Patient centricity: Moving from a ‘nice to have’ to best practice

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Duncan_Andison)
(Image: Getty/Duncan_Andison)

Related tags: Patient centricity, Clinical trials, Ppd

Patient centricity quite plainly means to put the patient at the “front and center,” explained Rhonda Henry, vice president, site collaborations and patient centricity, PPD – though many remain confused on how to be “patient centric.”

“Patients are at the center of clinical trials yet it has only been in recent years that the industry has acknowledged patients as key stakeholders in the clinical trial process,”​ Henry told us.

As the industry looks for answers, patient-focused roles are becoming standard within pharma, biotech, contract research organizations (CROs) and health care companies, she said.

These firms also are engaging directly with patients to understand better the burden of disease and barriers to clinical trial participation, to incorporate the patient voice in the protocol design process.

Read more:The CRO's role in advancing patient centricity

Additionally, global regulatory agencies also are partnering with patients and caregivers to define what is meaningful to them, gaining insight to develop guidance documents that aim to see patient engagement practices as the norm in the drug development process.

Technology’s role

Seemingly, on a daily basis, new “patient-centric” technologies and solutions are introduced with the goal of easing the burden associated with clinical trials.

“Even with these efforts, patient-centric initiatives are often considered as ‘nice to have’ versus a best practice,”​ said Henry, noting that broad implementation is challenged by time and money, “especially since the return on investment cannot be quantified as easily in traditional terms.”

As Henry noted, patient engagement requires planning and depending on the scale, can require an investment of time and money.

“A patient-centric trial must reflect real understanding of the patient and the disease burden, as well as eliminating as many barriers to participation as possible. Innovations and technologies that support patient engagement and retention, while also reducing the burden of clinical trial participation will be the most impactful,”​ she explained.

For Henry, this includes multipurpose patient engagement platforms that connect patients and provide better patient-to-trial matching, while facilitating communication and information sharing between patients and the industry.

Additionally, patient concierge services simplify patient participation in clinical trials by taking care of travel logistics. These services also ease the clinical trial site’s administrative responsibilities.

“Patient concierges ease the burden on patients and their caregivers by helping them navigate the complexity of clinical trials by providing help for all non-medical questions and support for trial comprehension, participation logistics, and technologies,”​ added Henry.

Read more: Site location, travel assistance key factors to clinical trial participation: BBK report

Reducing the need to travel on a whole, telemedicine and wearables are facilitating remote, decentralized trials that reduce the number of office visits – and will “make virtual trials more common place in the future,” ​said Henry.

The patient’s role

The proliferation of online resources has made the internet one of the patient’s main sources of medical information.

“Patients have evolved from passive participants in their health care to being actively engaged in treatment decisions,”​ said Henry, “with many patients having pre-diagnosed their condition and researched treatment options before ever stepping foot into a doctor’s office.”

Patients are connecting through social media and online communities, asking questions and sharing answers and experiences.

“We all have busy lives so health care needs to be convenient,”​ added Henry, noting that clinical trials are inconvenient due to the frequent, lengthy office visits. “Patients with life-threatening conditions are more willing to be inconvenienced to gain access to experimental but potentially beneficial treatment,” ​she said.

However, patients with access to other acceptable treatment options are less inclined to spend additional time at the doctor’s or experience invasive procedures – “all in the name of altruism,”​ said Henry.

“Because of this, patients are mobilizing through advocacy groups and advisory panels to share their recommendations with the industry and regulatory bodies alike,” ​she explained.

“Patients and caregivers want to work more closely with the industry to share their experiences and perspectives to make clinical trials more palatable for the patient and more efficient for all stakeholders such as health care professionals, regulators, sponsors and CROs.”

More new companies than ever are marketing products to facilitate the connection between the industry and patients. Henry said, “Telemedicine, home health and the concept of virtual trials are now viable options for reaching more patients, as well as making clinical trial participation more convenient.”

The key to success

In the future, Henry said the integration of the patient into the drug development process will become the norm – and also will be “the key to success.”

“From designing meaningful studies to communicating product benefits to regulators and payers, evidence generated through patient engagement is an integral and ever-growing part of the drug development process,”​ she added.

According to Henry, patient-focused development will continue to progress through regulatory initiatives, including requirements for patient experience data in new drug application (NDA) and biologics license application (BLA) submissions.

The US Food and Drug Administration (FDA) also is expanding its Patient Representative Program, which brings patients into the fold to discuss new medical products.

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