Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Risk-based Monitoring Strategies for Improved Clinical Trial PerformanceCognizant
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
Sandra Maddock, RN, BSN, CCRA and President of IMARC Research, Inc. presents on Applying FDA’s Risk-Based Approach in an audio conference on September 11, 2012.
Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device C...BostonBiomedical
Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services presented at the Opal Events Medical Devices Summit West on June 25, 2015 in San Jose, CA. The attached presentation entitled, “Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies,” will focused on the FDA Early Feasibility Study (EFS) program. The intention of the EFS program is for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process. Ms. Gamber discussed the background of the IDE process, the creation of the EFS program and guidance, along with the key steps and considerations to consider when pursuing this path, including lessons learned from on early interactions with the FDA in this program.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Risk-based Monitoring Strategies for Improved Clinical Trial PerformanceCognizant
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
Sandra Maddock, RN, BSN, CCRA and President of IMARC Research, Inc. presents on Applying FDA’s Risk-Based Approach in an audio conference on September 11, 2012.
Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device C...BostonBiomedical
Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services presented at the Opal Events Medical Devices Summit West on June 25, 2015 in San Jose, CA. The attached presentation entitled, “Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies,” will focused on the FDA Early Feasibility Study (EFS) program. The intention of the EFS program is for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process. Ms. Gamber discussed the background of the IDE process, the creation of the EFS program and guidance, along with the key steps and considerations to consider when pursuing this path, including lessons learned from on early interactions with the FDA in this program.
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
The FDA Early Feasibility Study Pilot and the Innovation PathwayTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
Presentation by Michael imhoff about the upcoming Medical Device Regulation (MDR) in the EU. Includeds compliance with the General Safety and Performance Requirements. Demonstration of conformity with the general safety
and performance requirements in clinical
evaluation. Clinical evaluation with evidence for safety
and performance of the medical device. Assessment of side effects and the acceptability of the risk-benefit-ratio, based on clinical data. MDR is not a health technology assessment for payers. Results of the clinical evaluation should be documented
in a clinical evaluation report (CER).
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
(Monitoring Of Clinical Trial Assignment ) " Write about the factors that de...Rishabh Sharma
"Write about factors that determine the strategy of monitoring of Clinical Trials (Monitoring Of Clinical Trial Assignment )
Includes Extent and nature of monitoring , components of a monitoring plan , Documentation / Monitoring activities , Procedures of Monitoring , Importance of Monitoring Report , Factors to consider when developing a monitoring plan
There are many areas to focus on when taking steps towards improving clinical trial operations. This presentation focuses on 4 areas: Patient Enrollment, Study Start-up, Monitoring, and Project Management.
FDA Guidance on EFS: The Device Evaluation Strategy ChallengesTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
CDISC & Risk Based Monitoring to Compress Clinical Trial DurationClinical Data Inc .
Technology adoption in the clinical trial space has lagged other industries resulting in high cost / risk of new drug development and ongoing safety concerns of clinical trials.
The focus of this presentation is to educate bio-pharma companies, data managers and CROs on technological advances in the clinical trial space.
Safety Monitoring and Reporting in Clinical Trials DIA Poster 2015KCR
How to get the plausible and precise safety data, maintaining the highest ethical standards
during clinical development?
KCR’s article presents critical points in safety monitoring and reporting at different stages of the clinical trial, as well the main difficulties faced by medical personnel and clinical team during their everyday practice.
A brief overview of Challenges in conducting Trial of medical devices. My small endeavor in understanding #clinicalTrials of MDs. Includes Medical Device rule 2017 too.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Medical Devices and Embase webinar - 18 Sept Ann-Marie Roche
Daniel E. McLain, President of Walker Downey & Associates, Inc., an evidence-based product safety and development consultancy located near Madison, WI. presented a webinar, which showcased a soon to be released Medical Device White Paper and walked us through a clinical evaluation using Embase.
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
The FDA Early Feasibility Study Pilot and the Innovation PathwayTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
Presentation by Michael imhoff about the upcoming Medical Device Regulation (MDR) in the EU. Includeds compliance with the General Safety and Performance Requirements. Demonstration of conformity with the general safety
and performance requirements in clinical
evaluation. Clinical evaluation with evidence for safety
and performance of the medical device. Assessment of side effects and the acceptability of the risk-benefit-ratio, based on clinical data. MDR is not a health technology assessment for payers. Results of the clinical evaluation should be documented
in a clinical evaluation report (CER).
