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PieroRivizzigno : healthcare   747

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Real-World Evidence and Randomized Studies in the Precision Oncology Era: The Right Balance | JCO Precision Oncology
Randomized clinical trials (RCTs) are the gold standard for rational therapeutics in evidence-based medicine.1 Although variable, the cost of conducting an RCT can be as high as $1 billion,1 putting into question their feasibility for every health care intervention. Also, the broader application of RCT outcomes has been subject to scrutiny, considering the inherent selection bias. Less than 5% of adult patients with cancer participate in clinical trials, and those who do are younger, healthier, and less diverse than their real-world counterparts.2 Today, RCTs remain the gold standard despite changing practice patterns; however, because of their limitations, coupled with unmet health care needs, a reassessment of whether this traditional approach should be required for low-risk interventions, particularly in cancer, is warranted.
healthcare  RCT  RWE  PRO 
7 days ago by PieroRivizzigno
Patient involvement toolkit for researchers | Cancer Research UK
Patient involvement can improve the quality and relevance of your work, helping you better understand and articulate the benefits your research can have for cancer patients. 

This toolkit provides guidance, tips and templates to help you plan, deliver and evaluate your patient involvement. Once you’ve planned how you want to involve patients, we can also help you find them. 
healthcare  patient-engagement  toolkit 
16 days ago by PieroRivizzigno
Statistical pitfalls of personalized medicine
Misleading terminology and arbitrary divisions stymie drug trials and can give false hope about the potential of tailoring drugs to individuals, warns Stephen Senn
healthcare  precision-medicine  counterpoint 
17 days ago by PieroRivizzigno
Researchers Explore a Cancer Paradox - The New York Times
Healthy cells carry a surprising number of cancer-linked mutations, but they don’t turn into tumors. What’s holding them back?
cancer  Cell  mutations  healthcare  counterpoint  growth 
5 weeks ago by PieroRivizzigno
Editor’s letter: The precision medicine issue
Precision medicine has led to incredibly effective treatments for cancer and inherited disease. But not everyone gets treated.
healthcare  MIT  precision-medicine 
5 weeks ago by PieroRivizzigno
A systematic literature review of individuals’ perspectives on privacy and genetic information in the United States
Concerns about genetic privacy affect individuals’ willingness to accept genetic testing in clinical care and to participate in genomics research.
healthcare  privacy  genetics 
5 weeks ago by PieroRivizzigno
Why Doctors Hate Their Computers
Digitization promises to make medical care easier and more efficient. But are screens coming between doctors and patients?
healthcare  digital-health  digital-culture  doctor  computer-aversion 
5 weeks ago by PieroRivizzigno
U.S. Cancer Centers Deceptive Testimonials Database | Truth In Advertising
TINA.org conducted a review of patient testimonials used to promote the 50 cancer treatment centers in the U.S. that spent the most money on advertising in 2017. Our results revealed that, of the cancer centers still in business in 2018, 43 out of 48 – or 90% – deceptively used patient testimonials in their marketing materials by promoting anecdotal, atypical patient results without clearly and conspicuously disclosing what the generally expected results for a patient in a similar situation would be.
healthcare  tina.org  deception  Advertising 
5 weeks ago by PieroRivizzigno
Science & Research (Drugs) > FDA’s MyStudies Application (App)
The U.S. Food and Drug Administration (FDA) is posting computer code and a technical roadmap that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app. The FDA MyStudies App is designed to facilitate the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries
healthcare  digital-health  app  FDA  MyStudies 
5 weeks ago by PieroRivizzigno
Decentralized clinical trials – Andrea’s Blog
A framework for “direct-to-patient,” “remote,” “site-less,” and “virtual” clinical research
healthcare  digital-health  trial  decentralized 
7 weeks ago by PieroRivizzigno
Google AI Blog: Applying Deep Learning to Metastatic Breast Cancer Detection
A pathologist’s microscopic examination of a tumor in patients is considered the gold standard for cancer diagnosis, and has a profound impact on prognosis and treatment decisions. One important but laborious aspect of the pathologic review involves detecting cancer that has spread (metastasized) from the primary site to nearby lymph nodes. Detection of nodal metastasis is relevant for most cancers, and forms one of the foundations of the widely-used TNM cancer staging.
healthcare  digital-health  breast-cancer  diagnosis  deep-learning  Google 
7 weeks ago by PieroRivizzigno
A Cancer Patient’s Guide to Clinical Trials — ProPublica
If you’re considering whether to enroll in a trial of an experimental drug, here’s what you need to know.
