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Caution for NIH's single IRB policy for multi-site researchBy Sue Coons, MA

A tions had to comply with the National Institutes of Health’s (NIH’s) Final

NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Researchpolicy established the expectation that a single institutional review board (sIRB) of record would be used in the ethical review of non-exempt human subjects research protocols funded by NIH that are carried out at more than one site in the United States.

It does not apply to career development, research training, or fellowship awards.

However, some institutions continue to be concerned about their ability to adhere to the policy and the cost of doing so. IRB executives say it is wise to be cautious. Some institutions could spend millions of dollars to upgrade their IRB infrastructure, while some IRBs already have many of the policy requirements in place. In addition, one IRB executive worries that past NIH actions

show that the agency could revise its policy

Emerging trends in clinical research: The need for changeBy John W. Mitchell, MS

T by emerging trends in the clinical trial research sector, consider insight from

a business author and a businessman/politi-cian. In his groundbreaking book, Good to Great: Why Some Companies Make the Leap…And Others Don’t,” Jim Collins wrote:

“Good is the enemy of great. And that is one of the key reasons why we have so little that becomes great. We don’t have great schools, principally because we have good schools. We don’t have great government, principally because we have good govern-ment.”

Secretary Donald Rumsfeld noted that one of the biggest threats to security was driven by factors that fell under the category of “we

don’t know what we don’t know.” In recent issues, Research Practitioner has

explored individual key emerging trends in clinical research, including patient centricity, eMobile advances, and precision medicine. As stand-alone trends, these innovations hold great promise and excitement.

But what insight is gained when all emerg-ing trends are considered in totality? What

clinical research? As Rumsfeld alluded, what might we not know that we don’t know? Are current advancements in clinical research, as Collins asserted, relevant enough to power (great) the sector beyond the status quo (good), given the rapidly evolving medical

ligence (AI), and the expectation of patients?

results on the use of electronic-sourced data, Hugo Stephenson, executive chairman of DrugDev and a physician investigator, observed: “I’m surprised and disappointed there hasn’t been much improvement in the entire clinical trial process, including the

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. Volume 19, Number 3

Learning Objectives/Outcomes:1. Explain the need for change in clinical research.

2. List key drivers of transformation in clinical trials.

3. Describe examples of clinical trial research trends in action.

4. Discuss why the clinical trial sector will make the jump from trends to practice.

Learning Objectives/Outcomes:1. List the details that local IRBs may know about their

study populations as opposed to a single IRB.2. Describe NIH’s reasoning for going to a single IRB

policy for multi-site research.3. Discuss the impact of using a single IRB on a study’s

direct costs.4. Explain the concern about NIH’s history of choosing

the lowest-cost provider.

42 CE program information

43 Issues in research management

52 SMART IRB

55 CE post-test

May–June 2018

see Emerging trends on page 44

see Single IRB on page 49

o understand the opportunity o�ered

In a 2002 Department of Defense brie�ng,

do these opportunities say about the �eld of

reality of interconnectivity, arti�cial intel-

�ese seem to be fair questions. In a Feb-ruary 2017 CenterWatch article about survey

s of Jan. 25, 2018, research institu-

�is

August 20, 2018

Industry Briefs…2-3

Drug & Device Pipeline News…6Sixteen drugs and devices have entered a new trial phase this week.

JobWatch…7Job listings, networking events and educational programs.

By Bill Myers

N IH has delayed a controversial new policy that would have required basic brain and behavioral research-

ers to treat their work as clinical trials. The measure, originally set to take effect

next month, called for scientists who study human cognition or behavior — for example using brain scans with healthy volunteers — to follow the same rules as studies testing drugs or diagnostics, including registering their studies and publishing results in the ClinicalTrials.gov federal database.

NIH made the move in response to a 2016 Government Accountability Office (GAO) report that slammed the agency for failing to keep track of nearly $3 billion in

taxpayer dollars it had allocated to support scientific research.

Psychologists and neurologists had pushed back against the policy, insisting it would subject them to extraneous gov-ernment oversight of experiments that, in their view, didn’t involve any real risk to hu-man subjects and made no sense for studies that weren’t testing a treatment.

They also balked about massive unneces-sary paperwork and administrative night-mares they predicted the new requirements would create — and complained that some of NIH’s language about “priority” research could be misinterpreted and block funding for exploratory research and training.

NIH Delays Basic Brain Research Rules

By Bill Myers

E xpansion cohorts can help bring life-saving drugs to market quickly, but sponsors should be sure to update

informed consent for patients and convene expert safety panels that meet regularly, the FDA says in new draft guidance.

