Advances in Clinical Research in Ecuador

By Thelvia I. Ramos, MD, MSc; Karina Alexandra Castro, MSc; Luis Santiago Escalante, MD; Nelson Santiago Vispo, PhD Found in: Article, Clinical Research, Clinical Trial Disclosure, GCP, Good Clinical Practices & QA

Ecuador is undergoing a process of clinical research development and strengthening. At the turn of the century...

DIA Webinar To Discuss How Technology and Collaboration Can Reinvent the Clinical Trial

Found in: Article, Clinical Research, Clinical Supplies, Safety & Pharmacovigilance, CMC

Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.

Special Populations in Clinical Pharmacology Studies Evolving Challenges

By William B. Smith, MD; Harry Alcorn, PharmD Found in: Article, Safety & Pharmacovigilance, Clinical Research, Clinical Trial Disclosure

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

DIA Global Center

Safety in FIH Trials A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost”

By Howard E. Greenberg, MD; Mattheus (Thijs) van Iersel, MD; Mary L. Westrick, PhD; William B. Smith, MD Found in: Article, Safety & Pharmacovigilance, Clinical Research

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in...

Clinical Project Management

DIA Global Center

Development of the Observable Behaviors of Autism Spectrum Disorder Scale

By Linda S. Deal, MSc; Carla DeMuro, MS; Dana DiBenedetti, PhD; Sandy Lewis, BSN, RN Found in: Article, Clinical Research

The objective of this research was to develop a caregiver-reported clinical outcome assessment (COA) measure designed to...

Advances in Clinical Research in Ecuador

By Thelvia I. Ramos, MD, MSc; Karina Alexandra Castro, MSc; Luis Santiago Escalante, MD; Nelson Santiago Vispo, PhD Found in: Article, Clinical Research, Clinical Trial Disclosure, GCP, Good Clinical Practices & QA

Ecuador is undergoing a process of clinical research development and strengthening. At the turn of the century...

Special Populations in Clinical Pharmacology Studies Evolving Challenges

By William B. Smith, MD; Harry Alcorn, PharmD Found in: Article, Safety & Pharmacovigilance, Clinical Research, Clinical Trial Disclosure

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...

Safety in FIH Trials A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost”

By Howard E. Greenberg, MD; Mattheus (Thijs) van Iersel, MD; Mary L. Westrick, PhD; William B. Smith, MD Found in: Article, Safety & Pharmacovigilance, Clinical Research

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in...

Development of the Observable Behaviors of Autism Spectrum Disorder Scale

By Linda S. Deal, MSc; Carla DeMuro, MS; Dana DiBenedetti, PhD; Sandy Lewis, BSN, RN Found in: Article, Clinical Research

The objective of this research was to develop a caregiver-reported clinical outcome assessment (COA) measure designed to...

Assessing Decision-Making Quality in Medicines Development

By Magdalena Bujar, BSc, MSc; Ronan Donelan, MSc, PhD, FRSC; Neil McAuslane, MSc, PhD; Stuart Walker, PhD, MFPM, FIBiol, FRSC, FRCPath; Sam Salek, RPh, PhD, FFPM, MRPSGB, MCMS, FESCP Found in: Article, Clinical Research, Regulatory Affairs, Strategic Planning

Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery...

Sample Sizes: 2 Monotherapies With Single Approved Dose Level

By Seung-Ho Kang, PhD; Juhee Park, MS Found in: Article, Statistics, Clinical Research

In this article, we study the sample size calculations for the combination drugs of 2 monotherapies with a single approved...

Ethical Considerations in Adaptive Design Clinical Trials

By Thomas Laage, MD, MPH,; John W. Loewy, PhD; Sandeep Menon, PhD; Eva R. Miller, PhD; Erik Pulkstenis, PhD; Natalia Kan-Dobrosky, PhD; Christopher Coffey, PhD Found in: Article, Statistics, PE / Quality of life / Health, Clinical Research

Adaptive design clinical trial methodologies offer both opportunities and challenges for observing basic ethical principles...