healthcare  trial  patient 
9 weeks ago by PieroRivizzigno
The market trend analysis and prospects of cancer molecular diagnostics kits | Biomaterials Research | Full Text
The molecular diagnostics market can be broadly divided into PCR (rt-PCR, d-PCR), NGS(Next Generation Sequencing), Microarray, FISH(Fluorescent in situ-hybridization) and other categories, based on the diagnostic technique. Also, depending on the disease being diagnosed, the market can also be divided into cancer, infectious diseases, HIV/STDs (herpes, syphilis), and women’s health issues such as breast cancer, cervical cancer, ovarian cancer, HPV(human papillomavirus), and vaginitis.
healthcare  molecular-diagnostic  market-size 
11 weeks ago by PieroRivizzigno
Frontiers | The Potential of CAR T Cell Therapy in Pancreatic Cancer | Immunology
This review summarizes the available preclinical data and highlights early phase clinical trials using CAR T cell approaches in pancreatic cancer, a disease state that is gaining attention as a conduit for cell therapy. Future directions in application of CAR T cell therapy are also considered including its ability to be directed against novel epitopes and combined with other therapeutic regimens.
healthcare  cancer  pancreas  CAR-T  immunotherapy 
11 weeks ago by PieroRivizzigno
A Run of Contrary Results | In the Pipeline
From the outside, medical progress looks a lot easier than it really is. Well, I realize that’s true of a lot of things, but it’s especially true in progress against disease, and that’s especially especially true (as I’ve said here before) when you’re talking about dietary influences and what can be learned from them. Butter, whole milk, and other dairy products – bad for your cardiovascular health, right? Not according to this new observational study of 136,000 people across 21 countries.
healthcare  nutrition  counterpoint 
11 weeks ago by PieroRivizzigno
(38) Pancreatic Cancer: Advances in Science and Clinical Care - YouTube
This AACR Special Conference, to be held September 21-24, 2018, in Boston, will convene world-renowned experts covering the breadth of research on pancreatic cancer, from early detection and genetics to precision medicine and immunotherapy.
healthcare  cancer  pancreas  AACR  state-of-art 
11 weeks ago by PieroRivizzigno
21st Century Physician: Triaging the Tsunami of Medical Information
I am occasionally asked for advice on keeping up with the tsunami of medical information while separating facts from spin. Here are my tips.
healthcare  how-to-read 
11 weeks ago by PieroRivizzigno
Genetic determinism rides again
And yet, here we are again with Blueprint, by educational psychologist Robert Plomin. Although Plomin frequently uses more civil, progressive language than did his predecessors, the book’s message is vintage genetic determinism: “DNA isn’t all that matters but it matters more than everything else put together”. “Nice parents have nice children because they are all nice genetically.” And it’s not just any nucleic acid that matters; it is human chromosomal DNA. Sorry, microbiologists, epigeneticists, RNA experts, developmental biologists: you’re not part of Plomin’s picture.
healthcare  genetics  determinism  reductionism 
11 weeks ago by PieroRivizzigno
How one pharmaceutical company is reinventing the clinical trial - STAT
Clinical trials are as essential today as drug discovery for bringing new drugs to market. But while new tools and technologies have helped advance techniques for new drug discovery, we’ve seen far less innovation in clinical trials. The process continues to be weighed down with regulatory paperwork, medical jargon, and participants’ time-intensive trips to trial sites.
healthcare  clinical-trial  trial  Jansen  Scripps  digital-health 
12 weeks ago by PieroRivizzigno
Sloan Kettering’s Cozy Deal With Start-Up Ignites a New Uproar - The New York Times
The company, Paige.AI, is one in a burgeoning field of start-ups that are applying artificial intelligence to health care, yet it has an advantage over many competitors: The company has an exclusive deal to use the cancer center’s vast archive of 25 million patient tissue slides, along with decades of work by its world-renowned pathologists.
healthcare  pathology  Memorial-Sloan-Kettering-Cabcer-Center  cancer  conflict-of-interest 
12 weeks ago by PieroRivizzigno
Everyday Sociology Blog: A Sociology of My Death
I’m dying. I don’t mean this figuratively—like I’m dying of thirst or dying to visit Hawaii. I mean it quite literally. I have incurable, stage IV lung cancer.