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
(Monitoring Of Clinical Trial Assignment ) " Write about the factors that de...Rishabh Sharma
"Write about factors that determine the strategy of monitoring of Clinical Trials (Monitoring Of Clinical Trial Assignment )
Includes Extent and nature of monitoring , components of a monitoring plan , Documentation / Monitoring activities , Procedures of Monitoring , Importance of Monitoring Report , Factors to consider when developing a monitoring plan
There are many areas to focus on when taking steps towards improving clinical trial operations. This presentation focuses on 4 areas: Patient Enrollment, Study Start-up, Monitoring, and Project Management.
FDA Guidance on EFS: The Device Evaluation Strategy ChallengesTrimed Media Group
WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.
CDISC & Risk Based Monitoring to Compress Clinical Trial DurationClinical Data Inc .
Technology adoption in the clinical trial space has lagged other industries resulting in high cost / risk of new drug development and ongoing safety concerns of clinical trials.
The focus of this presentation is to educate bio-pharma companies, data managers and CROs on technological advances in the clinical trial space.
Safety Monitoring and Reporting in Clinical Trials DIA Poster 2015KCR
How to get the plausible and precise safety data, maintaining the highest ethical standards
during clinical development?
KCR’s article presents critical points in safety monitoring and reporting at different stages of the clinical trial, as well the main difficulties faced by medical personnel and clinical team during their everyday practice.
A brief overview of Challenges in conducting Trial of medical devices. My small endeavor in understanding #clinicalTrials of MDs. Includes Medical Device rule 2017 too.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Medical Devices and Embase webinar - 18 Sept Ann-Marie Roche
Daniel E. McLain, President of Walker Downey & Associates, Inc., an evidence-based product safety and development consultancy located near Madison, WI. presented a webinar, which showcased a soon to be released Medical Device White Paper and walked us through a clinical evaluation using Embase.
NIST Special Publication 500-293: US Government Cloud Computing Technology R...David Sweigert
Uploaded as a courtesy by:
Dave Sweigert
NIST Special Publication 500-293: US Government Cloud Computing Technology Roadmap ◾ Vol. I, Rel. 1.0 (Draft) (High-Priority Requirements to Further USG Agency Cloud Computing Adoption) (Dec. 1, 2011) (full-text)
◾ Vol. II Rel. 1.0 (Draft) (Useful Information for Cloud Adopters) (Dec. 1, 2011) (full-text).
◾ Vol. III (First Working Draft) (Technical Considerations for USG Cloud Computer Deployment Decisions) (Nov. 3, 2011) (full-text).
Overview Edit
Volume I Edit
Volume I is aimed at interested parties who wish to gain a general understanding and overview of the background, purpose, context, work, results, and next steps of the U.S. Government Cloud Computing Technology Roadmap initiative. It frames the discussion and introduces the roadmap in terms of:
◾ Prioritized strategic and tactical requirements that must be met for USG agencies to further cloud adoption;
◾ Interoperability, portability, and security standards, guidelines, and technology that must be in place to satisfy these requirements; and
◾ Recommended list of Priority Action Plans (PAPs) as candidates for development and implementation, through voluntary self-tasking by the cloud computing stakeholder community, to support standards, guidelines, and technology development.
DoJ guidelines for CFAA hacker prosecutions David Sweigert
Uploaded has a courtesy by:
Dave Sweigert
The Computer Fraud#Fraud (Tag) and Abuse#Abuse (Tag) Act is a serious issue#issue (Tag) and source of terror#terror (Tag) for everyone in the cybersecurity#cybersecurity (Tag) industry, most especially pentesters#pentesters (Tag) and other ethical#ethical (Tag) hackers#hackers (Tag) testing#testing (Tag) systems for research purposes. This computer crime#crime (Tag) law is perhaps one of the most controversial, outdated#outdated (Tag), and hotly contested of its time (it may also be one of the most abused as well). The CFAA#CFAA (Tag) is a broad anti-hacking#anti-hacking (Tag) statute that criminalizes unauthorized#unauthorized (Tag) access#access (Tag); it is the same statute at issue in a recent ruling that puts acts like sharing passwords#passwords (Tag) on your Netflix#Netflix (Tag) account into federal crime territory.
During his talk at Black Hat 2015, Leonard Bailey, special counsel for national security at the Department of Justice's Computer Crime and Intellectual Property#Intellectual Property (Tag) Section, claimed the US government#government (Tag) had turned a corner with the CFAA. He implored attendees, saying the DoJ doesn't want to discourage legitimate research
Uploaded as a courtesy by:
Dave Sweigert
DRAFT NIST Cloud Computing Security Reference Architecture
The NIST Cloud Computing Security Working Group (NCC-SWG) issued Draft SP 500-299, NIST Cloud Computing Security Reference Architecture, in May 2013. See the NCC-SWG homepage for additional details.
NIST SP 800-125 Security for Virtualized TechnologiesDavid Sweigert
Uploaded as a courtesy by:
Dave Sweigert
The National Institute of Standards and Technology (NIST) has issued the final version of its recommendations for securely configuring and using full computing virtualization technologies. The security recommendations are contained in the Guide to Security for Full Virtualization Technologies(link is external) (NIST Special Publication (SP) 800-125). The draft report was issued for public comment in July 2010.
Virtualization adds a low-level software layer that allows multiple, even different operating systems and applications to run simultaneously on a host. "Full virtualization" provides a complete simulation of underlying computer hardware, enabling software to run without any modification. Because it helps maximize the use and flexibility of computing resources—multiple operating systems can run simultaneously on the same hardware—full virtualization is considered a key technology for cloud computing, but it introduces new issues for IT security.
For cloud computing systems in particular, full virtualization can increase operational efficiency because it can optimize computer workloads and adjust the number of servers in use to match demand, thereby conserving energy and information technology resources. The guide describes security concerns associated with full virtualization technologies for server and desktop virtualization and provides recommendations for addressing these concerns. Most existing recommended security practices also apply in virtual environments and the practices described in this document build on and assume the implementation of practices described in other NIST computer security publications.
Operations management using bar codes - health care industry - multi located center with Pathology, Health care, fitness & beauty services under one roof.
A clinical investigation is defined as “any systematic investigation or study in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of medical device.”
The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.
One of the purposes of a clinical investigation could be to establish and verify clinical safety, meaning to understand how to prevent and reduce risks, errors and harm that can happen to patients and personnel, such as doctors and nurses. The cornerstone of all clinical research is to provide a continuous improvement of treatment methods based on the understanding and learning from errors and adverse events detected.
Furthermore, the purpose of a clinical investigation can also be to establish and verify the performance of a device. This means checking the ability (or capability) of a device to perform as planned. This is done by looking at the technical, functional, or even diagnostic characteristics of the device. It needs to be verified whether it enables the manufacturer to achieve the intended purpose of the device and that it will lead to clinical benefits for patients.
Another purpose is to establish and verify clinical benefits, which is in its essence looking at the positive impact a device can have on the health of an individual. It is expressed in terms of a meaningful and measurable patient-focused outcome.
And finally, in the setting of a clinical investigation, side effects play a special role. One of the goals of a clinical investigation can be to gather additional information on the known side effects and to identify previously unknown side effects.
The overall purpose of a clinical investigation can be summed up to say that it is meant to translate scientifically tested innovations into clinical practice to provide patients with new (or improved) treatments.
A properly conducted clinical investigation, including compliance to the clinical investigation plan and local laws and regulations, ensures the protection of subjects, the integrity of the data and that the data obtained is acceptable for the purpose of demonstrating conformity to the Essential Requirements.
ISO 14155 outlines good clinical practice for clinical investigations of medical devices.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptx
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
1. Welcome to today’s
FDA/CDRH Webinar
Thank you for your patience while we register all of today’s
participants.
If you have not connected to the audio portion of the webinar,
please do so now:
U.S. Callers Dial:1-800-475-0553; Passcode:1759468
International Callers Dial: 1-415-228-5009; Passcode:1759468
2. Factors to Consider When Making
Benefit-Risk Determinations for Medical
Device Investigational Device
Exemptions (IDEs): Final Guidance
Karen Ulisney, M.S.,CRNP
Policy Analyst
Clinical Trials Program
Office of Device Evaluation
Center for Devices and Radiological Health
February 23, 2017 CDRH Webinar
3. 3
Agenda
• Highlights and Scope of Final Guidance
• Differences Between Draft and Final Guidance
• Overview of selected Benefit-Risk (B-R) Guidance Sections
Regulatory Standards and Subject Protections For IDE’s
B-R Framework Applied To Stages of Device Development
Assessing Benefits and Risks For IDE Applications – Risk
Characterization and Risk Management
Appendix A – Recommended General Framework for B-R
Assessment
• Questions
4. 4
Highlights of Final Guidance
• Contributes to FDA’s on-going efforts to improve patient access
to new devices by strengthening and streamlining clinical trials.
