Q&A: New rules for clinical trials conducted in the EU – 2 April 2014

Posted on April 7, 2014. Filed under: Research | Tags: , |

Q&A: New rules for clinical trials conducted in the EU – 2 April 2014

Extract

“Why is the current legislation being replaced?

The 2001 Clinical Trials Directive has been criticised by patients, researchers and industry alike for its disproportionate regulatory requirements. High costs and a lack of harmonisation of the applicable rules necessary for multinational clinical trials are a few examples.

Taken together, these restrictions have contributed to a significant decline in the number of clinical trials in the EU – a reduction of about 25 % in the last few years.

The new Regulation aims at restoring the EU’s competitiveness in clinical research and the development of new and innovative treatments and medicines by cutting red-tape and bringing patient-oriented research back to Europe.

What are the main changes introduced by the Regulation?

The new Regulation will make it easier to conduct multinational clinical trials, i.e. conducted in more than one Member State, in the EU. Measures that cut red tape and simplify the current rules are:

– A straightforward authorisation procedure allowing for a fast and thorough assessment of the application by all Member States concerned and resulting in one single assessment outcome. The authorisation procedure allows the individual EU countries to determine the roles of the bodies in charge of the assessment, on the condition that the assessment is fully independent and based on the necessary expertise.

– Simplified reporting procedures so that researchers no longer have to submit largely identical information on the clinical trial separately to various bodies and Member States.

– The possibility for the Commission to conduct controls in EU countries and third countries to make sure the rules are being properly supervised and enforced.

Finally, the new legislation will take the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on identical rules.

What role will Ethics Committees have under the new rules?”

… continues on the site

For more information on clinical trials in the EU:

http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm

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FDA works with partners to establish important therapeutic area data standards – ExpressPharma – 25 October 2012

Posted on October 31, 2012. Filed under: Research | Tags: , , |

FDA works with partners to establish important therapeutic area data standards – ExpressPharma – 25 October 2012

Extracts

“A new partnership between the FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path) was officially launched at the CDISC International Interchange in Baltimore. This partnership, called the Coalition For Accelerating Standards and Therapies or CFAST, will bring together clinical data experts from the FDA, the pharmaceutical industry, and the information technology sector, to develop and maintain data standards tailored to individual diseases and therapeutic areas.

Standardised data elements that are common to all clinical trials, such as age and gender, have been established using CDISC terminology. However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data from multiple trials can be more easily grouped for reporting and analysis.

In short, establishing common standards for data reporting will provide new opportunities to transform the massive amount of data from drug studies on specific diseases into useful information to potentially speed the delivery of new therapies to patients.”

CDISC Terminology

“Clinical Data Interchange Standards Consortium (CDISC) Exit Disclaimer is an international, non-profit organization that develops and supports global data standards for medical research. CDISC is working actively with EVS to develop and support controlled terminology for a wide spectrum of clinical and nonclinical studies. CDISC terminology goes through an extensive process of content development and public review before it is declared ready for release. CDISC controlled terminology is versioned by date. All previous versions of CDISC controlled terminology can be found by clicking on the directory links below and going into the Archive subdirectory.”

CDISC

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New website: NIH Clinical Research Trials and You – 6 February 2012

Posted on February 8, 2012. Filed under: Research | Tags: , |

New website: NIH Clinical Research Trials and You – 6 February 2012

“Agency-wide resource provides important information for the public and health care providers

The National Institutes of Health has created a new website, NIH Clinical Research Trials and You to help people learn more about clinical trials, why they matter, and how to participate. From the first cure of a solid tumor with chemotherapy to the use of nitroglycerin in response to heart attacks, clinical research trials — or research studies involving people — have played a vital role in improving health and quality of life for people around the globe.”

… continues on the site

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Clinical trials – postnote form the Parliamentary Office of Science and Technology, Houses of Parliament [England] – October 2011

Posted on October 18, 2011. Filed under: Pharmacy, Research | Tags: |

 

Clinical trials – postnote form the Parliamentary Office of Science and Technology, Houses of Parliament [England] – October 2011

 

“Clinical trials benefit the health and safety of patients by making proven new treatments available more quickly. This industry is also very important for the UK economy. However, recent years have seen a drop in the number of trials held in the UK. This POSTnote summarises some of the most important reasons behind this decline, and the actions being taken to improve the situation. It also highlights areas identified by key industry partners as opportunities for growth.”

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Public Engagement and Clinical Trials: New Models and Disruptive Technologies – Workshop Summary – Institute of Medicine – 14 October 2011

Posted on October 17, 2011. Filed under: Pharmacy, Research | Tags: , , |

Public Engagement and Clinical Trials: New Models and Disruptive Technologies – Workshop Summary – Institute of Medicine – 14 October 2011

“Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to determine whether they are effective and to assess any harm that may arise from treatment. There is growing recognition, however, that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. Many clinical trials never meet their recruitment goals and others accrue patients far too slowly. The divide between clinical research and clinical care is growing wider, with many patients and their physicians far removed from the clinical trials that are needed to create the data necessary to bring scientific discoveries into clinical practice.

To further examine the current challenges to U.S. clinical trials, the IOM Forum on Drug Discovery, Development, and Translation, in collaboration with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011 to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials. The workshop covered topics such as recruiting and retaining trial participants, increasing practicing clinicians’ participation in and referrals to trials, and strengthening public understanding of clinical trials. This document is a summary of the workshop.”

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A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program – 15 April 2010

Posted on April 16, 2010. Filed under: Oncology, Research | Tags: , , , |

A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program
Released: April 15, 2010
Type: Consensus Report

full text online

“Advances in biomedical research continue to create significant opportunities for improving cancer detection, treatment, and prevention. Clinical trials that test the safety and therapeutic benefit of promising treatments are essential in translating new knowledge into tangible benefits for patients with cancer. For the past 50 years, the National Cancer Institute’s (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. More than 25,000 patients and thousands of clinical investigators participate in the program’s clinical trials annually. In recent years, however, many stakeholders have expressed concerns that the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care. As a result, NCI asked the IOM to assess the state of cancer clinical trials, review the Cooperative Group Program, and provide advice on improvements.”

…continues

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Save Australian Clinical Trials

Posted on October 27, 2009. Filed under: Research | Tags: |

Save Australian Clinical Trials
Spokesperson:  Janelle Bowden – AccessCR
From AHHS News – Date:  Friday, 23 October 2009

 “Do you think clinical trials serve a valuable purpose for both Australian patients and the healthcare system? As with most industries, clinical trials are increasingly being placed outside of Australia in countries where there are larger population pools to draw from, and where trials can be run less expensively. In an effort to draw attention to this issue, and garner public support for government and industry efforts to increase Australia’s attractiveness and competitiveness for running clinical trials, Janelle Bowden, of AccessCR, is running a “Save Australian Clinical Trials” Campaign.
 
There is much to be lost if clinical research declines in Australia, not the least of which are the benefits to Australian patients, our healthcare system, jobs, and Australia’s reputation for medical research. Everyone who supports clinical trials being run in Australia is asked to register that support online before the end of October at the website below.”

AccessCR has a website too:

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