healthcare  sociology  death 
september 2018 by PieroRivizzigno
Cancer treatment in the last 6 months of life: when inaction can outperform action. ecancermedicalscience - The open access journal from the European Institute of Oncology and the OCEI
For example, when a patient’s life expectancy is less than 6 months, many oncologists will not embark on any active cancer treatments. However, multiple new anticancer drugs have been approved recently after being tested in end-stage cancer patients and demonstrating median OS in the experimental arm close to 6 months. Such practice, particularly when the treatment is also accompanied by serious toxicities and cost, can undermine a peaceful life-death transition.
cancer  ethics  healthcare  end-of-life 
september 2018 by PieroRivizzigno
TechCrunch - Disrupt SF 2018 | Anne Wojcicki (23andMe) | Facebook
23andMe CEO Anne Wojcicki on the tremendous opportunities that can be unlocked by genetic testing
healthcare  cancer  precision-medicine  23andme  interview  video 
september 2018 by PieroRivizzigno
(30) Understanding Nutrition and the Role and Benefits of PERT - YouTube
This animation describes pancreatic enzyme replacement therapy (PERT) and it’s role and benefit for patients who have exocrine pancreatic insufficiency (EPI). The animation provides an overview of the role of pancreatic enzymes in food digestion, the different types of PERT medications that are currently available, and provides tips for dosing and timing of PERT. For the majority of patients taking PERT, there is a significant improvement of symptoms, nutritional status, and overall quality of life.
Visit http://www.AnimatedPancreasPatient.com to learn more.
SHOW MORE
healthcare  cancer  pancreas  nutrition  enzymes 
september 2018 by PieroRivizzigno
OncoKB: A Precision Oncology Knowledge Base | JCO Precision Oncology
With prospective clinical sequencing of tumors emerging as a mainstay in cancer care, an urgent need exists for a clinical support tool that distills the clinical implications associated with specific mutation events into a standardized and easily interpretable format. To this end, we developed OncoKB, an expert-guided precision oncology knowledge base.
healthcare  cancer  precision-medicine  OncoKB  SMKC 
september 2018 by PieroRivizzigno
Neuroendocrine Cancer and Pancreatic Enzyme Replacement Therapy (PERT) – the Digested Version (Nutrition Series Article 5) – Ronny Allan – Living with Neuroendocrine Cancer
We eat food, but our digestive system doesn’t absorb food, it absorbs nutrients. Food has to be broken down from things like steak and broccoli into its nutrient pieces: amino acids (from proteins), fatty acids and cholesterol (from fats), and simple sugars (from carbohydrates), as well as vitamins, minerals, and a variety of other plant and animal compounds. Digestive enzymes, primarily produced in the pancreas and small intestine, break down our food into nutrients so that our bodies can absorb them.
healthcare  cancer  pancreas  nutrition  enzymes  Allan  reference 
september 2018 by PieroRivizzigno
Palliative Care in Metastatic Pancreatic Cancer
Panelists: John L. Marshall, MD, Georgetown University; George Kim, MD, 21st Century Oncology; Kabir Mody, MD, Mayo Clinic Cancer Center; Eileen M. O
Published: Monday, Aug 27, 2018
healthcare  cancer  pancreas  palliative  care 
september 2018 by PieroRivizzigno
Patient Checklist - Lustgarten Foundation: Pancreatic Cancer Research
As overwhelming as a pancreatic cancer diagnosis is, it is important to act quickly and put a treatment plan into place. Treatment should ideally begin within one month after you receive your diagnosis.
healthcare  cancer  pancreas  checklist  Lustgarten 
september 2018 by PieroRivizzigno
All study participants have a right to know their own results- STAT
Between the rise in direct-to-consumer products and more transparent medical care, people today have access to myriad types of data about their personal health — and they’ve come to expect it. Yet for participants in most research studies, outdated ethical standards prevent them from learning anything at all about what was found in their blood, urine, or any other tissue they donated for research.
healthcare  trial  data  patient  transparency 
september 2018 by PieroRivizzigno
Estimation of the Acquisition and Operating Costs for Robotic Surgery | Minimally Invasive Surgery | JAMA | JAMA Network
Despite evidence questioning the clinical benefit,1 the use of the robotic platform for surgical procedures is increasing.2 No benchmark exists for the cost of acquiring and operating robotic systems, and previous cost evaluations have either omitted key expenses1 or utilized billing records that do not itemize costs with sufficient granularity.2
healthcare  surgery  robotics  cost 
september 2018 by PieroRivizzigno
Dynamic Behavior of Ca 19-9 and Pancreatic Cancer Recurrence: Enough Data to Drive Salvage Therapy? | SpringerLink
Up to 80% of patients undergoing pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) followed by adjuvant therapy will recur within 2 years, with median recurrence-free survival (RFS) of only 1 year.1
healthcare  cancer  pancreas  surgery  CA-19.9  Verona 
september 2018 by PieroRivizzigno
The paradox of precision medicine | Nature Reviews Clinical Oncology
According to the paradigm of precision medicine, the administration of agents targeting the molecular alteration detected in a particular patient’s tumour reduces uncertainty in the clinical management of that patient. We describe how approaches to precision medicine can lead, paradoxically, to increased levels of uncertainty. We offer recommendations for how physicians can better navigate new uncertainties in precision medicine.
