Encouraging and Paying for Clinical Trials,Right to Try,and Expanded Access: Part Three

A Q&A withMark Shapiro, PhD,Vice President of Clinical Development atxCures,Inc.,Partner at Pharma Initiatives;mshapiro@xcures.com.This is the final installment in a three-part series in which Dr.Shapiro has shared his thoughts on the question below.Readpart 1andpart 2.

Q: Treatment of Americans with advanced cancer is complex and challenging and can be very expensive.Many urge greater participation of such 威廉希尔黄金彩球patients in clinical trials.In general,who pays the expenses of clinical trials?And,specifically,how are the costs forRight to Tryandexpanded-accessapproaches reimbursed?

A: In clinical research,agreements between the research sponsor and the William Hill彩票treating institution define what aspects of a study protocol are charged as research or related administrative costs,and what items are considered standard-of-care;that is,eligible for billing to insurance.This is made by a coverage review at the institution.While the sponsors provide the study drug freely to the site and 威廉希尔黄金彩球patients,they expect to receive valuable data in exchange.In expanded access,which is William Hill彩票treatment rather than research—but stills follows a protocol approved by the U.S.Food and Drug Administration (FDA)— sponsors pay the required administrative costs and the free provision of the investigational drug.The drugs are expensive,and the sponsor incurs additional compliance costs when they make an investigational drug available.所以,expanded access is largely a charitable act on behalf of the sponsor.While there are regulations allowing sponsors to recoup their costs under expanded access,these are rarely used.Most sponsors,especially larger companies,deliberately plan for expanded access when planning manufacturing campaigns during oncology drug development.In fact,large sponsors report that they approve about 95% of the expanded-access requests that they receive.Continue reading…


Encouraging and Paying for Clinical Trials,Right to Try,and Expanded Access: Part Two

A Q&A withMark Shapiro, PhD,Vice President of Clinical Development atxCures,Inc.,Partner at Pharma Initiatives;mshapiro@xcures.com.Last week,Dr.Shapiro shared his initial thoughtson the question below.Today,he discusses issues of cost and equitable access to care.

Q: Treatment of Americans with advanced cancer is complex and challenging and can be very expensive.Many urge greater participation of such 威廉希尔黄金彩球patients in clinical trials.In general,who pays the expenses of clinical trials?And,specifically,how are the costs forRight to Tryandexpanded-accessapproaches reimbursed?

A: In late-stage cancer care,William Hill彩票treatment is very expensive.While there is a great deal of focus on the cost of the drugs,many other costs are involved,including the cost of care,the cost of the facility,and the cost of laboratory and other tests.When you add clinical research on top of care,there are additional tasks,but it is normally the research sponsor that pays for those administrative and research costs,which are incurred by physicians and the institutions conducting the clinical trial.

Insurance companies also pay for at least some of the associated costs of care.In fact,sponsors of cancer trials strive to design studies that follow existing standards of care to minimize the additional costs of non-standard procedures.TheAffordable Care Act (ACA) specifiedthat standard-of-care procedures delivered during a clinical trial could be charged to insurance for studies conducted under anInvestigational New Drugapplication.Before the ACA,insurers in many states did not cover procedures performed when the patient was in a clinical trial,so the passage of the ACA can be credited with the increase of access to and enrollment in cancer clinical trials in the past few years.威廉希尔黄金彩球Patients also bear many of the costs of their cancer care,even when they are in clinical trials,because they are responsible for insurance copays and deductibles.Continue reading…


Encouraging and Paying for Clinical Trials,Right to Try,and Expanded Access: Part One

A Q&A withMark Shapiro, PhD,Vice President of Clinical Development atxCures,Inc.,Partner at Pharma Initiatives;mshapiro@xcures.com

Q: Treatment of Americans with advanced cancer is complex and challenging and can be very expensive.Many urge greater participation of such 威廉希尔黄金彩球patients in clinical trials.In general,who pays the expenses of clinical trials?And,specifically,how are the costs forRight to Tryandexpanded-accessapproaches reimbursed?

