Author Interviews, Biomarkers, Heart Disease, NEJM / 03.03.2022

MedicalResearch.com Interview with: [caption id="attachment_58828" align="alignleft" width="150"]Dr. PJ.Devereaux Dr. PJ.Devereaux[/caption] PJ Devereaux MD PhD Professor of Medicine, and of Health Research Methods, Evidence and Impact McMaster University President of the Society of Perioperative Research and Care  MedicalResearch.com:  What is the background for this study?  Response: More than 1 million patients undergo cardiac surgery in the United States and Europe annually. Although cardiac surgery has the potential to improve and prolong a patient’s quality and duration of life, it is associated with complications. Prognostically important heart injury – detected by an elevated blood concentration of either cardiac troponin or creatine kinase myocardial MB isoform (CK-MB) – is one of the most common complications after cardiac surgery and is associated with increased mortality. Although elevated CK-MB was historically used to define heart injury after cardiac surgery, this assay is no longer available in many hospitals worldwide, and consensus statements have recommended high-sensitivity cardiac troponin assays as the preferred biomarker. Based on expert opinion, the Fourth Universal Definition of Myocardial Infarction suggested that a cardiac troponin concentration >10 times the upper reference limit, in patients with a normal baseline measurement, should be the threshold used in the diagnosis of heart attack along with evidence of ischemia (e.g., ischemic ST changes on an ECG) in the first 48 hours after coronary artery bypass grafting (CABG). Although the Academic Research Consortium-2 Consensus stated there was no evidence-based threshold for cardiac troponin after CABG, they endorsed a threshold for the diagnosis of heart attack of ≥35 times the upper reference limit together with new evidence of ischemia, based on expert opinion. They also defined a threshold of ≥70 times the upper reference limit as a stand-alone criterion for clinically important periprocedural myocardial injury. Globally, many hospitals now use high-sensitivity cardiac troponin assays; however, limited data are available to define a prognostically important degree of myocardial injury after cardiac surgery based on these assays. We undertook the Vascular Events in Surgery Patients Cohort Evaluation (VISION) Cardiac Surgery Study to examine clinical outcomes after cardiac surgery. A primary objective was to determine the relationship between postoperative levels of high-sensitivity cardiac troponin I and the risk of death 30 days after cardiac surgery. 
Author Interviews, Diabetes, NEJM, Pediatrics, Technology / 20.01.2022

MedicalResearch.com Interview with: [caption id="attachment_58667" align="alignleft" width="200"]Dr Julia Ware (née Fuchs) Clinical Research Associate Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories  and Medical Research Council Metabolic Diseases Unit, University of Cambridge Addenbrooke’s Hospital, Cambridge  Dr. Ware[/caption] Dr Julia Ware (née Fuchs) Clinical Research Associate Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge Addenbrooke’s Hospital, Cambridge MedicalResearch.com: What is the background for this study? Response: Management of type 1 diabetes is challenging in very young children, due to their high variability of insulin requirements and unpredictable eating and activity patterns. As a result, many young children do not meet the recommended glycemic targets, or only maintain recommended glycemic control with extensive caregiver input. This in turn leads to high management burden and reduced quality of life for the whole family. While the increasing use of continuous glucose-monitoring devices and insulin-pump therapy has led to reductions in the incidence of severe hypoglycaemia and diabetic ketoacidosis, and has been accompanied by modest improvements in glycemic control, the burden of management has remained high. Hybrid closed-loop systems (also called an artificial pancreas), in which an algorithm automatically adjusts insulin delivery on the basis of real-time sensor glucose levels, may address ongoing challenges in this age group. However, to date hybrid closed-loop studies involving very young children have been small and of short duration and the efficacy and safety of longer term use of a closed-loop system, as compared with standard therapy, was unclear.   To address this knowledge gap, we compared 16-week use of the Cambridge closed-loop algorithm with sensor-augmented pump therapy in children aged 1 to 7 years with type 1 diabetes in a multi-national randomised crossover study.
Author Interviews, NEJM, OBGYNE / 05.01.2022