In the 17-page draft, the agency says it wants to “establish an infrastructure” to help sponsors use cohorts to expand oncology trials swiftly without compromising safety. But that means sponsors would have to stay on top of rapidly changing developments—and keep their patients in the loop, too.

“It is critical that investigators, IRBs and regulators are updated with new safety information so that they can provide the

necessary oversight for the protection of hu-man subjects and so that investigators can ensure that patients can provide adequate informed consent,” the document stresses.

On its face, the recommendations aren’t radical, but they do acknowledge the pace at which these kind of adaptive trials are being adopted, says Lindsay McNair, chief medical officer at WCG Clinical.

“I think [the FDA] recognizes that these studies are unique in both the type of safety data that is accumulating during them and the speed and volume at which the data may be accumulated,” she says.

Perhaps the most well-known drug to come through an expansion cohort trial is

FDA: New Guidance for Expansion Cohort Trials

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WCG | CWWeekly August 20, 2018 2 of 8

Industry Briefs

First Human Zika Vaccine Trial Researchers are launching the first human trial of an experimental live Zika vaccine. The vaccine, which contains a weakened version of the virus, was de veloped by scientists at the National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll a total of 28 healthy, non-pregnant adults, ages 18 to 50, at Johns Hopkins School of Public Health Center for Immunization Research and at the Vac-cine Testing Center at Larner College of Medicine at the University of Vermont. Trial participants will be randomly assigned to receive a single subcutaneous dose of the experimental vaccine (20 participants) or a placebo (eight participants). Neither they nor investigators will know who is receiv-ing the real thing. Participants will keep track of their tem perature on diary cards at home – and return to the clinic for periodic checkups for about six months. Researchers will take blood samples during visits to see if they’re developing antibodies in response to the vaccine. Anna Durbin, a professor of International health at Hopkins School of Public Health, is leading the Phase I clinical trial. Most people infected with the Zika virus — primarily transmitted by certain mosquitoes — have mild to no symptoms. But it can cause serious birth defects and developmental problems in babies born to women infected during pregnancy. That’s why the Centers for Disease Control and Prevention advises women who are preg-nant or planning to become pregnant not to travel to areas with a known Zika risk. “Zika virus infection remains a significant threat to pregnant women and their developing fetuses, and we can expect to see periodic outbreaks and cases in areas where Aedes aegypti mosquitoes thrive,” said NIAID Direc-tor Anthony Fauci. “NIAID remains commit-ted to developing safe and effective Zika vaccines, and we are pleased to begin clini-cal testing of a live attenuated candidate.”

“Triple Pill” May Keep a Lid on BP A low-dose, three-in-one pill may be an easy new way to treat high blood pressure. A trial led by The George Institute for Global Health in Sidney, Australia, found that a whopping 70 percent of patients who took the so-called Triple Pill — containing half doses of three different meds — reached blood pressure targets, compared to just over half of those who received usual care. Typically, patients begin treatment with one drug at a very low dose that’s gradually increased with other drugs added to the mix to reach target blood pressure measures. It takes time and tinker-ing with meds and doses to come up with the most effective cocktail. That means patients have to frequently visit their doctor to see if the meds are working or if they need to be changed or doses adjusted to meet treat-ment goals. “This is not only time inefficient, it’s costly. We also know that many doctors and patients find it too complicated and often don’t stick to the process,” said study co-author Ruth Webster. In an attempt to find a simpler approach, researchers enrolled 700 patients with an average age of 56 and blood pressure of 154/90 mm Hg in a six-month trial. Participants were randomly assigned ei-ther the combo pill or standard care. The test tablet contained the blood pressure meds telmisartan (20 mg), amlodipine (2.5 mg), and chlorthalidone (12.5 mg). The findings, published in JAMA: a significantly higher pro-portion of patients receiving the “Triple Pill” hit their target blood pressure of 140/90 or less (with lower targets of 130/80 for patients with diabetes or chronic kidney disease). The three-in-one option was not only more effec-

tive, it was also found to be safe, researchers said. The George Institute says it plans to examine the cost-effectiveness of the “Triple Pill” — and test its appeal among doctors and patients. An estimated one in three U.S. adults — around 75 million people — suffer from high blood pressure. But only about 54 percent have it under control, according to the Centers for Disease Control and Preven-tion (CDC). The condition ups the risk for heart attack and stroke, two of the leading causes of death in the U.S.