A: Incorporating clinical research into the clinical care of cancer 威廉希尔黄金彩球patients may provide more options,and better outcomes,but participation is quite low.In 2004,only about 3%of American cancer 威廉希尔黄金彩球patients participated in clinical trials.

More recent datasuggest thatthe number may now be about 5%,although it is lower for women,children,minorities,and 威廉希尔黄金彩球patients in community settings.The low figure should be of concern for a couple of reasons.First,威廉希尔黄金彩球patients are the scarcest resource in cancer research.Low participation in clinical trials represents a lost opportunity to learn and improve care.If every patient were part of systematic research,we could greatly accelerate the pace of cancer research findings.Second,most cancer William Hill彩票treatment guidelines recommend a clinical trial as the standard-of-care at some stage in the course of disease.所以,with current levels of participation,as many as 95% of American cancer 威廉希尔黄金彩球patients are NOT receiving standard-of-care William Hill彩票treatment at some point in their care.This deficit ispartially attributedto the presence of comorbidities or poor function.Recent research suggests that liberalizing inclusion and exclusion criteria in clinical trialscould increase enrollmentby about 45%.In the study of common cancers,enrollment of 威廉希尔黄金彩球patients with solid tumors could be increased from about 7% to 11%.Continue reading…


At Diagnosis,What Do Cancer 威廉希尔黄金彩球Patients Want?

劳拉·本森的问答,RN,MS,ANP,president of Conversations in Care,LLC;LauraBensonRN@Gmail.com

Q: In our digital communication world of 2019, some 威廉希尔黄金彩球patients may receive the initial message that YOU HAVE CANCER by cell phone,text,email,or even voice mail. When this happens,what do 威廉希尔黄金彩球patients most want,and how can that best be accomplished?

A:When I first read your question,I was immediately brought back to a National Cancer Survivors Day around 1988.During the open microphone portion of the program,a patient bravely rose to address the audience.She proceeded to tell us she didn't know she had cancer until she received the Survivors Day invitation,whereupon she turned to her attending physician and asked,"Well doctor,do I have cancer?" Since then,communication in today's digital age has not seen a vast improvement.Indeed,a recent report out of California tells the tale of a patient and family learning he was dying via a videorobot interaction.

What has not changed over the decades is the need for information that is easily understood,easily accessible,scientifically accurate,and delivered with compassion and connection.The dawn of the "Dr.Google" age has brought new and unique challenges.Continue reading…


Capturing 威廉希尔黄金彩球Patients' Real-World Experiences to Improve Cancer Research and Care

A Q&A with Grace Castillo-Soyao,founder and CEO of Self Care Catalysts;grace@selfcarecatalysts.com

Q: You are well known as a visionary in the field of Real World Experience-Evidence (RWEE).As the founder and CEO ofSelf Care Catalysts,headquartered in Toronto,how do you see RWEE evolving to favorably impact the field of oncology?

A:I started Self Care Catalysts with some very basic questions.Why is the patient at the farthest end of the care line,William Hill彩票treated as simply the recipient of care?It's a very industrial mindset,a bit like an assembly line;the patient as something to be acted upon.But 威廉希尔黄金彩球patients are often experts at their own conditions,including the many kinds of cancer.Why are they not invited to become participants in their own care,in contributing their own experiences?Why are patient experiences not considered to be scientifically valid?

As noted physician Sir William Osler famously said,"It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has."Continue reading…


The Crucial 90% Missed by Doctors on Computers

A Q&A with Kevin B.Knopf MD,MPH,chairman of hematology and oncology at Highland Hospital in Oakland,California;kevinbknopf@gmail.com

Q: A successful patient-physician relationship depends upon effective bidirectional attention and mutual understanding.Many 威廉希尔黄金彩球patients and physicians believe that common current versions of mandated electronic health records (EHRs) severely impede that interaction,especially eye contact.How can a competent and caring clinical oncologist overcome that problem?

