Author Interviews, Cleveland Clinic, Multiple Sclerosis, NEJM / 30.08.2018

MedicalResearch.com Interview with: [caption id="attachment_44175" align="alignleft" width="159"]Robert J. Fox, MD, FAAN Principal Investigator | SPRINT-MS Trial Mellen Center for MS  |  Cleveland Clinic Cleveland, OH 44195   Dr. Fox[/caption] Robert J. Fox, MD, FAAN Principal Investigator | SPRINT-MS Trial Mellen Center for MS  |  Cleveland Clinic Cleveland, OH 44195  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The current treatment options for progressive multiple sclerosis are very limited. The SPRINT-MS trial sought to obtain proof-of-concept evidence that ibudilast has beneficial activity in progressive multiple sclerosis. In a placebo-controlled, 96-week trial of 255 people living with progressive MS, treatment with ibudilast slowed the progression of brain atrophy (brain shrinkage) by 48% compared to placebo. Side-effects of ibudilast included gastrointestinal symptoms, headache, and depression. 
Author Interviews, Heart Disease, NEJM, Surgical Research / 27.08.2018

MedicalResearch.com Interview with: Jean François Obadia Adult Cardiovascular Surgery and Transplantation Louis Pradel HospitalJean François Obadia MD PhD Adult Cardiovascular Surgery and Transplantation Louis Pradel Hospital MedicalResearch.com: What is the background for this study? -By definition a secondary MR concerns a normal valve or sub normal valve inside a dilated heart with poor LV function in a population of Heart failure patients. It is perfectly established today that secondary MR is a predictor of poor clinical outcomes of thissevere population. -Therefore,it has been proposed to treat those regurgitation either by surgery (mainly the downsizing anuloplasty) or by percutaneous technique like the mitraclipwhich has been used more and more frequently recently. -However, a beneficial effect on hardclinical outcomes has never been provedandwe still don’t know if those regurgitations need to be corrected or not, We still don’t Know if the regurgitation is the cause, the consequence or just a marker of poor prognosis. -In this context according to the guidelines, there is a low level of evidence to support those treatments, and Europe and US Guidelines call for prospective randomized studies in this severe population.​ And this excatly what we have done with MITRA-FR
Author Interviews, CT Scanning, Heart Disease, NEJM / 25.08.2018

MedicalResearch.com Interview with: [caption id="attachment_44122" align="alignleft" width="150"]Prof David Newby FRSE FMedSci Personal Chair - BHF John Wheatley Chair of Cardiology University of Edinburgh Prof. Newby[/caption] Prof David Newby FRSE FMedSci Personal Chair - BHF John Wheatley Chair of Cardiology University of Edinburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are many tests that can try and determine whether a patient has heart disease. All are imperfect and do not directly see if the heart arteries are diseased. This study used a CT heart scan to see if there was any heart disease in patients who presented to the outpatient clinic with chest pains that could be due to coronary heart disease. The doctor use the scan result to decide whether they had heart disease and how to manage the patient. The study has found that if you use a CT heart scan then you are less likely to have a heart attack in the future. In the first year, you may require treatment with an angiogram and heart surgery (stent or heart bypass) but after the first year, you are less likely to need these treatments because the disease has already been treated promptly.
Author Interviews, HIV, NEJM, Yale / 17.08.2018

MedicalResearch.com Interview with: [caption id="attachment_43945" align="alignleft" width="149"]Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine Dr. Emu[/caption] Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications.
Author Interviews, HIV, Pharmaceutical Companies / 16.08.2018

MedicalResearch.com Interview with: TaiMed BiologicsStanley Lewis, M.D. TaiMed Biologics Irvine, CA 92614 MedicalResearch.com: What is the background for this study? Response: The phase III clinical trial was conducted to assess the efficacy and safety of Trogarzo™ (ibalizumab-uiyk) injection in patients with multidrug resistant HIV-1. The study design was approved by the FDA. Results obtained were included in the New Drug Application submitted to the FDA which approved Trogarzo™ on March 6, 2018. The phase III, open-label study, enrolled 40 patients with multidrug-resistant (MDR) HIV-1 in whom multiple antiretroviral therapies had failed. All patients at baseline were experiencing viral failure. After a seven-day control period, patients received an intravenous 2000 mg loading dose of Trogarzo™ which was the only change made to their antiretroviral regimen. Through the 24-week treatment period of the study, patients were given a maintenance dose of 800 mg of Trogarzo™ every two weeks along with an optimized background regimen that included at least one additional fully active agent.
Author Interviews, Breast Cancer / 08.11.2017

