This week, Clinical Trials Arena is all about the patient as today marks the start of Patient Centricity Week! Having long been a buzzword in the industry, patient centricity continues to be the focus of many a conference (as will be the case this week in San Diego if you’re attending Arena International’s OCT South California).

Cheap plugs aside, with the rise of direct-to-patient shipping, such advances within the clinical trial space indicate the needs of the patient is increasingly becoming front and center on the industry’s agenda. With that said, the time is apt to spotlight what challenges remain to make the ultimate patient-centric trial.

Be sure to visit us tomorrow when Robert Greene, President of HungerNThirst Foundation, explains why patients should have easier access to clinical trials. On Wednesday, another CTA regular, Deborah Collyar from PAIR shows us why public study summaries need more than plain language to be effective.

Later in the week, Jennifer Brandl of Kezar Life Sciences addresses a key hurdle to overcome to ensure a patient-centric clinical supply chain. And lastly, Ramani Aiyer of Shasta Bioventures offers a primer on patient recruitment strategies for rare disease clinical trials. So as you can tell, a deluge of topics will be explored on CTA, so be sure not to miss out this week!

In the meantime, catch up on some CTA’s most popular stories exploring ways in which the industry can make clinical trials patient-centric… (click on the headline to finish reading).

Patient-Centric Clinical Trials ¦ Why Patient Advocacy is Vital

The National Cancer Institute describes a patient advocate as a person who helps guide a patient through the screening, diagnosis, treatment, and follow-up of a medical condition, such as cancer. A patient advocate helps patients communicate with their health care providers so they get the information they need to make decisions about their health care. How can clinical trial professionals benefit from collaborating with patients, patient advocates and other stakeholders, and do they have the time needed to nurture such relationships?

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Research program managers, for example, are often faced with the challenge of balancing the workload staff members can manage, while still achieving study targets, maintaining data quality and compliance, and often at the top of the list, staying within budget. Collaborating with patients, patient advocates and other stakeholders may just prove successful in lowering the study workload associated with patient-centered encounters.

Patient Engagement in Drug Development: Building Guardrails to Ensure Patient Privacy

The transformative value of collaboration between pharmaceutical companies developing drugs and devices and the people living with health challenges is widely recognized within the health care industry. Clinical trial teams and patient volunteers have expressed the benefits of serious interchange that includes sharing the patient experience.

Widely accepted and supported in an increasing number of pharmaceutical companies such as Lilly, Sanofi and Novartis, the partnership embodied in the terms “patient engagement” and “patient centricity” has moved from a novel concept to one that is expected by clinical trial teams and patients as well as by health authorities.

Patient Centricity Means Patients ARE Your Endpoint

Terms like “patient centric” are all the rage these days. It’s meaning, however, depends on who bandies them about, but the ways in which to effectively achieve patient centricity are in very short supply. Unfortunately, the needs of the patients are usually at the tail end of the research process rather than the beginning.

In truth, the system has focused on everything else first, before the patients. This is evident in every journal article and, frankly, in every conference – all you have to do is peruse the titles. Patients feel like afterthoughts (at best), and think system priorities create barriers to what they need and want most. Sponsors often spend a great deal more time, money and effort on endpoints, regulations, and publications than they do on learning true patient needs and issues. While the Merriam-Webster dictionary provides a generic definition for the term “centricity,” patients use a different mantra, “Nothing about us without us!”

Exploring Patient-Centricity, from a Patient’s Perspective

After giving talks at a variety of life sciences conferences, I always stay and listen to the “experts.” The popular topic of patient centricity in clinical trials is front and center on the agenda. Before long, I want to shout, “You’re getting it all wrong.” However, I’m an uncommon guest; I’m a patient, a cancer survivor, still in treatment, to be exact. But I’m also a decided friend to the biopharma industry at conferences across the US and Europe.

It seems that almost all biotech and pharmaceutical companies have or will soon initiate one or more programs to achieve patient centricity in their clinical trials business. Much like the Six Sigma, TQM and ISO “quality” programs that swept across the manufacturing industry a few years back, we’re seeing waves of patient centric programs crashing (pun intended) on the beaches of biopharma. We hear “it just seems like the thing to do” or “let’s put patients first,” “we’re patient centric,” and so on.