Ambiguity in Clinical Trial Operations

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Ambiguity in Clinical Trial Operations

Posted On : Oct-16-2010 | seen (413) times | Article Word Count : 700 |

Global clinical research is exploring India. However, there are a few concerns about timelines for regulatory approvals, deficiencies in the functioning of the various Ethical committees, and an unethical approach to the recruitment of subjects in clinical trials conducted in India.

The Clinical Operations team of an organization conductsPhase I-IVclinical trials for drug discovery and development, maintaining the highest standards of ethics, quality and confidentiality. A team of highly capable professionals with extensive knowledge and experience in different therapeutic areas do successfully handle studies of national and international clients.
A brief insight into the various activities that are involved in the clinical trial management:
Study Management :
All projects require well organized execution by project managers, CRAs trained in ICH-GCP guidelines and relevant national and international regulations to oversee activities at study sites. This pooled with a proper plan provides responsive approach for successful completion of the study within the given timelines. Questions pertaining to protocol and other study related AE’s/SAE’s are reported to project manager and medical monitor, ensuring the reliability of clinical trial data.
Site Management :
The Clinical Operations team is dedicated to rapid site activation for clinical trials. They select sites during feasibility based on the facilities with good patient flow and any other protocol specific requirements. The team prepares the recruitment and retention plan unique to each site, giving attention to the site's strengths and experience. There has to be a well-established relationship with study sites to work closely with each site to develop successful recruitment and retention strategies. Beside these, team identifies the new sites and investigators and updates the database, provides proper training to them. All large and complex clinical trials can be efficiently executed by qualified clinical project managers and well trained CRA’s with proper planning and conduct.
Clinical Monitoring :
CRAs with Life Sciences and Medical background and strong organizational skills are like pillars of the Clinical Operations department. Beside these they should have, good written and oral communication skills.
CRAs add value to the conduct and timely execution of clinical projects. They travel to the study sites as per the protocol/sponsors’ requirements ensuring integrity, quality of the data, compliance to protocol, SOP’s, applicable regulatory requirements. The CRA’s follow up with the sites regularly and updates weekly status to the sponsor. Other tasks of a CRA includes and not limited to SDV, drug accountability, data collection, safety reporting.
Clinical Trial Supply Management :
Other most important activity of clinical operations is management of clinical supplies. They build logistic models in compliance with SOPs (CRO/Sponsor) and regulations in order to meet the sponsor specific needs. Based on sponsor requirements the department handles the task of destroying the drug. The team also gives assistance in other activities like obtaining import license and custom clearance.
Vendor Management :
The department has hands on experience in Vendor management with single point of contact promising continuous communication and coordination with the vendors.
Apprehensions in clinical research in India :
Although the entire set of personnel are required to execute a clinical trial are plenty in India today but still there is a need to change the framework which can be build further. The DCGI is responsible for approvals of clinical trials to be carried out in India. The DCGI’s office sometimes refers to external experts and other government agencies for advice. The US FDA gives an approval in an average of 30 days but most of the trials in U.S are delayed because of the time taken for enrolling patients. The potential for a fast patient recruitment in India may to some extent make up for the delay in approvals by regulatory bodies.
A survey conducted by ICMR shows evidence that there are only few ethics committees in institutions. Among which the other concern is there is no adequate representation by persons other than those from the medical fraternity. According to the guidelines, without the inclusion of persons from a non-scientific background, the opinion of the IEC is likely to be biased in favor of the study.
In spite of all the present hurdles, with dramatic transforms in the regulatory and investigators approach to attract more and more players. In order to facilitate the entry of global clinical trials regulations are being amended and strenuous efforts are made to train research professionals and increase the base of investigators and supporting staff. These initiatives are certain to improve the current situation.

