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Relationship-centric technology presents a sizable emerging opportunity for sponsors to improve the performance of clinical development, writes Tom O' Leary.
One of the most undervalued uses of technology, perhaps especially so in clinical development, is to bring people closer together. Relationship-centric technology presents a sizable emerging opportunity for sponsors to improve the performance of clinical development.
During a clinical trial, serious communications between people of diverse backgrounds - patients, investigators, and specialists at sponsors and CROs - do not always conclude ideally. For example, patients may consent to participation without fully understanding the required procedures or schedule of visits, only to drop out when their trust and comfort with their investigator degrades. Clever use of technology can help bridge perspectives, prevent misunderstandings, and remove distractions from the personal relationships that are the bedrock of a trial.
In fact, while many recent technological innovations aim to streamline repetitive tasks, gaining efficiency and quality data are only the beginning. We may find that broadening our expectations of technology will uncover new opportunities to transform the interpersonal relationships at the core of any trial’s success. When people work better together, we can gain more than just efficiency.
Many areas for improvement exist within relationships in the clinical research process and a number of related “relationship-centric” technologies are gaining traction today. While “false dawns” of software that “simplified workflows” to improve a clinical trial’s quality have appeared previously, recent adoption of clever designs and smarter algorithms that report trends instead of noise has led myself and colleagues to believe a new standard for clinical operations is emerging.
Lifting burdens to refocus site staff
The obvious target for applying a relationship-centric expectation for technology’s role is between patient and investigator.
Site staff, who balance day-to-day patient care alongside collection clinical trial data, receive a dizzying number of resources and tools for a trial. These may include a web portal for enrollment, another for recording clinical data, and yet one more for payments. Digital innovations that once “streamlined” paper-based processes have piled up to become a small mountain of logins and bookmarks. Parsing these websites is a common complaint for investigators, who report struggling to find time for trial tasks (e.g., entering visit data, responding to reconciliation queries) amid the constant demands of practicing medicine. Most sites house more than one clinical trial, thus multiplying the resources.
A benefit clearly exists from consolidating a trial’s myriad websites into one destination with one login. Indeed, we’ve observed many sponsors adopt single sign-on web portals. These portals resolve an impediment not only to productivity, but also a genuine investigator frustration. Based on our experience and discussion with other vendors, these portals increase investigator satisfaction, lead to sites delivering better quality data, and also motivate good sites in conducting additional clinical trials with that sponsor again.
Among these portals, the best emerged from programming objectives that were not to facilitate simplicity or efficiency (the low hanging fruit), but to help site staff strengthen communications with patients, CRAs, and other trial operations staff. In four recent Phase III trials conducted by ICON, the single-portal concept was extended to integrating the clinical and central laboratory databases. The impetus for database integration emerged from analysis of how a central lab staff and CRAs often find discrepancies during database merges, which then prompts multiple calls to sites to resolve minor issues (e.g., confirming demographic data). In those four Phase III trials, the integrated databases reduced queries to sites by 30–50%[i].
While these portal innovations helped to alleviate tedium from the investigator experience to reset expectations of relationships with sponsor and CRO staff, we have observed deeper improvements in sites’ relationships with trials from linking investigator training to the portal. Investigators’ comprehension and retention of a clinical trial’s protocol has already been identified as an area of opportunity. In the past, the primary training often occurred at a summit held months before the first patient visit. As that education faded, frequent protocol amendments, expanding case report forms, and site staff turnover muddied the waters and opened chances for non-compliance and delays.
Sponsors have begun to better support investigators by provisioning remote trial training modules, which can include media such as short videos and printable briefs inside the consolidated trial portal. When organized in a visit-by-visit guide, investigators can refresh prior training on demand throughout the duration of the trial.
Patient satisfaction and protection
A patient’s trust in an investigator and comprehension of a trial during enrollment is perhaps one of the most deserving areas for relationship-driven digital innovation.
A patient’s trust in the trial, built from his or her positive experiences with the investigator and comfort with the study’s requirements, is central to the decision to enroll and remain in the trial. Complicated protocols and technical procedures, however, are increasingly impenetrable to patients, leading to hesitation or, worse, regret which can lead the patient to leaving the trial. Understanding 30-page ICFs, which use vocabularies and concepts complex to many patients, can be particularly difficult in a doctor’s office. In this setting, restrictions on time and comfort may make asking the right questions challenging. The experience can be alienating and reduce the trust patients place in their investigators.
