Lisa Henderson

IQVIA’s Patient Centered Solutions (PCS) team is distributing print copies of a newly released book, 

Using Patient Experience Data to Evaluate Medical Interventions. Generating, Understanding and Using Patient Experience Data Within and Alongside Clinical Trials,

 at the DIA meeting in Boston at the end of this month. If you are not on hand to pick up a complimentary copy, it will also be available for purchase at the Kindle store as an eBook.

Edited by Matt Reaney, (PhD, CPsychol, CSci, MSc), head, science and analytics, PCS, at IQVIA, the content is timely and the company believes it has the potential to become the authoritative text on patient-experience data (PED) in drug development. It was created with all levels and roles of clinical research in mind, with the intent to use the content to facilitate their work in bringing their products to the market.

“Patient experience data (PED) in intervention development – what it is, why you should care, and how this book can help?”

 He writes, “The relevance of PED extends beyond patient­level healthcare and into the development of new interventions. Indeed, understanding PED in intervention development is an important precursor to patient-focused healthcare provision. The goal of intervention development has long been to maximize health and well-being, but it is only recently that developers and sponsors of intervention development have recognized the importance of the patient experience in achieving this goal.”

He continues to outline the reasons why PED could be considered confusing, why it is becoming more important and how it can be used effectively. For example, PED can help answer the following questions:

What signs and symptoms are most bothersome to patients?

How are patients' lives affected by disease and treatment?

How can we best understand treatment benefit?

Do patient preferences align with clinical priorities?

How well do typical trial endpoints align with outcomes that matter most to patients?

How do attitudes toward interventions vary by patient subgroup?

The book is broken down into four important sections of PED—generating, understanding, using, and developing a PED strategy. IQVIA contributing authors range the professional functions within the organization from PCS, to statistics, research, endpoints, and many more to reflect their expertise to the included sections.

, editor-in-chief, Applied Clinical Trials

Articles

Newly released book edited by Matt Reaney, (PhD, CPsychol, CSci, MSc), head, science and analytics, PCS, at IQVIA focuses on patient experience data with all levels of clinical research in mind. 

Patient Experience Data: Get Your Copy at DIA

CRAACO, Clinical Research as a Care Option, and the event of the same name, occurred in mid-May, and was in equal measures educational and inspiring. The goal is to enable more patients access into clinical trials by being identified closer to the point of care or diagnosis. It requires bridging the very real divide between the goals of healthcare and how they operate and the same with the clinical research enterprise, which is hard work.

But that work need not be for naught. In the “Building a Business Case” session, Henry Wei, MD, head of development innovation at Regeneron, described an October 2020 published 

. The Yale Cancer Center examined claims for its Oncology Care Model (OCM; CMS alternative payment model), which targets the expected spending for each OCM six-month episode using historical, geographic, and clinical factors, including clinical trial participation. Using data from July 2016 to July 2018, the authors concluded that OCM episodes with trial participation outperformed non-trial episodes in achieving savings relative to CMS spending targets. These savings were attributed to lower drug costs, suggesting that clinical trial enrollment shifts costs away from CMS and toward the sponsor.

Donna O’Brien, national advisor with Manatt Health, has extensive experience as a healthcare executive. She noted in the same session that in order to close the cost and access gap between academic medical centers and community health providers, a business case, such as above, is key for hospital executives. O’Brien said, “Trials are viewed as an add on and loss leader. It is hard to get [hospital] CFOs to understand how the financial model of trials work and educate CFOs on trial finances.”

The Henry Ford Health System, which prioritized clinical trials using Manatt Health as a consultant, was featured in a CRAACO session. David Lanfear, MD, VP, clinical and translational research, described the hard work and change management needed to integrate clinical trials with clinical care. Lanfear described analyzing their own internal capabilities, making decisions on what they should outsource vs. internal expertise and processes that need to controlled closely. While some challenges still exist—a centralized CTMS that accommodates a multi-year horizon—Lanfear expressed optimism that the health system will grow well past its 200 trials a year and enable an actual “care option” as part of their clinical trials.

Insights from KOLs at the mid-May CRAACO event.

A Business Case to Bridge Trials and Care

Chris Learn, PhD, PMP, Vice President, Cell and Gene Therapy Center of Excellence, Parexel describes highlights of his career, what originally spurred his interest in clinical research, the current landscape of CGTs and much more.

Podcasts

Cell And Gene Therapy: Still On A Learning Curve

Doug Warner, MD and CMO for eFFECTOR Therapeutics, a clinical stage biopharma targeting oncology, discusses the complexities of oncology clinical trials, bringing his career-long learnings with Amgen to his current role, and the important relationship medical directors should have with their clinical study teams.

Doug Warner, MD and CMO for eFFECTOR Therapeutics, discusses the complexities of oncology clinical trials, the important relationship medical directors should have with their clinical study teams, and more.

Clinical Studies Take Teamwork

 afoot to reduce the carbon footprint of clinical trials. In regard to sustainability and the environment, however, this is not a one-and-done solution. In fact, most pharmaceutical companies find it difficult to know where to start when addressing their internal practices that negatively impact the environment, but starting with CO2 emissions is a good beginning.

To that end, Janssen’s Clinical Innovation Team presented its own carbon footprint contributors at the Clinical Trials Europe 2022 Informa event six months ago, with the following 

 from a recent Phase I trial, reflecting share of CO2 emissions: patient journey, 30.8%; trial site utilities, 15.5%; Janssen staff commuting, 14.6%; patient accommodation, 11.8%; Janssen facility utilities, 7.5%; trial site staff commuting, 5.2%; testing kits, 5.2%; drug product, 4.7%; samples, 4.6%; external meetings, .1%.

It is this ability to measure and quantify that companies can initiate their journey for change with informed benchmarks. Such is the goal of the 

Pistoia Alliance’s Clinical Trial Environmental Impact Community of Interest

, launched in mid-October 2022. According to its website, the goal is to identify key drivers for carbon footprint in a clinical trial, develop metrics with estimates of each for a “typical” clinical trial, and then users of this dynamic model will be able to turn on and off key parameters, such as patient engagement, decentralized clinical trials (DCTs), and patient diversity activities in order to see the impact of each on carbon footprint.

This ability to turn on and off parameters makes it important to understand the unintended consequences of choices. For example, while DCTs may be desirable from a “patient journey” aspect of getting to and from a site, the downstream effect of drug delivery to the home could include emissions in the form of transportation, as well as eco-insufficient packaging choices.

At the Pharma 2023 Reuters event in April, a panel discussed this very conundrum. With the focus on climate change, one expert warned “If we change something, we need to ensure that we are not going to degrade the environment in another way.”

Panelists also discussed where companies should start their efforts, and all agreed: it starts with commitment, collective action, and a collaborative effort to share progress and standards.

Insights from recent industry events clear path for companies to identify how their internal practices could be harming the environment.

Striving for Carbon Footprint Benchmarks

Peter Benton, President and CO-CEO for Worldwide Clinical Trials, leads a diverse team of more than 3,000 people in more than 60 countries. Benton speaks about his unconventional entrance into the pharmaceutical industry, advice for clinops professionals, significant changes coming for industry, and much more.

Peter Benton, President and CO-CEO for Worldwide Clinical Trials, speaks about his unconventional entrance into the industry, advice for clinops professionals, and much more.