Lies and Deceit Plague Clinical Trials

Distracted by the COVID pandemic, clinical investigator sites that haven’t been paying attention to new privacy laws may find it difficult to conduct trials in 2021.

“Nine out of ten investigator sites in the U.S. don’t know anywhere near enough,” and “don’t have the right tools to be in compliance,” says an article on the Association Of Clinical Research Professionals blog.

An interview with Al O. Pacino II, president and CEO of BlueCloud by HealthCarePoint, discusses the details of two key privacy laws: the EU’s General Data Protection Regulation and California’s Consumer Privacy Act. Both impose significant restrictions on how personal data is collected, stored, used and shared. Both require businesses and organizations to inform individuals of the information they have and make it available to them. The California law exempts government and nonprofits.

In the European Union, the GDPR is supplemented by local privacy rules and, for clinical trials and medical data sharing, by organizational rules and governance. A study published in BMC Medical Informatics and Decision Making found enough lack of specificity and clarity among the privacy rules of each of the various study teams in just one EU program to give rise to challenges.

Noting that “Responsible data sharing in health research entails more than compliance with the GDPR,” the researchers found there was a need to reconcile local and individual investigative rules when creating “Big Data-driven translational research platforms” such as the BigData@Heart platform.

As in Europe, academic researchers in the US regularly share data. “The combination of even larger datasets into so-called ‘Big Data’ is considered to offer even greater benefits for science, medicine and society,” the Medical Informatics and Decision Making article observes.

With California’s privacy act – the toughest in the US – and other state laws now in effect and new ones under consideration, clinical researchers need to be aware of the rules, including the GDPR.

Investigator site leaders, says Pacino, must “understand modern laws and regulations that protect one’s personal data and privacy, learn how to take ownership of [their site data], and leverage modern e-vehicles that benefit healthcare professionals, sponsors, contract research organizations, and others.”    

Photo by Lianhao Qu on Unsplash

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Before the discovery of antibiotics, tuberculosis was the second most common cause of death in the US. Today, thanks to antibiotics, the few who contract the disease rarely die.

But as TB and other once-easily cured diseases grow increasingly antibiotic resistant, the very real fear is that medicine may run out of treatment options, leading to epidemics dwarfing COVID-19.

To head-off that kind of future, two dozen pharmaceutical firms have invested nearly $1 billion creating the AMR Action Fund with the goal of developing 2-4 new antibiotics by 2030.

AMR – antimicrobial resistance – arises when infectious disease pathogens become resistant to existing medicines. Tuberculosis is one of them, as are several others including the much publicized MRSA.

“AMR has the potential to render diseases that are relatively easy to treat today virtually incurable,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

“Left unchecked, AMR could significantly eclipse the global health challenge that the world is facing currently with COVID-19,” he said in a statement announcing the launch of the AMR Action Fund.

The initial funding pledges from the bioscience and drug firms – including $100 million pledged each by Johnson & Johnson and Pfizer – will be supplemented by non-industry partners, the Fund says on its website.

Explaining that “drug resistant bacteria are developing faster than new antibiotics can reach the market,” the Fund says there are few antibiotics in clinical development to meet current and anticipated needs. The reason is that the market for antibiotics “doesn’t support the level of investment needed to maintain a robust antibiotic pipeline.”

The website goes on to explain that smaller biotech firms have trouble financing trials of the antibiotics they do develop. Some that have developed new antibiotics “have declared bankruptcy or exited this space,” cautions the Fund, “Due to the lack of commercial sustainability, resulting in the loss of valuable expertise and resources.”

To achieve its goal of bringing to market the new antibiotics in a decade, the Fund said it “will invest in smaller biotech companies focused on developing new antibiotics that address the highest priority public health needs.”

Specifically, the AMR Action Fund will:

1. “Invest based on the WHO/CDC priority lists of pathogens, with the goal to address major unmet needs and maximize public health impact.
2. “Prioritize novel antibacterial treatments, as recognized by leading public health agencies, with significant and differentiated clinical utility and that reduces patient mortality.
3. “Invest across all stages of clinical development.”

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