MedicalResearch.com Interview with: [caption id="attachment_58612" align="alignleft" width="150"]Laura Schummers, ScD, (she/her/hers) Postdoctoral Fellow, Contraception and Abortion Research Team  CIHR Patient-Oriented Research Leadership Fellow Post-doctoral Trainee, ICES McMaster UBC - Department of Family Practice | Women's Health Research Institute Dr. Schummers[/caption] Laura Schummers, ScD (she/her/hers) Postdoctoral Fellow, Contraception and Abortion Research Team CIHR Patient-Oriented Research Leadership Fellow Post-doctoral Trainee, ICES McMaster UBC - Department of Family Practice | Women's Health Research Institute MedicalResearch.com: What is the background for this study? Response: Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, making the drug available as a normal prescription. This meant that the abortion pill could be prescribed by any doctor or nurse practitioner, dispensed by any pharmacist, and taken by patients when, where and if they choose.
Author Interviews, Columbia, Genetic Research, Hematology, NEJM / 16.12.2021

MedicalResearch.com Interview with: [caption id="attachment_58548" align="alignleft" width="150"]Markus Y Mapara, MD Professor of Medicine Director of the Blood and Marrow Transplantation Columbia University Medical Center Dr. Mapara[/caption] Markus Y Mapara, MD Professor of Medicine Director of the Blood and Marrow Transplantation Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Sickle cell disease is caused by a point mutation in the beta-globin gene of hemoglobin  resulting in the production of abnormal hemoglobin which leads to formation of sickle-shaped RBC under conditions of low oxygen. Sickle cell disease affects about 100,000 patients in the US which are predominantly African  American. The only curative approach is to perform an allogeneic bone marrow transplant which is however fraught with significant treatment-related risks if a matched sibling donor is not available. The current study describes the successful application of a novel gene therapy  to treat patients with sickle cell disease. The strategy is based on a gene-addition approach to introduce the genetic information for a Hemoglobin F-like molecule termed HgAT87Q into hematopoietic stem cells. The expression of this novel  hemoglobin prevents polymerization of HgbS  and has now been demonstrated to prevent the occurrence of vaso-occlusive pain crises in sickle cell disease patients.
Author Interviews, COVID -19 Coronavirus, NEJM, Vaccine Studies / 13.12.2021

MedicalResearch.com Interview with: [caption id="attachment_58519" align="alignleft" width="150"]Ronen Arbel, PhD Outcomes Research, Community Medical Services Division Clalit Health Services, Tel Aviv, Israel.  Director, Maximizing Health Outcomes Research Lab Sapir College, Sderot, Israel. Dr. Arbel[/caption] Ronen Arbel, PhD Outcomes Research, Community Medical Services Division Clalit Health Service Tel Aviv, Israel Director, Maximizing Health Outcomes Research Lab Sapir College, Sderot, Israel.  MedicalResearch.com: What is the background for this study? Response: The emergence of the SARS-CoV-2 delta variant and reduced effectiveness over time of the BNT162b2 vaccine (Pfizer-BioNTech) led to a recent Coronavirus 2019 disease (Covid-19) resurgence in early vaccinated populations. The Israeli Ministry of Health was the first in the world to approve a third (booster) dose of BNT162b2 to cope with this resurgence.
Asthma, Author Interviews, NEJM, Pediatrics, Pulmonary Disease, Vanderbilt / 08.12.2021

MedicalResearch.com Interview with: [caption id="attachment_58461" align="alignleft" width="200"]Leonard B. Bacharier, MD Janie Robinson and John Moore Lee Chair in Pediatrics Professor of Pediatrics Director - Center for Pediatric Asthma Research Scientific Director - Center for Clinical and Translational Research Section Chief - Pediatric Allergy and Immunology Division of Allergy, Immunology and Pulmonary Medicine Dr. Bacharier[/caption] Leonard B. Bacharier, MD Janie Robinson and John Moore Lee Chair in Pediatrics Professor of Pediatrics Director - Center for Pediatric Asthma Research Scientific Director - Center for Clinical and Translational Research Section Chief - Pediatric Allergy and Immunology Division of Allergy, Immunology and Pulmonary Medicine Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center  MedicalResearch.com: What is the background for this study?  Is Dupilumab used for other atopic conditions, ie eczema/atopic dermatitis?   Response: Many children with moderate-severe asthma continue to experience asthma exacerbations and poor asthma control despite use of controller therapies.  Dupilumab has been shown to reduce asthma exacerbations in adolescents and adults, as well as to improve atopic dermatitis in children and adults.
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, NEJM, Vaccine Studies / 02.12.2021

