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The medical experts at Europital Medical Consultancy, the consultancy division of Europital, have recently published an article regarding medical guidance in clinical trials. Below, you will find an overview of the publication:
During the conduct of clinical trials, appropriate medical guidance and safety oversight is provided by a qualified medical person designated as Medical Monitor (MM). It is imperative that a harmonized two way communication is established between MM and the clinical operation team, so that all study related medical support is delivered in a timely fashion to ensure the safety of study participants and scientific integrity of the study data. Apart from the minimal face to face interactions, usually during the start-up, the communication for rest of the study is done through telecommunication or electronic media. Here, we study the current industry practices regarding engaged tools to deliver Medical Guidance and how effective are these tools in achieving the desired goals.
Study Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard operating procedures (SOPs), Good clinical practice (GCP) and the applicable regulatory requirement is termed ‘Monitoring’. This responsibility is primarily fulfilled by the clinical monitors, usually the clinical research associates (CRAs) and the Medical Monitors (MM). They form the main line of communication between the sponsor and the investigator, ensuring that the trial is conducted and documented in an ethical way. This forms an integral component of trial quality assurance process necessary for GCP fulfillment, with the main objective to ensure the protection of rights and wellbeing of the trial participants. Hence the extent and appropriateness of trial monitoring depends hugely on the effectiveness of the existent communication between the MM and clinical operation personals.
Closing Remarks
To ensure appropriate documentation of relevant email communications, we believe that clear definitions of relevancy and the applicable documentation procedures for email communications should be set up at the start of each project and clearly understood by the involved team members. When deciding on the approach to be deployed in a project, the decision makers should take into consideration both the potential risk of losing out critical medical information, and the amount of time and resources needed for appropriate documentation of medical guidance communications in each of the available options.Generally, e-mail has been widely used as a communication modality in various professional sectors with considerable success. But to manage specialized, more targeted, and critical communications during medical management of a clinical research project, a custom built tool might suit the purpose more than a generic solution. For the time being, the challenge rests in addressing the constraints associated with the current practice.
The complete article has been published in the International Clinical Trials Magazine. You can access the online version by clicking on the following link (pages 38-41): ICT - Autumun Issue 2014
1- El Malt M., Rajendran V. Top Line Results, Acquiring Medical Guidance in Clinical Trials – Survey 1: Operations Team Perspective. Europital, 2014.
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1. Mohamed El Malt, MD, PhD
Chief Medical Consultant, Europital.Oncology Surgeon and expert Scientific Researcher with more than 31 years of experience as Medical Doctor, including 16 years of Clinical Research and Drug development experience in Academic Medical Centres, Pharma and CRO as Investigator, Project Leader and Medical Director, in addition to 15 years of experience as General and Oncology Surgeon.
2. Vijayanand Rajendran, MD
Clinical Research Physician, Europital.Qualified Physician with over 8 years of clinical and research experience. Hands on experience in Safety Monitoring of phase I-IV trials in a variety of Therapeutic Areas including Oncology, Hematology, Gastroenterology and Musculo-skeletal system.
Mail: info@europital-mc.comURL: