Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 03.09.2020

MedicalResearch.com Interview with: Yin Zhang MD Research Fellow in Medicine Brigham and Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Among modern hair dyes, permanent hair dye is the most popular type, and is the most aggressive and extensively used type that has posed the greatest potential concern about cancer risk. Monitoring and investigating the carcinogenic hazard to people from personal use of permanent hair dyes has major public health implications. In 2008, the World Health Organization's International Agency for Research on Cancer, after comprehensive reviewed prior evidence, classified occupational exposure to hair dyes as a probable carcinogen to humans (group 2A), whereas personal use of hair dyes was not classifiable as to its carcinogenicity to humans (Group 3). Data on hair dye safety has also been continuously monitored by the USFDA. Prior epidemiological evidence may have been influenced by not discriminating between personal and occupational exposure, an inability to distinguish types and colors of hair dyes used, imprecise assessment of several critical domains of exposure history (duration, frequency and cumulative dose), and inadequate control for potential confounding. (more…)
Accidents & Violence, Author Interviews, Brigham & Women's - Harvard, Emergency Care, JAMA, Surgical Research / 01.09.2020

MedicalResearch.com Interview with: Sarabeth Spitzer, MD Co-Chair of Board, Scrubs Addressing the Firearm Epidemic (SAFE) Department of Surgery, Brigham and Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Firearm injury is a significant cause of morbidity and mortality in the United States, resulting in almost 40,000 deaths annually in the United States, but very little is known about the epidemiology of nonfatal firearm injuries. Nonfatal firearm injuries can have significant long-term morbidity and are associated with significant cost. We found that there were over 81,000 nonfatal firearm injuries in California over the study period. Over the period, there was a decrease in nonfatal firearm injuries by 38.1%, driven primarily by a decrease in assault injuries.   (more…)
Author Interviews, Brigham & Women's - Harvard, Gastrointestinal Disease, Technology / 27.08.2020

MedicalResearch.com Interview with: Giovanni Traverso, MB, BChir, PhD Gastroenterologist and biomedical engineer Division of Gastroenterology at BWH Instructor of medicine at Harvard Medical School MedicalResearch.com: What is the background for this study? Response: We began working on this project with the goal to develop liquid drug formulations that could offer an easier-to-swallow alternative to capsules, especially for children. We started to think about whether we could develop liquid formulations that could form a synthetic epithelial lining that could then be used for drug delivery, making it easier for the patient to receive the medication by providing drugs in extended release formats. We discovered that an enzyme called catalase could help assemble molecules of dopamine into the polymer (poly-dopamine). These polymers have muco-adhesion properties, which means that after polymerization, the polymer can attach to the tissue very strongly. Also, catalase is found throughout the digestive tract, with especially high levels in the upper region of the small intestine. This is the first example, to the best of our knowledge, of small intestinal targeting system enabled through in-situ tissue-enzyme-catalyzed polymerization. The coating lasts up to 24 hours, after which it is shed and excreted based on experiments we conducted in pigs. (more…)
Author Interviews, COVID -19 Coronavirus, NYU, Rheumatology / 26.08.2020

MedicalResearch.com Interview with: Dr. Fernandez-RuizRuth Fernandez-Ruiz, MD Post-Doctoral Fellow Department of Rheumatology NYU Langone Heath  MedicalResearch.com: What is the background for this study? Response: Patients with systemic lupus erythematosus (SLE) represent a unique population in considering risk for COVID-19 with biologic, genetic, demographic, clinical and treatment issues at play. By the nature of their chronic inflammatory autoimmune condition, the presence of comorbidities, and regular use of immunosuppressants, these individuals would traditionally be considered at high risk of contracting SARS-CoV-2 and possibly having worse outcomes from the viral infection. However, it might be speculated that inherently elevated type I Interferon, characteristic of the majority of patients with SLE, confers a protective effect as a first line anti-viral defense. Additionally, hydroxychloroquine, which was suggested as a potential therapeutic agent for COVID-19 early on, is used in most patients with SLE. Accordingly, we initiated this study to provide critical data needed to address the frequency and severity of COVID-19 in patients with SLE. (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, JAMA, Social Issues / 21.08.2020