MedicalResearch.com Interview with: [caption id="attachment_58438" align="alignleft" width="200"]Dr. Barbra Dickerman, PhD CAUSALab investigator and instructor Department of Epidemiology Harvard T.H. Chan School of Public Health Dr. Dickerman[/caption] Dr. Barbra Dickerman, PhD CAUSALab investigator and instructor Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Early randomized trials showed that the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines were both remarkably effective at preventing symptomatic disease, when comparing each vaccine with no vaccine. However, head-to-head comparisons of these vaccines have been lacking, leaving open the question of which vaccine is more effective.  In this study, we analyzed the VA’s high-quality databases in a way that emulated the design of the hypothetical trial that would have answered this question. Specifically, we used the findings from the original trials to benchmark our methods and then extended them to provide novel evidence for the comparative effectiveness of these two vaccines in a real-world setting and across diverse subgroups and different time periods.
Author Interviews, Genetic Research, NEJM / 10.11.2021

MedicalResearch.com Interview with: [caption id="attachment_58367" align="alignleft" width="200"]Professor Sir Mark Caulfield Professor of Clinical Pharmacology William Harvey Research Institute Queen Mary University of London Professor Sir Caulfield[/caption] Professor Sir Mark Caulfield Professor of Clinical Pharmacology William Harvey Research Institute Queen Mary University of London  MedicalResearch.com: What is the background for this study? Response: Rare diseases affect 6% of the population in western nations and there are approximately 10,000 different disorders and many remain without a genomic diagnosis after usual testing during their life time. In 2013 the UK Government launched the 100,000 Genomes Project and created Genomics England to investigate the role of whole genome sequencing in rare disease, cancer and infection. Whole genome sequencing gives the most comprehensive read out of the entire genome. To do this we partnered with the National Institute for Health Research (NIHR) BioResource and 9 hospitals across England1. Our New England Journal of Medicine paper published on the 11th November 2021 reports findings on the early rare disease participants who helped us pilot procedures and processes that would be used to enrol at scale across the NHS and revealed the potential benefits for rare disease1.
Asthma, Author Interviews, NEJM / 27.10.2021

MedicalResearch.com Interview with: [caption id="attachment_58297" align="alignleft" width="150"]Prof. Brightling Prof. Brightling[/caption] Professor Chris Brightling, NIHR Senior Investigator Department of Respiratory Sciences University of Leicester Leicester, UK MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Risankizumab is an anti-IL23 monoclonal antibody. It is a very effective licensed therapy for plaque psoriasis. IL23 has been implicated in asthma and therefore we chose to study the effect of risankizumab in people with severe asthma. The time to first asthma worsening was earlier and the frequency of asthma worsenings was higher in those treated with risankizumab versus placebo. We found that the gene expression of key molecules involved in the response to infection were decreased in airway samples in those treated with risankizumab. It is possible that the increased asthma worsening following risankizumab was related to this suppression of anti-microbial immunity. 
Author Interviews, NEJM, Stroke, University Texas / 08.09.2021

MedicalResearch.com Interview with: [caption id="attachment_58061" align="alignleft" width="160"] Dr. Grotta[/caption] James Grotta, MD Director of Stroke Research Clinical Institute for Research and Innovation Memorial Hermann - Texas Medical Center Director, Mobile Stroke Unit Consortium University of Texas Health  MedicalResearch.com: What is the background for this study? Response: We have good stroke treatments (thrombolysis and thrombectomy).  Since the initial studies showing benefit of thrombolysis, it has been difficult to improve on the amount of benefit except by speeding its delivery; the earlier the treatment, the better the outcome. Biologically, treatment in the first hour is likely to have greatest benefit since the brain is less irreversibly damaged and the clot is more soluble. But treatment in the first hour is rare if it is carried out in the emergency department.  So MSUs take the emergency department to the patient. We know that Mobile Stroke Units (MSUs) can speed treatment; our study addressed if this be accomplished in the US, and how much difference does it make in outcome.  In particular, outcomes important to patients given the probable costs of implementing MSUs. 
Author Interviews, Heart Disease, NEJM, Salt-Sodium, Stroke / 03.09.2021

