CLINICAL TRIAL & 13 Principles of ICH GCP

In Clinical Trials to achieve Quality readiness one needs to understand the Principles of Good Clinical Practices. GCP has been well defined in EU Directive 2001/20/EC, under Clause 2 of Article 1, which discusses about scientific quality requirements for designing and conducting clinical trials.

The data obtained from Clinical trials should be credible as well Clinical trials should protect the rights, safety and wellbeing participating subjects as per National Research Act and Belmont Report, to ensure the authenticity of data and protection of human subjects The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created Good Clinical Practices in the year 1996, which eventually became mandatory to be followed in the year 2004 for conducting trials on all Investigational Medicinal Products (IMP).

Principles of GCP are summarized as follows

1.Clinical Trials should be conducted as per Declaration of Helsinki, which provides ethical guidelines on human experimentation.

2.Before the initiation of clinical trial, the risks for subject and society should be weighed against its anticipated benefits. 

3.The safety and rights of the participating subjects should considered with utmost importance over the benefits of trial. 

4.Clinical information and non-clinical information on the investigational medical product should be adequate to support the trial.

5.Specifics of clinical trials should be well defined and explained in Protocol

6.Protocol should be approved by Institutional review board (IRB)/independent ethics committee (IEC), following which clinical trial should be conducted in compliance with Protocol. 

7.During the trial, qualified physician would be responsible for the well the being of the subject 

8.The staff conducting the trail should be qualified in education, training and experience to perform task allocated to them.

9.Prior to the clinical trial signed informed consent should be obtained from the subject

10.To allow accurate reporting, interpretation and verification of clinical trial data, measures to and record and maintain the data should be sought out.

11.The records identifying the confidentiality of subject should be protected in respect to privacy and confidentiality regulations.

12.The Investigational medicinal product in Clinical Trials should be manufactured as per Good manufacturing practices (GMP) and should be used in accordance to the protocol. 

13.Quality systems should be maintained to ensure quality in Clinical Trials.

Reference: GCP 13 Principles
(Url:  https://www.abdn.ac.uk/hsru/documents/GCP%2013%20Principles.pdf )

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Clinical Research- opening new doors to Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD) is a muscular dystrophy characterized by severe muscle weakness due breaking of skeletal muscles. DMD mostly occurs in boys at around age of 4. The aetiology of DMD is said to be attributed to the mutation of a gene called dystrophin located at locus Xp21 or on Chromosome X. Dystrophin is responsible for connecting the cytoskeleton of each muscle, without dystrophin, excess calcium would enter into the cell and cause the cell to burst.

It was not too long before Erin realized that her two year old son Oliver Lambright was diagnosed with Duchenne muscular dystrophy, a generic disorder which occurs in one in 3000 boys. She looked at every possible treatment on the internet, only to realize that there was no cure, till she found Dr. Jean Mah, who was an Associate Professor at Cumming school of Medicine in the Department of Paediatrics, she told her family that there is ongoing clinical trial on DMD at the University of Calgary in Alberta, Canada in which around 100 patients with DMD from all over the world participated in the trial.

Clinical trials are essentials as it paves way for new line of treatment drugs. Before a drug is dispensed in a clinic,It has to undergo clinical trial. At the University of Calgary there are around 563 active trials.

Reference: UToday, University of Calgary

Url: http://ucalgary.ca/utoday/issue/2018-05-16

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Our Classroom sessions for new batch commences from 21^st May 2018. Enrol now to avail 10% discount. For more information contact us at 9910068241, 9560665441, 9560102587or email us at info@cliniminds.com