Another example of technology’s ability to build relationships at the outset of a trial is online patient communities. PatientsLikeMe, has built an online community for patients to understand diseases in their terms, alongside peers. By letting patients speak directly and openly about their disease and treatment, PatientsLikeMe has invented a new way for patients to find and understand trials, accelerating the flow of information about trials to potential patients. Additionally, the volunteered patient data including demographics, medical histories, and experiences - all available only because of the human relationships facilitated by the online community - has helped sponsors identify appropriate patient populations and accelerate recruitment rates, according to PatientsLikeMe internal data. Similar concepts are at play with ClickItForward, which applies the principles of altruistic viral marketing to accelerate patient recruitment.
Trial participants’ other major need, besides trust and comprehension, is safety. A number of emerging technologies are addressing safety protections in ways that can strengthen relationships.
Polypharmacy is a common safety risk, particularly for central nervous system indications. Patients with chronic conditions are often prescribed multiple medications, each with specific instructions including dosage and time of dose. The smart pill bottle developed by AdhereTech simplifies sorting these details for patients, alerting patients if a dose is due or has been missed. While the device is useful to sponsors to record adherence data for regulatory submissions, AdhereTech’s design emphasizes relationship-centric features in how the device interacts with patients and clinicians to generate more value for the trial. The smart pill bottle’s alerts demonstrate to patients how the trial sponsor cares for their wellbeing and understands how difficult their healthcare can become between patient visits. For investigators, this technology helps build stronger relationships with patients because they can respond to non-adherence more quickly and refocus their conversations with patients on deeper issues.
Other connected devices - from the wearable sensors to the litany of apps and gadgets for smartphones - will benefit from considering the same approach. Mobile devices, heralded as a revolution for data acquisition and compliance, devices may tempt us to collect more data, but collection alone will be unlikely to simplify trials or reduce costs. We must be judicious about the data we collect, how we analyze that data, and most of all how those data are used to benefit the patient and investigator. Will implementation strengthen patients’ connection to a trial? Will it benefit patients by providing new ways to protect their safety? How will implementations minimize burden on patient’s lives? Considering that half of consumers who own wearables ceased using them within a few months of purchase, the strongest clinical deployment of connected devices will require a clear emphasis on relationship-centric design and utility.
Finally, in some cases, relationship-centric technology for safety may be already in use, although patients may not be aware of this. Real-time and near real-time electronic data capture and database systems are example technologies that are rarely discussed with patients, but directly benefit them through accelerated adverse event identification and reporting. The latest analytics identify abnormal values that are not simply from clinical guidelines, but are personal to patients (the “biological passport” concept). This personalized care can provide patients tangible, memorable benefits and security. Explaining these technologic advantages for patients can create opportunities to build trust and thus enhance fundamental components of study performance.
Sponsor staff experience
As the average time from the commencement of clinical testing to marketing now tops seven years, inefficient project management and meetings accumulate to enormous sums of human labor and vendor costs.
Reports about the status of a clinical trial are prepared before and after status meetings, but their circulation through an organization may be slow or uneven. Sponsor staff, however, must continue to make decisions daily. The uneven, asynchronous distribution of knowledge can mask problems, slow down decision-making, and preclude proactive actions to protect trial quality and timelines.
Opportunity exists for the real-time data platforms to resolve the time lag between collection and trend analysis of clinical data, to transform relationships between sponsor employees. Clever pairing of real-time data and predictive analytics can also help sponsor–CRO meetings so that relationships focus less on status review and more on value-generating strategic discussions.
The bigger picture
While digital innovation has remarkably transformed clinical research in the past two decades, continued application of the standard strategies will present fewer opportunities to extract equally large economic gains. We have now reached a tipping point where we need to explore a new design philosophy: that technology must focus on human relationships to increase engagement.
Big data presents one of the largest opportunities. Data from past trials, real world data and medical records can be mined for valuable insights that can help improve engagement during a trial. For example, physicians could more easily suggest a clinical trial to patients if we could detect eligibility automatically based on notes in electronic medical records. The notes could also inform suggestions for potential modifications to treatments plans that would alter eligibility requirements.
By examining how big data and technologies can not only improve trial design and delivery, but also transform how stakeholders in the trial interact with one another, we can create substantial opportunities to deliver more effective clinical programs.
[i] ICON. The Efficient Trial: Integrating Clinical and Laboratory Operations. 2015. (The figures are from case studies in a white paper currently under development.)
About the Author
Tom O' Leary is Chief Information Officer at ICON.