One of the most common phrases used to describe investigative sites sought after to participate in clinical trials is ‘high quality’. Quality can be somewhat of an elusive term, however. Although the definition is quite clear, ‘quality’ in itself is not always tangible. The quality of a diamond is clearly observed by the level of flawlessness and clarity; however the quality of the ring setting may be more subjective. How do we measure quality when there is no formal scale on which to evaluate? What defines a ‘high quality clinical trial site’?
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. CDM is the process of collecting, cleaning, and managing subject data in compliance with regulatory standards, with the aim of generating high-quality, reliable, and statistically sound data.
The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practices (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry. This article discusses how the ICH has changed with the recently approved Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) and outlines some of the major areas where sponsors can develop more efficient approaches in the design and conduct of their clinical trials.
Ebola struck three West African nations in 2014, mobilizing the World Health Organization and bringing doctors from around the world to the affected areas. The following year, the Zika virus spread throughout major portions of Latin America. Events like these have led to calls for expedited approvals of vaccines and drugs undergoing clinical trials in order to nip these and future outbreaks in the bud.
Multi-country clinical trials have risen in recent years, and new regions have emerged as today’s most promising venues for clinical trials. The major forces behind these changes include the varying degrees of regulatory friendliness and access to patient populations in different countries around the world. Of course, cost plays a major role as well, as researchers have become increasingly attracted to developing regions where the cost of conducting a trial are considerably lower.
With the myriad of technology advances available and proven to overcome the challenges of paper based approaches, the methods used to conduct and support clinical trials can be cutting edge. However, some sponsors and their CROs continue to operate based on error-prone manual processes and siloed databases that extend development timelines and inflate costs. This article explores why so many continue to collect, aggregate and report clinical trial data manually when automated solutions are proven to streamline operations, yield better results and reduce trial costs and timelines.
As mHealth continues to grow and apps expand into different areas, the opportunities for health improvements also grow, as do complexities. This article ─ including comments from ERT’s Dr. Chris Watson and Gavin Birchnall ─ reviews how pharmaceutical companies will need to carefully balance mHealth innovation with a clear understanding of the evolving regulatory guidelines. This article reviews the huge potential of mobile health, or mHealth not only for patients, caregivers, and physicians, but also for pharmaceutical companies.
At the annual American Society of Clinical Oncology (ASCO) meeting, the focus was significantly on targeted therapies, with studies demonstrating significant – and potentially practice-changing – results.
The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
This is the first post in a blog series from the annual meeting of the world's leading cancer experts, the American Society of Clinical Oncology (ASCO) meeting.
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