healthcare  cancer  precision-medicine  counterpoint 
september 2018 by PieroRivizzigno
Opinion | Are We Being Misled About Precision Medicine? - The New York Times
Doctors and hospitals love to talk about the cancer patients they’ve saved, and reporters love to write about them. But deaths still vastly outnumber the rare successes.
healthcare  cancer  precision-medicine  counterpoint 
september 2018 by PieroRivizzigno
Addressing Financial Barriers to Patient Participation in Clinical Trials: ASCO Policy Statement: Journal of Clinical Oncology: Vol 0, No 0
Research conducted through clinical trials is essential for evaluating new treatment modalities, establishing new standards of cancer care, and ultimately improving and prolonging the lives of patients with cancer. However, participation in trials has been low, and this is attributable to various factors including patient financial barriers.
healthcare  trial  patient  participation  barriers  financial 
september 2018 by PieroRivizzigno
Identification of performance indicators across a network of clinical cancer programs
Cancer quality indicators have previously been described for a single tumour site or a single treatment modality, or according to distinct data sources. Our objective was to identify cancer quality indicators across all treatment modalities specific to breast, prostate, colorectal, and lung cancer.
healthcare  cancer  kpi  center 
august 2018 by PieroRivizzigno
WuXi NextCODE: A Contract Genomics Organization
Built over twenty years on the world’s largest collection of human genomes, our platform today powers the biggest and most innovative precision medicine efforts on four continents, including pioneering population-optimized genome tests and wellness products in China.
healthcare  digital-health  Platform  genomics 
august 2018 by PieroRivizzigno
Providing help and guidance to HealthCare.gov applicants
Building on that work, our design team reimagined the end-to-end help experience, and established help content design patterns for the entire site. The primary goal: to respectfully and clearly guide people through what can oftentimes be a deeply personal process, one that will determine how they care for themselves and their family.
healthcare  Design  applications 
august 2018 by PieroRivizzigno
A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems | Implementation Science | Full Text
Implementing new practices requires changes in the behaviour of relevant actors, and this is facilitated by understanding of the determinants of current and desired behaviours. The Theoretical Domains Framework (TDF) was developed by a collaboration of behavioural scientists and implementation researchers who identified theories relevant to implementation and grouped constructs from these theories into domains
healthcare  TDF  new-practices 
august 2018 by PieroRivizzigno
Periodontal disease, edentulism, and pancreatic cancer: a meta-analysis. - PubMed - NCBI
Periodontal disease (PD), now our commonest infectious disorder leads to tooth loss, and has been linked to various systemic diseases, including various types of cancer. The aim of this study is to provide a systematic review and a meta-analysis of the relationship between PD, edentulism, and pancreatic cancer (PC).
healthcare  cancer  pancreas  periodontal-disease 
august 2018 by PieroRivizzigno
The Most Powerful Doctor You Never Heard Of
The new law even creates a Patient-Centered Outcomes Research Institute that aims to extend the type of work Krumholz does in cardiology to other medical arenas such as cancer and psychiatry.
healthcare  PRO 
july 2018 by PieroRivizzigno
What Can Odd, Interesting Medical Case Studies Teach Us? - The New York Times
These days, we typically write observational reports on single patients to teach students about the past: This is how this medical mystery was cracked. But perhaps we might revive the case study that looks to the future: I cannot diagnose this condition, or explain it away, but I will record it in its fullest, richest form for another generation of medical students to puzzle over.
healthcare  medical-case  report  mystery 
july 2018 by PieroRivizzigno
Dr. O'Reilly on Immunotherapy in Pancreatic Cancer
Eileen O'Reilly, MD, associate director for clinical research at Memorial Sloan Kettering Cancer Center, discusses the role of immunotherapy in the treatment of patients with pancreatic cancer.
