NEWS ROUNDUP: Pharma Invests In Patients, More Trials Use FitBit Trackers
By Ed Miseta, Chief Editor, Clinical Leader
Pharma Makes Greater Investments In Patients
A report produced by Accenture, titled “The Patient Is In: Pharma’s Growing Opportunity In Patient Services,” finds 84 percent of U.S. pharma companies plan to make greater investments in areas expected to improve the overall patient experience. The results were gathered from over 200 survey responses of executives in the U.S. and Europe working across seven therapeutic areas. The study was fielded in the fall of 2015 and primarily involved individuals working in the areas of patient services.
The report noted three key findings:
- Patient services are delivering value today, with significant increases in focus and investment expected over the next two years.
- Significant investment is expected to be made in digital engagement technologies and supporting analytics.
- Much of the investment is expected to be aligned with what patients’ value.
The greatest increases in investment, expected to be between 77 percent and 100 percent, are in benefit coverage and access support, transportation arrangements, engagement insight development, and health coaches/counselors. The patient services outcome objectives cited as most important are improved patient outcomes, improved healthcare professional relationships, and improved patient satisfaction.
FitBit Activity Trackers Gain Acceptance In Trials
Despite reports questioning the accuracy of data collected by FitBit activity trackers, the devices are gaining acceptance in clinical trials. Last month MobiHealthNews published a list of 21 clinical trials using FitBit trackers. Additional research has now discovered 18 more trials utilizing the devices.
Bayer, the Hospital for Special Surgery, Mount Sinai Medical Center, York Teaching Hospitals, NHS Foundation Trust, and 15 universities including Yale, Northwestern, UC Davis, Emory, and Florida State are all conducting FitBit-enabled trials. The studies involve using the devices for everything from diabetes and heart health to lupus and dementia.
New Hep C Combination To Begin Trials in Malaysia And Thailand
Aidsmap.com is reporting on a new hepatitis C combination that is ready to enter clinical trials. The DNDI (Drugs for Neglected Diseases Initiative) is set to launch clinical trials in Malaysia and Thailand that will test a combination of sofosbuvir and ravidasvir in at least 800 subjects with hepatitis C virus (HCV). Pharco, an Egyptian company, is manufacturing the combination treatment. If found to be safe and effective, a course of the treatment could be made available to patients for $300.
Ravidasvir, an NS5A inhibitor, has already been studied in patients with genotype 4 HCV infection in Egypt. Its combination with sofosbuvir was found to cure between 86 percent and 100 percent of patients, depending on the duration of treatments and whether ribavirin was included in the treatment regimen. The new studies will compare results with sofosbuvir and daclatasvir, the only currently recommended pangenotypic combination.
Prostate Cancer Requires More Clinical Trials
The NIH’s National Cancer Institute estimates close to 2.8 million men are living with prostate cancer in the U.S. alone. Each year another 138 out of 1,000 men are diagnosed, and 21 out of 100,000 will die. The good news is the survival rates have been increasing, with the five-year survival rate now at 98.9 percent. That success has been made possible by clinical trials.
Prostate Cancer News Today reports treatments include drugs, hormonal therapy, chemotherapy, radiation, and surgery. But all treatment options must first be tested in actual prostate cancer patients before being granted approval by the FDA, thereby highlighting the need for clinical trials.
“Despite successes in the treatment of prostate cancer, new treatments and studies are still needed,” says Ana de Barros, PhD. ”Clinical trials are a necessary mechanism that can help advance research, and they are a legally required step for new treatments to advance and eventually be approved for use by physicians and patients.”
Pancreatic Cancer Survival Rates Higher In Clinical Trials
Curetoday.com is reporting pancreatic cancer survival rates are higher in patients participating in clinical trials than they are in the real world. The research, presented at the 2016 Gastrointestinal Cancers Symposium, notes patients in clinical trials have “profoundly improved survival.”
The research showed as much as a 92 percent difference in median overall survival (OS) between patients treated in randomized controlled trials and “real world” data from the Surveillance, Epidemiology, And End Results (SEER) database. Patients treated in clinical trials also had a 72.2 percent increase in two-year OS rates compared with the SEER findings.
For the study, researchers conducted a literature search of Phase 3 trials published between 2005 and 2012 for patients with pancreatic cancer. Findings from the clinical trials were compared with patients from the SEER program, matching for diagnosis year, age, and stage of disease.
Clinical Trials Need More Patients
This week the Wall Street Journal reported what most of you already know: Clinical trials are in need of more subjects. In an article, WSJ writer Laura Landro points to studies showing fewer than 10 percent of Americans participate in clinical trials, with the number falling to just 3 percent to 5 percent for cancer patients. Unfortunately, many patients are not aware that trials are a treatment option for them and too many physicians may not be suggesting them. In fact, the rate at which researchers are able to recruit and retain patients is at an all-time low.
Landro notes the problem is not simply ignorance. Many patients do not trust the research process, a situation not helped by media portrayals of subjects being treated as guinea pigs. For those patients who do get involved, complicated protocols and eligibility requirements can be a turn off. As a result, 40 percent of trials do not meet their recruitment goals.
The NIH is working to make the purpose, risks, benefits, and time requirements of trials more transparent. The Clinical Trials Transformation Initiative (CTTI), a public-private consortium co-founded by the FDA and Duke University, is preparing to issue new recommendations to researchers. It is urging them to work more closely with all stakeholders involved in the clinical trial process, including patients and advocacy groups.
CTTI recommends, at a minimum, that patients be asked what questions are important to them, how many procedures they are willing to tolerate, and how written consent forms can be improved.
Trust in a physician is a main reason many patients decide to participate in a trial, while others are swayed by a desire to help advance the research on their disease. Additionally, social media is increasingly becoming a way for researchers to recruit patients.
NYT: Make The Most Of Clinical Trial Data
The opinion page of The New York Times has made a pitch for pharma to make better use of clinical trial data. The editorial board opinion piece notes data from a trial can be used to draw new conclusions about a disease long after the study has ended. Unfortunately, researchers rarely take advantage of these data resources even though access to these valuable data sets is available. In some cases, a reanalysis of the original data can even reveal problems with the original analysis.
Today, many large pharma companies make their clinical trial data available, while as many academic institutions and smaller companies do not. Even when that data is available, its use by outside researchers is rare. “A recent study found that on three data-sharing platforms, researchers had requested access to the data from just 15.5 percent of the trials available,” notes the editorial.