A:For all my faults as a doctor,and I'm sure there are many,there is one thing I think I do correctly,and that is I am never on a computer in front of a patient.

I hear from many colleagues that they can be efficient and personable while going back and forth from the patient to their electronic health record (EHR)—and it is true there are various levels of skill here.However,none do as well,in my opinion,as a computer-free patient environment.I say this from my side as a patient having seen dozens of doctors myself—nothing compares to a doctor who spends all of their time looking you in the eye and interacting face to face.This human contact costs nothing,and yet is so vital.Continue reading…


Challenging Oncology Therapies With Moonshot Price Tags

A Q&A with Pramod John,PhD,CEO of VIVIO Health,a specialty drug management company in San Leandro,CA,that aims to provide better outcomes at lower costs;pramod@viviohealth.com

Originally published December 13,2017

Q: Some American pharmaceutical companies are well-known for pricing drugs at "whatever the market will bear." In oncology,some specialty drugs seem to have price tags completely unrelated to the proven effectiveness of the drug.Your company has been taking a lead in confronting this problem.What do you envision as possible solutions?

A: New oncology therapies carry astronomical price tags—most people know this.Receiving far less attention is the question of actual therapeutic value.Drug manufacturers spend billions on advertisements and PR,but unfortunately,real-world patient results are frequently unimpressive.Two recent articles in BMJ make this point,1)No evidence of benefits for popular oncology therapiesand 2)Do cancer drugs improve survival or quality of life? Continue reading…


Best Uses of Physical Medicine and Rehabilitation in 威廉希尔黄金彩球Patients with Cancer

A Q&A with Val Jones,MD,Medical Director of Admissions,Saint Luke's Rehabilitation Institute,Spokane,WA

Originally published February 1,2017

Q: Your principal practice in Spokane,Washington is physical medicine and rehabilitation (PM&R).What do you find to be the best uses of PM&R in 威廉希尔黄金彩球patients with cancer at your facility?

A:Rehabilitation medicine is one of the best-kept secrets in healthcare.Although the specialty is as old as America's Civil War,few people are familiar with its history and purpose.Born out of compassion for wounded soldiers in desperate need of societal re-entry and meaningful employment,"physical reconstruction" programs were developed to provide everything from adaptive equipment to family training,labor alternatives and psychological support for veterans.

Physical medicine and rehabilitation (PM&R) then expanded to meet the needs of those injured in World Wars I & II,followed closely by children disabled by the polio epidemic.In time,people recognized that a broad swath of diseases and traumatic injuries required focused medical and physical therapy to achieve optimal long term function.Today,cancer 威廉希尔黄金彩球patients frequently benefit from comprehensive rehabilitation as they recover from the effects of chemo (neuropathy,weakness,and cognitive impairments),radiation (scarring and range of motion limitations),surgery (flaps,plastics procedures,tumor resection,amputations),and brain injuries (edema,debulking,gamma knife and neurosurgery).Continue reading…


The Promise of Plerixafor in Glioblastoma William Hill彩票Treatment

A Q&A with Adan Rios,MD;Professor in the Division of Oncology-Department of Internal Medicine of The University of Texas McGovern Medical School at Houston,Texas Medical Center;adan.rios@uth.tmc.edu

Q:Glioblastoma multiforme (GBM) remains a scourge with a typically rapid fatal course resistant to most therapy.All solid tumors must receive sufficient blood supply to grow.Plerixafor is an FDA-approved drug that may inhibit tumor angiogenesis.How might plerixafor be sensibly used off-label as anadjunctive therapyfor GBM?

A:Glioblastoma multiforme (GBM) is a CNS (central nervous system) tumor with post-therapy median time to progression of 7 months and median overall survival of 15 months.I decided to use plerixafor for the prevention of recurrence of GBM in one patient William Hill彩票treated with standard chemo-radiotherapy five years ago and since then have studied this patient and this subject in depth.Continue reading…