Linda Smith has osteoarthritis in her knees. Wanting to avoid surgery, but needing relief, she went to ClinicalTrials.gov in search of a trial that might help her condition. She found a trial that she felt would fit the bill. But when she inquired, she got more bad news. The study involved stem-cells and to participate in the trial she would be responsible for costs totaling $14,000.
Smith’s story, reported in The Washington Post, brings to light some of the shortcomings of the National Institutes of Health (NIH) website, put in place to help patients locate applicable clinical trials. The ClinicalTrials.gov website, which has been in place for 16 years, does not provide information about charges to participants. It also does not vet any of the listings nor require sponsors to disclose potential costs.
“The site’s lack of transparency is a growing concern, in part because of the surge in stem cell research and clinics offering unproven, high-priced treatments, said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics. “It’s not just a handful of patients who are encountering these so-called studies on ClinicalTrials.gov and not just a handful of studies. It is a bigger problem than that.”
Rebecca Williams, the website’s assistant director, described it as primarily a clearinghouse, noting that just because a study is included does not necessarily mean it is endorsed by the federal government. ClinicalTrials.gov relies heavily on the honor system and is not legally required to verify information provided by study sponsors. She also notes there is no policy that would exclude for-profit studies from being included on the site.
Does Patient Opt-In Signal A Shift To Patient Empowerment?
The Statewide Health Information Network of New York (SHIN-NY) now has 8.8 million patients opting into its health information exchange (HIE). According to an article on PatientEngagementHIT, approximately 62,000 providers and millions of patients are now taking part in the statewide patient record look-up (sPLR). sPLR allows providers to access patient data across the exchange. The HIE warehouses 40 million patient records and processes more than 2.8 million transactions per month.
The article notes this opt-in approach shows higher levels of patient engagement, with patients taking the initiative to facilitate better health data exchange between themselves and their providers. With all stakeholders obtaining access to patient data, providers can more easily coordinate care and support positive patient outcomes.
“We are quickly approaching the moment when patients can be confident that health records from one provider can be viewed by another provider without having to transfer physical copies or faxing of documents,” says New York Health Commissioner Howard Zucker. The numbers show an improvement in trust amongst patients, providers, and interoperable health exchanges.
Fitbit Leads Wearable Technologies In Clinical Trials
Although Apple ResearchKit and high-end medical devices may be the future of wearable technologies in clinical trials, for the time being Fitbit is the fitness tracker of choice. Although some have questioned the accuracy of its heart rate and sleep data features, the device seems to be useful for a host of clinical trials.
An article on Wearable notes Fitbits, along with the research platform Fitabase, has been changing the way medical research is being conducted. Institutions including Johns Hopkins University and the University of Texas MD Anderson Cancer Center are among those who have chosen to tap into data from Fitbit users around the world. Fitabase has collected over 2 billion minutes of physical data over four years on behalf of research customers.
Aside from collecting huge volumes of data, Fitbit's trackers are also believed to be improving recruitment and retention for clinical studies. Apple and its ResearchKit medical research platform are also gaining traction with over 50 researchers and developers from across the world harnessing data from iPhone and Apple Watch users. Fitbit has shipped 36.7 million trackers since 2014, far eclipsing its rival fitness trackers.
Lack Of Clinical Trial Information Adds To Patient Stress & Low Recruitment
Las Vegas Valley physicians and patients say that in addition to the stress and pain of being sick, people with serious illnesses may also be suffering from a lack of information about their conditions. An article on ReviewJournal notes that amid recent emphasis by the National Institutes of Health (NIH) on clinical trials, members of the local research community say there’s a communication gap that prevents some patients from finding out about available experimental treatments.
“You can’t believe how difficult it is to convince the patients to go on a trial,” said Dr. James Sanchez, medical oncologist and practice director for the Comprehensive Cancer Centers of Nevada. Part of the issue seems to be the lack of publicity for locally offered trials. Patients will often have to hound their medical providers for more information before eventually being told about an available trial.
Sanchez notes there are other barriers to patient involvement, such as patients fearing they will be placed in placebo groups rather than receiving experimental treatments in early-stage trials. Some trials are also looking for specific participant profiles, meaning researchers will have to go through many volunteers before finding eligible candidates. This can delay research and possibly discourage individuals from seeking out other trials. The cost to patients can also become an issue depending on the trial and patients’ health insurance coverage.
India Lagging Behind In Clinical Research On Hepatitis
A clinical research body has said India is lagging behind in hepatitis research that is needed for the effective and affordable treatment of the infectious disease burdening the country. The Indian Society for Clinical Research (ISCR) said India has 17 percent of the global population and 20 percent of the global disease burden but less than 1.4 percent of all global clinical trials are done in India.
According to a report on IndiaTimes, India was never a country that had a high percentage of trials relative to the trials being done in the rest of the world. "It was not our objective to be the number one country in the region or globally for doing trials,” says Suneela Thatte, ISCR President. “What is important is that the trials being done in India are significant enough to address our growing disease burden and the unique healthcare requirements of our country. People living with viral hepatitis have a right to safe, affordable and effective care and treatment."
This year, the theme for World Hepatitis Day is “elimination.” WHO has set an ambitious target to eliminate the hepatitis as a public health threat by 2030. One of the five core intervention areas of the global elimination strategy is treatment, including new, well-tolerated medicines and treatment regimens for people with chronic hepatitis virus infection.