Updated clinical trial common protocol templates aim to speed up research, align objectives & endpoints

common protocol templates clinical trial research stockThe NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key additions to the new templates and how they will help advance research.

First and foremost, both the FDA/NIH and TransCelerate BioPharma templates aim to increase efficiencies in clinical trial protocol development. The FDA/NIH template is intended for NIH-funded studies. Global, multi-center trials requirements are covered by the Transcelerate CPT. During the interview, Gill described the key principles needed in a Common Protocol Document. “Structure must be streamlined and consistent, it must enable common wording relevant for all phases, and… it must enable endpoints that map to objectives and support the use of [Clinical Data Interchange Standards Consortium] CDISC therapeutic area standards,” Gill explained. These requirements acted as the foundation on which Gill and his team built the new common protocol template.

Aligning objectives to endpoints

The CPT includes new elements that align objectives to endpoints. Most importantly, the newly established level 1 and 2 heading structure allows sites and regulator reviewers to easily find information. These structural changes appear in both the Transcelerate and NIH-FDA protocol templates. Additionally, “establishing common endpoints aligned to CDISC Therapeutic Area standards and common language when used consistently will speed the time to first draft and reduce human errors,” Gill stated.

The existence of a Common Protocol Template will ease protocol interpretation and review by sites, IRBs, and regulators. Protocols have increased in complexity as the number of new studies registered in Clinicaltrials.gov steadily increases year-by-year. Sponsors currently provide protocols in their own structure and sites spend more time deconstructing and interpreting protocols. That time could be spent more effectively, Gill lamented, which justified the need for a structural alignment between protocols. “[The] collaboration with NIH-FDA to align structures of CPT and their newly released protocol template will take harmonization and information sharing even further… a harmonized template will also enable review and even comparisons of studies by regulators.”

Next steps for the CPT initiative could include changes in automation, content reuse, and traceability. Gill hopes that these next steps could further reduce the time to study startup. Pearl IRB provides expedited and full board ICF/protocol reviews. Our efficient, experienced team delivers superior IRB services that effectively balance the needs of human subjects, sponsors, and institutions. Contact us today to discuss your clinical research needs.

Regulatory 101 workshop for medical device industry will feature Gretchen Bowker, co-founder & COO of Pearl IRB

IMDMC regulatory 101 workshop REG 101 indy life science eventThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been developed to provide practical examples and regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising. Participants will then work through recalls, QSR & MDR reporting and inspections, while addressing other areas of regulation along the way.

Pearl IRB COO and co-founder, Gretchen Bowker RAC, FRAPS, will present during REG 101, which is Day 1 of the two-day workshop. REG 102 will occur the following week on May 24.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Wednesday, May 17, 2017, 8:00 AM to 5:00 PM EDT (REG 101) and

Wednesday, May 24, 2017 8:00 AM to 5:00 PM EDT (REG 102)

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today for one of the classes or register for both at a reduced price!

Day 1 Agenda 5/17/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • FDA Overview & intro to Hypothetical
  • Clinical Trials/IDE’s
  • Pathways to Market 510K Requirements
  • Pathways to Market PMA Requirements
  • Other Submissions & Special Issues
  • Pre-Market QSR
  • Labeling, Advertising & Promotion
  • Panel Discussion “Linking the Pieces” and Q&A

Day 2 Agenda 5/24/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • Review of Hypothetical
  • Post-Market QSR
  • Complaint Handling/Medical Device Reporting
  • Sales & Marketing: Regulatory Aspects
  • Recalls and Field Corrections
  • Inspections
  • Other Liability Mechanisms
  • Enforcement
  • Panel Discussion “Linking the Pieces” and Q&A

Registration closes this week. Register today to learn from medical device industry experts and network with your peers!

Accelerating clinical trials during an epidemic

Map of Ebola outbreak stock image clinical trials epidemic

Map of Ebola outbreak – October, 2014

How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies of Sciences, Engineering, and Medicine (NASEM) turned to the 2014 Ebola epidemic as a case study to answer these questions and others.

The Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the US Food and Drug Administration (FDA) tasked NASEM to analyze clinical trials conducted in West Africa during the Ebola epidemic. Upon completing their analysis, NASEM recommended ways to improve and accelerate clinical trial research during future infectious disease outbreaks. The committee determined that randomized clinical trials (RCTs) are “both ethical and preferable in the context of an epidemic as RCTs provide the fastest way to identify beneficial treatments and vaccines while minimizing risk.”1 Michelle Mancher, program officer for the NASEM report, explained that “during the Ebola outbreak, while the trial teams moved at lightning speeds, the trials started after the peak of the epidemic and were still too late… to be successful in the future, work will have to be done during and between outbreaks” during in an Outsorcing-Pharma.com interview. The NASEM report covers three recommended focus areas: communication and community engagement, capacity strengthening, and internal coordination and collaboration.