MedicalResearch.com Interview with: [caption id="attachment_37960" align="alignleft" width="112"]Dr Hongchao Pan PhD Medical Research Council Population Health Research Unit Clinical Trial Service Unit & Epidemiological Studies Unit Nuffield Department of Population Health Oxford  Dr Hongchao Pan[/caption] Dr Hongchao Pan PhD Medical Research Council Population Health Research Unit Clinical Trial Service Unit & Epidemiological Studies Unit Nuffield Department of Population Health Oxford MedicalResearch.com: What is the background for this study? What are the main findings? Response: We’ve known for a long time that recurrences can occur late in women with oestrogen receptor positive breast cancers. Our study aimed to assess how big the risk was for women who had taken endocrine treatment (tamoxifen or an aromatase inhibitor) for 5 years, which greatly reduces the risk of recurrence (by about a half during treatment and one third for the 5 years after stopping). We also wanted to find out what factors influenced the risk of recurrence, and whether some women had such a low risk that they could safely stop hormonal treatment after 5 years or, conversely, whether other women had a particularly high risk so it would make sense for them to keep on taking hormonal treatment. What we found by following the progress of over 60,000 women who had stopped hormonal treatment at 5 years is that the risk of the cancer spreading stays about the same for the next 15 years. This risk is much higher for women whose breast cancer had spread to the nodes when first diagnosed but even for those with the best outlook (no spread to the lymph nodes and small tumours), there was a 10% chance of cancer spread over 15 years.
Author Interviews, NEJM, Prostate Cancer / 15.09.2016

MedicalResearch.com Interview with: [caption id="attachment_27922" align="alignleft" width="150"]Professor Jenny Donovan PhD OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK Prof. Jenny Donovan[/caption] Professor Jenny Donovan  PhD OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years. The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).
Author Interviews, Leukemia, NEJM, Transplantation / 08.09.2016

MedicalResearch.com Interview with: [caption id="attachment_27654" align="alignleft" width="133"]Dr. Filippo Milano, MD, PhD Assistant Member, Clinical Research Division Associate Director Cord Blood Transplantation Cord Blood Program Assistant Professor, University of Washington Fred Hutchinson Cancer Research Center Dr. Filippo Milano[/caption] Dr. Filippo Milano, MD, PhD Assistant Member, Clinical Research Division Associate Director Cord Blood Transplantation Cord Blood Program Assistant Professor, University of Washington Fred Hutchinson Cancer Research Center MedicalResearch.com: What is the background for this study? Response: When first introduced, cord blood (CB) graft was used only as a last resort when no suitable conventional donor could be identified, largely due to the limiting cell doses available in a cord blood graft. A CB graft, however, is attractive due to the increased level of HLA disparity that can be tolerated, without increased risk of graft versus host disease, allowing nearly all patients to find such a donor. The main intent of the study was to evaluate whether or not, at our Institution, cord blood SHOULD STILL BE considered only AS an alternative DONOR or IF instead outcomes were comparable to those obtained with more “conventional” types of transplants from matched and mismatched unrelated donors.
Author Interviews, Breast Cancer, NEJM / 19.02.2015

  Swain_SandraMedicalResearch.com Interview with: Sandra M Swain, MD, FACP, FASCO Medical Director, Washington Cancer Institute MedStar Washington Hospital Center Washington DC 20010 MedicalResearch: What take-home message would you like the general public to understand about this new analysis from the Cleopatra study? Potential Key Message Options:
  • Updated results from the CLEOPATRA study showed that people treated with the combination of pertuzumab, trastuzumb and chemotherapy lived 15.7 months longer than those who received trastuzumab and chemotherapy alone (median survival of 56.5 months versus 40.8 months).
  • The survival improvement of nearly 16 months observed in CLEOPATRA is unprecedented among studies of metastatic breast cancer. This is the kind of survival improvement that those of us who treat breast cancer strive for, and this data will be incredibly meaningful to patients and their families.
  • Furthermore, the median survival of nearly five years observed in CLEOPATRA patients treated with the pertuzumab regimen is the longest ever observed in a clinical study of people with HER2-positive metastatic breast cancer, once one of the most aggressive forms of breast cancer.
  • Patients who responded with shrinkage of their tumor had a response that was 8 months longer with the pertuzumab regimen compared to the trastuzumab and chemotherapy regimen.