FDA OKs Optivo for Lung Cancer The FDA last week approved Bristol-Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small cell lung cancer (SCLC) that fails to respond to platinum-based chemother-apy and at least one other therapy. “Small cell lung cancer can be a very challenging disease, particularly for those who have already been through multiple types of treatment, as most patients relapse within a year of diagnosis,” said Andrea Ferris, president and chairman of the LUNGevity Foundation. “This approval marks a major milestone for the patients touched by this unrelenting disease and may motivate them to pursue further treatment where there previously were no other ap-proved options.” The agency OK’d Optivo after 12 percent of 109 patients (in the SCLC cohort of the ongoing Phase I/II CheckMate -032 clinical trial) responded to it after chemo and another therapy failed. According to research-ers, 12 patients had a partial and one (0.9 percent) a complete response. The median duration of response (DOR) was 17.9 months.

WCG | CWWeekly (ISSN 1528-5731)

Lisa Stein Editorial DirectorBill Myers Clinical Trials SpecialistRenee Breau Production

CenterWatch Main and Editorial Offices10 Winthrop Square, Fifth Floor, Boston, MA 02210editorial@centerwatch.com / sales@centerwatch.com

© 2018 CenterWatch. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher. Permission requests can be obtained via fax at (617) 948-5101 or emailed to editorial@centerwatch.com. Advertising packages and reprints are available. Email sales@centerwatch.com or call (617) 948-5100.

see Optivo on page 3 »

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WCG | CWWeekly August 20, 2018 3 of 8

Industry Briefs (continued from page 2)

The drug was discontinued in 10 percent of patients and one dose was withheld in 25 per­cent because of side effects. Some 45 percent of trial participants experienced serious side effects. SCLC is a very aggressive cancer that makes up about 10 to 15 percent of all lung cancers. About 27,000 cases are diagnosed in the U.S. each year.

Schizophrenia: If At First You Don’t Succeed, Try Clozapine? A new study suggests doctors may want to consider prescribing the potent, atypical an­tipsychotic drug clozapine earlier for schizo­phrenia if a typical antipsychotic doesn’t work. Physi cians generally don’t prescribe clozapine for newly diagnosed patients until they’ve tried at least two other less potent antipsychotics. But a trial found that if the first drug didn’t help, switching to another similar antipsychotic usu­ally didn’t have much of a clinical impact, either. So researchers concluded it might be more effective to skip the second antipsychotic – and move onto clozapine earlier. New York’s Mount Sinai Hospital recruited 486 newly diagnosed schizophrenia patients and gave them up to 800 mg per day of the antipsy chotic amisulpride for four weeks. Patients whose symptoms didn’t subside were then either continued on amis­ulpride or switched to up to 20 mg per day of olanzapine, another typical antipsychotic, for six more weeks. After 10 weeks, patients still suffer­ing from hallucinations and/or other schizophre­nia symptoms were given up to 900 mg per day of clozapine for 12 weeks. Ten weeks is gener ally

considered very early to start prescribing clozap­ine. But lead researcher Rene Kahn says the trial found that trying it then “could potentially save time and reduce suffering.” The findings were published The Lancet Psychiatry.

Cetuximab Can’t Clear Trial for Throat and Mouth Cancer Cetuximab, a targeted anti­cancer drug believed to be less toxic than its rival cisplatin, has failed to show it can help curb the growth of throat and mouth cancers caused by HPV. There was a lot of hope for cetuximab when researchers began a Phase III trial of 849 patients with HPV­related mouth or throat cancers in June 2011 in which they received a combination of radiation therapy and either cetuximab or the more potent cisplatin. But researchers found that cetuximab was far less effective than cisplatin at controlling tumor growth. “The goal of this trial was to find an alternative to cisplatin that would be as effective at controlling the cancer but with fewer side effects. We were surprised by the loss of tumor control with cetuximab,” said lead investigator Andy Trotti of the Moffit Cancer Center in Tampa, Florida. Cetuximab, most commonly known by its brand name Erbitux, is already approved for treatment of metastatic colorectal cancer, some cancers of the head and neck, non­small cell lung cancer and a form of skin cancer. Its most common side effects are relatively mild — ranging from a rash to nausea. Cisplatin, on the other hand, may cause kidney damage, hearing loss and bone marrow suppression. Researchers plan to release their full findings in October.

