Volume 23, Issue 26. © 2019 CenterWatch. All rights reserved.

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see Real-World Evidence on page 4 »

July 15, 2019

Up and Coming…2

Industry Briefs…3

Drug & Device Pipeline News…7Twenty drugs and devices have entered a new trial phase this week.

JobWatch…9

see Ask the Experts on page 5 »

CenterWatchWeekly

This monthly feature presents a variety of questions from clinical trial profes-sionals with answers from WCG Clini-

cal’s expert staff. To ask a question of WCG’s experts, click here: https://bit.ly/2XB9F6R.

Question:When a research activity includes a

translated consent form, does the principal investigator need to sign both the translated consent form and the English consent form? — Director, state university human research protections program

Answer:The regulations for informed consent

are divided into those that govern the contents of informed consent documents and those that describe the requirements

for documenting consent (i.e., signing informed consent forms). There are no regulations that specifically address trans-lations. In fact, the word “translation” does not appear in the regulations.

As a result, the requirements for signing translated consent forms are no different than they are for original forms. In an FDA-regulat-ed clinical trial, both the participant and the person obtaining consent should sign and date the consent document that was used to facilitate the process with the participant. If a consent process was conducted in Korean us-ing a Korean-language document, then that is the document that should be signed.

In addition to the standard approach to documenting informed consent, 21 CFR

Ask the Experts: Consent and Reconsent

By Brandon May and James Miessler

U sing real-world data (RWD) and real-world evidence (RWE) in clinical trials is growing in popularity among both

industry and the FDA, but both groups agree that all stakeholders need to be on the same page when it comes to definitions and ways to measure results.

“There is a tremendous interest in making use of the vast amount of data that’s already been collected in healthcare systems to more efficiently generate evidence,” the FDA’s Robert Temple told participants at a joint FDA and Duke University workshop last week.

“What people mean by RWE, and the specific study designs to be considered, is not clear,” said Temple, who is deputy director for clinical science in the agency’s

Center for Drug Evaluation and Research. “In fact, the specifics of the data generated by an RCT (randomized clinical trial) within a healthcare system could vary tremendously.”

In a draft guidance issued in May, the FDA provides the following definitions:

}} RWD are data relating to patient health status and/or the delivery of healthcare that are routinely collected from a vari-ety of sources; and

}} RWE is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.

But even these definitions may not entirely solve the problem, according to comments on the draft guidance the agency

Role of Real-World Evidence in Clinical Trials Needs Definition, Industry and FDA Agree

PipelineNews

FDA Actions

Company name Drug name Indication FDA action

Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment

510(k) clearance granted

Varian Calypso Anchored Beacon transponder

tumor detection 510(k) clearance granted

Conavi TM Medical Inc. Novasight Hybrid System simultaneous imaging of coronary arteries with both intravascular ultrasound (VUS) and Optical Coherence Tomography (OCT)

510(k) clearance granted

Prisyna, the oral care division of Synedgen

Moisyn product line xerostomia 510(k) clearance granted

C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers

510(k) clearance granted

Amerigen Pharmaceuticals Limited and Dipharma S.A.

Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option

aNDA � led

Sage Therapeutics intravenous formulation of brexanolone (SAGE-547)

postpartum depression (PPD) NDA � led

Veloxis Pharmaceuticals A/S

de novo indication of ENVARSUS XR (tacrolimus extended-release tablets)

Prophylaxis of organ rejection in kidney transplant patients

sNDA � led

Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution

cataplexy and Excessive Daytime Sleepiness (EDS) in pediatric narcolepsy patients

sNDA � led

Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of San� lippo syndrome Type A (MPS IIIA)

RMAT Designation granted

Immusoft Corporation Immune System Programming MPS I (Mucopolysaccharidosis type I) Orphan Drug Designation granted

Stealth Biotherapeutics elamipretide Leber’s hereditary optic neuropathy (LHON) Orphan Drug Designation granted

P� zer Inc. TRUMENBA (Meningococcal Group B Vaccine)

Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years

Breakthrough Therapy Designation granted

MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene

Fast Track Designation granted

The following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including the FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/.For custom drug intelligence reports, email marketresearch@centerwatch.com. Join the LinkedIn Drug Research Updates group!