Analysis of Japanese Patients Enrolled in Oncology MRCTs

By Akihiro Hirakawa, PhD; Fumie Kinoshita, MSc, RPh Found in: Article, Statistics, Clinical Research

The Japanese regulatory agency, the Ministry of Health, Labour and Welfare, requires sponsors to enroll a specific number or...

Use of Investigational Drugs in Public Health Emergencies

By Matthew Carl Kirchoff, PharmD, MS, MBA; Jerome F. Pierson, RPh, PhD Found in: Article, Clinical Research, Public Policy / Law

The paradigm for the use of investigational drugs in public health emergencies has been recently tested to prevent and treat...

Transitions, Introductions and a Notable Announcement

By J. Rick Turner, PhD Found in: Article, Clinical Research, Regulatory Affairs

It is a pleasure to write this Editorial as the Interim Editor-in-Chief of TIRS, and a privilege to shepherd the journal in the…

Clinical Trials in India: Government Announces Beneficial Reforms

By Dr. Annappa Kamath Found in: Article, Clinical Research, Clinical Supplies, Regulatory Affairs

The regulatory environment in India for clinical trial conduct has been evolving since 2013, when the Indian Supreme Court...

ICH/DIA Joint Tokyo Workshop after ICH Japan Meeting

By Junichi Nishino Found in: Article, Regulatory Affairs, Clinical Research

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has now reached...

Europe: What We Can Expect in 2017

By John Lisman Found in: Article, Clinical Research, PE / Quality of life / Health, Public Policy / Law, Pricing / Reimbursement

On the health care products front, 2017 presents issues of concern, along with some positive developments...

“Less Well-Understood” Adaptive Designs Challenge

By Weili He, PhD; Paul Gallo, PhD; Eva Miller, PhD; Yannis Jemiai, PhD; Jeff Maca, PhD; Ken Koury, PhD; Xiaoyin Frank Fan, PhD; Qi Jiang, PhD; Cunshan Wang, PhD; Min Lin, PhD Found in: Article, Clinical Research, Statistics

The draft adaptive design guidance released by FDA in 2010 included references to adaptive study designs that were described...

Estimands & Sensitivity Analyses in Clinical Trials

By C. Fletcher, MSc; S. Tsuchiya, MS; D.V. Mehrotra, PhD Found in: Article, Clinical Research, Statistics

An addendum to the International Conference on Harmonisation E9 (ICH E9) guidance document (Statistical Principles for...

Less Well-Understood Adaptive Designs Best Practices

By Eva Miller, Paul Gallo, Weili He, Lisa A. Kammerman, Kenneth Koury, Jeff Maca, Qi Jiang, Marc K. Walton, Cunshan Wang, Katherine Woo, Cynthia Fuller, Yannis Jemiai Found in: Article, Clinical Research, Statistics

Adaptive design (AD) clinical trials use accumulating subject data to modify the parameters of the design of an ongoing study...

Sivelestat Versus Standard Acute Lung Injury Therapy

By Satoru Fukimbara, PhD; Kouji Niibe; Michio Yamamoto, PhD;Takuhiro Yamaguchi, PhD Found in: Article, Clinical Research, Statistics

To confirm the effectiveness of sivelestat, a clinical trial was conducted comparing sivelestat with conventional treatment in...

Program-Level Considerations for Phase 2 Designs

By James Bolognese, MStat; Jaydeep Bhattacharyya, MS; Chris Assaid, PhD; Nitin Patel, PhD Found in: Article, Clinical Research, Statistics

Traditionally, sample size considerations for Phase 2 (Ph2) trials are based on the desired properties of the design and...

