From The Editor | April 11, 2016

NEWS ROUNDUP: Santa Claus, The Easter Bunny, And Patient Centricity?

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader

TopNews

Can Twitter Help Recruit Cancer Clinical Trials?

Finding patients to participate in oncology clinical trials is very difficult. The large number of treatments in company pipelines, coupled with the low participation rates, has researchers checking every avenue for participants. Is the increased use of Twitter an untapped resource?

An article on Medpace reports a research letter published on JAMA Oncology notes when English-speaking people tweet about lung cancer, they discuss clinical trials about 18 percent of the time. This may suggest a role for Twitter in spreading the word about trials and recruitment efforts.

Currently 70 percent of patients report enrolling in a clinical trial on the advice of a physician. Yet less than 5 percent of patients currently choose to participate. The authors of the letter believe social media may be the new infrastructure for cancer centers, researchers, physicians, and the public to interact. Part of that interaction could include stimulating interaction in clinical trials.

Although cancer centers are using Twitter for health promotion and education, greater efforts can be made to use it for sharing information about trials.

NIAID Sponsors Clinical Trial Of Anti-HIV Antibody

ManagedCaremag.com is reporting enrollment has begun in the first of two multinational clinical trials of an investigational antibody for preventing human immunodeficiency virus (HIV) infection. The trials will test whether giving patients an anti-HIV antibody called VRC01via intravenous infusion every eight weeks is safe and effective at preventing HIV infection.

The trials, which are expected to enroll over 4,000 adults, will assist researchers with HIV prevention and vaccine research.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will sponsor and fund the studies. The VRC01 antibody was discovered by the Vaccine Research Center (VRC), which is part of the NIAID. It was discovered in 2010 in the blood of an HIV infected person and has since been shown to prevent 90 percent of HIV strains worldwide from infecting human cells.

The first trial will take place at 24 sites in the U.S., Brazil, and Peru and will involve 2,700 men and transgendered individuals who have had sex with men. The second study will involve 1,500 sexually active women in Africa. Patients will receive either VRC01 or a placebo. Results are expected in 2022.

New Bill Addresses Lack Of Diversity In Clinical Trials

The lack of patient diversity in clinical trials remains an issue for the pharma industry, and now a new bill introduced in the Senate will attempt to address the issue. A bi-partisan bill sponsored by senators Susan Collins, Patty Murray, Elizabeth Warren, Tammy Baldwin, and Mark Kirk has passed the Senate Health, Education, Labor and Pensions committee and promises to fix the long-standing problem.

Of the 10,000 oncology clinical trials funded by the National Cancer Institute between 1993 and 2013, less than 2 percent had enough minorities to meet NIH targets. The lack of women and minorities in trials present a risk to these patients when they are administered approved drugs that have not been properly tested on them.

The Advancing NIH Strategic Planning and Representation in Medical Research Act calls for the director of NIH to develop a six-year plan to address diversity gaps and demands better collaboration between NIH researchers.

INC Research And CISCRP Partner To Focus On Patients

INC Research and CISCRP have formed a strategic relationship to jointly develop and implement educational initiatives to bring greater awareness to the importance of clinical trial participation.

Ken Getz, the founder of CISCRP, notes without clinical trial participants, new medicines would not be possible. Engaging patients and the healthcare community is therefore essential to the drug development process. Only by raising public awareness and educating the patient community will we be able to increase participation rates in trials.

A main component of the partnership will be an event called the Inspiring Hope Ideathon. Co-hosted by CISCRP and INC Research, the event will bring together industry leaders and advocacy groups to discuss new ideas and innovative methods of raising awareness of clinical trials. INC Research will also sponsor CISCRP events such as Aware For All and Medical Heroes, as well as collaborate with CISCRP on future patient awareness events.

Should Every Clinical Trial Have An App?

Should every clinical trial have an app for patients participating in the research? That’s the opinion of Glen De Vries, president and co-founder of Medidata. In a bylined article appearing on STATNews.com, De Vries notes engaged consumers want deeper connections with the companies they choose to engage via their mobile devices. While pharma companies should be doing the same thing, unfortunately, most of them are not.

When a patient participates in a clinical trial, that is oftentimes the first opportunity a sponsor has to engage with someone who is likely to be a future customer. By ignoring this opportunity to properly engage them, pharma is also failing to capture valuable information about their products and the people taking them.

According to De Vries, an engaged patient participating in a clinical trial should have an open and consistent dialogue with doctors and clinicians, understand the purpose of the trial and their role in it, and be committed to the trial and the completion of it. But few trial sponsors help patients meet this level of engagement. Two statistics make that clear: 80 percent of trials don’t finish on time, and 30 percent of patients drop out.

Today’s technologies can change that. Devices like Fitbits and Jawbones help researchers to better understand patients, while new platforms like Apple CareKit with help create new healthcare apps.

According to De Vries, Pharma companies need to act now, be objective, and go with what works and what patients know. Combining emerging technologies with traditional clinical measurements and techniques will help companies engage patients and better relieve the burden of trials. It also moves the industry a step closer to reducing the time and cost of conducting a clinical trial.

Santa Claus, The Easter Bunny, And Patient Centricity?

If you are reading this article, you probably already know that Santa Claus, the Easter bunny, and the tooth fairy are myths. But what about the concept of patient centricity in pharma? Is it a real thing and if so, what exactly does it mean?

Patient centricity is probably one of the hottest buzz-words in pharma, but while it’s a topic that everyone is discussing, an article on MediaPost.com wonders if it is all a myth. “Putting the patient at the center of everything we do” is a common mantra, which seems to translate into providing services to patients in the most considerate and comprehensive manner possible. But that may not be an entirely realistic strategy.

Jay Denhart-Lillard, author of the article, notes there are other considerations in a doctor’s office or clinic, and some may rate a higher priority. This includes safety protocols and efficiencies that enable better management of population health. While patients deal with a myriad of issues during each visit, physicians have to deal with packed schedules, electronic medical systems, and of course patients. Patients matter, but so do the needs of the physicians. According to Denhart-Lillard, we should be looking for ways to optimize the entire experience.

So what needs to be done? Thoughtfulness is a necessity in any good point-of-care experience. A host of factors must be considered, including goals of the players, tensions and frustrations, available artifacts (i.e. smartphones), and past history. Good healthcare experience planning to deal with these situations include interactive experiences supported by technology and equipment that support care, content-driven experiences that make use of story-telling to better engage patients, and services that recognize, customize, and personalize the experience for participants.

“This kind of care gives all players the opportunity to re-connect and check in on their progress together,” says Denhart-Lillard. “”The health care provider can make a more positive impact on their patient’s health. The payer can help motivate and inspire the provider and patient to work together in ways that increase the quality of care.”