9:45 AMiPad3

Addressing Barriersto Entry and Retention

By Sony Salzman

B eing a principal investigator (PI) is tough. So tough, in fact, that more than half of new investigators give up er

thei rst FDA-regulated drug trial.Studies by the T s Center for the Study of

Drug Development (CSDD) have revealed a variety of challenges for rst-time investigators.

e rst — and some would say worst — challenge is that the path to success for PIs is murky, said Gerrit Hamre, project manager of CTTI and co-author of the group’s paper on the study. Although there are training programs and resources for investigators, most new investigators are unaware of their existence (outside of GCP training), and un-derestimate the infrastructure, st ng, bud-geting, contracting, and operational skills necessary to succeed.

e second overwhelming obstacle for edgling investigators is administra-

tive burden. Complex protocols, rigorous reporting demands and multiple technol-ogy platforms place a huge strain on inves-tigators and sta .

e third major obstacle new PIs face is the lack of accolades and/or s cient nancial reward to make all of that e ort worthwhile.

With mounting evidence that the prob-lem isn’t getting better, sponsors and CROs are rethinking the site selection process and trying to develop new ways to support inex-perienced investigators.

Sponsors and CROs are doubling-down on their top-performing sites — a trend that has helped fuel industry consolidation, says Ken Getz, director and associate professor of CSDD.

“At the same time that sponsors are look-ing for scaled, experienced sites and site networks, the CROs are buying them,” said Getz.

He predicts that in the short term, the in-dustry will continue to see the largest and most expensive sites and site networks build more share of the market.

Yet sponsors can’t rely solely on vetted academic medical centers and large com-mercial sites for all of their study partici-pants; the burgeoning elds of rare disease and oncology research in particular require them to cast a wider net for patients.

Experts agree that rst time investiga-tors can take some steps to bolster success — including nding a mentor, hiring an ex-perienced research coordinator, learning to budget appropriately and being technologi-cally savvy and platform-agnostic — but most also agree that ultimately, sponsors and CROs need to step up if they want their PIs to thrive.

“I’m sympathetic to investigators because you don’t know what you’re getting into,” says Hamre, adding, “I do think investiga-tors very en bite o more they can chew, but they don’t realize it. In that regard, I think it’s the sponsors and the CROs that have a bit more responsibility.”

Getz added that sponsors must “take ownership for site selection practices that

Industry Tries to Stem Investigator Dropout

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CRA/CRC Shortages Slow Clinical Trial Pace

June 2018 A CenterWatch Publication Volume 25, Issue 06

see CRA/CRC on page 8

Industry DevelopingStandardized TrainingBy Daphne Butas

As clinical trials continue to change, the evolving roles of CRAs and CRCs are exacerbating the problems sponsors and

CRO nding well-trained candidates.“What’s going to really get interesting is how

much these roles are going to evolve as more new initiatives come forward, like eConsent,

ePRO and risk-based monitoring,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). As risk-based monitoring has taken hold and more monitors are analyzing data from a central loca-tion rather than traveling to the sites, sponsors and CROs are looking for CRCs with more of a robust math background, he said. And as the sponsors’ and CROs’ relationships with sites becomes ever more important, sponsors and CROs are looking for CRAs who excel at forg-ing friendly, supportive connections with sites.

“I think we’re going to see a morphing of these role into subspecialties — a data analyst and site-relationship manager type of CRA, along with the traditional role that the CRA has always had,” said Kremidas. “With CRCs, I think we’ll begin to see a quality assurance focus, someone who oversees the input of the data into the eCRFs. I think we’ll see a tech-nology type of specialist for patients to call in order to get help logging on. And I think the traditional role will be there, too.”

see Investigator Dropout on page 6

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Up and Coming

This feature highlights changes in clinical research organizations’ personnel.

HealthixHealthix has announced that Todd Rogow will lead the organization as its new presi-dent and chief executive officer. Rogow pre-viously served as senior vice president and chief information officer at the company.

TRANSEARCHLarry Glines has joined TRANSEARCH Inter-national as managing director for life sciences and healthcare. Glines previously was presi-dent of Glines Associates, an executive search firm devoted to the healthcare and life sciences industry, a company he founded in 1995.

Carrick TherapeuticsCarrick Therapeutics has announced the ap-pointment of Tim Pearson as chief execu-tive officer. Pearson previously was execu-tive vice president and chief financial officer for TESARO. Elaine Sullivan will step down as CEO and will continue with the company as executive entrepreneur and advisor to the board of directors, based in Dublin.