5th Basic Statistical Concept Workshop in Japan

By Satoru Fukimbara, PhD; Ayano Takeuchi, PhD; Junichi Nishino Found in: Article, Statistics, Clinical Research

Non-statisticians need to understand when and what (and not only “how”) to apply statistical concepts in the context of...

How PDUFA Aligns Clinical & Regulatory Science

By Chris Slawecki Found in: Article, Regulatory Affairs, Clinical Research, PE / Quality of life / Health, R&D

Enacted in 1992 and renewed every subsequent five years, PDUFA authorizes FDA to collect user fees from companies that produce…

Promise of Academia-Industry Interaction in Japan

By Kihito Takahashi, MD, PhD Found in: Article, Clinical Research, R&D

Effective and successful collaborations between academia and industry is an emerging theme in the pharmaceutical industry...

DIA Patient Engagement in Drug Development Study

By Elizabeth Lincoln, DIA Global Director of Engagement Found in: Article, PE / Quality of life / Health, Clinical Research

DIA, the leading professional community and knowledge exchange for global health care product development, announced today...

Optimizing Clinical Trial Electronic Data Sources

By Ed Kellar, MS; Susan M. Bornstein, MPH; Aleny Caban, BS; Catherine Célingant, MA; Michelle Crouthamel, MS; Chrissy Johnson, MS; Patricia A. McIntire, BSc; Kenneth R. Milstead, MS; Jaclyn K. Patterson, BS; Brett Wilson, BSP Found in: Article, eClinical, Clinical Data Management, Clinical Data Management, Clinical Research

TransCelerate BioPharma has created the eSource Initiative with the intent to facilitate the industry’s movement toward...

Japan Drug Use: Clinical vs. Regulatory Practice

By Nanae Tanemura, PhD; Yoshiaki Uyama, PhD; Kengo Nagashima, PhD; Takahiro Suzuki, MD, PhD; Yasuko Asahina, PhD; Yoshio Kobayashi, MD, PhD; Masaomi Iyo, MD, PhD; Koutaro Yokote, MD, PhD; Hideki Hanaoka, MD, PhD Found in: Article, Clinical Research, Regulatory Affairs

In this study, differences in older patients between drug use as reported in clinical practice and in clinical trials for...

Precompetitive Target Identification & Validation

By Tobias Bergauer, PhD, MSc; Thorsten Ruppert, PhD; Laurent Essioux, PhD; Olivia Spleiss, PhD Found in: Article, Clinical Research, R&D

Focused interviews were conducted with global pharmaceutical company representatives in order to derive a consistent view on...

Raltegravir Formulation and Clinical Feasibility

By Rajesh Krishna, PhD, FCP; Matthew L. Rizk, PhD; Patrick J. Larson, MS; Valerie Schulz, MS; Evan Friedman, MS; Pranav Gupta, PhD; Fillippos Kesisoglou, PhD; Alyson Connor, PhD; John McDermott, PhD; Ronald Smith, PhD; Philip Evans, MD Found in: Article, Clinical Research

Raltegravir is an integrase strand transfer inhibitor indicated in combination with other anti-retroviral medicinal products for...

Organizational Size and Phase 3 Completion Times

By Harold E. Glass, PhD; Lucas M. Glass, MA; Phuong Tran, PharmD; Hani Alghamdi Found in: Article, Clinical Research, R&D

The pharmaceutical industry has continued to experience a large number of mergers, often involving the very largest companies...

Pediatric Drug Development Hypothesis & Simulation

By Ann W. McMahon, MD, MS; Kevin Watt, MD, MPH; Jian Wang, PhD; Dionna Green, MD; Ram Tiwari, PhD; Gilbert J. Burckart, PharmD Found in: Article, Clinical Research

Pediatric drug development is plagued by small sample sizes, unvalidated clinical endpoints, and limited studies...

Why "Therapeutic Innovation and Regulatory Science"

By Stephen P. Spielberg, MD, PhD Found in: Article, Clinical Research, Rare, Orphan Diseases

Alex died two years ago, just shy of his 40th birthday. I spoke at his memorial service; it was the first time in my life I could...