[caption id="attachment_58038" align="alignleft" width="265"]Maoyi TIAN PhD Program Head, Digital Health and Head, Injury & Trauma Senior Research Fellow The George Institute Dr. Tian[/caption] MedicalResearch.com Interview with: Maoyi TIAN PhD Program Head, Digital Health and Head, Injury & Trauma Senior Research Fellow The George Institute MedicalResearch.com: What is the background for this study? Response: There is clear evidence from the literature that sodium reduction or potassium supplementation can reduce blood pressure. Reduced blood pressure can also lead to a risk reduction for cardiovascular diseases. Salt substitute is a reduced sodium added potassium product combined those effects. Previous research of salt substitute focus on the blood pressure outcome. There is no evidence if salt substitute can reduce the risk of cardiovascular diseases or pre-mature death. This study provided a definitive evidence for this unaddressed question. MedicalResearch.com: What are the main findings? The main findings of the research were:
  • The salt substitute reduced the risk of stroke by 14%
  • The salt substitute reduced the risk of major adverse cardiovascular events by 13%
  • The salt substitute reduced the risk of pre-mature death by 12%
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, Kidney Disease, NEJM / 18.08.2021

MedicalResearch.com Interview with: [caption id="attachment_57955" align="alignleft" width="200"]Toni K. Choueiri, MD Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Jerome and Nancy Kohlberg Chai Professor of Medicine, Harvard Medical School Dr. Choueiri[/caption] Toni K. Choueiri, MD Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Jerome and Nancy Kohlberg Chai Professor of Medicine, Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The standard of care for patients diagnosed with locoregional RCC is partial or total nephrectomy. Nearly half of patients will eventually experience disease recurrence following nephrectomy and no standard, globally approved adjuvant therapy options are currently available for this population. The phase 3 KEYNOTE-564 study met its primary objective of demonstrating a statistically significant and clinically meaningful improvement in disease-free survival with pembrolizumab vs placebo as adjuvant therapy for patients with RCC post nephrectomy, supporting pembrolizumab as a potential new standard of care for patients at high risk of disease recurrence following surgery.
Author Interviews, NEJM, Neurology, Pain Research / 18.08.2021

MedicalResearch.com Interview with: [caption id="attachment_57964" align="alignleft" width="200"]Jessica Ailani M.D. FAHS FAAN FANA Director Medstar Georgetown Headache Center Vice Co-Chair of Strategic Planning for MedStar Neurology Professor of Clinical Neurology MedStar Georgetown University Hospital Dr. Ailani[/caption] Jessica Ailani M.D. FAHS FAAN FANA Director Medstar Georgetown Headache Center Vice Co-Chair of Strategic Planning for MedStar Neurology Professor of Clinical Neurology MedStar Georgetown University Hospital MedicalResearch.com: What is the background for this study? Response: Migraine is a common neurological disease that causes disabling attacks that can be frequent. Preventive treatments can help reduce the frequency of attacks and improve patient function, reducing disease burden.
Author Interviews, Cancer Research, Dermatology, NEJM / 20.07.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc. MedicalResearch.com: What is the background for this study? Response: Tirbanibulin is a first-in-class synthetic molecule that has potent anti-proliferative activity by inhibiting tubulin polymerization and disrupting src kinase signaling. It has been formulated as an ointment for the treatment of actinic keratosis, a very common precancerous condition of UV-damaged skin that affects over 50 million people in the US. The most commonly adopted management approach is to remove AK lesions as it is hard to predict which lesion will become cancerous. Lesion-directed treatment like cryotherapy can effectively remove lesions one at a time but does not treat larger field of cancerization. Also, it is limited by associated pain and long term complication such as scarring. Currently approved topical treatments involve cumbersome application courses of weeks or months, and induce considerable local skin reactions that were not well tolerated by patients. The Phase 3 studies demonstrated that a short 5-day once daily course of tirbanibulin ointment 1% is an efficacious and safe topical treatment of actinic keratosis.
Author Interviews, Beth Israel Deaconess, Gastrointestinal Disease, NEJM / 01.07.2021

