Specialise in pharmacovigilance and data management
Dr Mary Francis Dean, ICTCR & Director
Jovis Clinical Research.
These are exciting times in the field of clinical research. Not only is the stream of applied science gaining importance in both educational as well as industry terms, but with newer avenues of excellence opening up within the stream itself, for educationists like us, it is extremely challenging to work out specialised courses for students. Of these, the two main streams that are expanding rapidly in importance within the clinical trials industry are Pharmacovigilance and Data Management.
In strict terms, pharma-covigilence is the study of the adverse effects of a new drug, being tested. But in this case, the vigilance doesn’t end at the clinical trial stage itself. It goes on, even once the drug is in the market and ensures that any adverse reaction, even if it is a minor one, is recorded, processed, understood and prevented. The protection of the patient group from any adverse drug reaction is priority in any clinical trial. Naturally, the scope of this work, is enormous.
Pharmacovigilance is important because despite the best efforts of the industry, each drug is tested only on a few thousand patients/ volunteers and while it does tell us a lot about the drug and its working, the variables in a clinical trial are controlled and results relate only to the trial group. Once out in the market, the drug is used by a larger group, often in combination with drugs for other diseases and treatment and maybe by people of varying age groups, all of which increases the risk base of the drugs. Also, with a lot of high profile drugs being recalled in the markets, the crucial role of pharmacovigilence cannot be more underlined.
Pharmacovigilance at the clinical trial stage, involves drawing up protocols for setting up systems to assess the aim of the research, consider the reasons for recording and notifying adverse events at the trial and which events should be recorded and why. It is the sponsor who is mainly responsible for putting the systems in place and setting up SOPs for ensuring quality standards for recording, reporting and managing adverse effects. The sponsor is also responsible for reporting and notifying investigators and ethics committees and regulatory bodies of any adverse effect reports, conduct of the trial after the reporting and the impact it has on the trial.
The sponsor must also set up systems on safety issues, maintain records and check that all activities of the project are correctly documented in paper trails and procedures are being followed. For international trials, reporting from other countries should also be clarified, and documented.
In order to ensure the status of pharmacovigilence in clinical trials, a tripartite harmonised ICH guideline was finalised, to aid in planning pharmacovigilence activities in the early post marketing period of a new drug. These guidelines mainly focus on the Safety Specification and Pharmacovigilance Plan that is to be submitted at the time of license application.
Careers in Pharmacovigilance
Career opportunities will be in both the management, marketing and the executive leagues: Formulation of appropriate guidelines and operating procedures, providing and following up on the requirements of reporting, developing of case reports from all new trials to ensure that the elements of safety reporting are followed among others, ensuring regulatory compliance and adherence, managing and developing drug safety team and assisting in monitoring projects.
Posts will also include those of clinical pharmacovigilence officer, associate, regulatory affairs associate, clinical drug safety associate, and clinical CRF designer, among others.
Data management is at the core of clinical trials. Regardless of what the size of the trial, the number of patients involved, the drug details or the complexity of the tests, accurate results of any trial are determined by the quality of the data collected, the acumen with which it is collated, understood, and analysed. Failure to efficiently manage data results in compromising trial results, patient safety and validity of data.
As the ICH GCP guidelines, 1.24 states, `A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials should provide assurance that the data and reported results are credible and accurate…”.
As a single trial throws up multitudes of information in various fields, the challenge to a data manager is not just to establish data collection methods, but ensure data standards, set up clinical data management systems and keep it evolving to meet the ever-changing nature of technology. Data management, thus involves, design build tests, (activities involved in data management), data checks, data review query processes, quality check lock data base, and data transfer archive studies. Data Management Programs describe in advance how a clinical data management unit will process the data during the life cycle of a single project and also have to describe standard procedures, any study specific procedures to be followed, sponsor SOPs and related procedures to be applied. Software applications are used to manage such data studies and are called clinical database management systems (CDMS), in itself an exciting and challenging field related to clinical research.
Careers in Data Management
Data management involves, a working knowledge of mathematics and statistics, an ability to assimilate the millions of information to come to acceptable conclusions. Data management is a part of every step in a Clinical Trial beginning from setting up systems for protocol submission, approval, monitoring, patient data management, screening, data collection, monitoring and reporting.
Careers in data management involve working as database managers, research associates, data coordinators and statisticians, clinical data management associate, clinical data coordinator, clinical data monitor, clinical data auditor, clinical data analyst, coder, and validators.
Why specialised courses
Pharmacovigilance and data management are vast fields of knowledge and information, which may not be addressed with its due importance in a regular course of Clinical Research.
Apart from understanding the nature of the subject, especially in pharmacovigilence, a student has to be rigorously trained in order to be a specialist with case studies, analysis of a crisis situation, intensive studies of international guidelines on the issue and an understanding of healthcare systems of various communities and societies.
In data management, a student can be an expert only on and after being trained hands-on on computer models, processes and systems on data collection, setting up systems for the various stages of data analysis, and especially management skills to be able to get every head of every department in the trial to agree with the findings of the data managed and analysed. With more and more IT companies like TCS, Accenture, Cognizant getting into the business of formulating data management systems, it is a lucrative option for those who love number crunching – this time, to save lives!