VeracyteKeith Kennedy has been appointed chief op-erating officer, in conjunction with his current role as chief financial officer, effective imme-diately, at Veracyte. Prior to joining Veracyte as CFO in 2016, Kennedy served in key executive leadership positions at MCG Capital, Arlington Capital Partners and GE Capital.

Viela BioViela Bio has named Mitchell Chan to the position of chief financial officer. Chan previ-ously served as Viela’s vice president, head of finance and corporate strategy.

SquarexJack Talley has been appointed chief executive officer at Squarex. Talley currently serves on the board of Mitotherapeutix and

recently served as CEO, president and direc-tor of Izun Pharmaceuticals.

Pharmaceutics InternationalPharmaceutics International, Inc. (Pii) has announced the expansion of its commercial team. Wayne Ideus has been named senior di-rector, business development; Wayne Grellner has been appointed senior director, business development; and Ryan McFarlane has been named executive director, business manage-ment. Ideus was previously key account direc-tor with Mallinckrodt Pharmaceuticals. Grellner was most recently director, global business development at Samsung. McFarlane was pre-viously executive director of global marketing operations and global enrollment operations at Accelerated Enrollment Solutions.

Platelet BioGenesisSam Rasty has been named president and chief executive officer at Platelet BioGenesis. Rasty was most recently chief operating of-ficer of Homology Medicines, Inc.

Smithers AvanzaSmithers Avanza has appointed Frank Ro-tella as director of operations. Rotella most recently served as manager of bioanalysis at Syneos Health.

HighTide TherapeuticsHighTide has named Adrian Di Bisceglie as chief medical officer. Di Bisceglie was previ-ously professor of internal medicine and chief of hepatology, division of gastroenter-ology and hepatology at St. Louis University.

Amplity Health Pravin Wilfrid has been named chief technology officer at Amplity Health. Wilfrid most recently held roles as CIO/SVP at HTA/Verra Mobility.

Inari MedicalThomas Tu has been appointed chief medical officer and chief business officer at Inari Medi-cal. Tu is the CEO and president of World Health Initiative and most recently was the director of the cardiac cath lab at Louisville Cardiology.

Royal PhilipsBritta Lesaux has been named president and chief executive officer at Philips Canada. Lesaux was formerly the executive director of the health care business group at 3M Canada.

TeckroTeckro has expanded their leadership team. Brendan Buckley has been appointed chief medical officer; Kelly Brown has been named chief marketing officer; Sandra Blaser has been made vice president of customer suc-cess; Anita Callan has been appointed vice president of product; and Neil Flanagan has been named vice president of engineering. Buckley served as chief medical officer and executive vice president of ICON from 2011-2017. Brown was previously vice president of marketing in Europe for Veeva Systems. Blaser established the customer success function for Veeva Systems in Europe. Callan most recently held product and content strategy positions at Aer Lingus. Flanagan was previously head of digital operations at Munich Re.

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Industry Briefs

Presenting Live Procedures in Device Trials Raises Special Con-sent IssuesClinical trials that ask participants to allow live broadcast or recording of their proce-dures must go to extra lengths to ensure proper informed consent, the FDA says.

In a final guidance aimed at clinical investigators and IRBs, the agency discusses special assurances that should be included in the informed consent procedure, includ-ing a statement that participating in a “live case presentation” provides no additional direct benefit to the patient. The subject also should be told that participation is optional.

The informed consent for a live case pre-sentation may be a separate document, the agency says, as long as it clearly outlines any differences between the live procedure and the study protocol, and explains additional risks that may be presented by the live pro-cedure, including to subject confidentiality.

Read the final guidance here: https://bit.ly/2JBBUsi.

FDA Guidance Sets Criteria for Trials of Hormonal Contracep-tive DrugsTrials of hormonal pregnancy prevention drugs would need to apply narrow enroll-

ment criteria under a new FDA draft guid-ance released last week.

According to the guidance, trials should enroll nonpregnant, premenopausal women who have no history of infertility, engage in regular heterosexual vaginal intercourse with a normally fertile partner, have regular menstru-al cycles and show no evidence of dysplasia or invasive cervical cancer upon screening. Trials also should represent all ages of premeno-pausal women, including adolescents.