MedicalResearch.com Interview with: [caption id="attachment_57710" align="alignleft" width="152"]Prof. Schuppan, MD, PhD Prof. Schuppan, MD, PhD[/caption] Prof. Dr. D. Schuppan, MD, PhD Professor of Medicine Director Institute of Translational Immunology University Medical Center of the Johannes Gutenberg University Consultant Gastroenterologist and Hepatologist Director Celiac and Small Intestinal Disease Center Director Center for Food Intolerances and Autoimmunity Director Liver Fibrosis and Metabolism Research Research Center for Immune Therapy (FZI) Mainz Project for Chemical Allergology (MPCA) Mainz, Germany Professor of Medicine, Division of Gastroenterology Beth Israel Deaconess Medical Center Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: Celiac disease (CeD) is a common intestinal inflammatory disease that affects about 1% of most wheat consuming populations worldwide. CeD is caused by the ingestion of gluten containing foods, such as wheat, spelt, rye and barley, that activate small intestinal inflammatory T cells. The only current therapy is the rigorous avoidance of even traces of gluten in the daily diet, which is difficult and a social and psychological burden. We previously identified the body’s own enzyme tissue transglutaminase (TG2) as the CeD autoantigen. Moreover, TG2 drives celiac disease pathogenesis by enzymatically modifying dietary gluten peptides that makes them more immunogenic. We therefore developed an oral small molecule (ZED1227) that specifically inhibits TG2 activity in the intestine. While this should attenuate CeD in patients exposed to dietary gluten, it was unclear if  it could prevent gluten induced intestinal inflammation and damage.
Author Interviews, Dermatology, NEJM / 28.04.2021

MedicalResearch.com Interview with: [caption id="attachment_57254" align="alignleft" width="200"]Prof. Kristian Reich, MD, PhD Professor for Translational Research in Inflammatory Skin Diseases Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg-Eppendorf Prof. Reich[/caption] Prof. Kristian Reich, MD, PhD Professor for Translational Research in Inflammatory Skin Diseases Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg-Eppendorf MedicalResearch.com: What is the background for this study? What are the main findings? Response: Complete skin clearance is an important treatment goal for patients with psoriasis and is closely associated with treatment satisfaction and improved quality of life. However, it remains an unmet need for many patients. The interleukin (IL)-17 isoforms IL-17A and IL-17F play central roles in psoriasis pathophysiology and are overexpressed in psoriatic tissues. Existing biologic therapies, such as secukinumab, inhibit IL-17A only. However, increasing evidence indicates that IL-17F contributes independently to the pathobiology of plaque psoriasis, and that blocking both IL-17A and IL-17F may lead to more complete suppression of inflammation and superior clinical outcomes, compared with blocking IL‑17A alone. Bimekizumab is a humanized monoclonal IgG1 antibody that has been designed to selectively inhibit IL-17F in addition to IL-17A.
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, NEJM / 22.04.2021

MedicalResearch.com Interview with: Aditya Bardia MD, MPH Director, Breast Cancer Research Program, Attending Physician, Massachusetts General Hospital Harvard Medical School [caption id="attachment_57202" align="alignleft" width="200"]Aditya Bardia MD, MPH Director, Breast Cancer Research Program, Attending Physician, Massachusetts General Hospital Harvard Medical School Dr. Bardia[/caption]  MedicalResearch.com: What is the background for this study? Response: Triple negative breast cancer (TNBC) represents an aggressive subtype of breast cancer associated with guarded prognosis. For patients with pre-treated metastatic TNBC, standard chemotherapy is associated with low response rate (5-10%) and poor progression-free survival (2-3 months), highlighting need for better therapies. Sacituzumab govitecan is an antibody drug conjugate (ADC) which  combines SN-38, an active metabolite of irinotecan, with an antibody against Trop-2, an antigen overexpressed in majority of triple negative breast cancer.
Alzheimer's - Dementia, Author Interviews, Eli Lilly, NEJM / 16.03.2021