EU-US Collaboration to Boost Medicine Development for Rare Diseases

Found in: Article, Rare, Orphan Diseases, Regulatory Affairs, Clinical Research

The European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) have set up a new “cluster” on rare diseases to…

Make Mine Mobile: Bring the Trial to the Patient

Found in: Article, Clinical Research, Comparative Effectiveness, PE / Quality of life / Health

At DIA 2016, Joseph Kim (Eli Lilly and Company) challenged the clinical trial industry to figure out what the banking industry…

How Far Can Regulators Drive Patient Engagement?

Found in: Article, Clinical Research, Comparative Effectiveness, PE / Quality of life / Health, Regulatory Affairs

Patient engagement is a full-fledged global movement driven not only by patients but by agencies such as the US FDA and the UK…

Past, Present, Possibilities: DIA & Patient Engagement

By Yves Juillet, PhD Found in: Article, PE / Quality of life / Health, Clinical Research

Dr. Yves Juillet has been involved with DIA since 1990 and was the impetus behind the association’s first formal steps…

FDA Commissioner Califf Speaks with "Global Forum"

By Alberto Grignolo, PhD, Global Forum Deputy Editor Found in: Article, PE / Quality of life / Health, Comparative Effectiveness, Clinical Research, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion International Regulatory...

Editorial: Glory Enough for All

By Stephen P. Spielberg, MD, PhD; Editor-in-Chief, DIA Publications Found in: Article, Clinical Research, Medical Writing

At this time of year when Nobel prizes are awarded, I am reminded of the movie Glory Enough for All, based on the book The…

Clinical Trials & The Disney Effect

By John Reites, Head of Digital Health Acceleration, Quintiles Found in: Article, PE / Quality of life / Health, Clinical Research

Today’s consumers expect seamless, value-driven experiences when they engage with a brand. From buying products online, to…

How to Assess PAO’s Readiness to Collaborate

By Elizabeth Lincoln, DIA Global Director of Engagement Found in: Article, PE / Quality of life / Health, Clinical Research

The ultimate purpose of any medical product is to meet the needs of the patient. In the past few years the idea that patient need…

Collaboration Benefits Rare Disease Research & Patients

By Vinciane Pirard, MD, DIA Global Forum Content Editor for Rare Diseases & Unmet Medical Needs Found in: Article, PE / Quality of life / Health, Clinical Research, Rare, Orphan Diseases

Rare diseases don’t share a common etiology or biology; they don’t affect the same organs or present with similar symptoms; but…

AMED & NCATS Talk Collaboration: DIA Japan 2015

By E. Stewart Geary, MD Found in: Article, Investigator Site, Clinical Research

Dr. Makoto Suematsu, President of the Japan Agency for Medical Research & Development (AMED), and Dr. Christopher Austin, Director of…

New SIP Eases Investigators’ Burden

By Christine Pierre Found in: Article, Investigator Site, Clinical Research, Safety & Pharmacovigilance

In 2012, TransCelerate BioPharma Inc. was launched as a non-profit organization to improve the health of people around the world by…

Open Payments: Clinical Site Intelligence Source

By Jeffrey DiFrancesco Found in: Article, Investigator Site, Clinical Research, Strategic Planning

The Open Payments dataset annually issued by the Centers for Medicare & Medicaid Services (CMS) is an unparalleled source of the…

Urban Myth: Increased Protocol Complexity

By Harold Glass, PhD Found in: Article, Investigator Site, Clinical Research

The design and execution of new drug clinical trials are demanding tasks by any standard. Much of the most challenging effort falls most…

Good to Great: Progress through Collaboration

By Christine Pierre, President, Society for Clinical Research Sites Found in: Article, Investigator Site, Clinical Research

In a commentary published in the Journal of the American Medical Association, Robert M. Califf, MD, then Vice Chancellor for Clinical…