In addition to enrollment criteria, the guidance advises on study type and length. Single-arm, open-label, historically con-trolled trials of at least one year in length are usually adequate for establishing efficacy, it says. Longer-lasting trials are recommended for long-acting reversible contraceptives like intrauterine systems. Shorter trials may suf-fice for products that include drug substanc-es with well-characterized safety profiles.

Comments on the draft guidance are due by Sept. 11.

Read the draft guidance here: https://bit.ly/2XYoC26.

Altimmune to Acquire Spitfire PharmaAltimmune has announced it will acquire Spitfire Pharma, including its product

candidate SP-1373, a potent GLP-1/Gluca-gon receptor co-agonist for the treatment of NASH.

Spitfire, a portfolio company of Pre-sidio Partners, was founded for the sole purpose of developing the NASH drug candidate, which will be renamed ALT-801. Altimmune hopes to begin phase 1testing in 2020.

FDA Issues Recommendations on Pharmacokinetic Analysis in TrialsThe FDA released a draft guidance on Thursday on the use of population pharma-cokinetic analysis by sponsors of drug and biologic trials.

Population PK analyses can help in selecting dosing regimens, sampling schemes, exposure metrics and in pediatric study designs, the agency says. Population PK models can also be used to simulate drug exposures that are expected to occur following doses or dosing regimens that have not been directly investigated in prior clinical trials.

Comments on the draft guidance are due by Sept. 11.

Read the guidance here: https://bit.ly/2J AfCai.

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Features

Real-World Evidencecontinued from page 1 “An exploding amount of RWD,

paired with new and increasingly sophisticated methods of turning that RWD to RWE, have demanded

a call to make that evidence actionable for a wide range of

clinical decisionmakers.”

—Gregory Daniel, Margolis Center for Health Policy, Duke University

has received. While they applaud the FDA’s attempts to incorporate real-world evidence (RWE) into regulatory decisionmaking, two major sponsors’ comments indicate more work is needed.

Pharma giants Novartis and Gilead believe the agency’s draft guidance on identifying drug submissions that use RWE is too limited in scope — while the Asso-ciation of Clinical Research Organizations (ACRO) recommended adding standardized summary assessments of the quality of data underlying RWD submissions. The associa-tion also recommended adding a glossary of key terms to aid understanding.

The clinical evidence listed for RWE in the guidance is too limited, Novartis said, suggesting the agency expand its scope to include patient reported outcomes (PROs) and quality-of-life factors.

Novartis stressed that the guidance needs to clearly distinguish between RWD and RWE and asked the agency to clarify how RWE can be applied in single-arm trials that lack external/historical arms.

Gilead also recommended that the guid-ance be expanded. The company said the agency should include sNDAs and sBLAs in its list of submissions and allow lab data linked to medical claims or electronic medi-cal records as a source of RWD. Additionally, the different types of observational studies — cohort, case control and cross-sectional studies — should be detailed.

Speakers at the FDA workshop rang the same bell, saying the ability to accurately

define and quantify outcomes that matter most to decisionmakers (e.g., patients, clini-cians, regulators, payers and caregivers) has remained elusive.

“An exploding amount of RWD, paired with new and increasingly sophisticated methods of turning that RWD to RWE, have demanded a call to make that evidence ac-tionable for a wide range of clinical decision-makers,” said workshop moderator Gregory Daniel of Duke University’s Margolis Center for Health Policy.

Prior to generating RWE from clinical trials, it’s imperative to develop a consensus on which specific outcomes are the most helpful.

Outcomes, whether objective or subjec-tive, may not be easily identified, Temple explained. “Whether a person did or did not have an outcome of interest, and the sever-ity of that outcome, is not always obvious, even for ‘hard endpoints,’” he said.

Regardless, there is a need to identify and capture outcomes that are relevant to patients and to define whether the endpoints

are also relevant to stakeholders and regula-tors. Once these outcomes are determined and agreed upon by a multidisciplinary network, researchers can then identify which RWD elements are valid reflections of those outcomes.

Accuracy, validity and reproducibility of RWD used to generate RWE are a cause of concern. Electronic health records, for instance, may be helpful for identifying outcomes of prescribing practices but lack insight on medications filled or dispensed.

And in the process of measuring out-comes in RWD, some form of measurement error will inevitably occur, said Sean Tunis, founder and director of Stanford University’s Center for Medical Technology Policy. The key is to measure and account for that error. “Ignoring measurement error and reporting about error but not correcting for it is bad practice,” Tunis said.