• Clarifies the principal factors that FDA considers when assessing
the benefits and risks of medical devices in IDE submissions to
improve transparency, predictability and consistency of this
process.
• Does not propose to revise the sponsor requirements for
providing a Benefit-Risk analysis as part of an IDE application or
the way FDA reviews IDE submissions.
6. 6
Differences Between Draft and Final Guidance
• Minor changes included clarification on terminology and modify
language to align with our regulations.
• Minor modifications to the text and the examples to clarify how
study design considerations, the stage of device development
and incorporation of patient preference principles and tools can
impact the B-R assessment.
7. 7
Regulatory Standards for IDEs
Regulations that apply to the review of IDE applications in the
context of B-R and grounds for disapproval:
21 CFR 812.30(b)(4) “There is reason to believe that the risks to the
subjects are not outweighed by the anticipated benefits to the
subjects and the importance of the knowledge to be gained, or
informed consent is inadequate, or the investigation is scientifically
unsound, or there is reason to believe that the device as used is
ineffective”
21 CFR 812.30(b)(5) “It is otherwise unreasonable to begin or to
continue the investigation owing to the way in which the device is
used or the inadequacy of (i) the report of prior investigations or the
investigational plan; (ii) the methods, facilities, and controls used for
the manufacturing, processing, packaging, storage, and where
appropriate, installation of the device; or (iii) monitoring and review
of the investigation”
8. 8
Regulatory Standards for IDEs
A Key principle of subjects protections in Clinical Investigations is
the Informed Consent Process
Sponsors are required to address B-R in the clinical study Informed
Consent Document–
21 CFR 50.25 Basic elements of informed consent. In seeking
informed consent, the following information shall be provided
to each subject:…
(2) A description of any reasonably foreseeable risks or discomforts
to the subject.
(3) A description of any benefits to the subject or to others which
may reasonably be expected from the research.
9. 9
B-R Framework Applied To Device
Development Regulatory Pathway
EFS Traditional
Feasibility
Pivotal Post Market
Uncertainty
Stages of Device Development
10. 10
How Does the B-R Assessment For IDEs
Differ From B-R assessment For Marketing
Applications?
• Clinical investigations by definition are research studies with
greater uncertainty regarding :
Relative benefits and risks of a given device
Device technology
Treatment with the Device
• Less evidence available for IDE applications compared to
marketing submissions.
• Benefits of the research study are considered directly to the
subject and to others (e.g., indirect – knowledge to be gained
from research or contribute to developing treatments)
11. 11
Assessing Benefits and Risks in the IDE
Realm
BENEFITS RISKS
Type
Magnitude
Probability
Duration
Type /Severity
Likelihood
Duration
Management
Risk Controls/
Mitigation
12. 12
Assessing Risks for IDE Applications
21 CFR 812.25
The investigational plan shall include…
(c) Risk analysis.
• a description and analysis of all increased risks to which
subjects will be exposed by the investigation;
• the manner in which these risks will be minimized;
• a justification for the investigation;
• and a description of the patient population, including the
number, age, sex, and condition.
13. 13
Risk Management
The B-R Guidance incorporates the principles from ANSI/AMMI/ISO
14971: Application of risk management to medical devices
• ISO 14971 describes a process through which the medical device
manufacturer can…estimate and evaluate risks, control these
risks, and monitor the effectiveness of those controls through
the product’s lifecycle.
14. 14
Assessing Risks for IDE Applications
Assessing Risk of the Investigation:
• Harms – Specifying how a hazard could lead to clinical sequelae
including length of time experienced and residual affect (if any)
or other harmful event
• Likelihood – Focusing on severity of a risk along with likelihood
is important for a complete estimation of that risk.
• Residual risk and completeness of risk control – Many identified
risks are reduced to an acceptable level through effective risk
controls.