The global community and CROs

Effectively responding to the next epidemic and preventing future epidemics will require a global effort. Healthcare providers, life science professionals, the at-risk population, and others all have roles to play. Contract research organizations (CROs) must participate as well. “During a future epidemic,” Mancher explains, “when time is of the essence, CROs can play critical logistical support roles for clinical trial teams…For example, to immediately address the technical or infrastructure demands, including establishing contracts to secure clinical monitoring, safety monitoring, data management, and cold chain assistance.”1

Assuming clinical trials can be planned and coordinated efficiently and without delay after and during an outbreak is “unrealistic” according to Mancher. Work needs to be done in the interim, before and between epidemics, to ensure the best response can be administered quickly to reduce a disease’s impact on a given population.

Our AAHRPP accredited independent review board can promptly review your next study to prepare for human subject trials. Contact Pearl IRB for more information. Looking for support services for your clinical research such as safety monitoring, data management, quality services, etc.? Contact us at Pearl Pathways to learn more about our niche CRO offerings.



Save the date: RAPS Indiana Chapter hosts a senior FDA representative to speak about drug safety lifecycle management

raps indianaOn March 9th, the RAPS Indiana Chapter, chaired by Pearl Pathways COO Gretchen Bowker, will host an interactive presentation from a senior FDA representative. The FDA representative, Jill R. Bourdage, RPh, PMP, will speak about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). The presentation will provide an overview of the OSE and its role in the continuum of drug safety lifecycle management. Anticipated updates from PDUVA VI will be covered and the audience will learn how the role of the OSE Safety Regulatory Project Manager and regulatory expert as point of contact for industry can help achieve optimal communication.

Presentation title: Optimizing Communications with the Office of Surveillance & Epidemiology

Date: March 9, 2017

Time: 5:30 – 8:00pm EST

Location: Purdue University: Seng Liang Wang Hall

West Lafayette, IN

Registration and more information about the content can be found here.

21st Century Cures Act: potential impact on the clinical research landscape

clinical trialsThe historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during news cycles leading up to the bill’s signing, but several other sections will impact the clinical research ecosystem over the next several years. An article published in this month’s volume of the Journal of Clinical Research Best Practices outlines the major sections of the Cures Act that affect clinical trials.

The aforementioned Cancer Moonshot leads the bill, creating a $4.8B “NIH Innovation Account” that will allocate funds to the Precision Medicine Initiative, BRAIN Initiative, Cancer, and Adult Stem Cells research. Another $500M will be set aside for an “FDA Innovation Account.” The Eureka Prize Competition section allocates prize money for significant advancements in biomedical sciences and/or improving health outcomes in serious yet disproportionate research areas. Three sections address confidentiality of personal health information for study participants: Privacy Protection for Human Research Subjects, Protection of Identifiable and Sensitive Information, and Data Sharing.

To support emerging scientists, the NIH will develop and prioritize policies that promote opportunities for new researchers. The NIH also addresses Educational loan repayment addresses by increasing repayments from $35k to $50k in exchange for research work in the areas of basic science, AIDS, and emerging needs. This section also instructs the NIH to prioritize research conducted by professionals from disadvantaged backgrounds.

Reducing administrative burden for researchers also makes up a large section of the bill. Within two years, HHS is to “harmonize and eliminate duplicative Conflict of Interest reporting… [and] examine the varying minimum thresholds, consider allowing for just in time reporting, and consider redefining which investigators and sub-investigators need to report.” Several sections address the patient experience during clinical trial studies. The FDA will create guidance explaining the use and requirement of patient experience data such as data collected by non-clinicians (e.g. patients, family, etc.), the impact of disease and therapy on patient lives, and patient treatment preferences.

The bill would not be complete without detailing the penalties for violation of grants, contracts, and other agreements created under the 21st Century Cures Act. The bill outlines fines from $10k-$50k for each false statement or omission in addition to $10k-$15k fines per day for delays in the transfer of funds to HHS.

Do you need assistance with your NIH funded research? Please contact us at Pearl IRB.

FDA finalizes Guidance for Electronic Informed Consent

food and drug administration united statesDecember 2016 – The U.S. Food and Drug Administration (FDA) finalized its guidance intended for institutional review boards (IRBs), investigators, and sponsors engaged in (or responsible for) oversight of human subject research under the Department of Health and Human Services (HHS) and/or FDA regulations. The guidance, created in conjunction with the HSS and Office for Research Protections (OHRP), provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent.