The discussion of RWE’s role in clinical trials also is taking prominence in the UK. The National Institute for Health and Care Excellence (NICE) has issued its own call for comments on plans for using real-world data.

NICE is considering using data from audits of procedures, registries that collect data on how particular treatments are used, surveys of patients using services, and data on national trends, such as the number of people who have a condition. The deadline for submitting comments to NICE is Sept. 13.

Read the nine comments on the FDA draft guidance here: https://bit.ly/2XHjTxF.

Read NICE’s statement and submit com-ments here: https://bit.ly/2ZCwsMf.

The case for patient engagement to improve clinical trialsBy John W. Mitchell, MS

I n the quest to achieve better out-comes, control costs, and improve health under a slew of government

policies and laws in recent years (i.e., the -

able Care Act [ACA]), something un-precedented happened: Clinicians of all stripes began asking: What do patients want?

“Patient engagement is the blockbuster drug of the century,” Farzad Mostashari,

-tional Coordinator of Health Informa-

Phar-maceutical Outsourcing, patient involve-

engagement, which has alternatively been known by many names, including patient centricity and patient activation, refers to the process of involving and empowering patients to improve their healthcare. … Even as patient engage-

ment in clinical trials takes multiple shapes, the end goals are nearly always

The issue of proper documentation in IRB liabilityBy Sue Coons, MA

T he guidance Minutes of Institutional Review Board (IRB) Meetings in

Federal Register describes the requirements for IRB meet-ing minutes and provides recommenda-tions for meeting applicable regulatory

Protections (OHRP) and Food and Drug Administration (FDA). It is intended for institutions and IRBs responsible for oversight of human subject research under HHS and FDA regulations.

However, a court case from the early -

ing IRB meeting activity not only puts IRBs in violation of regulatory standards, but also could put them in legal cross-hairs if research participants are harmed or perceive harm in a clinical trial.

Inadequate documentation in IRB

during FDA inspections, the guidance

FDA’s website for bioresearch monitor-ing (www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm -cies found during IRB inspections to be: inadequate initial and/or continuing review; inadequate written procedures; inadequate meeting minutes and mem-

bership rosters; quorum issues; prompt reporting of noncompliance, suspension/termination; Subpart D issues; and lack of or incorrect risk determination.

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. Volume 19, Number 1

Learning Objectives:

1. List some of the documentation deficiencies FDA is finding in its IRB inspections.

2. Describe the claims plaintiffs in Robertson v McGee made against IRB members.

3. Explain the importance of proper documentation of IRB activities.

4. Discuss the concept of individual liability in IRB decisions.

Learning Objectives:

1. Explain the state of patient engagement in clinical trials.

2. Describe the barriers to and case for patient engagement strategies in clinical trials.

3. List examples of marketing and sales strategies in patient engagement.

4. Discuss the future of patient engagement in clinical trials.

2 CE program information

3 Regulatory update

6 IRB meeting minutes

16 CE post-test

In this issue:

see IRB liability on page 4

see Patient engagement on page 10

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Features

Ask the Expertscontinued from page 1 “In addition to consent process

considerations, the enrollment of non-English speaking participants should be approved by the sponsor and consideration should be given

to the impact of the language barrier on data collection.”

—David Borasky, vice president of IRB compliance, WCG Clinical

50.27(b)(2) also permits the use of a short-form consent document. Short-form con-sent documentation is typically used when an individual participant speaks a language for which there is no prepared translation.

In this situation, the research site may utilize a short-form written consent docu-ment stating that the elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative.

The short-form process also requires the presence of a witness to the oral presen-tation. When the short-form approach is used, there are additional documentation requirements. In these situations, the short form is signed by the participant (or the representative) and the witness. In addition, the witness also signs the English-language consent document along with the person obtaining the consent. A copy of both the English-language consent document and the short form must be given to the partici-pant. Many IRBs have short-form templates in several foreign languages.

In addition to consent process consider-ations, the enrollment of non-English speaking participants should be approved by the spon-sor and consideration should be given to the impact of the language barrier on data collec-tion. For example, participant diaries and other instruments may only be available in English.