healthcare  cancer  pancreas  immunotherapy  O'Reilly-E  video 
july 2018 by PieroRivizzigno
The Online Gene Test Finds a Dangerous Mutation. It May Well Be Wrong. - The New York Times
Third-party analysis of raw DNA is not as rigorous as that done in a certified laboratory. But many consumers don’t understand that their results are not conclusive.
healthcare  genomics-testing  counterpoint 
july 2018 by PieroRivizzigno
What Patients Look for When Browsing Online for Pancreatic Cancer: The Bait Behind the Byte | SpringerLink
Suitability is a patient-centered metric defined as how appropriately health information is targeted to specific populations to increase knowledge. However, suitability is most commonly evaluated exclusively by healthcare professionals without collaboration from intended audiences. Suitability (as rated by intended audiences), accuracy and readability have not been evaluated on websites discussing pancreatic cancer.
healthcare  cancer  pancreas  online-info  digital 
july 2018 by PieroRivizzigno
Identifying How Patient Portals Impact Communication in Oncology: Health Communication: Vol 0, No 0
Patient portals are becoming widespread throughout health-care systems. Initial research has demonstrated that they positively impact patient–provider communication and patients’ health knowledge, but little is known about the impact of patient portals in the cancer setting, where highly complex and uncertain medical data are available for patients to view. To better understand communicative behaviors and perceptions of the patient portal and how it is utilized in oncology
healthcare  cancer  oncology  patient-communication  patient-portal 
july 2018 by PieroRivizzigno
Immunotherapy: hype and hope - The Lancet Oncology
As the dust settles after a busy week at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (June 1–5, 2018; Chicago, IL, USA), there is an opportunity to reflect on the impact of the largest cancer congress of the year. The goal of “Delivering discoveries: expanding the reach of precision medicine” was evident throughout the event. Among this year's highlights were a predictive 21-gene expression assay that suggests most women with early-stage breast cancer might not need chemotherapy, and findings that pre-operative chemoradiotherapy improves disease-free survival for patients with pancreatic cancer. However, these results were once again dwarfed by the intense media focus on immunotherapy.
healthcare  cancer  immunotherapy  counterpoint  hype 
july 2018 by PieroRivizzigno
FDA Repays Industry by Rushing Risky Drugs to Market — ProPublica
As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.
healthcare  ProPubblica  FDA  drug-approval  counterpoint 
june 2018 by PieroRivizzigno
Ioannidis: Most Research Is Flawed; Let's Fix It
Eric J. Topol, MD: Hello. I am Eric Topol, editor-in-chief of Medscape. With me today is Professor John Ioannidis from Stanford, who I have been dying to have a chat with for a long time. I'm so glad we could get together. John, welcome.
bad-science  Ioannidis  healthcare 
june 2018 by PieroRivizzigno
Cancer Doctor's Tweets Poke Holes In Hyped Science : Shots - Health News : NPR
New advances in medicine also tend to come with a hefty dose of hype. Yes, some new cancer drugs in the hot field of precision medicine, which takes into account variables for individual patients, have worked remarkably well for some patients. But while many patients clamor for them, they aren't currently effective for the vast majority of cancers.
healthcare  precision-medicine  cancer  Vinay-Prasad  ASCO2018 
june 2018 by PieroRivizzigno
Healthcare Data As Property Can Change Everything
Remember Cambridge Analytica?

It was just the tip to the data iceberg. Issues around vast data sets, advanced analytics, revenue potential and ownership are all swirling together and reaching critical mass. But let’s take a step back
healthcare  data  ownership  blockchain  Hu-manity.co 
june 2018 by PieroRivizzigno
Patient Groups & Clinical Trials | Clinical Trials Transformation Initiative
Patient groups have increasingly been recognized as equal partners in the clinical trials enterprise, however there is uncertainty about how patients and research sponsors can best work together to improve the medical product development process. CTTI’s recommendations highlight important roles for patient groups throughout all stages of the process. These solutions also provide best practices that sponsors, patient groups, and other stakeholders can use to ensure the relationship is mutually beneficial.
healthcare  trial-transformation  PRO  CTTI 
june 2018 by PieroRivizzigno
How Digital Therapeutics are Transforming the FDA – Tincture
Digital therapeutics are poised to dramatically change the pharma landscape by marrying software with clinical interventions to produce more effective and economical treatments and therapies.