MedicalResearch.com Interview with: Monik Carmen Jimenez, Sc.D Assistant Professor of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: We wanted to get a comprehensive picture of the epidemiology of COVID-19 in carceral facilities that included jails and was not restricted solely to prisons. We utilized publicly available data collected in Massachusetts, pursuant to a court order. These data included prison and jail systems and were used to calculate rates of confirmed cases of COVID-19 and testing rates among incarcerated individuals. We were also able to compare those to changes in the population size within each system. (more…)
Author Interviews, Genetic Research, Nature, NYU / 17.08.2020

MedicalResearch.com Interview with: Professor Aneel K Aggarwal, PhD Pharmacological Sciences and Oncological Sciences Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: DNA polymerase ζ  (Pol ζ) is the crucial enzyme that allows cells to cope with DNA damage resulting from exposure to environmental and industrial carcinogens and to other daily genotoxic stresses. At the same time, Pol ζ has emerged as an important target for discovery of therapeutics in the treatment of chemotherapy-resistant cancers.  MedicalResearch.com: What are the main findings?   Response: We have succeeded in resolving the 3-D atomic structure of the complete Pol ζ enzyme using cryo-electron microscopy. (more…)
Author Interviews, HIV, University of Pittsburgh / 14.08.2020

MedicalResearch.com Interview with: James Egan, Ph.D., M.P.H. Assistant Professor Behavioral and Community Health Sciences Pitt Public Health MedicalResearch.com: What is the background for this study? Response: When taken as a daily pill, pre-exposure prophylaxis (PrEP) reduces the risk of getting HIV from sex by about 99%, according to the Centers for Disease Control and Prevention. However, adhering to a daily medication regimen doesn’t work for everyone for reasons that include cost and individual concerns about the biological consequences of long-term medication. Previous studies have shown that there are certain periods when some men who have sex with men may be more vulnerable to contracting HIV, including when traveling, on vacation, moving to a new city or after a break-up. Our team set out to explore whether these men might be more receptive to adhering to PrEP treatment during these times. We followed 48 adult men from Pittsburgh or Boston who have sex with men in a pilot program to test the daily use of PrEP for 30 days that included an out-of-town vacation, with the men starting the medication seven days before the trip and continuing for at least seven days after vacation. The men were also given a brief session introducing them to the use of PrEP and discussion adherence. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology, JAMA / 14.08.2020

MedicalResearch.com Interview with: Maryam M. Asgari, MD MPH Professor Department of Dermatology, Massachusetts General Hospital Department of Population Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? What are Topical Calcineurin Inhibitors used for?  Response: Topical calcineurin inhibitors (TCIs) are FDA approved for the treatment of atopic dermatitis (though they are used off-label to treat a wide range of inflammatory conditions of the skin, including psoriasis, seborrheic dermatitis, and contact dermatitis).  There are currently two drugs available – tacrolimus and pimecrolimus – both of which carry a black box label warning users about the potential for increased skin cancer risk.  The risk associated with keratinocyte carcinoma, the most common cancer (defined as basal cell carcinoma and squamous cell carcinoma), remains poorly defined because findings from large-scale post-marketing surveillance studies are lacking.  (more…)
Author Interviews, Heart Disease, JAMA, Lipids, Metabolic Syndrome, UCSF / 12.08.2020

MedicalResearch.com Interview with: Prakash Deedwania, MD, FACC,FAHA,FASH,FHFSA,FESC Professor of Medicine, UCSF School of Medicine, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Response: This paper describes the findings form the FOURIER study, a very large study evaluating the efficacy of evolocumab, a PCSK9 inhibitor in patients with metabolic syndrome and preexisting atherosclerotic cardiovascular disease (ASCVD) who were already being treated with statins. In this largest study of its kind of 27,000 patients we found that 60% of patients with ASCVD had metabolic syndrome. We also found that the presence of metabolic syndrome identified a higher risk of future cardiac & coronary events in these patients despite them receiving maximum tolerated doses of statin. Furthermore, study treatment with evolocumab was efficacious in reducing the increased risk during the median follow up of nearly 3 years . Unlike treatment with statins there was no risk of new-onset diabetes with evolocumab, which was generally well tolerated. What was interesting thatpatients without metabolic syndrome had much less benefit with PCSK9 inhibition. These findings suggest that the presence of metabolic syndrome can help the clinicians identify the ASCVD patients who are most likely to benefit from treatment with PCSK9 inhibitors. This will be of great help for the cost containment of therapeutic strategy as PCSK9 inhibitors as a class are still quite expensive drugs. (more…)
Alzheimer's - Dementia, Author Interviews, Blood Pressure - Hypertension, Neurology, UCSF / 10.08.2020

