NEWS ROUNDUP: Precision Medicine And Patient Data, FDA Accuses CRO Of Data Fudging
By Ed Miseta, Chief Editor, Clinical Leader
Will Precision Medicine Compromise Patient Data?
Patient data lies at the heart of precision medicine. But will concerns over privacy and unanticipated use cause problems for large-scale research efforts?
An article on the website Health IT Analytics notes the Precision Medicine Initiative (PMI) is generating a lot of excitement among researchers, patients, and developers. Potential benefits include curing cancer, managing diabetes, and eliminating Alzheimer’s disease. The Precision medicine movement has also received the attention of the current presidential administration and commitment from top federal agencies. But, finding cures to these diseases also requires patients to entrust their personal data to researchers and data banks.
“Understanding the nation’s changing attitudes towards consent and data sharing – and developing regulations that are both firm and flexible to meet future challenges – will be essential if the healthcare industry is to continue building the foundations of a system that can truly harness what precision medicine has to offer,” notes Director of Editorial Jennifer Bresnick. “Just getting to the point of turning the PMI into a national effort has taken years of difficult, anonymous, and often under-funded work.”
While precision medicine efforts can result in medicines that save countless lives, bad practices can turn into insurmountable roadblocks. Bresnick states one problem is the growing disconnect between current patient privacy regulations, like HIPAA, and the quickly evolving opinions of the public, with many patients now sharing personal information across social media and the internet. There is also the problem of a genetic profile being unique to an individual. Ultimately, it can be matched back to a person even if their name and address are not included in a file.
Precision medicine researchers also run into problems when it comes to reusing patient data for future projects. Patients may not always be aware of how their information will be used in additional studies, nor do they always have control over where their data might end up.
FTC Helps Mobile Health App Developers Understand Laws/Regulations
The Federal Trade Commission (FTC) has announced the creation of a web-based tool designed to assist developers of mobile health apps with identifying and understanding federal laws and regulations that might apply to their apps. The tool was developed in conjunction with other health-related federal regulators, including the Department of Health and Human Services, the Office for Civil Rights, and the FDA.
By answering developers a series of 10 “yes/no” questions related to their app, the tool identifies and describes 4 potentially applicable federal laws and regulations. The questions relate to an app’s function, the data it collects, and services provided. The four laws/regulations are HIPAA, the Federal Food, Drug, and Cosmetics Act, the Federal Trade Commission Act, and the FTC’s Health Breach Notification Rule.
While the tool does not provide legal advice about compliance obligations, it does give a snapshot of important laws and regulations and is meant to be a starting point for app developers.
The FTC also has a set of best practices for developers that fall into eight areas, including limiting access, minimizing data, security by design, and communicating with users.
A Dilemma For Editors: Retrospectively Registered Clinical Trials
Prospective clinical trial registration aims to address bias in reporting and publication. But Stephanie Harriman, editor at BioMed Central, reports not all clinical trials are registered before they begin. This creates a dilemma for editors, who must then make a decision on the credibility of a study.
When a trial is registered before the first participant is enrolled, there is a publically available record of the intentions of the researcher. This includes details on the number of patients needed, proposed/potential outcomes, and how the outcomes will be measured.
“The existence of this publicly available record is vital to address the well-documented problems of publication bias and reporting bias,” says Harriman. “Without prospective trial registration, researchers could decide to change their outcomes once they have analyzed their results, omit results that don’t ‘fit’ with their hypotheses, or not publish them at all if they really don’t like what they find.”
How widespread is retrospective registration? Harriman and colleague Jigisha Patel performed research to discover the extent to which it existed. They looked at all clinical trials published in a one-year period in the BMC series. To their surprise, Harriman and Patel found retrospective registration widespread and prevalent in journals. Sixty-seven percent of the studies identified were registered retrospectively, with the registration delay ranging from a few days after enrollment of the first participant to registration after submission to the journal.
More Clinical Trials Needed For Stem Cell Research
New Straits Times Online reports more clinical trials and public forums are needed to advance stem cell therapies for the treatment of disease. In Malaysia, a plethora of new products are available with stem cell branding. But while media and websites are abuzz with the application of these therapies, most of the research is ongoing and still in the clinical trial phase.
Clinical trials are necessary to ensure new treatments are safe and effective. New treatments must also pass all stages of the clinical trial process to be regulated in accordance with the guidelines of the national health authorities. Although early results indicate patients receiving stem cell treatments showed a lower rate of heart-related problems, more research must still be performed.
The article notes a science blog reported a nine-year-old boy had stem cells injected into various regions of his brain to treat a crippling disease and was diagnosed with a brain tumor a few years later. This is the potential danger of patients seeking unproven treatments.
“Continuous engagement between researchers and the public is necessary to restore the trust and confidence of the latter on issues concerning healthcare and research funding, besides making the information synchronized and readily accessible to the public so that society is able to make informed decisions regarding the treatments they wish to undergo,” notes S. Mathana Amaris Fiona, author of the report.
New Patient Engagement Tools Enhance Patient Compliance
Bracket has announced upgrades to its eCOA and RTSM platforms to support SMS messaging with patients and other stakeholders participating in clinical research programs. The updates promise to expand the medication compliance and adherence functionality across the Bracket eClinical portfolio, as well as provide an effective solution to support patients participating in trials.
The growing importance of patient engagement programs has made patient communication tools an essential component of any clinical trial. Text messaging has also become an effective and scalable tool for improving medication adherence with patients. With text messaging, patients can be reached in a confidential and unobtrusive manner, resulting in an instantaneous relay of information. A recent JAMA study found a 50 percent increase in patient adherence rates when text messaging was used, along with a high acceptance and satisfaction level among participants.
The mobile text messaging platform can also be used to issue alerts to clinical sites, study sponsors, and CROs working with the Bracket RTSM and eCOA tools.
FDA Accuses Indian CRO Of Data Fudging
The FDA has accused Semler Research, a Bangalore-based contract research organization, of fudging data while performing clinical research on drugs for pharmaceutical companies. The FDA released a statement specifying the discovery of serious violations of federal regulations, including the substitution and manipulation of study samples during inspections at the facility conducted in the fall of 2015.
The findings will alarm companies that had research performed at the facility. The FDA notes there are data integrity concerns over drugs that had research performed by Semler, and that and that NDAs and ANDAs based on that research have been rejected. Sponsor companies affected by the decision have been notified and asked to repeat the clinical research performed by Semler. Thus far, no serious safety concerns have been identified as a result of the improprieties.
The International Business Times reports the company is reviewing the concerns and would provide a detailed response after consulting with data experts. Several Indian pharma companies, including Emcure Pharma and Alkem Laboratories, recently received warning letters from the FDA and EMA in regard to data fudging in clinical trials.