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<h1>Ambiguity in Clinical Trial Operations		 </h1> Author: <a href='http://www.articleseen.com/profile_Ragalahari.aspx'>Ragalahari</a> The Clinical Operations team of an organization conductsPhase I-IVclinical trials for drug discovery and development, maintaining the highest standards of ethics, quality and confidentiality. A team of highly capable professionals with extensive knowledge and experience in different therapeutic areas do successfully handle studies of national and international clients.
A brief insight into the various activities that are involved in the clinical trial management:
Study Management : 
All projects require well organized execution by project managers, CRAs trained in ICH-GCP guidelines and relevant national and international regulations to oversee activities at study sites. This pooled with a proper plan provides responsive approach for successful completion of the study within the given timelines. Questions pertaining to protocol and other study related AE’s/SAE’s are reported to project manager and medical monitor, ensuring the reliability of clinical trial data.
Site Management :
The Clinical Operations team is dedicated to rapid site activation for clinical trials. They select sites during feasibility based on the facilities with good patient flow and any other protocol specific requirements. The team prepares the recruitment and retention plan unique to each site, giving attention to the site's strengths and experience. There has to be a well-established relationship with study sites to work closely with each site to develop successful recruitment and retention strategies. Beside these, team identifies the new sites and investigators and updates the database, provides proper training to them. All large and complex clinical trials can be efficiently executed by qualified clinical project managers and well trained CRA’s with proper planning and conduct.
Clinical Monitoring :
CRAs with Life Sciences and Medical background and strong organizational skills are like pillars of the Clinical Operations department. Beside these they should have, good written and oral communication skills. 
CRAs add value to the conduct and timely execution of clinical projects. They travel to the study sites as per the protocol/sponsors’ requirements ensuring integrity, quality of the data, compliance to protocol, SOP’s, applicable regulatory requirements. The CRA’s follow up with the sites regularly and updates weekly status to the sponsor. Other tasks of a CRA includes and not limited to SDV, drug accountability, data collection, safety reporting. 
Clinical Trial Supply Management :
Other most important activity of clinical operations is management of clinical supplies. They build logistic models in compliance with SOPs (CRO/Sponsor) and regulations in order to meet the sponsor specific needs. Based on sponsor requirements the department handles the task of destroying the drug. The team also gives assistance in other activities like obtaining import license and custom clearance. 
Vendor Management :
The department has hands on experience in Vendor management with single point of contact promising continuous communication and coordination with the vendors. 
Apprehensions in clinical research in India :
Although the entire set of personnel are required to execute a clinical trial are plenty in India today but still there is a need to change the framework which can be build further. The DCGI is responsible for approvals of clinical trials to be carried out in India. The DCGI’s office sometimes refers to external experts and other government agencies for advice. The US FDA gives an approval in an average of 30 days but most of the trials in U.S are delayed because of the time taken for enrolling patients. The potential for a fast patient recruitment in India may to some extent make up for the delay in approvals by regulatory bodies.
A survey conducted by ICMR shows evidence that there are only few ethics committees in institutions. Among which the other concern is there is no adequate representation by persons other than those from the medical fraternity. According to the guidelines, without the inclusion of persons from a non-scientific background, the opinion of the IEC is likely to be biased in favor of the study. 
In spite of all the present hurdles, with dramatic transforms in the regulatory and investigators approach to attract more and more players. In order to facilitate the entry of global clinical trials regulations are being amended and strenuous efforts are made to train research professionals and increase the base of investigators and supporting staff. These initiatives are certain to improve the current situation.About the Author: A short review on clinical research in India by experts of <a rel="nofollow" href="http://www.makrocare.com"title="CRO India">MakroCare </a> a clinical research organization. Article Source: <a href='http://www.articleseen.com/Article_Ambiguity-in-Clinical-Trial-Operations_37930.aspx'> http://www.articleseen.com/Article_Ambiguity in Clinical Trial Operations		 _37930.aspx</a>

Article Source : http://www.articleseen.com/Article_Ambiguity in Clinical Trial Operations _37930.aspx

Author Resource :
A short review on clinical research in India by experts of MakroCare a clinical research organization.

Keywords : clinical trail operations, patient recruitment, smo, site management organization, clinical trail monitoring ,

Category : Health and Fitness : Health and Fitness

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