From The Editor | April 7, 2017

Clinical News Roundup: RBM Leads To Cost Savings

Source: Clinical Leader
Ed Miseta

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

clinical news

Life science firms look to risk-based monitoring (RBM) to reduce costs associated with clinical studies, according to a study by business intelligence firm Cutting Edge Information.

According to the study, "Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes," the largest potential for financial impacts come from longer RBM trials -- often Phase 2 or Phase 3 studies. Surveyed companies report the greatest savings during Phases 3 and 4 -- at an average 21 percent and 22 percent total savings, respectively. These data are significantly impacted by an outlier, a device company reporting 80 percent total savings during Phases 1 and 4 -- the highest percentage saved by any company in any development phase.

This device company's reported savings influence the small and device company average as well as the overall average. Top 10 and Top 50 pharmaceutical companies reveal that their greatest savings occur during Phase 3 (where the longest trials typically happen) at 32 percent. Surveyed CROs report similar savings during Phases 3 and 4, following the overall trend. These companies average 21 percent and 23 percent savings from risk-based monitoring, respectively.

"Employing an RBM strategy will create new expenses like statistical monitoring programs and associated personnel," said Sarah Ray, Senior Research Analyst at Cutting Edge Information. "However, these costs pale in comparison to the savings that arise from reducing onsite monitoring throughout a clinical trial."

The study also includes:

  • Key steps to help implement RBM to help clinical operations executives reduce overall costs by balancing existing budget and staffing resources
  • Strategies to help clinical operations executives avoid implementing overly complicated RBM techniques
  • RBM framework and tactics to allow clinical teams to remotely track sites' progress during trials and map out clinical strategy well before trial initialization
  • Profiles of company that implement risk-based monitoring tactics

Do We Need A Culture Change Around Clinical Data?

On April 4, 2016, the editor of one of the nation’s top medical journals called for a “culture change” in the scientific community around clinical trials. Instead of solely glorifying researchers who author papers, scientists should also bestow reverence upon those who generate high-quality data sets for others to analyze.

 

Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine, said this was one of the main takeaways of a two-day summit held in Boston. The summit attracted 140 patients, data scientists, and researchers who conduct clinical trials. Thousands of others followed along via an online livestream.

The question of the day: What’s the right balance to strike between sharing data from those trials and keeping them private? The former might speed treatments and help patients. But some scientists have expressed some reticence to immediately share all their data, worrying that competitors will beat them to the punch of analyzing it.

NEJM has found itself in hot water before on this issue, when an editorial coauthored by Drazen raised the possibility of “research parasites” who don’t put in the work to do studies, but just leech off others’ data. Drazen later clarified that he was describing the concerns of other researchers who conduct clinical trials

Researchers wanted to make sure their data was being used responsibly, including that credit was given to its originators. They noted that sharing data costs money — and a blanket requirement to upload data could well result in a bunch of data sets that wouldn’t be used.

“It is going to come at a financial cost, and if the financial cost is not worth the benefit for all trials, we should invest that time, money, and energy into doing more clinical trials,” said PJ Devereaux, a professor at McMaster University who has run clinical trials. He supported making data from big, important clinical trials available, but questioned whether it was worth it for every study.

Others pointed out that if the data behind a scientific paper is shared, then other researchers can examine it and verify or disprove the conclusions.

House Bill Proposes 35 Percent Tax Credit For Research

A bipartisan bill that plans to allow a tax credit for expenses of contracted research—often done by CROs—has been introduced in the U.S. House of Representatives and was quickly hailed by the industry. The H.R. 1234 bill, also referred to as the Domestic Research Enhancement Act of 2017, intends to amend the Internal Revenue Code of 1986 by adding a tax credit for 35% of research expenses incurred by those doing researches under contracts.

The bill was introduced by Rep. Patrick Meehan, R-Pa., and cosponsored by two North Carolina congressmen Republican Rep. George Holding and Democratic Rep. G. K. Butterfield. North Carolina is home to several CRO giants, including: PRA Health Sciences, located in the state’s capital city Raleigh; INC Research, currently in the move from Raleigh to the nearby Perimeter Park complex in Morrisville; PPD, headquartered in Wilmington; QuintilesIMS, with its CRO businesses based in Durham; and Covance’s parent company LabCorp, which has its corporate HQs set in Burlington.

Pennsylvania also accommodates several CROs and at the same time sees many others, including the ones mentioned above, build offices and labs there. These CROs are cash cows for the states, producing billions of dollars in revenues each year. The newly merged behemoth QuintilesIMS, for example, reported revenue of $7.8 billion in 2016, while the former CRO Quintiles reported more than $4.32 billion for 2015. INC Research garnered about $1.03 billion in 2016, while PRA Health Sciences harvested $1.58 billion.