MedicalResearch.com Interview with: [caption id="attachment_56959" align="alignleft" width="200"]Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  Dr. Salloway[/caption] Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  MedicalResearch.com: What is the background for this study? Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.  MedicalResearch.com: What are the main findings? Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease. There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans.  Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval.
Author Interviews, Cancer Research, Dermatology, NEJM / 11.02.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc.  [caption id="attachment_47929" align="alignleft" width="200"]One example of actinic keratoses on scalp DermNZ One example of actinic keratoses on scalp
DermNZ[/caption] MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by actinic keratoses? How common are they and who is primarily affected? Response: Actinic keratosis is a very common precancerous skin condition that affects about 58 millions people in the US. Most commonly affected people are older (over 40 years old) men with fair skin type. Actinic keratosis lesions are red scaly bumps on sun-damaged skin mostly on the face, scalp, back of hands, forearms and legs. As there is a risk of 0.025-16% per year for each actinic keratosis to progress to skin cancer and it is not possible to predict which actinic keratosis will become cancerous, early treatment of actinic keratosis is generally recommended. Currently approved topical treatments require weeks or months of application and may lead to intolerable side effects that undermine compliance and reduce efficacy of treatment. Tirbanibulin ointment is a novel anti-proliferative agent that inhibits tubulin polymerization and disrupts Src kinase signaling, and has the potential to inhibit growth of abnormal skin cells in actinic keratosis. The current report described two Phase 3 randomized vehicle or placebo-controlled clinical studies that demonstrated that a 5-day course of tirbanibulin ointment applied once daily by patients was safe, well-tolerated, and effective in clearing actinic keratosis on the face or scalp compared to vehicle control.
Author Interviews, Blood Pressure - Hypertension, NEJM, OBGYNE / 28.01.2021

MedicalResearch.com Interview with: [caption id="attachment_56486" align="alignleft" width="133"]DAVID K. TUROK, MD, MPH, FACOG Clinical Senior Lecturer Honorary Consultant in Cardiology Institute of Health Informatics Faculty of Pop Health Sciences University College London Dr. Turok[/caption] DAVID K. TUROK, MD, MPH, FACOG ASSOCIATE PROFESSOR OF OBSTETRICS AND GYNECOLOGY CHIEF OF THE DIVISION OF FAMILY PLANNING UNIVERSITY OF UTAH MedicalResearch.com: What is the background for this study? Response: Researchers and clinicians have long known that copper intrauterine devices (IUDs) work extremely well for emergency contraception, using contraception after sex to prevent pregnancy. However, the hormonal IUD (levonorgestrel 52 mg IUD) has distinct characteristics that many people prefer. Namely, it reliably reduces or eliminates menstrual bleeding and cramping. Until now we did not know if the levonorgestrel IUD worked for emergency contraception. Now we know. In a first-of-its-kind study, our team at the University of Utah Health and Planned Parenthood Association of Utah found that hormonal IUDs were comparable to copper IUDs for use as emergency contraceptives.
AstraZeneca, Author Interviews, Cancer Research, ESMO, Lung Cancer, NEJM, Yale / 08.10.2020

MedicalResearch.com Interview with: [caption id="attachment_55606" align="alignleft" width="133"]Roy S. Herbst, M.D., Ph.D. Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology Chief of Medical Oncology Yale Cancer Center and Smilow Cancer Hospital Associate Cancer Center Director for Translational Research Yale Cancer Center Dr. Herbst[/caption] Roy S. Herbst, M.D., Ph.D. Ensign Professor of Medicine (Medical Oncology) and 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? How does osimertinib differ from prior versions of EGFR-TKI Inhibitors? o   ADAURA is a randomized, double-blinded, global and placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, and IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with osimertinib 80 mg once-daily oral tablets or placebo for three years or until disease recurrence. The primary endpoint is disease free survival (DFS) in Stage II and IIIA patients, and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. Osimertinib is not currently approved in the adjuvant setting in any country. o   Osimertinib is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. The results of the Phase III ADAURA trial of osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer for patients. o   ADAURA results were first presented in May during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program.
Author Interviews, COVID -19 Coronavirus, Emory, NEJM, NIH, Vaccine Studies / 04.10.2020

