Clinical News Roundup: FDA Approves Oncology Trial For Cuban Treatment

By Ed Miseta, Chief Editor, Clinical Leader

A groundbreaking lung cancer vaccine developed in Cuba has received approval from the FDA to begin clinical trials in the U.S. The trials will be conducted at Roswell Park Cancer Institute in Buffalo. The announcement is just the latest medical victory for Cuba, which has a global reputation for quality healthcare and innovation in disease research, including Ebola and cancer. With the recent thaw in relations between the U.S. and Cuba, medical leaders are looking at additional opportunities coming out of the island nation.

CIMAvax-EGF, developed by Havana's Center of Molecular Immunology, is a form of immunotherapy – training the body's immune system to attack and destroy cancer. The trial, expected to begin next month, will involve 60 to 90 adult patients who have Stage IIIB or Stage IV non-small cell lung cancer. Patients must have a life expectancy of at least six months and must have already tried first-line systemic chemotherapy.

The vaccine manipulates the body's immune system to block a type of protein that cancer cells need to grow. Unlike treatments similar to chemotherapy, it does not aim to “kill” the cancer cells directly. Instead, it starves them, making it impossible for the protein to attach to the cell's receptor. Without this connection, the cell cannot grow and multiply, and eventually it will die.

AstraZeneca Suspends Recruitment In Two Cancer Trials

AstraZeneca (AZ) said it had suspended enrollment into two large clinical trials on head and neck cancer while it investigates whether the treatment is causing patients to bleed. The company said it had observed bleeding in some patients as part of routine safety monitoring of the two trials and had paused recruitment to analyze those incidents.

According to a company spokesperson, the bleeding is a known complication in treatments of head and neck cancers due to the nature of the underlying disease, the proximity of tumors to major blood vessels, and use of prior cancer therapies, which may involve surgery and radiation.

The trials in question are testing whether a drug called durvalumab, used alone or in combination with one of AZ's other experimental cancer medicines, prolongs survival in patients with head and neck cancer. Patients already enrolled in the trial will continue to take the drugs.

SCRS Releases Payment White Paper

The Society for Clinical Research Sites (SCRS) released a Site Payment White Paper on site payments at its annual Global Site Solutions Summit. The white paper documents five burdens the current site payment structure places on sites, as well as solutions to address these issues. Additionally, the paper outlines further burdens that will be examined over 2016-17 by the SCRS payment initiative working group.

This white paper comes four years after SCRS published a previous white paper on the same subject and finds many of the same issues still at play. However, advances in technology, such as near 100 percent adoption of electronic data capture (EDC) for Phase 3 studies, mean that the time is suitable for some of these burdens to be lifted.

"We have legacy payment processes that haven't changed since data was collected on paper case report forms 20 years ago," said Christine Pierre, President of SCRS. "Meanwhile the profit margin at sites has continued to go down. Equally as alarming is the finding from the 2017 SCRS Site Landscape survey that 66% of sites have less than 3 months operating cash in the bank. Sites must be paid in a timely manner from when the data is entered and this working group advocates for payments within 30 days."

Learn more about the findings and advocate for change by familiarizing yourself with the Site Payment white paper. Download the paper here.

Does Pharma Face A Shortage Of Experienced CRAs?

Clinical Research Associates (CRAs) are one of the 10 best careers in America in terms of job growth rate, worker pay, and satisfaction, according to CNN Money. Still, the clinical research industry has experienced a global shortage of experienced CRAs. There are over 14,000 open positions for CRAs on Indeed.com alone, and by 2018 demand for CRAs is expected to grow annually by more than 5,000 positions. For the pharma industry, the shortage will contribute to higher costs and extended drug development timelines.

As a result of the highly competitive job market, many sponsors and CROs are finding themselves in a neverending recruitment cycle for qualified CRAs. According to Maria Ladd, Senior Manager, Global Study Start Up, at inVentiv Health, “The CRA/site relationship is a critical factor in the overall clinical trial process. In an industry with ever-increasing demands to ‘beat the clock,’ the face-to-face, human connection between the CRA and site staff can bridge the gaps in site morale potentially created by the pressures to speed activation, enroll the contracted number of appropriate subjects, and maintain complete and clean data. The right CRA can keep site staff grounded and engaged, ultimately serving to meet the goals of both the CRO and the sponsor.”

Three consequences expected to result from the CRA shortage are rising costs, limited career growth for experienced CRAs in companies afraid to lose them to promotions, and extended trial timelines and lost revenue for sponsors.

Why Is The Clinical Trial Recruitment Model Broken?

It now takes many years and billions of dollars to get a new medicine to market. And that is only if it is not one of the 85 percent of new drugs that fail. It certainly doesn’t help that today’s clinical trial recruitment system is deeply flawed.

“Unfortunately, the traditional clinical trial recruitment model is not keeping pace with demand, and researchers are unable to secure an adequate number of qualified participants on a timely basis,” said Tom Dorsett, president and CEO of ePatientfinder, an EHR-centered, clinical trial solutions provider. “When recruitment goals are not met, delays ensue and cost increases.”

It costs approximately $2.6 billion to develop and gain marketing approval for a new drug, according to the Tufts Center for the Study of Drug Development. A significant portion of that goes toward clinical trials, and a third of those costs are spent and often lost on what Dorsett says are ineffective patient recruitment processes, which include direct-to-patient marketing such as billboards, TV commercials, and Google ads.

According to HIT Consultant, there are three reasons why the clinical trial recruitment system is broken.

1. Lack of Awareness - Historically, only a very small segment of the population has been aware of the opportunities presented in clinical trials. There is a similar lack of awareness on the side of physicians.  For example, there are hundreds of thousands of physicians treating patients with cancer and chronic diseases. However, without the proper support, it’s tough for any doctor to be aware of every trial available that could help his or her patients.

2. Lack of Physician Involvement - There’s a huge lack of physician involvement in the clinical trial recruitment process, especially when it comes to community physicians making patients aware of opportunities for advanced care that could help them.

3. Inefficient Site-Based Assessment - Direct-to-patient site recruitment may produce a lot of referrals, but in most cases, they end up not being qualified. The research site gets overwhelmed trying to assess a large pool of non-qualified participants, which can adversely affect trial timelines, costs, and employee morale.

While technology is essential to solving the problem, it has to be the right kind that can effectively filter through the enormous amount of health data available today. However, the process begins by moving away from traditional marketing means and forming partnerships with EHR vendors and physicians