Doctors Are Key To Clinical Trial Diversity

Last year, 76 percent of clinical trial participants were white, according to FDA. Latinos, African Americans and Asians have long been underrepresented in these trials. The California Medical Association Foundation and its Network of Ethnic Physicians Organizations (NEPO) hope to change that through an initiative to educate them on the benefits of drug trials.

The foundation has distributed 350 posters to ethnic physician organizations and medical societies in California. The initiative also includes a public service announcement. As part of the initiative, doctors in NEPO are having more conversations with their patients about the benefits of drug trials.

Dr. Margaret Juarez, chair of NEPO, says trials are not limited to terminal illnesses. A patient not responding well to their diabetes medication could be eligible. "That could be an area of focus,” she says. “Perhaps there are certain medications that work in certain populations. We won't know until we ask the question and until we get the patients involved in the study."

Capital Public Radio previously reported that a lack of trust in the health care system is one reason why people of color may not try new treatments. Medical experiments like the Tuskegee Study of Untreated Syphilis in the Negro Male and the U.S. government sterilization of 3,406 American Indian women without their permission between 1973 and 1976 are just a couple of examples.

Can Mexico Become A Regional Powerhouse For Clinical Trials?

Located between the United States and Central America, Mexico’s geography and Spanish language put it in an ideal position to act as a gateway to Latin American pharmaceutical markets. With an estimated size of $10 billion in 2016, the country’s pharmaceutical market ranked twelfth globally, lagging behind only Brazil as the second biggest market in Latin America. Mexico has a stable economy, and although it is classified as upper-middle income, it also offers lower costs than other countries.

In Mexico, where healthcare is a constitutionally guaranteed right, most of its nearly 120 million citizens have some degree of coverage. A majority of citizens rely on a decentralized public sector to receive healthcare through three main institutions — the Mexican Social Security Institute (IMSS), Institute for Social Security and Services for State Workers (ISSSTE), and Seguro Popular (SP) — and three smaller institutions. In contrast, less than 10 percent of the Mexican population is covered by private health plans. The population is diverse and is experiencing an epidemiological transition from diseases typical of less-developed regions to chronic diseases associated with lifestyle such as diabetes. This variety increases the probability of successfully recruiting candidates for varied clinical trials. In addition, physicians in Mexico are highly specialized, many of them having received training in Europe or the United States.

The Mexican pharmaceutical market is dynamic, and most new treatments become available in the country within one to three years of their launch in more mature markets such as the U.S. or the EU. The regulatory processes for medicines are considered strong and are recognized worldwide: The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) is classified as a Level 4 national regulatory authority by the Pan American Health Organization/World Health Organization (PAHO/WHO) and has signed bilateral agreements with other regulatory agencies that recognize registrations made by COFEPRIS. As a result, having a registration issued by COFEPRIS brings important benefits for products seeking registration in markets such as Colombia or Chile.

However, there are several significant barriers to running clinical trials in Mexico. Approval of clinical trials usually takes a long time due to a complex regulatory process and shortage of specialized staff. As a result, pharmaceutical companies prefer to run trials in countries with faster approval processes than Mexico’s. COFEPRIS has been working on changing regulations and optimizing processes that would alleviate these barriers, and thereby increase the number of clinical trials in the country.

Does Patient Trust In Clinicians Improve Patient Satisfaction?

Patients who have more trust in their clinicians have better perceptions about the quality of the care they received and have higher patient satisfaction levels, according to a study published in the journal PLOS One.

In the age of patient-centered and value-based care, healthcare professionals have been hearing calls for more empathetic care that will instill better trust from their patients. Fostering a trusting patient-provider relationship has been lauded as a core tenet in better healthcare.

“Patients have to trust their health care professionals to work in their best interest and outcome,” the research team explained. “In this regard, trust in the health care professional has been suggested to be the foundation for effective treatments and fundamental for patient-centered care.”

But to what extent does a patient’s trust in his or her provider drive positive clinical outcomes? Does patient trust truly lead to a higher quality care experience? Patient trust only leads to more positive perceptions of care, the research team stressed, and not necessarily improved health metrics.

In a literature review of 47 qualitative analyses of the association between patient trust and clinical outcomes, the researchers found a small to moderate correlation between the two principles. However, the researchers identified some differences when breaking down various aspects of clinical outcomes.

There was no correlation between patient trust and objective clinical metrics, the researchers found. Additionally, there was no correlation between patient trust and observer-reported outcomes measures. Even so, there were at least moderate associations between patient trust and patient perceptions of care. There was a 0.3 correlation between patient trust and patient-reported outcomes, or a subjective review of clinical outcomes. There was also a notable correlation between trust and healthy behaviors, quality of life, and symptom severity.