FDA Approves EpiPen Generic The FDA last week approved the first direct generic competitor to the EpiPen, paving the way for cheaper competition that may lower prices. The new generic will be made by Israeli generic manufacturer Teva Pharmaceuticals. It was greenlighted after the FDA issued new guidance for generic copies of products like the EpiPen, the most widely prescribed epinephrine auto­injector in the U.S. Epineph­rine reduces swelling in airways and increases blood flow in people suffering anaphylaxis or life­threatening reactions to foods, insect stings or medicines. “This approval means patients living with severe allergies who require constant access to lifesaving epineph­rine should have a lower­cost option, as well as another approved product to help protect against potential drug shortages,” FDA Com­missioner Scott Gottlieb said in a statement. Mylan, which bought the rights to the EpiPen from Pfizer, has been under fire for hiking the price of the EpiPen to more than $600 for a twin pack. The approval covers generic copies of EpiPen and EpiPen Jr. for kids. Teva Pharma­ceuticals can market its generic epinephrine auto­injector in 0.3­milligram and 0.15­mil­ligram doses, the FDA said. The company didn’t say how much it would charge for the generic version or when it would be available. Anaphylaxis occurs in approximately one in 50 Americans, according to the FDA. “People who have had an anaphylaxis episode always face the risk of another one,” Gottlieb said. “Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.”

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Cardiology/Vascular DiseasesDermatologyDevicesEndocrinologyGastroenterologyHealthy VolunteersImmunologyInfections and Infectious DiseasesInternal MedicineMusculoskeletalNeurologyObstetrics/Gynecology (Women’s Health)OphthalmologyOrthopedics/Orthopedic SurgeryPharmacology/ToxicologyPsychiatry/PsychologyPulmonary/Respiratory DiseasesRheumatologyUrology

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Optivo

Cohort Trials (continued from page 1)

WCG | CWWeekly August 20, 2018 4 of 8

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. CWW2233

“I think [the FDA] recognizes that these studies are unique in both

the type of safety data that is accumulating during them and the speed and volume at which the data may be accumulated.”

—Lindsay McNair, chief medical officer, WCG Clinical

Merck’s anti-cancer blockbuster Keytruda, which some analysts predict could reach $10 billion in annual sales. The drug, which hit the market in May 2017, has been approved for treatment of 10 different types of cancer.

Dozens of other, similar drugs are in the pipeline, FDA records show. ClinicalTrials.gov lists nearly 147 expansion cohort trials completed in recent years—and another 416 in some stage of development.

Despite the successes, not everyone is on board. Some researchers worry expansion trials open the door to potential safety gaps — an issue the FDA hopes oversite commit-tees can keep an eye on and avoid. Plus, the jury’s still out on whether adding cohorts enhances the success rate in later trials by catching and fixing possible snags early.

A 2017 study, published in a Journal of the American Association for Cancer Research,

analyzed 533 phase I cancer trials between 2006 and 2011. It found the ones that used expansion cohorts went on to have success-ful phase II trials at nearly twice the rate (48 percent) as those that didn’t (27 percent). But just a year earlier, a team of researchers

analyzed 252 cancer trials (conducted be-tween 2004 and 2014) and found expansion cohorts made little or no statistical difference between success or failure in phase II trials.

Still, WCG’s McNair says there’s no ques-tion they help researchers “get to decision-making points more quickly.” And the FDA believes that with recommended new protections, they’ll prove to be a safe, quick way to bring new potentially vital meds to people who need them.

“A lot of time and cost of clinical develop-ment is spent waiting in between the start and end of the phases of trials,” FDA Com-missioner Scott Gottlieb said in a statement. “Expansion cohort trials can bring efficiency to drug development, potentially reducing development costs and time.”

Read the FDA’s draft guidance here: www.fdanews.com/08-10-18-DraftGuidance.pdf.

NIH postponed the move a year — until Sept. 24, 2019 — after Congress asked it to delay action.

In the interim, behavioral researchers will still have to register their proposed studies “with the expectation that data will eventually be transported to ClinicalTrials.gov,” the NIH says. They’ll also have to take special training on clinical practices, regardless of the focus of their research.

NIH is the nation’s largest funder of clinical trials. After the GAO released its report, the agency acknowledged that it “had difficulty re-

porting how many clinical trials it has funded” and that “results from many NIH-funded clini-cal trials are never published or reported in a public database.”

The new policy was among steps it took designed to remedy the lapses and increase transparency of NIH-funded clinical trials.

Last year more than 3,500 scientists signed an online petition urging NIH Director Francis Collins to scrap the plan —and opponents

had hoped NIH would scuttle it. But they said they’re pleased to have extra time to adjust and provide more input.