Breaking News: New Breakthrough Pathways

Found in: Article, Regulatory Affairs, R&D, Rare, Orphan Diseases, Clinical Research

Patient advocacy, unmet medical needs and regulatory innovations are driving accelerated review and approvals of critical…

FDA Accelerated Pathways: The New Normal

By Barry Farrimond, Jonathan Fleming and Mark Mathieu Found in: Article, Regulatory Affairs, Clinical Research, Rare, Orphan Diseases

The FDA’s accelerated pathways (APs) – including Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Fast Track…

Elevate Patient Voice to Advance Drug Development

By Ann Meeker-O'Connell, DIA Global Forum US Regional Editor Found in: Article, Regulatory Affairs, Clinical Research, Patient Engagement

The development of the US FDA’s Patient-Focused Drug Development (PFDD) initiative in 2012 heralded a new era of patient…

Core Competencies: Clinical & Translational Research

By Stephen A. Sonstein, PhD Found in: Article, Investigator Site, Clinical Research, Professional Education, Training & Development

At a spring 2013 meeting of the Multi-Regional Clinical Trials Initiative, a broad-based and widely representative group of clinical…

What Device are YOU Wearing Today?

By Jackie S. Hoover Found in: Article, Investigator Site, Devices & Diagnostics, Clinical Research

New technology and the incredible amounts of data that is and will be generated from various digital health applications and innovations…

Increasing Racial & Ethnic Diversity in Clinical Trials

By Sheila Thorne Found in: Article, Investigator Site, Clinical Research, PE / Quality of life / Health

America is in the midst of two seismic demographic shifts. While the population is turning gray, it is also becoming increasingly…

Overcoming the Cold Start Site Selection Challenge

By Lucas Miller Glass Found in: Article, Investigator Site, Clinical Research, Strategic Planning

In the “big data” world of clinical development, most companies conducting clinical trials now have the ability to identify how well…

Clinical Research Sites in Perspective

By Dr. Harold Glass, Christine Pierre Found in: Article, Investigator Site, Clinical Research

Within this Special Section you will find a wide-ranging view of several industry issues, often with the clinical research site at the…

RbM: Hype, Paradigm Change or New Frontier?

By Dr. Peter Schiemann Found in: Article, Regulatory Affairs, Clinical Research, Good Clinical Practices & QA, Project Management

Since FDA and EMA published their guidance and reflection paper on risk-based monitoring (RbM) and oversight in clinical trials…

Editorial: Progress on Behalf of Children

By Stephen P. Spielberg, MD, PhD; Editor-in-Chief, DIA Publications Found in: Article, Clinical Research, Regulatory Affairs

In July 2000, our working on group on ICH E-11 completed its task of writing a document designed to harmonize...

The Common Rule Refresh: HHS Modernizes its Human Subject Protection Regulations

By Ann Meeker-O’Connell Found in: Article, Clinical Research, PE / Quality of life / Health, Public Policy / Law, Public Policy, Health Care Compliance, Law

The US Department of Health and Human services (HHS) has recently proposed to revise the Federal Policy for the Protection of...

Editorial: Advances in Clinical Outcome Assessments

By Joseph C. Cappelleri, PhD, MPH, MS; Stephen P. Spielberg, MD, PhD Found in: Comparative Effectiveness, Clinical Research, Investigator Site, Article

Clinical trials may fail for many reasons. The most obvious cause is that the drug does not work for the selected indication...

Access and Attitude to Clinical Trial Technology: The Global Investigator Perspective

By Elisa Cascade, MBA, President; Claire Sears, PhD, Director of Investigator Engagement; DrugDev Data Solutions Found in: Article, Clinical Research, Investigator Site, Information Technology

The pharmaceutical industry has been criticized for being outdated, old-fashioned, and for relying on traditional paper-based...

