by Mark Heinemann | 6 Feb, 2020 | CHCUK News & Articles, Consultation, Data Privacy, News, NIS, PASS, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Intelligence
2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, FDA Guidance, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Grade RWE
It’s here! The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA’s Real World Evidence Program The Cures Act is...
by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence
FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...
by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials
It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...
by chuck_ltd | 10 Sep, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, White Paper
White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Enhancing the Application of Real-World Evidence In Regulatory Decision-Making Washington Plaza Hotel • Washington, DC March 3 & 4, 2016 Event Details The last decade has seen important progress in the development of evidence from routine clinical practice,...
by chuck_ltd | 5 Aug, 2016 | CHCUK News & Articles, HTA, NIS, Pragmatic Trials, Real Word Evidence
The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and...
by chuck_ltd | 16 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, News, Patient Centricity, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Davis, CA. – March 07, 2016 – Mytrus, a pioneer in innovative technologies for improving patients’ participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...
by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar
Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....
by chuck_ltd | 8 Feb, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Reimbursement
February 2016 is expected to see the launch of a single market of medicines in the framework of the Eurasian Economic Union, which may be a game changer in the industry. Currently over 30 draft acts have been adopted, establishing EEU rules and principles for movement...
by chuck_ltd | 26 Jan, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Registry, Virtual Clinical Research
Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory. Link: https://submissions.swissethics.ch/en/ No submissions or updates outside of BASEC...
by chuck_ltd | 16 Jan, 2016 | CHCUK News & Articles, GCP, GCP Inspections, News, Pragmatic Trials
The system has been made available on 13 January 2016. The summary results will be gradually made available for public access from that date, once the information has been reviewed and verified. Full access for sponsors has also been restored from that date. In the...
by chuck_ltd | 15 Jan, 2016 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence
Ministry of Health of Ukraine Amends the Procedure for Conducting Clinical Trials of Medicinal Products On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research
On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
by chuck_ltd | 21 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
EMA Public Consultation on – ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations’ Start of public consultation: 21 December 2015 Deadline for comments: 31 May 2016 Provide comments using...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence
Transcelerate Common Protocol Template The resources have been made available to enable use of a streamlined model protocol template with common structure and language. The Common Protocol Template contains sections marked as common text or text that may be used...
by chuck_ltd | 14 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Human Rights Day – 10 October Herbert Smith Freehills LLP – Stéphane Brabant Beyond the traditional judicial fora where business enterprises can be challenged for human rights violations, they now also face ‘new judges’ such as NGOs, consumers, financial...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002. Since then,...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Introducing the Observatoire Français de la Sclérose en Plaques (OFSEP), a registry whose objective it is to maintain and expand the cohort of patients with MS in France, to enrich existing clinical data with imaging and medical-economic data and with biological...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Why are Academics Not Keen on Pharma Funding? Less (or no) kudos for industry studies Study design often ‘fixed’ Usually ‘sponsored’ by industry Institution keeps all the money Study question of limited interest Good publications ‘difficult’ Opportunity cost; less...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Introduction (Highlights from the ENCePP Plenary Meeting, 24 November 2015) Xavier Kurz set the scene by presenting a brief introduction highlighting ENCePP’s potential role and contribution so far to the regulatory need for continuous monitoring and investigation of...
by chuck_ltd | 7 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice. This guidance covers common inspection...
by chuck_ltd | 5 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials
Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014” Draft proposal for an addendum, on transparency, to the “Functional...
by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Industry-changing technology will help break down healthcare and clinical research silos, empowering organizations to connect and share verifiable information in real time. Texas-based healthcare and clinical research networking-technology company HealthCarePoint...