We would recommend that you work closely with the IRB of record and the spon-sor as requirements may vary when it comes to documentation of consent. — David Borasky, vice president of IRB compliance, WCG Clinical

Question:I am working with a study where a new

informed consent form has come out. We have subjects who are just waiting for a final phone call, and no more on-site visits are required. Can the ICFs be discussed with the subjects over the phone and answer any

questions they have and then mail the ICF to them for signature and return? — Clinical Research Associate, CRO

Answer:Technically, there are no regulatory

requirements that address the issue or process for “re-consenting” participants in an ongoing study. This obligation really stems from the required element of consent which states that if there is new information that becomes available during the study which might affect the participants’ decision about whether to continue in the research, that information will be provided promptly.

When there is an update to informed consent information, the first question to consider is which of the study participants may need to know this information. If the change is related to screening procedures, then participants who are already on the study drug won’t reconsider study participa-tion because of that change. A revision to the drug dosing schedule won’t matter to participants who have completed dos-ing and are in the follow-up phase. New information that secondary cancers may be seen in people who receive this class of drug, even years later, would be important to future, current and past participants; if they’ve finished dosing, it can’t affect their decision about being in the study, but it may impact their future clinical care.

In this case, if participants are just wait-ing for a final follow-up call, do the changes to the consent information impact their participation or their future clinical care? If not, it may be reasonable to say that they don’t need to be reconsented at all. But if it does impact them, then the next question is the process.

FDA regulations allow a waiver of documentation of informed consent, which means that the consent process can be conducted verbally and a note can be written to document that the participant provided consent, without having their actual signature (56 CFR 109.1). The FDA also announced in late 2018 that it will allow a waiver of informed consent in certain circumstances.

In your example, if it is appropriate to inform the participants in follow-up, it may be that obtaining verbal consent with documentation of that agreement in their research record is sufficient and it is not necessary for the informed consent docu-ment to be mailed and returned. It may even be better to rely on verbal consent, as some organizations are uncomfortable with obtaining signatures remotely, as there is no way to tell who actually wrote the signature when it is unwitnessed.

Usually, the reviewing IRB will include directions for who needs to be recon-sented when they approve the revised consent information, but not all IRBs do this. The sponsor can certainly suggest a plan for who should be reconsented and how reconsent will be obtained (e.g., sign-ing the new written consent form for new participants and those on the study drug, and waiver of documentation of consent requested to allow verbal reconsent by phone for participants off study drug but in long term phone follow-up), which may be logistically feasible and less burden-some on both staff and participants. — Lindsay McNair, chief medical officer, WCG Clinical

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Setting you Up for Success from the Start.At WCG, we use our evidence-based insights to help set you up for success from the start. From strategic site selection to accelerating enrollment, our solutions empower you to anticipate problems, make better decisions and gain greater control over the key elements of your clinical study startup.

wcgclinical.com

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Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactEmmaus Life Sciences, Inc.

pharmaceutical-grade L-glutamine (PGLG)

diverticulosis Phase 1 trial initiated enrolling 10 patients at multiple sites

emmauslifesciences.com

Enanta Pharmaceuticals, Inc.

EDP-514 hepatitis B virus (HBV) Phase 1a/1b trial initiated enrolling 98 subjects

enanta.com

Neurovive Pharmaceutical AB

KL1333 mitochondrial disease Phase 1a/1b trial initiated enrolling healthy subjects in the UK after successful completion of the first stage of enrollment

neurovive.com

Auris Medical Holding Ltd.

AM-201 antipsychotic-induced weight gain and somnolence

Phase 1b trial initiated enrolling healthy volunteer subjects in Europe

aurismedical.com

4D pharma plc MRx-4DP0004 asthma Phase 1/2 trial initiated enrolling 90 subjects not adequately controlled on their current inhaler maintenance therapy

4dpharmaplc.com

Vedanta Biosciences VE416 peanut allergy Phase 1b/2 trial initiated enrolling 40 subjects 12 years of age and older at MassGeneral Hospital for Children in Boston

vedantabio.com

ActoBio Therapeutics, Inc.

AG019 early-onset type 1 diabetes (T1D)

Phase 1b/2a trial initiated enrolling subjects 12 to 17 years of age

actobio.com

ActoBio Therapeutics, Inc.

AG019 combined with teplizumab (PRV-031)

early-onset type 1 diabetes (T1D)

Phase 1b/2a trial initiated enrolling adult subjects

actobio.com

Biohaven Pharmaceutical Holding Company Ltd.

rimegepant treatment refractory trigeminal neuralgia

Phase 2 trial initiated enrolling subjects at Johns Hopkins Medical Center

biohavenpharma.com

GlaxoSmithKline otilimab moderate to severe rheumatoid arthritis (RA)

Phase 3 trial initiated gsk.com

BiondVax Pharmaceuticals Ltd.

