Clinical News Roundup: GSK Uses Apple ResearchKit For Clinical Research
By Ed Miseta, Chief Editor, Clinical Leader
GlaxoSmithKline (GSK) is using Apple’s ResearchKit in a clinical trial for a rheumatoid arthritis study, marking the first time a major pharmaceutical company is using the Apple framework for medical research. ZDNet reports the study marks a major milestone for ResearchKit which, after its launch in March 2015, quickly piqued the interest of researchers and consumers.
ResearchKit is a framework for gathering health data from iOS devices for medical research. According to Apple CEO Tim Cook, just a few weeks after it launched, more than 60,000 people had signed up to participate in trials running on the system, giving researchers a relatively large group of participants to tap for clinical trials.
GSK built an app using ResearchKit for its Patient Rheumatoid Arthritis Data from the Real World (PARADE) study. The study isn't testing any medication -- instead, the pharmaceutical company is going to analyze the data it collects to determine what studies it should design to develop drugs more effectively.
The PARADE app will use iPhone sensors to track common rheumatoid arthritis symptoms like joint pain, fatigue, and mood. It will also track activity and quality-of-life metrics for 300 patients over a three-month period. Patients using the app can access and share their personal data via a dashboard.
EMA & EU Revise Guidance On First-In-Human Trials
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public comment. Comments on the proposals should be sent to FIH-rev@ema.europa.eu prior to September 30, 2016.
The release of the concept paper is part of a review of the EMA guideline published in 2007 that provides advice on first-in-human clinical trials, in particular, on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants. This review identified those parts of the current guideline which need to be amended to take into account the evolution of study practices since the guideline was first published. The review also takes into account the lessons learned from the fatal incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.
India Promotes Transparency In Clinical Research
India has been a hot spot for conducting clinical research. Now Computer World India reports that along with that growth has come technological evolution. India is promoting transparency in clinical research by giving up traditional pen and paper and moving to the cloud.
While electronic data capture (EDC) for clinical trial research is not a new phenomenon in India, the cloud is giving it a boost. This means costs are more manageable, which makes it viable for researchers and sponsors. But costs do vary from study-to-study on the basis of study volume and duration.
A transition from paper to software has brought in more than one benefit. For example, the Public Health Foundation of India (PFHI) carries out hundreds of studies. For PFHI, like most research firms, transparency and quality drug development is of utmost importance. The range of studies includes trials for mental health, cardiovascular diseases, tuberculosis, health financing, health economics, child health and pollution, cancer, and diabetes. The research is crucial, meaning downtime is not an option.
With the cloud, downtime is minimized and as an additional advantage, transparency is ensured. EDC comes with geo-tagging, meaning the location of the data entry is tracked. This makes data validation possible as well. In addition, the cloud has proven to be a boon when compared to traditional computing because it comes with reduced costs.
Sanford Clinical Trial Helps Prevent Vomiting In Chemotherapy
A new drug is now available that can reduce nausea and vomiting caused by chemotherapy, thanks to a national clinical trial that included Sanford Health sites in North Dakota and Minnesota.
The Daily Globe reports Sanford oncologist and cancer researcher Dr. Steven Powell of Sioux Falls was a leader in the study that used the drug olanzapine and found 75 percent of the 192 patients in the study had no nausea after taking one pill for four days after a chemotherapy treatment. Powell notes the new treatment will be the standard for use with cancer patients.
The pill is a generic, so in addition to reducing the likelihood of vomiting, it also comes at a low cost. The medicine, an FDA-approved antipsychotic agent most often used to treat people with schizophrenia, sells for only 50 cents per pill. Powell notes it is being phased out for treatment of mental illness because of the weight gain often associated with its use. It will now be “repurposed’ for the treatment of nausea for cancer patients.
Can Pharma Nudge Patients Into Clinical Trials?
Clinical trials are a vital part of the drug discovery process. No therapy makes it to market without patients first being willing to try the experimental drug. But finding willing patients is a struggle for pharma companies. According to ClinicalTrials.gov, there are now 220,000 trials taking place worldwide, with 81,000 of them in the U.S. alone.
With recruitment being a constant challenge, The San Diego Union-Tribune notes companies must sometimes resort to new and novel ways of getting patients to participate. Some are now offering cash, while others are doing their best to remove obstacles that might prevent participation. For example, Axovant Sciences, which is about to launch a study on a new Alzheimer’s drug, is offering patients free transportation to trial sites via the ridesharing service Lyft.
In addition, researchers believe other incentives should be tested scientifically, including non-cash rewards such as iPads, opt-out enrollment in low-risk trials, or even guaranteeing patients they will be informed about the clinical trial results. Any option will have potential benefits and drawbacks, and the researchers are urging companies to track outcomes to see what works best.
“Sometimes patients are not made aware of the clinical trials. They might not understand how clinical trials work. They might want more control over their medication regimen or how they’re going to proceed,” said Eric Van Epps, one of the researchers. He states patients may also be overwhelmed by the volume of paperwork required. While paperwork is necessary for legal and ethical reasons, Epps believes it’s possible to simplify the informed consent paperwork to make it more understandable and less intimidating.
Worldwide Clinical Trials Looks At Role Of CROs
A recent survey by Worldwide Clinical Trials reveals that 62 percent of respondents are more likely to engage a clinical research organization (CRO) partner for clinical research than they were five years ago. This demonstrates the increasingly vital role that CROs are playing in modern drug development and the importance of partnering with a CRO that offers medical and scientific expertise. Conducted at DIA 2016, the survey gauged the opinions of nearly 300 drug development leaders and executives from pharmaceutical and biotechnology companies who visited the Worldwide Clinical Trials booth during the DIA meeting.
In response to a question about the impact of innovative approaches from a CRO, almost a third (29 percent) of respondents said that innovation in overall trial management would have the greatest impact on clinical development, with just over a quarter (26 percent) saying that innovation in patient recruitment and retention would have the second biggest impact. When considering barriers to drug development, those surveyed by Worldwide Clinical Trials selected the cost of discovery research and clinical development, regulatory guidance, and the risk associated with the clinical development process as the most critical issues.