Human drug and biological products, medical devices, and combinations thereof are included in the guidance. The information presented to a subject, processes used to obtain informed consent, and documentation of the electronic informed consent (eIC) must abide by the regulations set forth in the guidance. The FDA operationally defines eIC as “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and obtain and document informed consent.” It is wise to define a detailed definition of eIC, for the term informed consent can mistakenly be understood as obtaining a handwritten signature on a written consent form. This represents only one piece of the consent process; it also includes providing the subject with adequate information to make a decision, ask questions, and ongoing communication throughout the study.

In addition to defining the full eIC process, the guidance provides answers to commonly asked questions concerning instituting an electronic informed consent process. For questions about the new guidance as it may relate to your current clinical research process, please contact us today to start a conversation.

FDA Issues Official Withdrawal of Proposed Rule Concerning Public Disclosure of Unapproved Gene Therapies

Two weeks ago, the US Food and Drug Administration (FDA) announced the withdrawal of a proposed rule from 2001. The rule would have required the public disclosure of summaries of safety and effectiveness data from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans.

In its notice of withdrawal, the FDA announced “[we have] reconsidered our position on the issue and deemed our concerns from 2001 outdated. We will continue to assess whether rulemaking in this area is necessary, and if so, we will proceed with a new proposed rule.”

RAPS explains that “non-proprietary and non-trade secret information and data related to investigational new drug applications (INDs) for xenotransplantation and gene therapies would have been disclosed.” RAPS goes on to detail the categories of information that would have been disclosed under the rule:

  1. product and patient safety data and related information, including results from preclinical and clinical studies and tests that demonstrate the safety and/or feasibility of the proposed procedures
  2. the name and address of the sponsor
  3. the clinical indications to be studied
  4. the protocol for each planned study, including a scientific abstract and a nontechnical abstract, a statement of the objectives, purpose, and rationale of the study, the name and address of each investigator, the name and address of the official contacts of each local review body as appropriate (IRB, IBC) and dated copies of approval by each group, the criteria for patient selection and exclusion, an estimate of the number of patients to be studied, a description of the treatment that will be administered to patients, and the clinical procedures, laboratory tests, or other measures to be taken to monitor the safety and effects of the drug in human subjects and to minimize risk
  5. written informed consent forms
  6. identification of the biological product(s) and a general description of the method of production, including a description of product features that may affect patient safety
  7. IND safety reports
  8. information submitted to FDA in an annual report
  9. the regulatory status of the investigation, the date of such action and the reason for such action
  10. other relevant data and information that the director of the Center for Biologics Evaluation and Research determines as necessary for the appropriate consideration of the public health and scientific issues, including relevant ethical issues

The FDA closed their notice of withdrawal by stating “the withdrawal of these proposals identified in this document does not preclude the Agency from reinstituting rulemaking concerning the issues addressed in the proposals listed in the chard. Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment.” If your company needs help navigating the FDA’s ever-changing rules and the complex regulatory landscape, please contact us.

HHS investigates FDA in 2016

According to Zachary Brennan of RAPS, The U.S. Department of Health and Human Services Inspector General will be investigating FDA on post-marketing requirements, supply chain exchanges, hospital medical device oversight, and three additional programs on food and tobacco regulations.

The Office of the Inspector General (OIG) aims to assess to what extent “FDA requires post-marketing studies and clinical trials for new drug applications.” They are interested in how FDA exchanges the information of drug traceability and safety within the supply chain, as well as the possibility of computerized medical devices in hospitals providing opportunity for security and privacy failures.

For the HHS’ 2016 work plan, click here. To read Brennan’s article, click here. Need help with post-marketing surveillance or managing your supply chain? Contact us.

FDA bans API manufacturer after 483

According to Zachary Brennan’s article on RAPS, an Indian active pharmaceutical ingredient (API) manufacturer, Megafine, was banned from FDA after a 483 inspection. Other regulators around the world have approved the company; however that may change soon. The notes indicated manipulated lab tests and unjustified difference in test results.

In order for companies to be removed from the unapproved list, they must demonstrate to FDA that the issues have since been resolved. Need help in overseeing your manufacturer CMOs? Contact us.

To read Brennan’s article, click here.

Obama nominates Robert Califf as FDA commissioner

With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner.

Concurrently, the US Senate is working to permanently expedite the process of FDA drug approval through legislation. For Zachary Brennan’s full article, click here. For an additional article on this topic, check out Medscape.