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Indian pharma is of the view that the draft of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) norms for good clinical practices (GCP) will boost better human studies outcome as India is the hub of global clinical trials.
To this end, ICH GCP will ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the world, the guidelines have considerably reduced duplication of clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.
According to the Indian pharma and clinical research organisations, this is the best that could happen. The need for faster clinical trial completion is dependent on GCP which is a global ethical, scientific and quality standard to undertake the human studies.
Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected. It covers the gambit of activities across planning, initiating, performing, recording, oversight, evaluation, analysis and reporting activities The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
ICH has noted in the guidance that human studies vary widely in scale, complexity and cost. Careful evaluation of the priorities involved in each trial and the risks associated with the priorities will help ensure efficiency by focusing on activities critical to achieving the trial objectives.
Therefore the guideline applies to interventional clinical trials of investigational products that are o be submitted to regulatory authorities. It could also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.
Noting that clinical trials are a fundamental part of clinical research that support the development of new medicines or uses of existing medicines, ICH has noted that well-designed and conducted human studies help answer key questions in healthcare and drug development. Their results are essential for evidence-based healthcare decisions. Trials with inadequate design or poorly conducted may place participant safety at risk and yield inadequate or unreliable evidence and are unethical. They waste resources and the efforts and time of investigators and participants.
The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. It includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, the characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality is needed for each clinical trial, said ICH.
Innovative clinical trial designs and technologies help include diverse patient pools. The design of the trial focus should be for meaningful trial outcomes, protect the rights, safety and well-being of participants. Implementation of Quality by Design will identify the data and processes that are critical to ensuring trial quality . The risk mitigation strategies implemented to support the conduct of the trial will accelerate safety and data reliability. Trial designs need to operationally feasible and avoid unnecessary complexities, said ICH.
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