As with any transformational change in a regulated industry, the development of digital therapeutics has initiated a regulatory transformation as well, one that promises to redefine the inner workings of the FDA. Let’s explore how Digital Therapeutics are transforming the FDA.
healthcare  FDA  trial  digital-health 
june 2018 by PieroRivizzigno
Finding Cancer Patients Is the Pharma Industry’s Unlikely Challenge - Bloomberg
The world’s biggest pharmaceutical companies, looking to sell a new type of cancer drug that could transform treatment, are grappling with an unusual challenge: finding patients.

The new medicines aim to shrink tumors by targeting a rare genetic anomaly -- appearing in 1,500 to 5,000 patients’ tumors in the U.S. annually -- that can spur cancer’s growth. Bayer AG is out in front with a drug that could go on sale by the end of the year. Roche Holding AG is pursuing the same target.
healthcare  cancer  genomic  Foundation-One  Roche  rare-cancer  Bayer 
june 2018 by PieroRivizzigno
Diabetes after 50 could be early sign of pancreatic cancer - CNN
The onset of diabetes after the age of 50 could be an early sign of pancreatic cancer, a new study suggests.
healthcare  cancer  pancreas  prevention  diabetes 
june 2018 by PieroRivizzigno
UK report warns DeepMind Health could gain ‘excessive monopoly power’ | TechCrunch
DeepMind’s foray into digital health services continues to raise concerns. The latest worries are voiced by a panel of external reviewers appointed by the Google-owned AI company to report on its operations after its initial data-sharing arrangements with the U.K.’s National Health Service (NHS) ran into a major public controversy in 2016.
healthcare  DeepMind  NHS  report  power  colonialism 
june 2018 by PieroRivizzigno
Google Is Training Machines to Predict When a Patient Will Die - Bloomberg
AI advances by the 'Medical Brain' team could help the internet giant finally break into the health-care business
healthcare  Google  App  DeepMind  monopoly  data 
june 2018 by PieroRivizzigno
Gut Microbiome Promotes Pancreatic Cancer Progression | GEN
Understanding the appropriate balance of “good” bacteria within the intestinal tract has been the focus of much ongoing research for a number of years. Links between gut dysbiosis and the onset of disease are continually being established with the hope that therapeutic interventions may be developed soon to halt disease progression. Now, investigators at the NYU School of Medicine, Perlmutter Cancer Center, and NYU College of Dentistry have just released data that describes how a population of bacteria in the pancreas increases more than a thousand-fold in patients with pancreatic cancer—becoming dominated by species that prevent the immune system from attacking tumor cells.
healthcare  pancreas  cancer  microbiome 
june 2018 by PieroRivizzigno
Pancreatic Cancer Patients with BRCA Mutation May Benefit from Targeted Drug | The University of Arizona Cancer Center
PARP is a protein that repairs damaged DNA in tumor cells, helping cancer to grow. Rucaparib is a PARP inhibitor, a drug that blocks PARP from repairing DNA, thereby killing cancer cells. Because it is effective in breast and ovarian cancers with the BRCA mutation, Dr. Shroff hoped to learn if it would work in pancreatic cancer patients with that mutation as well.
healthcare  cancer  pancreas  PARP 
june 2018 by PieroRivizzigno
Progress Against Cancer Depends on Efficient Drug Approval System That Brings Safe, Effective Treatments to Patients | ASCO Connection
As a lifelong proponent of well-conducted and properly controlled clinical trials, I am sympathetic to concerns recently raised in a New York Times editorial (“Easier Drug Approval, at What Price,” June 10, 2018) about efforts by the U.S. Food and Drug Administration to “bring new science to the marketplace faster.” As a pragmatic investigator and physician who has witnessed remarkable progress in the treatments we can now offer individuals with cancer, however, I believe the FDA’s support of more rapid and nimble testing and approval of new therapies should be applauded.
trial  healthcare  approval-process  drug-development 
june 2018 by PieroRivizzigno
Progression-Free Survival: Meaningful or Simply Measurable?: Journal of Clinical Oncology: Vol 30, No 10
The last few years have seen an increase in the number of randomized controlled trials (RCTs) of new agents in metastatic solid tumors using progression-free survival (PFS) as the primary end point. Some trials showing improvement in PFS, without a corresponding increase in overall survival (OS), have led to approval of new drugs and/or changes in standard of care. This suggests a growing belief in the oncology community that delaying progression in metastatic disease is a worthy goal, even if OS is not improved. But is a new treatment that improves PFS really an advance for patients?
healthcare  cancer  trial  metrics  evaluation  PFS 
june 2018 by PieroRivizzigno
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