From The Editor | January 12, 2017

Clinical News Roundup: Is Duke Underreporting Clinical Trial Results?

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

clinical news

The Duke Chronicle reports an analysis performed by the University of Oxford suggests the University is among the worst in the U.S. in terms of reporting clinical trial results.   The report compiled clinical trial statistics through, a federal database of all government-funded and many privately-funded studies. Using the data, the investigators found that several companies and universities had neglected to report or publish findings resulting from their clinical trials. This includes Duke, which is missing results for 41.9 percent of all trials since 2006, according to the analysis.

Although only certain types of clinical trials are legally required to be published, these findings nonetheless have ethical consequences, argued Dr. Ben Goldacre, a senior research clinical fellow at the University of Oxford and leader of the study. “Sharing clinical trials [is] an ethical rather than a legal obligation,” he says. “We cannot make informed decisions about which treatments work best when the results of clinical trials are withheld from doctors, researchers and patients.”

The most recent results were published in October 2016 as part of the University of Oxford’s TrialsTracker website in partnership with the AllTrials initiative. According to TrialsTracker, Duke ranks 25th worst out of 291 companies and universities surveyed in not reporting clinical trial results since January 2006. Out of universities in the United States, Duke is better than some peer institutions such as Stanford University and the University of Pennsylvania.

Denis Snyder, associate dean for clinical research at Duke, notes just because some trials are not being reported does not mean Duke has not complied with legal requirements. Snyder adds Duke itself has been in compliance with federal guidelines for Applicable Clinical Trials.

NCI Formulary Will Expedite Agent Use In Trials

The National Cancer Institute (NCI) has launched a new drug formulary (the “NCI Formulary”) that will enable investigators at NCI-designated cancer centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. It is also one of NCI’s efforts in support of the Cancer Moonshot, answering Vice President Biden’s call for greater collaboration and faster development of new therapies for patients. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process — sometimes up to 18 months — that has been required for investigators to access such agents on their own.

“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, M.D. “Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”

Tufts: Poor Physician Engagement Leads to Low Enrollment Rates

Although physicians and nurses are familiar with, and comfortable discussing, clinical trials, they refer a mere fraction of their patients for these studies. This reflects, in part, a failure by sponsors, contract research organizations, and investigative site personnel to engage health care providers as partners in the clinical research process, according to an analysis conducted by the Tufts Center for the Study of Drug Development.

The study, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that nearly all physicians (91 percent), and the majority of nurses (72 percent) feel 'somewhat' or 'very' comfortable discussing the opportunity to participate in a clinical trial with patients, but physicians refer less than 0.2 percent of their patients into clinical trials. Nurses refer even fewer.

According to Ken Getz, associate professor and director of sponsored research at Tufts CSDD and leader of the study, lack of familiarity and comfort level with referring patients into clinical trials on the part of physicians and nurses are often cited to explain low referral rates. However, he noted, the study results show that these factors are playing a much smaller role.

"The study results challenge the long-held notion that health care providers are a barrier to recruitment, and suggest opportunities to rethink and leverage the role of health care providers as facilitators and critical partners in engaging patients before and during clinical trial participation," said Getz.

Will 2017 Be The Year Of Patient-Centric Creativity?

MediaPost notes the healthcare sector has always lagged behind other sectors, especially when it comes to consumer centricity. This is mainly due to the tendency for healthcare marketers to want to educate around the features and benefits of their products instead of trying to connect with their end-customer, the patient. Over the past few years, many companies have resolved to focus on patient centricity as a guiding principle, though it has yet to be fully realized. That said, with the explosion of health tech and the advent of the tech-empowered patient, there’s a new sense of urgency. Now, finally, it’s all about the patient. 

“We’re living in an unprecedented time in which we have the potential to truly shift how we care for patients,” says columnist Elizabeth Elfenbein. “This patient-centered world is here to stay and will only continue to grow as tech continues to innovate in this sector. The future of personalized medicine is all about patients. Whole-genome sequencing is here, empowering patients to identify and prevent health issues before they even happen. And with the humanization of health tech, we now have the ability to care for patients while lightening the burden of the caregiver. This is only the beginning of how we’ll   redefine prevention, treatment, and how we need to communicate. This is an incredibly exciting time, and this brave new patient-centered world provides a unique creative platform from which to build.”

Elfenbein believes there are five things that need to be done to bring about greater patient centricity.

1. Empathy: This is defined as walking in the shoes of the patient, and will allow pharma to focus on the feelings of the patient and connect with them on an emotional level. It will also help researchers understand their struggles.

2. Authenticity: This refers to being real and being human.  Speak their language, be down to earth, and be authentic.

3. Humanize Technology: Technology is cold but humans are warm. Making health technology more human offers the potential to make health gadgetries desirable in today’s households.

4. Put A Face On Compliance: Consider today’s pop-culture trend of using emojis to create a form of expression that behaves as a compliance tool. By playing and creating in spaces where patients already live, you have a greater chance of achieving improved compliance and adherence to a medicine or health routine.

5. Create Experiences: Remember that patients are consumers, too. When you create a brand experience, put the patient at the center, not the brand. Create experiences that touch and strike emotional chords with the patient. Create value-added services as key differentiators of your product, which will repeatedly demonstrate that you (as a brand) are there to support their health.