An analysis of why it is necessary to harmonize clinical research practices with the contribution of bodies such as the International Conference on Harmonisation.
Clinical trials are critical to the advancement of valuable treatments. Human testing can be however a challenging task that must be preceded by laboratory studies, which normally encompasses years of non-clinical trials. If the non-clinical trials prove to be successful, the companies sponsoring the research submit the data to the United States Food and Drug Administration (FDA) and request for an Investigational New Drug (IND) process approval (Reisberg, et al., 1996).
Following approval, the research enters the clinical trials stage, which usually involves three phases, with each phase having a large number of participants. Phase I of the clinical trial is usually concerned with the drug’s safety and its potential side effects. Phase II lasts longer than Phase I since it involves double-blinded trials involving an experimental group and a control group. The last Phase, Phase III is also known as the pre-approval phase whereby the new drug is usually involves a series of studies aimed at offering richer understanding of the drug’s efficiency as well as its common side effects.
In 1996, ICH-GCP guidelines (International Guidelines for Good Clinical Practices) (ICH-GCP) were introduced and quality research framework designed and adopted in a good number of countries thus opening up broad opportunities to researchers to take part clinical trials(Britten, et al., 2008).Sharing study materials among different institutions remains to be the main reason behind harmonization of clinical researches (ICH E9 Expert Working Group, 1999). ICH guidelines have made communications among researchers and drug regulatory experts easier and faster. For many years, institutions and researchers have always shared information under a confidentiality arrangement. This has always been beneficial to all parties involved and it has helped in the innovation of better and more efficient drugs. The harmonization of the way clinical trials are conducted further increased the efficiency of these communications since all researchers fully understand the clinical trial process (Britten, et al., 2008).
Over the resent years, there has been growing pressure on researchers to reduce the drug development timelines. This can be done through the implementation of a number of strategies including ensuring that all players are responsible and there is a clear guideline on their duties (Reisberg, et al., 1996). Another strategy that could be used to reduce drug development timeline is ensuring that a high quality drug is produced the first time to avoid any significant modifications of the original product during later stages of development. ICH guidelines play a significant role in the success of these strategies.
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The quality of the product being developed is an important area for potential partners in the clinical trial process (Reisberg, et al., 1996). There are two key areas that can be associated with quality, organizational quality and internal quality. Although the application ICH guidelines increase the administrative burden, it helps ensure that researchers follow the right participant recruitment processes and they also conduct the research in an ethical manner (ICH E9 Expert Working Group, 1999).
The introduction of the Common Technical Document (CTD), has enabled electronic submission of documents (eCTD) thus increasing efficiency. In the past, drug development applications were so many that they were conveyed to FDA by a truck. The recent implementation of an electronic submission option that allows new drug developers to submit applications electronically has made the review process much more efficient. The submissions are usually available to the reviewer instantly.
This advancement has eased the need for researchers and organizations within the industry to generate and compile the bulky paper based applications previously used. This has not only lessened the workload but it has also helped save time, thus reducing the drug development timeline (Reisberg, et al., 1996). The eCTD has played a critical role in improving the process of application submission proficiencies and increasing reviewer efficacy(ICH E9 Expert Working Group, 1999). Besides delivering application submissions to FDA, the eCTD application format makes it easier for FDA to use harmonized reviewer e-templates as well as review tools for the different review disciplines.
Lastly, harmonized format has made the development and application of harmonized good appraisal practices easier. Whatever is appraised in a review is usually closely related to the data entreated(Britten, et al., 2008). Consequently, there is substantial connection between ICH guidelines and what may be considered as good evaluation practices. Since ICH guidelines have harmonized most of the material provided for marketing approval, ICH regulators can therefore harmonize their practices easily too (Reisberg, et al., 1996). Effective review practices encourage transparency and dependability, which are key qualities in promoting industry regulatory structure.
Although the application of ICH guidelines has its disadvantages, it has many more advantages making it an important part of effective clinical trials regulation. To reliably increase the participation of various institutions in clinical studies, there must follow a set of clear rules and guidelines. All institutions involved with clinical trials must adapt to these guidelines so as to increase and maintain their desirability as a suitable base for sponsored clinical researches.
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