15. 15
Assessment of Risk to Study Subjects
• Focus on risks supported by objective scientific evidence and are
reasonably foreseeable
• Include a description and analysis of incremental risks subjects
will be exposed to in the study and how the risks will be
minimized
• Describe the relationship between Hazards (potential source of
harm) and ultimate Harm (injury or damage)
16. 16
Assessment of Risk – Characterization
The extent of risk(s)/harm(s) in an IDE study takes into account the
following factors, individually and in aggregate:
1. Type of Risk(s) (including severity) – Basic safety, device-related
serious and non-serious adverse events, procedure-related
complications due to the investigation, risk associated with the
study itself (not resulting directly from use of the device), and Risk
from false-positive or false-negative results for diagnostics.
17. 17
Assessment of Risk – Characterization
2. Probability or Likelihood of Risk(s) – Use of relevant historical
data, prediction using analytical or simulation techniques, use of
data from prior investigations, reliability estimates, production
data and post production information, and use of expert judgment.
• During earlier device development stages, this may be less
certain. Probability levels within an estimated range may be
acceptable.
• Includes the likelihood of the hazard resulting in a harmful
event. FDA considers whether an event occurs once or
repeatedly in assessing the probability of risks.
18. 18
Assessment of Risk – Characterization
3. Duration of Risk(s) - Exposure to subjects temporary, minor
harm; cause repeated but reversible harm; cause permanent,
debilitating injury.
• Duration or how long the adverse consequence lasts should be
considered along with severity of risk.
19. 19
Assessment of Risk – Management
4. Risk Management – Provides a summary and assessment of
efforts to mitigate the identified safety concerns, or ensure device
use is directed to participants for whom the risk is considered
acceptable so not to outweigh the potential for benefit.
• Risk control measures (including risk mitigation):
reduce the likelihood and severity of harm to study subjects
improve the B-R profile of the proposed study
intended to reduce the risk to an acceptable level
20. 20
Assessment of Risk – Management
• Sponsors should:
Conduct an initial determination of which risk controls are
appropriate
B-R assessment should focus on residual risk and reduction
to acceptable levels relative to the anticipated benefits to
subjects
Provide a clear justification for the investigation considering
risks for the intended study participants and plan for
minimizing those risks.
21. 21
Assessment of Risk – Management
• Forms of risk controls that may be applied to IDE studies are
outlined in detail in the guidance under A.4. Risk Management.
Examples:
Safety by Design
– Device features and/or modifications to improve safety
Protective Measures
– Study Design
– Study Oversight
– Adverse Event Reporting
22. 22
Assessment of Risk – Management
5. Residual Risk Evaluation – After risk control measures are
applied, the following measures may be considered when
evaluating residual risk:
• Risk communication and disclosure of residual risk during the
informed consent process (e.g., how subjects can/should act to
further control or mitigate risk)
• When reliable information is available, consider subject
perspective and tolerance for assuming risk relative to anticipated
benefit
• Initially limit study subjects most likely to experience benefits or
subject subset where B-R profile is more favorable (e.g.,
treatment-refractory patients)
23. 23
Assessment of Other Risks Considerations
In addition to the previously discussed Risk Characterizations and
Management FDA may consider other risks as well:
• Risks related to interpretation of the study data
Risk of drawing a false conclusion based on clinical data obtained
Risk of data which are inconclusive or difficult to interpret
• Risks to others to consider for example:
Risk of radiation exposure of health care practitioner
Treated subjects become drowsy while operating a vehicle
24. 24
Assessing Benefits and Risks in the IDE
Realm
BENEFITS RISKS
Type
Magnitude
Probability
Duration
Type /Severity
Likelihood
Duration
Management
Risk Controls/
Mitigation
25. 25
Assessment of Anticipated Benefits to Study
Subjects
Direct Benefits: Benefits that may be realized by subjects
participating in the research include:
• Type of benefit(s) – Examples include; closer surveillance of
clinical management and QoL. For diagnostics; identify a specific
disease for early intervention, or identify patients more likely to
respond to therapy.
• Magnitude of benefit(s) – anticipated change in subjects
condition or clinical management, questionnaire analysis
provides insight into subjects’ preference
26. 26
Assessment of Anticipated Benefits to Study
Subjects
Direct Benefits (cont.):
• Probability of subject experiencing one or more benefit(s) –
Based on evidence from prior investigations and early stages of
device development it may not be possible to assess the
probability of subjects experiencing one or more benefits.
