Question

Please write a minimum of 1000 words essay on how implementation of good clinical practice guidelines protects the interest of patients in clinical trials.

Answer 1

ESSAY:

Good Clinical Practices(GCP) guidelines are designed to protect clinical trial participants.The need to protect human subjects who participate in clinical research is recognized worldwide and reflected in Good Clinical Practice (GCP) guidelines. Many countries have adopted GCP guidelines and regulations, which consist of internationally approved protocols for the planning,implementation, monitoring, and reporting of clinical trials, which encourages future approaches to more meaningful clinical trials that will ensure human subject protection and reliability of trial results.The regulations,guidance and industry standard that make up good GCP are to provide rights,safety and well being of the participants.The GCP also ensures that the outcome of the research is scientifically precised data.Previously various jurisdications used to follow different guidelines but now with the introduction of ICH(International Conference of Harmonisation),conducting clinical trials globally have become more uniform in all aspects.

Companies undergoing clinical trial should develop certain procedures for implementing GCP guidelines.The procedures may include investigator site selection,document of regulations to be collected, reviewed and submitted,financial disclosure,initiation of investigator site,product distribution and tracking,monitoring of site,safety ,quality assurance audits,documentation of masterplan,vendor quality verification,compensation and insurance to name a few.

Basically, GCP  should have some fundamentals like oversight of local ethics committee,choosing verified investigator,Investigator's Brochure explaining the study protocols,informed consent of participant and most importantly ,proper required documentation of the trial.

The thirteen basic principles of GCP as laid down by ICH are quite simple.

1.Ethical principles which as its name suggests abide by ethical laws of the local ethical committee and ICH developed principles like Declaration of Helsinki.

2.Favourable benefits and Risks :Before a clinical trial ,the forseeable risks should be taken into account against the benefits of the participant and mankind .In short ,benefits should justify the risks.

3.Subjects Rights:The Subject is a human being and therefore his rights should be placed above science and benefits of the trial.

4.Adequate supporting Data:The proposed product for trial should have sufficient clinical and non clinical data supporting the conduct of its clinical trial.

5.Scientific Protocols:The protocols should be scientifically precise and simple.

6.Independant ethics committee approval:The protocols which were previously reviewed or given approval by Independant Ethics Committee(IEC) should be used.

7.Medical care given by qualified investigator:The clinical decisions made on the participants behalf should always be taken by a qualified physician or dentist.

8.Qualified Team :Each personnel taking part in the trial should be qualified in the position and work they are carrying out.

9.Informed consent from evry subject should be taken free of cost before evry trial.

10.All relevant documents should be recorded and kept in good condition for proper outcome of the trial.

11.Confidentiality of the subjects should be protected as it is one of their basic rights.

12.Good Manufacturing Practise(GMP) of the manufacturing product should be according to the protocols regarding its manufacturing,handling and storage.

13.Quality assurance and monitoring should be ensured in evry aspect of trial so that maximum benefits are reaped as outcome.

Therefore the role of GCP(Good Clinical Practises) as international ,ethical and quality standards to safeguard the rights of human subjects in clinical trial is undoubtably immense.Regardless of the trial being large or small scale the manufacturing companies and investigators should keep in mind that they are dealing with fellow beings.Keeping that in mind, the manufacturing companies ,sponsors,investigators,ethical committee or any clinical research organisations should follow the standards Good Clinical Practices.