IOM Report on Sharing Clinical Trial Data

By Harold Glass, PhD; Christine Pierre, Society for Clinical Research Sites; DIA Global Forum Content Editors for Clinical Trials: Design Tools and Management Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Research, Clinical Trial Disclosure, Hot Topic, Patient Engagement

Sharing clinical trial data, in particular individual patient data, constitutes a major opportunity for new drug development and…

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

By Stephanie Krumholz-Bahner, Dr rer medic, NDA Regulatory Service Switzerland GmbH, Switzerland; Mimmo Garibbo, Ethical GmbH, Switzerland; Kenneth A. Getz, MBA, Tufts University; Beat E. Widler, PhD, Widler & Schiemann Ltd, Switzerland Found in: Article, Clinical Research, Regulatory Affairs, Study Endpoints

Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants…

Physicians Need to Understand Drug Development…and a Lot More: Interview with DIA 2015 Co-Chair Dr. Michael Rosenblatt

By Alberto Grignolo, PhD, Corporate Vice President, PAREXEL International Found in: Article, Clinical Data Management, Clinical Research, Clinical Trial Disclosure, Hot Topic, Professional Development, Professional Education, Training & Development, Patient Engagement

“Many doctors who write a prescription may not have a sense of what’s behind that prescription in terms of discovery...

DIA Japan Annual Meeting Plenary to Feature Dr. Christopher Austin

By Alberto Grignolo, PhD, Corporate Vice President, PAREXEL International Found in: Article, Academic Health Centers, Clinical Research, Non-clinical Safety, Rare, Orphan Diseases, R&D

“Rare diseases really are the exemplar for what we now call precision medicine...

Breakthrough Therapy Designation Bringing Innovation Swiftly to Patients

By Arpita Shah, PharmD, RPh; Regulatory Affairs, Celgene Corporation Found in: Article, Clinical Research, Public Policy / Law, Public Policy, Health Care Compliance, Law, R&D, Regulatory Affairs

In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate...

Working Towards a New Sociology of Partnerships

By Stephen P. Spielberg Found in: Clinical Research, Public Policy / Law, R&D, Article

2014 has indeed been a year of rapid changes in the global discovery and development of new medical products.

The Transparency Agenda: Pandora’s Box and Rabbit Holes

By Andrew Garrett, PhD Found in: Clinical Data Management / eClinical, Public Policy / Law, Clinical Research, Article

Requiring public access to clinical trial results is very different to requiring public access to the data used to generate those results

Clinical Data Transparency

By Janet Woodcock, MD and Anne M. Rowzee, PhD Found in: Clinical Data Management / eClinical, Public Policy / Law, Regulatory Affairs, Clinical Research, Article

It’s no surprise that DIA thought leaders have named “Clinical trial data transparency/data sharing” as the #2 trend to shape the world of medical product development in 2015.

Global Forum Special Section: Social Media @DIA

By Brandon King Found in: Article, Anti-doping, Academic Health Centers, Alternative / Herbal Med, Biotechnology, Clinical Data Management, CMC, Safety & Pharmacovigilance, Clinical Research, Clinical Supplies, Devices & Diagnostics, Medical Communications, Managed Health, Medical Writing

Social media is essentially like talking to someone, just through your respective computers, iPhones, smart devices or other electronic or digital tool.

Global Forum Special Section: Q&A with Gayatri Rao, Director, OOPD

By Gayatri R. Rao, MD, JD Found in: Regulatory Affairs, Article, Clinical Research, Anti-doping, Rare, Orphan Diseases

Gayatri R. Rao, MD, JD, serves as Director for the Office of Orphan Products Development (OOPD) at FDA.

Global Forum Special Section: Orphan Drugs in the 21st Century

By Chris M. Slawecki Found in: Article, Safety & Pharmacovigilance, Clinical Research, Rare, Orphan Diseases

The US National Institutes of Health estimate that there are approximately 6,000 rare diseases affecting 25 million Americans. EURORDIS, the Voice of Rare Disease Patients in Europe, estimates the number of persons in Europe suffering from a rare disease at more than 30 million. Many of these conditions have no current treatment.

