Originally published in Contract Pharma
John Wilson and Tammy D’Lugin-Monroe, RN, MA06.07.22
The traditional responsibility of the contract research organization (CRO) has been a straightforward one: execute the protocol defined by the clinical trial sponsor. Going forward, this is no longer going to be sufficient to build sustainable success. The sought-after CRO of the future will have the ability to help trial sponsors forge a competitive advantage in a technology- and consumer-driven world where life science companies that stick to a business-as-usual model will trail behind.
Three key factors are shaping this “new normal” in clinical trial design and implementation: the COVID-19 pandemic, consumer/patient expectations and novel technology.
1. COVID-19 pandemic prompts decentralized trial adoption
COVID-19 has changed the way individuals interact with their world, and there’s no returning to old ways. One obvious example in healthcare is the soaring popularity of telehealth. Patients, reluctant to go to clinics or physicians,’ offices eagerly embraced virtual care, as did many providers, earning telehealth a permanent berth in the pantheon of treatment options. Similarly, when 80 percent of clinical trials shut down during the height of the pandemic for the health and safety of participants, the benefits of deploying a decentralized clinical trial model that uses technology to bring the trial to patients, rather than patients to the trial site, became glaringly clear.
Although decentralized clinical trial solutions existed before the pandemic, life sciences companies were often reluctant to implement them. But when COVID-19 forced them to change study designs mid-course, life sciences companies saw that the decentralized solutions improved patient access, adherence, and satisfaction without any negative impact on final product approval.
As a result, the pandemic has helped change attitudes and accelerate decentralized trial adoption. CROs are finding that their clients are now proactively asking them to evaluate and apply decentralized solutions. In fact, up to 65 percent of life sciences companies plan to run clinical trials remotely after the pandemic.1
2. Consumer/patient expectations play a bigger role
The so-called Amazon Effect that has disrupted conventional retail markets stretches into many other sectors, including healthcare. Not only do we expect products we order online to arrive within hours – we increasingly demand near-instantaneous access to anything we want, need or care about, whether it’s data on our phone or streaming movies or changes in our heart rate. In other words, we’ve grown to anticipate everything to come to us at our fingertips.
The same expectations hold true with respect to participating in clinical trials. Just as every successful consumer-based brand or experience has figured out how to fit comfortably into its customers’ lives, life sciences companies need to focus on creating non-invasive, non-intrusive experiences that work seamlessly for subjects and demonstrate clear benefits.
While patient-centricity has been a buzzword for quite some time, the participant’s perspective has often been overlooked in traditional clinical trials. Decentralized models enable patients to participate more actively and have greater input throughout the trial, which in turn supports better engagement, satisfaction, and compliance.
3. Technology supports oversight and insight
Life sciences companies are shifting more of their R&D budgets toward emerging technologies as digital solutions increasingly demonstrate powerful potential to improve the quality and cost of clinical trials2 as well as the quantity and quality of patient data.
Continuous remote patient monitoring (cRPM) that continuously collects and tracks every breath, heartbeat, movement, and other vital physiological data from patients in the real world in real time can be key to providing a safer, more positive patient experience throughout the trial. For example, it can alert clinicians to potential clinical risks if patients become short of breath or less active. Alternatively, patients who experience worrisome symptoms can instantly reach out directly to the clinical site via a mobile app and have a clinician check vital signs in real-time to determine if intervention is needed. This ongoing protective clinical oversight reassures patients, helping them to feel more engaged and willing to participate in a clinical trial.
In addition, the ability to analyze Big Data with artificial intelligence allows CROs and life sciences sponsors to more efficiently identify the right patients to recruit for clinical trials by looking at pathological features of specific populations. For example, companies now can use genomic lab data to screen patients for specific gene mutations or access prescription data to pre-identify people with resistant hypertension.
Moving forward, life sciences organizations will be able to capitalize on deeper, richer data insights in numerous other ways as well, including reducing the number of patients required in a trial by including external control arms, providing prescriber guidance, and pioneering value-added products and services.
New normal reshapes the CRO’s outlook
These three disruptors have set the stage for a new normal that demands CROs move beyond their role as implementors to become innovators who now enable and facilitate success in a marketplace that looks dramatically different than only a few years ago. CROs must not only help trial sponsors adapt to this new world driven by these factors but also to develop a competitive advantage using them as cornerstones.
Clinical trials typically aim to meet the following goals—identify the right participants for enrollment, safely engage them in the trial and demonstrate and/or evaluate the efficacy and safety of the therapy. Despite the potential of digital tools for improving participant recruitment and retention, expanding, and streamlining data collection, and capitalizing on advanced analytics to optimize trial results, more than 40 percent of clinical trials still do not use them.3
Investing in, and pioneering the use of, innovative digital solutions is essential to enabling life sciences companies to meet clinical trial performance goals productively and efficiently. Because CROs are not technology companies at their core, building technology from scratch has often proven to be a rocky road. Staying on top of technology also presents a challenge because it evolves at lightning speed, making it easy to become obsolete. For most CROs, teaming up with a best-in-class technology partner offers a more promising and effective strategic path toward creating the competitive and growth opportunities they seek.
Partnering for added value
Developing effective, user-friendly decentralized trial solutions requires collaborating with a carefully selected partner or team of partners whose capabilities align with the study design. CROs should thoroughly evaluate potential technology partners based on several criteria:
- Do they offer a medical-grade, scalable digital platform that can support multiple therapeutic areas?
- How extensive are their global operational capabilities relating to wearable sensors, continuous data streams and international electronic health record (EHR) access?
- Do they offer analytically and clinically validated algorithms and proven data science expertise?
- What is their track record of success with the FDA? Is data from their platform recognized and accepted by the FDA in new drug submissions? Does their data collection process meet all FDA Good Clinical Practice (GCP) requirements?
- Do they develop products under formal quality systems regulations and harmonized standards?
- Are their solutions suitable for interventional studies and/or post-approval studies?
- Are they reliably able to deliver products and services on time that perform as promised, or are they over-extended?
- Do they offer unique solutions and expertise?
To build sustainable success in the new normal, CROs need partners that provide integrated, proven, end-to-end digital technology solutions. Platforms should be designed to continuously capture biosensor-generated, real-world patient data anywhere, 24/7, and be able to generate personalized patient insights using FDA-cleared artificial intelligence analytics.
For both CROs and pharmaceutical sponsors, the end game depends on the ability to accelerate clinical trials, reduce R&D costs and speed new drugs to market. In the future, CROs must have the ability to deliver a distinct competitive advantage that enables life science companies to thrive in a fast-changing, disruptive environment.
- TMF Futures 2021 Report, Arkvium (as reported by Fierce Biotech, 8/9/21)