MedicalResearch.com Interview with: [caption id="attachment_55564" align="alignleft" width="180"]Evan J. Anderson, MD Associate Professor of Medicine and Pediatrics Emory University School of Medicine Dr. Anderson[/caption] Evan J. Anderson, MD Associate Professor of Medicine and Pediatrics Emory University School of Medicine MedicalResearch.com: What is the background for this study? Response: Older adults have suffered a disproportionate number of the hospitalizations and deaths due to COVID-19. A vaccine is clearly needed for older adults.  For a number of vaccines, the immune response and efficacy of vaccines decreases with increasing age. A prime example would be influenza and the need for high dose influenza vaccine in the elderly. We had previously conducted a Phase I study in 18 – 55 year old adults of mRNA-1273 vaccine – published in NEJM 2020 with Lisa Jackson as the lead author. This phase I study was expanded to include older adults in 2 separate cohorts (56 – 70, >70 years of age) and 2 different doses.
Author Interviews, Cancer Research, HPV, Karolinski Institute, NEJM, Vaccine Studies / 30.09.2020

MedicalResearch.com Interview with: Dr. Jiayao Lei PhD Prof. Pär Sparén PhD Karolinski Institute MedicalResearch.com: What is the background for this study? Response: The efficacy and effectiveness of quadrivalent HPV (qHPV) vaccine protecting against HPV infection, genital warts and high-grade precancerous cervical lesions have been shown. However, there is lack of population-based studies in examining the association between HPV vaccine and invasive cervical cancer on individual level. 
Author Interviews, Diabetes, NEJM / 24.09.2020

Remarks from: [caption id="attachment_55474" align="alignleft" width="140"]Julio Rosenstock, M.D Director, Dallas Diabetes and Endocrine Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX Dr. Rosenstock[/caption] Julio Rosenstock, M.D Director, Dallas Diabetes and Endocrine Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX MedicalResearch.com: Why was the study initiated / What is the background of the study? Response: Most people with type 2 diabetes, would prefer simplicity, with fewer injections than currently provided by once-daily basal insulin treatment regimens. Therefore, there is a need to continue to offer innovative treatment options to support people living with type 2 diabetes and hopefully improve their glycemic outcomes. As a once-weekly basal insulin, insulin icodec has the potential to offer a simpler, efficacious and well-tolerated treatment option thereby reducing the potential burden on people living with type 2 diabetes.
Author Interviews, ESMO, Immunotherapy, Melanoma, NEJM / 03.09.2020

MedicalResearch.com Interview with: [caption id="attachment_55278" align="alignleft" width="133"]Reinhard Dummer, Prof. Dr. med. Stv. Klinikdirektor Universitätsspital Zürich, Dermatologische Klinik Zürich Prof. Dummer[/caption] Reinhard Dummer, Prof. Dr. med. Stv. Klinikdirektor Universitätsspital Zürich, Dermatologische Klinik Zürich MedicalResearch.com: What is the background for this study? Response: Based on molecular biology analysis, a substantial proportion of melanomas are driven by mutations of BRAF resulting in an ongoing growth activating signal. Based on the key role of BRAF several multiple kinase molecules have been developed in order to target this crucial pathway. These medications have shown to improve progression free survival and overall survival in advanced metastatic melanoma. Because there is a tendency for improved outcome in patients with low tumor burden, combined targeted therapy using Dabrafenib and Trametinib have been investigated in the adjuvant (after complete surgical resection) setting in stage III melanoma. And the 5 year data are now available in the New England Journal of Medicine.
Author Interviews, Clots - Coagulation, NEJM / 12.08.2020