MedicalResearch.com Interview with: Laure Rouch, PharmD PhD Department of Psychiatry Dr. Kristine Yaffe, MD (Senior Author) Departments of Psychiatry, Neurology, and Epidemiology University of California San Francisco, San Francisco VA Medical Center, San Francisco, CA, USA MedicalResearch.com: What is the background for this study? Response: Worldwide, around 50 million people have dementia and this number is set to triple by 2050. Prevention of dementia and identification of potentially modifiable risk factors are, therefore, critically important. Postural changes in blood pressure increase with advancing age and affect 20% to 30% of older adults. Yet it has not been explored deeply how orthostatic hypotension and blood pressure postural changes variability over time are associated with dementia risk. As multiple pharmacologic and nonpharmacologic interventions may improve orthostatic symptoms, this question has major public health implications. (more…)
Author Interviews, NYU, Orthopedics / 10.08.2020

MedicalResearch.com Interview with: Bruce N. Cronstein, MD Paul R. Esserman Professor of Medicine NYU School of Medicine Director, NYU-H+H Clinical and Translational Science Institute Director, Division of Translational Medicine NYU Langone Health New York, NY 10016  MedicalResearch.com: What is the background for this study? Response: Osteoarthritis is the most common type of arthritis affecting about 10% of the adult population and 25% of the population over 60. We had previously found that adenosine, a molecule generated by nearly all cell types, is critical for maintaining cartilage health by activating specific adenosine receptors on the surface of cells (A2A receptors). Moreover, giving adenosine into the joint could prevent deterioration of cartilage (progression of osteoarthritis) in a rat model of osteoarthritis. Because people do not usually go for treatment of osteoarthritis until they have developed symptoms we asked whether administration of adenosine or adenosine that had been modified to be a more potent and specific stimulus for A2A receptors, carried in fat bubbles called liposomes, could reverse osteoarthritis after it had already started. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, University of Pennsylvania / 09.08.2020

MedicalResearch.com Interview with: Genevieve Kanter, PhD Leonard Davis Institute of Health Economic Research Assistant Professor, General Internal Medicine, Assistant Professor, Medical Ethics and Health Policy Perelman School of Medicine MedicalResearch.com: What is the background for this study? Response: With the resurgence of COVID-19 and the likely seasonal resurgences, we were interested in whether those in low-income areas would be able to get access to the hospital care they might need. So we examined the distribution of ICU beds across the country and also looked at differences in the availability of ICU beds by household income in the community.  (more…)
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, Race/Ethnic Diversity, Social Issues / 03.08.2020

MedicalResearch.com Interview with: Marc Weisskopf, PhD, ScD Cecil K. and Philip Drinker Professor of Environmental Epidemiology and Physiology Departments of Environmental Health and Epidemiology Harvard T.H. Chan School of Public Health Boston, MA 02115  MedicalResearch.com: What is the background for this study? Response: There is a long history of health disparities by race. We were interested to see whether these also show up in professional football players, with the thought that perhaps the advantages that come with being an elite athlete in a sport (e.g. related to income, potential access to carte, prestige) might minimize health disparities. (more…)
Author Interviews, Dermatology, FDA, Regeneron, Sanofi / 31.07.2020

MedicalResearch.com Interview with: Elizabeth Laws, PhD Vice President and Global Project Head for Dupilumab/Dupixent Sanofi Marcie Ruddy, MD, MA Strategic Program Direction, Immunology and Inflammation Regeneron  Dr. Laws and Dr. Ruddy discuss the FDA approval of a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab) for all indications in patients aged 12 years and older.   MedicalResearch.com: What is the background for this announcement? What are the main indications for Dupixent? Response: Until now, Dupixent 300 mg dose was available only in pre-filled syringe for administration. The approval of the pre-filled pen provides an additional, easy-to-use option for patients to self-administer Dupixent. Dupixent is approved to treat patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis (AD) and can be used with or without topical treatments. Dupixent is also approved for use with other medicines for the maintenance treatment of uncontrolled moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older, and with other medicines for the maintenance treatment of uncontrolled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, respectively. The pre-filled pen is approved for use in patients prescribed Dupixent who are 12 years of age and older across current indications, at the 300 mg dose. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, JAMA / 28.07.2020

