Thoughtful Technology to Reduce Burden For Clinical Trial Sites and Patients

Contributed by:

Kevin T. Williams, MBA/MS, VP, Corporate Development, DrugDev

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The concept of patient-centricity in research is about offering patients a better clinical trial experience. As such, there are a PV0616_KevinWilliamsDrugDevvariety of ways to enhance the engagement of the patient. These include empowering other key stakeholders — sponsors, CROs, and sites — with better tools to improve the interactions with their patients.  Every patient’s needs are different, but below are three pillars of patient-centricity for an engagement solution:

Transparency: Patients should have access to their agreements, documents, and data with minimal red-tape.

Communication: Patients should be kept in the loop regarding their responsibilities, risks, benefits, and contribution during and after their trial, without compromising their privacy.

Continuity: Patients should feel like they’re interacting with one, inter-connected service (e.g. eConsent, ePRO, payments, site, sponsor, CRO) even though multiple parties are likely involved.

Anyone in life sciences knows patients for clinical trials are an obvious and essential component to advancing medicine, along with the investigators. As a matter of reference, the chart on the left from a 2015 CISCRP study provides a look at an array of concerns raised by patients participating in a clinical trial. While there are many avenues that need improvement, the point is to understand as research professionals that our job is to explore opportunities to improve the patient experience.

Innovation and Point Solutions

As an industry, broad efforts are being made to leverage technology to bring efficiency and streamline processes across the many moving parts of trial execution.  Patients should be no exception.  As active users of the Internet and mobile apps, they too should have simple, electronic access and connectivity with their study – documents, messaging, scheduling, lay summaries and more to share with family and their medical professionals.   In a growing world of solutions for patient engagement, we need to be thoughtful about the patient experience when it comes to introducing technology.

Over the last several years, many point technology solutions have been introduced and implemented in clinical trials, all aimed at improving different components of the process.  While successful and often innovative, these point solutions eventually reach a time in their lifecycle where they need to be integrated – either through acquisition or strategic relationship with other components of the process to maximize efficiency.  This model is not very different from the way new medicines have been brought to market in the last 15 or so years.  Years ago, big pharma primarily discovered and developed new medicines within their own massive R&D shops.  However, the boom of entrepreneurs in the small pharma and biotech sector helped pave the way for specialization and assisted with the refueling of pharma pipelines.  Eventually, as with new drug compounds, investment in specialized technology solutions will make it easier for sites and patients to participate and stay engaged in clinical trials.  Moreover, unifying certain layers of these point solutions to drive standards will yield greater impact and drive down clinical development costs.

The relevance of the discussion on point solutions ties specifically into usability and the burden placed on stakeholders, especially as we consider trial patients as technology users. Integration and unification is particularly important given the burden that has been placed on the investigator sites over the last several years — the horror stories of laptops and sticky notes with logins strewn across the physician’s office. With advancements in technology for patient engagement and the mindset of patient-centricity, we need to ensure we’ve learned our lesson and not subject patients to the same disconnected experience that sites have endured; we would not want to see “confusing technology” on the next CISCRP participant survey.

The top two reasons patients volunteer for clinical trials are to advance medicine and improve the lives of others; however, about 22% of respondents of a 2015 CISCRP survey indicate their clinical study experience was “somewhat” to “very” stressful. We sometimes forget these patients may be ill and have health issues to contend with as well. We need to reduce the stress, streamline the process, and improve the experience for patients participating in clinical trials, and one of the ways we can do that is with thoughtful technology.  (PV)

DrugDev’s unified clinical suite enables sponsors, CROs, and sites to do more trials through industry-wide collaboration, standardization, and a beautiful technology experience.
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