MedicalResearch.com Interview with: [caption id="attachment_55120" align="alignleft" width="133"]Elizabeth Webb, M.P.H Physiotherapy Department Calvary Public Hospital Bruce Bruce, Australia Elizabeth Webb[/caption] Elizabeth Webb, M.P.H Physiotherapy Department Calvary Public Hospital Bruce Bruce, Australia MedicalResearch.com: What is the background for this study? Response: Our study showed that in patients with a history of leg swelling (chronic edema), compression therapy by a skilled lymphedema therapist reduced the risk of infection in the leg (cellulitis) by a huge 77%. With up to 47% of patients experiencing recurrence of cellulitis in their legs within 3 years, this result is a game-changer in terms of our approach to managing patients with leg swelling and recurrent cellulitis. Until now, the use of prophylactic antibiotics to prevent cellulitis has been the only evidence-based practice. We know however, there are many reasons why avoidance of antibiotics is important within our community.
Author Interviews, NEJM, OBGYNE, Surgical Research / 29.07.2020

MedicalResearch.com Interview with: Jane Daniels PhD Professor of Clinical Trials, Faculty of Medicine & Health Sciences School of Medicine University of Nottingham MedicalResearch.com: What is the background for this study? MedicalResearch.com: What are the main findings? [caption id="attachment_54976" align="alignleft" width="200"]One example of a large fibroid-Wikipedia image One example of a large fibroid-Wikipedia image[/caption] Response: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. They are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (myomectomy) or completely remove the womb. A newer approach, known as uterine artery embolization, involves blocking the blood supply to the fibroids in the womb. Fibroids may be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed. Both treatments improve quality of life, but myomectomy will provide greater benefit to women on average. MedicalResearch.com: What should readers take away from your report? Response: This study is the largest to date comparing women treated with either myomectomy or uterine-artery embolization for their fibroids. It was completed in hospitals across the UK, and included a substantial number of women of African-Caribbean ethnicity, who are more likely have bothersome fibroids, so we can be confident that the findings are important and relevant. Women, including those desiring a future pregnancy, should be provided with the evidence generated by the FEMME trial to enable to make a fully informed decision regarding their fibroid treatment.
Author Interviews, Flu - Influenza, Infections, NEJM, Vaccine Studies / 15.07.2020

MedicalResearch.com Interview with: [caption id="attachment_54859" align="alignleft" width="181"]Frederick Hayden MD Stuart S Richardson Professor Emeritus of Clinical Virology Professor Emeritus of Medicine Division of Infectious Diseases and International Health University of Virginia Dr. Hayden[/caption] Frederick Hayden MD Stuart S Richardson Professor Emeritus of Clinical Virology Professor Emeritus of Medicine Division of Infectious Diseases and International Health University of Virginia  MedicalResearch.com: What is the background for this study? Response: Although primary prevention approach for influenza infections is vaccination, vaccine efficacy is incomplete and uptake rates are variable in the population. Preventing people who have been exposed to someone with influenza from developing the disease is an important way to prevent its rapid spread, reduce the disruption to peoples' lives and, in some cases, reducing the risk of serious illness or even death.  Prior studies have shown that antivirals like oseltamivir and inhaled zanamivir can reduce the risk influenza illness in those exposed. The BLOCKSTONE study was designed to assess the efficacy of postexposure prophylaxis with a single oral dose of baloxavir for the preventing influenza in household contacts. This antiviral drug was approved first in 2018 for treatment of adults with uncomplicated influenza. 
AstraZeneca, Author Interviews, NEJM, Pulmonary Disease / 29.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54747" align="alignleft" width="200"]Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca Dr. Trudo[/caption] Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca MedicalResearch.com: What is the background for this study? Response: ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations. MedicalResearch.com: How does PT010 differ from other treatments for COPD?
  • Highly competitive: PT010’s Phase III clinical trial program demonstrates it has a highly competitive clinical profile in decreasing moderate or severe exacerbations. Severe exacerbations were defined as exacerbations leading to hospitalization or death.
  • All-cause mortality: In a secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate. The data from ETHOS show that reducing risk of all-cause mortality is achievable for patients with this progressive disease and could transform treatment goals in COPD.
  • Two potential dose options: This is also the first time we have seen the benefit of closed triple-combination therapy at two ICS doses, which could transform care by allowing physicians to select the optimal dosing option for individual patients.