enrollment process is to leverage more sophisticated informed consent solutions that incorporate training components to shift the focus of the Informed Consent Process from risk mitigation to truly educating the patient about the trial.
Patient Retention: One would hope that getting patients screened and enrolled would be the end of the patient challenges, but unfortunately patient retention is just as much of a problem. As trials become more complex and longer in duration we run the risk of losing more and more patients which can cause a myriad of issues. We can attempt to mitigate the challenges to patient retention by leveraging eConsent processes (mentioned above) to better prepare patients for the trial and providing more frequent and personalized communications/schedule management via technology.
Safety and Outcome Monitoring/Analysis: As we tackle more challenging therapeutic areas it is becoming more and more common to rely on patients to provide us signals around safety and outcomes. This needs to be balanced by the burden we place upon them. Putting too high of a burden will reduce retention and will lead to infrequent and inaccurate submission of information. To offset this, we can improve how we collect data from patients in a passive and active manner. From a passive perspective we can take advantage of new technologies to passively monitor patient stats (heart rates, activity, etc.). From an active perspective we can leverage new technologies (ResearchKit, etc.) to collect data on patient ability (coordination, response time, etc.); we can also improve data collection mechanisms where data entry is required (ePRO, etc.) so that they mimic the more consumer-oriented online experiences of which people are becoming much more comfortable.
We keep hearing about how Investigative Sites are no longer flocking to clinical trials like they used to. What can we do to makes sites more interested in participating in clinical trials?
Improve Site Start-up Process: The process of performing feasibility and site activation continues to be a burden to both sites and Sponsors due to the repetitive nature of activities; and timelines which are hard to manage and are always slipping. One way to improve the site-facing aspect is to reduce or eliminate redundant activities they must complete. TransCelerate has begun this process with their standardization of CVs, recognition of GCP training, and the Shared Investigator Platform which allows reuse of feasibility survey responses across studies. Additionally, by leveraging portals (TransCelerate’s SIP, TrialNetworks, ePS, etc.) which support improved regulatory documentation exchange with sites you reduce the burden on both sites and clinical team members. Lastly, leverage technology (goBalto, Veeva, etc.) that allows study teams to have more insight into the progress and path forward for site activation.
Improve Site Payment Efficiency: One of the biggest complaints from Investigative Sites is the lack of predictability around grant payments. They are not sure what they are going to get paid and when they can expect it. By implementing a payments system that is integrated into other eClinical systems (to support automated triggers) and accessible by sites (to support transparency) you are improving your relationship with sites and moving towards being a “Sponsor of Choice”.
Improve Site Relationship Management Practices: Traditionally, study teams are so busy doing normal monitoring activities (visit report forms and source data verification) that they aren’t developing strong relationships with the sites. This hinders long-term stability and increases the chances that payment issues, difficult protocols, or other factors cause the site to ditch the Sponsor. One trend that is evolving to change this is the emergence of risk-based monitoring. By taking advantage of risk-based monitoring you can shift monitor time/effort into developing rapport with the sites and continuing study training. This will help to improve site retention but will also lead to better study execution at the site.
In today’s world it is evident that Sponsors are not in the clinical trial business by themselves. They are increasingly supported by CROs and other partners. These partners are becoming more and more ingrained into the Sponsor landscape (systems and processes).
TMF Management: TMF management has been challenge for partnerships because CROs are often being penalized by having to perform redundant activities around TMF management in order to follow their SOPs and support Sponsor inspection readiness. Conversely, some Sponsors are burdened by having to ingest study TMFs from CROs when the study is over. Thankfully, we have seen some progress recently due to two shifts:
- Reduced variability between eTMF content structures by aligning around the TMF Reference Model which was updated last year.
- Externalization of Sponsor eTMF systems to the CROs and having them process content directly into it instead of “copying” content from their eTMF.
CRO Oversight: CRO oversight continues to cause many Sponsors to struggle because much of the information required to perform oversight is manually generated and/or not real time. This causes excessive effort to be allocated to oversight while still not achieving results that leadership expects. By increasing the rigor applied to oversight preparation you can reduce the effort needed for oversight execution. This can be implemented by focusing on adopting a consistent clinical operations metrics approach (MCC, etc.) and incorporating your CRO partners into the definition and execution of this approach. Additionally, implementing analytics/dashboarding tools to provide real-time reports to relevant stakeholders can reduce the reliance on Excel and manual report creation.