Clinical News Roundup: U.S. To Start Trials For Dengue Vaccine

By Ed Miseta, Chief Editor, Clinical Leader

The U.S. said on Tuesday it intends to develop a dengue vaccine and start clinical trials to prevent "unnecessary" loss of life due to the vector-borne disease. Over 15,000 cases of dengue have already been reported in India this year. Secretary of State John Kerry, on a visit to India, said the U.S. intends to develop vaccines both for dengue and tuberculosis, which has also been termed a major public health challenge.

DNA India notes Kerry made the comments while addressing a joint press interaction with External Affairs Minister Sushma Swaraj after the Second India-US Strategic and Commercial Dialogue. According to the data provided by National Vector Borne Control Disease Program under the Health Ministry, 15,099 dengue cases have been reported in various states throughout India by July 28. Twenty-six people have died due to the disease.

Last year, there were 99,913 cases were reported across India, claiming the lives of 220 people. There has been a sudden spurt in dengue cases in the national capital with 487 cases of the disease reported. In the month of August, 368 cases have been recorded.

India has also been fighting the onslaught of tuberculosis. According to a study in 2014, 6.3 million cases of tuberculosis worldwide were reported to WHO with India accounting for over a quarter of these cases, the highest of any country. It also said that the number of tuberculosis cases in India may be two to three times higher than current estimates.

Dr. Reddy’s Launches Patient-Centric Platform

Dr. Reddy’s Laboratories has launched Purple Health, a platform designed to inspire patient-centric innovation and deliver solutions to address the unmet needs of patients. Purple Health is built around four pillars of therapy for patients: Awareness, Access, Adherence, and Experience. The platform is another step in institutionalizing patient-centricity across the organization.

As the first major initiative under Purple Health, the company launched a new range of patient-centric packaging that aims to enhance the therapy experience for over 20 million patients each year. The entire packaging initiative spanned a period of 24 months from research to concept development to implementation. Starting with the India market, the new packaging will be rolled-out in phases over the next 6 months for 25 of its focus brands.

Dr. Reddy’s identified medicine packaging as an underserved area to innovate, as it has traditionally been designed to meet technical and regulatory requirements with little to ensure patient convenience. The company partnered with consulting firm IDEO and applied a “Human-Centered Design” approach to finding solutions during the design phase of the project. The team met a cross-section of patients, doctors, and pharmacists across the country, conducting in-depth interviews and observational studies to understand patient’s needs. Based on the insights, the company redesigned its blister packs and syrup bottles to address identified pain points.

Tablet-Based App Recruits 5,000 Patients

Health in Our Hands, a patient network and an initiative of REACHnet, has reached a milestone by recruiting more than 5,000 patients using an innovative tablet-based application presented to patients in their physician's examination room. The electronic process obtains patients' consent to participate in a network that integrates patient perspectives into research and connects them to research projects supported by their health system.

The enrollment milestone was achieved by deploying 258 tablets in 20 clinics at Ochsner Health System, EXCELth Family Health Center, Access Health Louisiana, and Tulane Lakeside Hospital for Women and Children in the Greater New Orleans and Baton Rouge areas.

The state-of-the-art application, including mobile and web-based versions, collects patient-reported health information, provides an avenue for patients to inform and partner in the research process, recruits patients into pragmatic clinical trials, and facilitates ongoing trial participation and management. Patients consenting into Health in Our Hands agree to be contacted outside of clinical settings to learn about these opportunities, including participation in research trials. The ability to expand engagement and recruitment efforts outside of the clinical setting through email and text message makes it possible to connect to the existing 5,000 network patients without waiting for their next clinic visit.

Leapcure And Scientist.com Partner To Accelerate Patient Recruitment

Leapcure, a provider of patient engagement solutions for clinical trials and pharmaceutical research, announced it has teamed up with Scientist.com, a marketplace for pharmaceutical services. The partnership will provide patient recruitment services for users of Scientist.com’s network of 10 pharmaceutical research marketplaces. The partnership will provide white-label, global clinical recruitment services using Leapcure’s smart patient engagement platform.

“The way organizations recruit and engage patients for clinical trials is changing, and Leapcure is empowering organizations with the tools they need to reach and retain the right patients,” says Zachary Gobst, CEO of Leapcure. “By partnering with Scientist.com, we will allow their worldwide membership to connect with reliable patient recruitment services and technology with the same ease of transaction they have come to expect when they purchase other research services on the Scientist.com marketplace.”

Leapcure’s Adaptive Patient Screening Platform (APSP) recruits patients based on the study’s conditions, inclusion/exclusion criteria, location, and procedure. This allows better quality patients to sign up, reduces the recruitment process to days instead of months, and ensures patient retention throughout the trial.

Validic Forms Strategic Relationship With SAP

Digital health platform manufacturer Validic has announced a strategic relationship with SAP. Through this relationship, healthcare and life science organizations can accelerate the development and delivery of patient-centered solutions to improve health outcomes, reduce costs, and provide a personalized approach to medicine. The announcement was made at the SAP Personalized Medicine Forum in Bonn, Germany.  

Technology and healthcare are converging in powerful ways, enabling better access to care, better treatment options, and better opportunities for engagement. The massive amount of patient data now available to healthcare stakeholders offers new opportunities to deliver personalized medicine and value-based care.

Powering the shift toward personalized medicine is the integration of patient-generated health data captured outside of the clinical setting into care treatment plans, clinical research studies, remote monitoring programs, and preventative wellness initiatives. Through this strategic relationship, Validic enables SAP and its global healthcare clients the opportunity to scale access to patient data from clinical devices, wearables, and consumer health applications. Having a broad set of patient data integrated into one system will allow healthcare providers to better analyze a patient's health, resulting in personalized treatment options.

Number Of Heart Disease Drugs In Clinical Trials Fall

Although heart disease remains one of the leading causes of death worldwide, International Business Times reports a new study has found the number of drugs in development to combat the illness has fallen in the last 20 years.

The study, published in JACC: Basic to Translational Science, analyzed data from a vast commercial database of drug development activity focusing on all drugs intended to treat cardiovascular disorders that entered Phase 1 clinical trials from Jan. 1, 1990 to Dec. 31, 2012. The database carried information that tracked the pipeline of pharmaceutical research and development projects.

About 347 drugs meant for treating cardiovascular disease entered Phase 1 clinical trials during this time frame. Most drugs were antihypertensive agents, lipid-lowering agents, and anticoagulants. From 1990 to 1995, 16 percent of drugs that entered Phase 1 trials were meant to treat cardiovascular diseases. However, between 2005 and 2012, only 125 cardiovascular drugs (five percent of drugs) made it to Phase 1 testing.

The number dipped further in 2012 when cardiovascular drugs accounted for only seven percent of Phase 3 testing, indicating the number of cardiovascular drugs entering clinical trials in all stages of development had fallen over time. Conversely, the number of cancer drugs in development increased in the same time frame.