Category Archives: Best Practices

Best Practices Series: Know What WE Know About ICH GCP

The ICH (international Conference of Harmonization) plays a major role in providing pharmaceutical standards, accepted by regulatory authorities across the globe, and GCP (Good Clinical Practice) is no different.? The ICH GCP guideline was developed with an aim to protect the rights and safety of human subjects while assuring credible and internationally acceptable clinical trial data.? Along with WHO (World Health Organization) recommendations, the international ethical and scientific standards for clinical trials involving human test subjects (GCP) from the regions of Europe (EU), United States of America, Japan, Australia, Canada, and Nordic countries were all taken into consideration.

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Importance of GCP
It is safe to say that GCP in clinical trials requires a lot of time and resources. While following best practices protocols when conducting a research does yield more reliable data and strict ethical protocols protect the subject rights and safety, the GCP for any study was in the clinician?s domain until relatively recently. However, loose GCP protocols were not acceptable by regulatory authorities and The Declaration of Helsinki in 1964 provided a foundation for internal GCP guidelines for many organizations.

Under ICH GCP, all crucial aspects of best practices were unified under one guideline. For the independent researchers or noncommercial trials, this guideline can feel to restrictive and demanding, bringing extra paperwork and increased cost. However, the document represents the way of thinking that should be always present, when conducting trials on humans; the same rigorous quality, ethical, and safety protocols should be followed, regardless of the trial type or origin.

ICH GCP and Its Principals
Frequent poor data monitoring, flawed statistical design and analysis, and questionable ethical methods used in clinical trials in the past have all contributed to a growing public and professional concern about research misconduct, and have lead to misleading, and sometimes even hazardous trial results. ICH GCP plays a vital role in assuring sound clinical trials and reliable trial results while protecting the patients rights and safety.

Ethical Aspects?
Clinical trials should be conducted in accordance with the ethical principals of the Declaration of Helsinki, and a study should be conducted only if the potential benefit for the society outweighs the possible risks for the subject.

Clinical Protocol
The trials should have scientifically sound and clear objectives, supported by prior clinical and nonclinical information, and should be conducted in compliance with a detailed protocol, approved by IRB (institutional review board) or IEC (independent ethic committee). Freely given informed consents should be obtained from every subject in the study.

Record Keeping
Every individual involved in conducting a study should be properly educated and trained, all clinical trial data should be properly recorded, handled, and stored, and the subject’s confidential data should be protected.

Study Report
The study report needs to be prepared at the end of the study, regardless of the study phase or the number of participants that were included in the trial. Following ICH GCP principles is crucial to providing significantly increased quality of treatment.

While some of the procedures in the ICH GCP can seem tedious, past experiences shows all of them make sense. Not only do they provide a safe environment for the participants, and improved treatments for society, they ensure that negative trial results are well documented and can prove as useful as positive results in future clinical trials. Along with the obvious benefits of complying with the best practices, apparent hindrances, such as increased bureaucracy and cost, can be greatly reduced with proper study design and utilization of approved clinical trial system and experts.?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 03 Jan 2013 20:57:00 GMT

Translational Science for Cancer Research – The Consortia Model

Cancer Exploration for the New Millennium

What advantage does a clinical consortia group have over regular trial groups when it comes to innovative cancer treatments???In some important ways, through Translational Science methodologies. The most important conceptual difference between the classical clinical trial and the Consortia approach is that the Consortia model, with its highly experienced clinical scientists, is involved on an intellectual advisory level with every step of clinical investigation in a cancer study. ?Classical clinical trials groups most often have patient accrual as their most substantive role.
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cancer-attackA Consortia can readily interface translational science with clinical outcomes and can show the value of translational science to a positive outcome of regulatory approval process and is critical to the Consortia?s contribution to research projects. ?Consortia institutions have the capability to collect tissue and have access to labs to analyze and interpret data. Consortia sites have been selected for their access to patients with specific diseases and for their ability to enroll such patients on clinical trials.

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Here’s why: The discipline of clinical and translational science encompasses a broad spectrum of research, extending from basic discoveries with implications for human health to community-based epidemiologic and health services studies. The unifying theme is a commitment to apply scientific methodologies to address a health need. SCTS (The Society for Clinical and Translational Science) defines it as:? “…a multi-dimensional, cross-cutting discipline that encompasses multidisciplinary investigative teams from many different subspecialty areas. Moreover, success in clinical and translational science commonly requires constructive partnerships with industry, granting agencies, public health agencies, and regulatory agencies.”

Criterium’s Core Science Solutions’ Academic Consortia’s for both GI and Myeloma use the translational science model and can streamline cancer treatment research. Take a look at: http://www.criteriuminc.com/css.php?or visit?www.agicc.org and www.ammyc.org?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersFri, 19 Oct 2012 14:29:00 GMT