Biomarkers Paving Way for Personalized Medicine?

By Katja Malec, Junior Scientist, DIA EMEA Found in: Article, Clinical Research, Biotechnology, PE / Quality of life / Health

Despite improvements in preclinical research, clinical trial attrition rates remain significant. One clear path to improvement is…

IMI Satellite Session: Patient-Centricity

By Katja Malec, Junior Scientist, DIA EMEA Found in: Article, Clinical Research, PE / Quality of life / Health

Few doubts remain about the importance of involving patients in the development of medicines. However, many aspects of moving…

Structured Benefit-Risk Assessment Across the Product Lifecycle

By Meredith Y. Smith, PhD, MPA; Isma Benattia, MD; Carmit Strauss, PharmD; Laura Bloss, PhD; Qi Jiang, PhD Found in: Article, Clinical Research, Regulatory Affairs

Assessing the benefit-risk profile of a medicinal product is a complex but fundamental activity that sponsors and regulators must...

Better Tools, Better Data, Better Medicine—Found in Translation

By Gary J. Kelloff, Caroline C. Sigman, David R. Parkinson Found in: Article, Clinical Research, R&D, Rare, Orphan Diseases

In 2015 and 2016, a set of articles in the Global Forum laid out initiatives and collaborations, infrastructure under development…

The ICH MRCT Guideline Is Becoming Reality

By Yoshiaki Uyama Found in: Article, Clinical Research, Regulatory Affairs

The ICH E17 expert working group (E17 EWG) was formed in June 2014 with the goal of establishing an internationally-harmonized…

AVAREF: Creating a Better Regulatory Environment for Clinical Development in Africa

By Dr. David Mukanga Found in: Article, Regulatory Affairs, Clinical Research

Several countries in Africa have unclear, confusing, and suboptimal regulatory processes for review and oversight of...

Past Insights Inform Future Patient Input in Health Product Life Cycles

By Deborah Collyar Found in: Article, Patient Engagement, Clinical Research

You can’t join health product discussions these days without hearing terms like “patient engagement.” While some turn rhetoric into operational...

Clinical Trials Ready to Embrace the IoE?

By Richard Strobridge Found in: Article, Clinical Trial Disclosure, Clinical Research, Devices & Diagnostics, Medical Devices & Diagnostics

The Internet of Everything (IoE) is having an enormous impact. With Gartner listing the IoE as one of the top ten strategic...

The DIA Statistics Community: Turning Data into Knowledge

By Joan Buenconsejo and Susan Duke Found in: Article, Statistics, Clinical Research

Our mission includes providing global forums for the sharing of statistical knowledge and experience, and identifying and...

7000 Unsolved Diseases Inspire Cures Within Reach

By Dr. Bruce Bloom Found in: Article, Rare, Orphan Diseases, R&D, Clinical Research

Seventeen years ago, when Cures Within Reach (the non-profit I lead) funded one of the early clinical trials to repurpose the...

RARE DISEASES Challenges and Opportunities in India for Medical Product Developmen

By Sanish Davis, MD, DM Found in: Article, Rare, Orphan Diseases, Clinical Research, Regulatory Affairs

India, in 2009, produced Paa, which chronicled the life of a child afflicted with Hutchinson– Gilford progeria syndrome. The...

Overcoming Challenges to Practical Use: 1st DIA Cell Therapy Products Symposium

By Akiko Ikeda Found in: Article, Regulatory Affairs, Public Policy, Health Care Compliance, Law, Public Policy / Law, Public Policy / Law, Clinical Research

In Japan, the development of regenerative medicine has gained much attention since Professor Shinya Yamanaka won the Nobel...