MedicalResearch.com Interview with: Frank Wharam, MD, MPH Department of Population Medicine Harvard Medical School and Harvard Pilgrim Healthcare Institute Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response:  There is substantial concern that high-deductible health plans increase people’s risk of major adverse health events such as heart attack and stroke. No studies have examined this question. This study examines the effects of a transition to a high-deductible health plan on the risk of major adverse cardiovascular outcomes (myocardial infarction and stroke). The study group included individuals with risk factors for cardiovascular disease who were continuously enrolled in low-deductible (<$500) health plans during a baseline year followed by up to 4 years in high-deductible (≥$1000) plans after an employer-mandated switch. The matched control group included individuals with the same risk factors who were contemporaneously enrolled in low-deductible plans.  We examined time to first major adverse cardiovascular event, defined as myocardial infarction or stroke.  (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Osteoporosis / 28.07.2020

MedicalResearch.com Interview with: Daniel Hal Solomon, MD, MPH Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Rheumatology, Immunology Boston, MA 02115 Editor’s note: Prolia® is the trade name for denosumab.  MedicalResearch.com: What is the background for this study? Response: We conducted this study to assess whether delays in denosumab (injections were associated with an increased risk of fractures. In a prior study, we found that the improvements in bone mineral density were reduced among patients who delayed injections. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dental Research, Esophageal, Gastrointestinal Disease / 24.07.2020

MedicalResearch.com Interview with: Mingyang Song, MD, ScD. Division of Gastroenterology Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School Department of Nutrition and Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: Recent studies showed a presence of dysbiotic oral microbiome in patients with esophageal and gastric cancer, suggesting a link between oral health and these cancers. However, how periodontal disease and tooth loss may influence the risk of these cancers has been inconsistent.  MedicalResearch.com: What are the main findings? Response: Our findings support a possible role of oral health in the development of upper GI cancer. Individuals with periodontal disease and tooth loss are at higher risk of developing esophageal and gastric adenocarcinoma. The risk is particularly high for individuals with both periodontal disease and tooth loss.  (more…)
Author Interviews, Columbia, COVID -19 Coronavirus, Kidney Disease, Transplantation / 09.07.2020

MedicalResearch.com Interview with: Syed Ali Husain, MD, MPH Assistant Professor of Medicine Division of Nephrology, Department of Medicine Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital The Columbia University Renal Epidemiology Group New York, New York  MedicalResearch.com: What is the background for this study? Response: One group of patients thought to be at a high risk of severe COVID-19 manifestations is kidney transplant recipients, since they take medications that suppress their immune system and they often have other medical problems that have been associated with severe infection. We wanted to understand whether it is safe to manage kidney transplant recipients who develop COVID-19 as outpatients, without admitting them to the hospital. (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Lipids / 08.07.2020

MedicalResearch.com Interview with: Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Assistant Professor of Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Statins are cholesterol lowering medications that have been proven to prevent heart attacks, strokes and death in middle-aged adults. Current guidelines for cholesterol lowering therapy are uncertain as to treatment for older adults due to a lack of available data, even though older adults are at the highest risk of heart disease and death. (more…)
Author Interviews, JAMA, Sleep Disorders, Stanford / 07.07.2020

MedicalResearch.com Interview with: Eileen B. Leary, Ph.D. Student Epidemiology and Clinical Research Stanford University MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by REM sleep? Response: Sleep is a regulated, reversible, and recurring loss of consciousness that is a critical requirement for a happy, healthy life. REM sleep is an important component of sleep defined by rapid eye movements and commonly associated with dreaming. We learned from previous studies that sleep duration is associated with mortality, however little was known about how the different sleep stages relate to timing or cause of death. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Sleep Disorders / 01.07.2020

MedicalResearch.com Interview with: Dr. Rebecca Robbins, PhD MS Fellow at Brigham & Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Sleep difficulties are common among older adults and are associated with cognitive decline. We used data collected over 10 years from a large, nationally representative longitudinal survey of adults over the age of 50 in the U.S. We examined the relationship between specific sleep difficulties and cognitive function over time. MedicalResearch.com: What are the main findings?  Response: Our results show that early difficulty falling asleep and early morning awakenings, when experienced "most nights" of the week, were each associated with worse cognitive function. Conversely, reports of waking feeling rested was associated with better cognitive function, over time.   (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, NEJM, Pediatrics / 24.06.2020