“APA supports policies that encourage open science approaches such as preregistra-tion of studies and data sharing,” Howard Kurtzman, executive director of the American Psychological Association, which opposes the policy, told CenterWatch. “Such policies should be developed with the input of the research community and be sensitive to the purposes and nature of the research being conducted.”

The NIH said it plans to work with scientists to iron out wrinkles and ease compliance over the next year.

NIH Delays Rules (continued from page 1) NIH postponed the policy for a

year – until Sept. 24, 2019 – after Congress asked it to delay action.

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Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactAmicus Therapeutics Galafold (migalastat) Fabry disease Approval granted by the FDA amicusrx.com

Arbutus Biopharma Coporation and Alnylam Pharmaceuticals, Inc.

ONPATTRO (patisiran)

Hereditary transthyretin amyloidosis

Approval granted by the FDA arbutusbio.com

Ivantis, Inc. Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device

Mild to moderate primary open-angle glaucoma in conjunction with cataract surgery

Approval granted by FDA ivantisinc.com

Genentech Xlair®(omalizumab) Prevention of severe allergic reactions following accidental exposure to foods in people with allergies

Breakthrough Therapy Designation granted by the FDA

gene.com

Samsung Bioepis, Co., Ltd.

SB26 ulinastatin-Fc (UTI-Fc) fusion protein

Severe acute pancreatitis Phase I trial set to begin samsungbioepis.com

Sesen Bio, Inc. Vicinium™ Non-muscle invasive bladder cancer (NMIBC)

Granted Fast Track Designation by the FDA

sesenbio.com

BeiGene Ltd. Tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy

Potential first-line treatment for patients with Stage IIIB or IV squamous non-small cell lung cancer (NSCLC)

Phase III clinical trial initiated clinicaltrials@beigene.com

Eiger BioPharmaceuticals, Inc.

Avexitide (formerly exendin 9-39)

Post-bariatric surgical patients who experience post-bariatric hypoglycemia (PBH)

Completion of enrollment in Phase II clinical trial

eigerbio.com

Izana Bioscience Namilumab Ankylosing spondylitis Phase II proof-of-concept clinical trial initiated

izanabio.com

Rafael Pharmaceuticals, Inc.

CPI-613 in combination with bendamustine

Relapsed or refractory T-Cell Lymphoma

Activation of a second clinical trial site for the Phase I study

rafaelpharma.com

Endomag Magtrace, the first non-radioactive, dual-tracer

Lymphatic mapping in patients with breast cancer undergoing a mastectomy

Granted premarket approval granted by the FDA

endomag.com

Cannabics Pharmaceuticals, Inc.

Cannabics SR 5mg, daily for 3 months

Advanced Cancer and Cancer Anorexia Cachexia Syndrome (CACS)

Conclusion of trial announced; officials results are being evaluated

cannabics.com

OrthoTrophix, Inc. TPX-100 Osteoarthritis Phase II trial results: improvements in function and cartilage in 55 percent of TPX-100 treated knees

orthotrophix.com

Entasis Therapeutics ETX2514SUL Complicated urinary tract infections, including acute pyelonephritis (kidney infection) in adults

Positive topline results from Phase II trial

entasistx.com

Realm Therapeutics PR022 Atopic dermatitis Phase II trial failed to reach endpoint goals

realmtx.com

INOVA Diagnostics, Inc.

QUANTA Flash® HMGCR

Aids in the diagnosis of idiopathic inflammatory myopathy (IIM), a group of conditions that affect the skeletal muscles

Received FDA clearance inovadx.com

For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!

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Infectious Diseases - Tenure leading PositionUNMC College of PharmacyOmaha, NE

Senior Medical Director/PIQuotient SciencesMiami, FL

Clinical Research CoordinatorCatalina Research Institute, LLC Montclair, CA

Clinical Project ManagerGlycoMimetics, Inc.Rockville, MD

Clinical Trials AnalystMount Sinai New York, NY

Regulatory Affairs Clinical Foster City San Mateo, CA

Associate Clinical Education Assistant Cincinnati, OH

Clinical Studies Manager South San Francisco, CA

Process Operator - Scientific Union City, GA

Regulatory Affairs Manager Product Development Small Molecule Palo Alto, CA

QA Raw Materials Specialist Cambridge, MA

Manufacturing Visual Inspection Technician Raleigh, NC

Senior Laboratory Technician (Cell and Molecular Biology) - NIH Bethesda, MD

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