M-001 influenza Phase 3 trial initiated biondvax.com

Alexion Pharmaceuticals, Inc.

SOLIRIS (eculizumab) neuromyelitis optica spectrum disorder (NMOSD) in adult subjects who are anti-aquaporin-4 (AQP4) antibody positive

Approval granted by the FDA alexion.com

Janssen DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd)

subjects with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT)

Approval granted by the FDA janssen.com

Pfizer ZIRABEV (bevacizumab-bvzr)

metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer

Approval granted by the FDA pfizer.com

continues on next page »

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WCG | CWWeekly July 15, 2019 8 of 9

Drug & Device Pipeline News (continued from page 7)

Company Drug/Device Medical Condition Status Sponsor ContactJanssen

Genmab

Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment

multiple myeloma subjects who are ineligible for autologous stem cell transplant (ASCT)

Approval granted by the FDA janssen.com

genmab.com

Alexion Pharmaceuticals

Soliris (eculizumab) neuromyelitis optica spectrum disorder (NMOSD) in adult subjects that express a specific biomarker

Approval granted by the FDA alexion.com

Teva Pharmaceuticals 1% Sodium Hyaluronate

osteoarthritis (OA) of the knee in subjects who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen)

Approval granted by the FDA tevapharm.com

Retrophin Thiola EC (tiopronin) 100 mg and 300 mg tablets

cystinuria Approval granted by the FDA retrophin.com

Grifols Xembify 20% subcutaneous immunoglobulin

primary immunodeficiencies Approval granted by the FDA grifols.com

Elizabeth Weeks-Rowe

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WCG | CWWeekly July 15, 2019 9 of 9

Upcoming Event HighlightsThe Source for Clinical Research Jobs and Career Resources

More Jobs

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Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

Jobs via Kelly Services

JobWatch

Assistant Clinical Research CoordinatorStanford UniversityStanford, CA

Clinical Trials AssociateTalaris Therapeutics, Inc.Louisville, KY

Clinical Project ManagerIntegriumDurham, NC

Clinical Research AssociateTechnical Resources International, IncBethesda, MD

Clinical Study Project ManagerBiotrial, Inc.Newark, NJ

Clinical Trials CoordinatorNorth Bay Neuroscience InstituteSebastopol, CA

Data Monitoring Committee Project ManagerWIRB-Copernicus Group (WCG)Bala Cynwyd, PA

Clinical Site Services SpecialistWIRB-Copernicus Group (WCG)Eden Prairie, MN

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Global Studies ManagerSouth San Francisco, CA

Drug Safety Specialist I San Francisco, CA

Research Associate Seattle, WA

Clinical Lab Specialist St Louis, MO

Associate Scientist South San Francisco, CA

Laboratory Associate- Formulations Fremont, CA

Senior Analytical Chemist Eden Prairie, MN

Clinical Protocol Coordinator - NIH Bethesda, MD

Director, Clinical Science Emeryville, CA

Research Associate I-II Seattle, WA

Pharma/Clinical Meeting Planner Mettawa, IL

Accounts Receivable Insurance Processor Tyler, TX

Research Scientist Carlsbad, CA

Clinical Research Assistant Rochester, NY

Conferences

S E P T E M B E R 4 - 5 , 2 0 1 9 Clinical Trial Risk & Performance Management SummitPhiladelphia, PA

S E P T E M B E R 2 7 - 2 9 , 2 0 1 9 Society of Clinical Research Associates 2019 Annual ConferenceSan Antonio, TX

O C TO B E R 2 3 - 2 5 , 2 0 1 9 FDA Inspections SummitBethesda, MD

O C TO B E R 2 7 - 3 0 , 2 0 1 9 MAGI Clinical Research Conference 2019 WestLas Vegas, NV

[ V IE W A LL CONFER ENCES ]

Webinar

AU G U S T 1 5 , 2 0 1 9 Real World Evidence and Data: A Tufts Study of 30 Pharma Companies 1:30 p.m. – 3:00 p.m. EDT

Based on their knowledge, and using several recent case studies, Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share valuable information on:

}} Types of technology used to access or collect RWD and evidence and partnerships that support usage

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