MedicalResearch.com Interview with: Christopher P. Landrigan, MD, MPH Chief, Division of General Pediatrics, Boston Children’s Hospital Director, Sleep and Patient Safety Program, Brigham and Women's Hospital William Berenberg Professor of Pediatrics, Harvard Medical School Boston Children's Hospital Boston, MA 02115 MedicalResearch.com: What is the background for this study? Response: An enormous body of literature demonstrates that sleep deprivation adversely affects the safety and performance of resident physicians, as well as individuals across other occupations.  Resident physicians are at greatly increased risk of suffering motor vehicle crashes and needlestick injuries, and are at substantially increased risk of making medical errors, when working on traditional schedules that include 24-hour shifts. We previously conducted a randomized controlled trial in two intensive care units that found resident physicians made 36% fewer medical errors when a scheduling intervention was introduced that eliminated 24-hour shifts but held resident workload constant. The current study, ROSTERS, was a 6-center study that again introduced a scheduling intervention to eliminate 24-hour shifts in intensive care units.  Due to varying resources and unit organization across sites, each hospital developed its own staffing plan to accommodate the intervention​. (more…)
Accidents & Violence, Author Interviews, Cannabis, JAMA, NYU / 23.06.2020

MedicalResearch.com Interview with: Julian Santaella Tenorio, MSc DrPH Epidemiology Center for Opioid Epidemiology and Policy Division of Epidemiology, Department of Population Health New York University Langone School of Medicine, New York, New York MedicalResearch.com: What are the main findings? car-accident-traffic-accidentResponse: This study found that recreational cannabis laws were associated with increases in traffic fatalities in Colorado (mean of 75 excess fatalities per year) but not in Washington State.  These findings suggest that unintended effects of recreational cannabis laws can be heterogeneous and may be specific to variations in how these laws are implemented
(eg, density of recreational cannabis stores).   (more…)
Author Interviews, Heart Disease, JAMA, Opiods, Surgical Research, University of Pennsylvania / 20.06.2020

MedicalResearch.com Interview with: Chase Brown, MD Associate Fellow, Leonard Davis Institute of Health Economics Integrated Cardiac Surgery Resident Hospital of the University of Pennsylvania Nimesh D. Desai, MD, PhD Director, Thoracic Aortic Surgery Research Program Associate Professor of Surgery Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Dr. Chase Brown:  Opioid use in the United States is a public health emergency. We know that opioids prescribed after general surgery operations to patients who never received them within the year prior to their surgery are at increased risk for continuing to take opioids months later. However, this has not been studied in patients undergoing cardiac surgery, who often times have more severe post-operative pain. Our goal in this study was to determine how many patients after cardiac surgery and are opioid naive are continuing to take opioids within 90-180 days after their surgery.   (more…)
Author Interviews, Diabetes, Duke, Telemedicine / 15.06.2020

MedicalResearch.com Interview with: Matthew J. Crowley, MD Core Investigator, Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) Affiliated Investigator, VA Office of Rural Health Staff Physician, Endocrinology Section, Durham VA Health Care System Elizabeth Kobe, BS Medical Student Durham VA Health Care System Duke University School of Medicine MedicalResearch.com: What is the background for this study? With whom were the telehealth sessions performed? (MDs, PAs, Dieticians etc). Response: Diabetes management in rural populations is especially challenging due to limited access to specialty care and self-management programs. Telehealth is a potential strategy for extending high-quality diabetes care to rural areas. The Veterans Health Administration (VHA) has a robust Home Telehealth (HT) system that is currently used for telemonitoring patient blood glucose values. In order to address the challenges of managing diabetes in rural areas in a clinically feasible manner, we strategically designed an intensive diabetes management intervention – Advanced Comprehensive Diabetes Care (ACDC) – for delivery using existing VHA HT infrastructure and clinical staffing. ACDC is a 6-month telehealth intervention that combines telemonitoring with module-based self-management support and medication management. ACDC is delivered entirely by existing clinical staff (a clinical HT nurse and a medication manager (typically a PharmD)) through bimonthly, 30-minute calls. Our initial randomized controlled trial found that ACDC improved HbA1c by a clinically and statistically significant  -1.0% relative to usual care at 6 months, while also improving blood pressure and diabetes self-care. Our goal with the present work was to improve diabetes care in clinical practice for rural Veterans whose type 2 diabetes remained uncontrolled despite receiving available services. To this end, we partnered with the VA Office of Rural Health to implement ACDC into VA sites across the country with large rural populations.  (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale / 13.06.2020

MedicalResearch.com Interview with: Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
  • In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
  • DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
(more…)
ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)