• Duration of effect(s) – How long can the benefit be expected to
last? Some treatments are curative and others are repeated
over time. To the extent the effect is known, the duration of
effect may influence how the benefit is defined over time.
27. 27
Assessment of Benefits to Others
A benefit to others of an investigational study is the “importance
of knowledge to be gained” (21 CFR 812.30(b)(4))
• A societal benefit or increases the understanding of a disease
condition, potential treatment or diagnostic applications
• Benefit unique to research (e.g., doesn’t apply to marketing
applications)
• Subjects may not receive direct benefit but willingness to
participate due to indirect benefits of increasing generalizable
about the disorder or condition being studied.
28. 28
Putting It All Together - Framework
For B-R Assessment
Type
Magnitude
Probability
Duration
Type
Severity
Likelihood
Duration
Management
DISEASE /
CONDITION
AVAILABLE
ALTERNATIVES
BENEFITS
RISKS/HARM
RISK
CONTROLS
Risk
Mitigation
UNCERTAINTY
EVIDENCE +
KNOWLEDGE
CONTEXT
Includes benefit to
others & importance
of knowledge to be
gained
Domains – clinical,
non-clinical, patient
PATIENT
PERSPECTIVE
29. 29
Assessing Benefit and Risks for IDE
Applications – Device Description
Regulations require that the Investigational Plan includes:
Description of this device (a description of each important
component, ingredient, property, and principle of operation of the
device and any anticipated changes in the device during
investigation - 21 CFR 812.25(d)
• Appendix C in the guidance lists the device attributes that
FDA recommends to include in the IDE application; Device
Description Section
• Deficiencies related to an incomplete or inadequate device
description are the single most common type of non-
protocol related deficiency and results in failure to attain
full IDE approval
30. 30
Assessing Benefit and Risks For IDE
Applications – B-R Framework
Appendix A – Guidance
1. Context of Proposed Investigation
Summary of the disease/condition, context of
currently available treatment or diagnostic options,
brief description of trial objective/design.
2. Assessment of Risks
Summary of key risk elements identified in Section 5 of
the guidance including risk characterization, risk control
measures (i.e.; risk mitigation) and residual risk.
31. 31
Assessing Benefit and Risks For IDE
Applications – B-R Framework
3. Assessment of Benefits
Summary of key benefits identified in Section 5 of the
guidance including direct benefits to study subjects and
benefits to others (importance of knowledge to be
gained or contribute to developing a treatment)
4. Consideration of Patient Preference Information
Summary of patient preference information if
available. If none, state that none available.
32. 32
Assessing Benefit and Risks For IDE
Applications – B-R Framework
5. Assessment of Uncertainty
Summarize key sources of uncertainty in the available
evidence and proposed investigation identified in
Section 5 of the guidance.
Provide a rationale for why the level of uncertainty is
acceptable for the proposed investigation.
6. Conclusions
Summarize how the consideration of the factors
discussed in this summary justify the decision to
proceed with the clinical investigation.
33. 33
References
Guidance Document Links
• Factors to Consider When Making Benefit-Risk Determinations for
Medical Device Investigational Device Exemptions - 2017
• Factors to Consider When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo Classifications -
2016
• FDA Decisions for Investigational Device Exemption Clinical
Investigations - 2014
• Investigational Device Exemptions (IDEs) for Early Feasibility
Medical Device Clinical Studies, Including Certain First in Human
(FIH) Studies - 2013
• Patient Preference Information – Voluntary Submission, Review in
Premarket Approval Applications, Humanitarian Device Exemption
Applications, and De Novo Requests, and Inclusion in Decision
Summaries and Device Labeling - 2016
34. 34
Panel Discussants
• Karen Ulisney, M.S., CRNP, Policy Analyst, Clinical Trials Program,
Office of Device Evaluation
• Owen Faris, Ph.D.; Director, Clinical Trials Program, Office of
Device Evaluation
• Soma Kalb, Ph.D.; Director, IDE Program, Office of Device
Evaluation
• Special Thank you to Katie O’Callaghan (CDRH, Assistant
Director for Strategic Programs) for her expertise and
contribution to this guidance development
35. Questions?
Division of Industry and Consumer Education:
DICE@fda.hhs.gov
Slide Presentation, Transcript and Webinar Recording
will be available at:
http://www.fda.gov/training/cdrhlearn
Under Heading: How to Study and Market your Device
Clinical Studies/IDE