by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
HealthCarePoint BlueCloud Enhances Collaborations Between Institutional Review Boards and Investigators to Help Site Sustainability HealthCarePoint (HCP) announces its collaboration with independent institutional review boards (IRBs). The announcement follows a...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Background: The Danish National Patient Registry (DNPR) is one of the world’s oldest nationwide hospital registries and is used extensively for research. Many studies have validated algorithms for identifying health events in the DNPR, but the reports are...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, News, Pragmatic Trials, Real Word Evidence
Abstract: National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Background A national Electronic Health Record (EHR) has been identified by HSE National Directors and clinical leaders as a key capability requirement for the future delivery of healthcare. While technology solutions are a key component, there will be a primary focus...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials
Bryan Cave LLP – Robert Dougans and Tatyana Talyanskaya A feature of medical research is that clinical trials are often carried out by those hoping to manufacture and market a particular drug for a particular condition. Researchers have an obvious incentive to...
by chuck_ltd | 27 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990–2013: quantifying the epidemiological transition Lancet: Volume 386, No. 10009, p2145–2191, 28 November 2015...
by chuck_ltd | 26 Nov, 2015 | CHCUK News & Articles, HTA, News, NIS, Pragmatic Trials, Real Word Evidence
Observational (OBS), Pragmatic (PRA), and Indirect (IND) Methodologies for Comparative / Relative Effectiveness (RE) and Benefit-Risk (BR) Analyses Dr Florian Eichmann, Kathrin Kreyenberg – Late Stage Business Unit, inVentiv Health Clinical, Munich, Germany...
by chuck_ltd | 22 Nov, 2015 | CHCUK News & Articles, News, Pragmatic Trials
There has been a recent resurgence in the use of the term ‘pragmatic clinical trial’, but what are they? This free report (2015-11-22_Pragmatic-Clinical-Trials_CHCUK#1) summarises the current literature, proposed legislative changes (i.e., the EU Clinical Trials...
by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
The Forum of International Research & Development Pharmaceutical Companies (the Forum) in co-operation with the independent scientific journal Medicina danes and Finance Business Academy organized the fourth annual conference The Value of Innovation. This year’s...
by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, Consultation, News, NIS, Pragmatic Trials, Real Word Evidence
Proposed Revisions to Modernize, Strengthen, and make more Effective the Federal Policy for the Protection of Human Subjects Various US departments and agencies propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Pragmatic Trials, Real Word Evidence
Morrison & Foerster LLP – Paul D. McKenzie and Wei Zhang One of the more dramatic privacy law developments in China in 2014 was the August criminal conviction of foreign nationals Peter Humphrey and Yu Yingzeng for their violation of Article 253 of the...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, Medical Apps, News, Pragmatic Trials, Real Word Evidence
Buchalter Nemer – Kathleen Juniper Smart medical devices that can deliver health care services are increasingly consumer friendly. Using the latest technologies and sophisticated algorithms, some devices are capable of collecting data directly from consumers...
by chuck_ltd | 5 Nov, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Ezekiel J. Emanuel, M.D., Ph.D. November 4, 2015DOI: 10.1056/NEJMp1512463 Background In 1972, Jean Heller of the Associated Press reported on a 40-year-old research study that had followed black Alabama sharecroppers, some of whom had syphilis. The revelation of...
by chuck_ltd | 3 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Over the past year, PCORI have more than doubled the number of rare disease studies in our research portfolio, and those 21 awards address a diverse set of conditions. PCORI’s authorizing law calls for a focus on rare diseases, which have been defined as conditions...
by chuck_ltd | 27 Oct, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials
According to a consultation document released by the UKs Health Research Authority… In many cases we don’t always know (due to a lack of evidence) which of the large number of existing treatments routinely used in the NHS is best for an individual patient,...
by chuck_ltd | 26 Oct, 2015 | CHCUK News & Articles, Pragmatic Trials
This page provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where...
by chuck_ltd | 26 Oct, 2015 | CHCUK News & Articles, Pragmatic Trials
Few clinical trials are entirely explanatory (done in an idealized setting) or entirely pragmatic (done in a usual-care setting); rather, trials are situated somewhere along a continuum of applicability. Pragmatic clinical trials are trials designed with pragmatic...
by chuck_ltd | 26 Oct, 2015 | Pragmatic Trials
Earlier this year, the NIH Collaboratory conducted a series of interviews with the principal investigators of its first round of pragmatic clinical trial Demonstration Projects. These projects completed a pilot phase before scaling up to full implementation in...