First Regional ICH Training on CMC

By Silke Vogel, Hozanna Ngoh Found in: Article, Regulatory Affairs, Clinical Research, Quality Assurance, Quality Control

Newly formed with a purpose to more strategically oversee ICH training efforts, the ICH Training Subcommittee recently...

Clinical Trials in Brazil: New Push Needed

By Jaime Oliveira Found in: Article, Clinical Research, Public Policy / Law, Regulatory Affairs

There is consensus among relevant stakeholders in Brazil that a friendlier regulatory environment for clinical trials is a…

Making News in Europe

By John Lisman Found in: Article, Regulatory Affairs, Clinical Research, Devices & Diagnostics, Public Policy / Law

Three themes are hijacking the news in Europe at this point in time. The first two are refugees and terrorism. These issues have…

Clinical Research in India: Swing of the Pendulum

By Dr. Suresh Menon Found in: Article, Clinical Research, Public Policy / Law, Regulatory Affairs

Despite its definite potential and early promise, India has yet not contributed meaningfully to global clinical drug development…

“Drug Innovation Driven by Unmet Medical Needs” – 9th DIA China Annual Meeting

By Minhua Chu, Dr. Ling Su Found in: Article, Clinical Research, PE / Quality of life / Health, R&D

The opening session of the 9th DIA China Annual Meeting, one of the largest healthcare conference events in China held on May…

DIA Then and Now: A Half-Century Odyssey

By J. Rick Turner, PhD Found in: Article, Clinical Research, Regulatory Affairs, R&D

As I considered potential topics for this Editorial, the first one written since attending our Global Annual Meeting in Chicago…

Being a Patient Gave Me Insight on How to Improve Clinical Trials

By Daniel Diaz Found in: Article, Clinical Research, Rare, Orphan Diseases

Editor’s Note: Dan Diaz shares his personal story to explain how having amyotrophic lateral sclerosis (ALS), commonly referred to…

Patient-Centered Therapy Development for Myotonic Dystrophy

By Sharon Hesterlee, PhD; Shashi Amur, PhD; Lisa J. Bain, MA; John Carulli, PhD; Sarah Clarke, MD; John W. Day, MD, PhD; Cynthia Gagnon, PhD; Katharine Hagerman, PhD; Chad Heatwole, MD, MS-CI; Nicholas E. Johnson, MD; Richard Moxley, MD; Nikunj Patel, PharmD; Charles Thornton, MD; Woodie Kessel, MD, MPH; Molly White, MA Found in: Article, Clinical Research, R&D, Rare, Orphan Diseases

Myotonic dystrophy (DM) is an autosomal dominant, repeat expansion, progressive disorder with no drug therapies. Consequently...

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

DIA Global Center

Clinical Project Management

DIA Global Center

Canadian Pharmacovigilance and Risk Management Strategies Conference

Ottawa Marriott Hotel

DIA Annual Canadian Meeting

Ottawa Marriott Hotel

Metrics in Patient-Centered Drug Development Conference

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Philadelphia University City

Biosimilars Conference

Hyatt Regency Bethesda

Combination Products Conference

Bethesda North Marriott Hotel and Conference Center

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Basics of the NDA Phase

Adaptive Design in Clinical Trials: When and How to Apply

DIA Global Center

Pharmacovigilance and Risk Management Strategies Conference

Omni Shoreham Hotel

Regulatory Submissions, Information, and Document Management Forum

Bethesda North Marriott Hotel and Conference Center

Advertising and Promotion Regulatory Affairs Conference

Bethesda North Marriott Hotel and Conference Center

Medical Affairs and Scientific Communications Forum

Omni Las Ranchos Palmas Resort & Spa

Biostatistics Industry and Regulator Forum

Bethesda North Marriott Hotel and Conference Center

DIA Webinar To Discuss How Technology and Collaboration Can Reinvent the Clinical Trial

Found in: Article, Clinical Research, Clinical Supplies, Safety & Pharmacovigilance, CMC

Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.