Investigators – An Important Cog in the Clinical Research Machinery

Pharmaceutical companies are constantly at the pinnacle of healthcare research and development

. Once the market research provides critical information about the prevalence or possibility of an epidemic or pandemic or any other complication, the research and development team starts investigating new compounds to combat the menace. The market research helps in framing a clinical development plan that shows the framework on the development of the drug.

Safe, tried and tested drugs for a multitude of complications can only then be available to the population once the compound has been clinically researched, tested and approved by the regulatory authorities.

Clinical research is conducted in Phases. Once the investigative compound has been tested in vitro, it is then pronounced safe for human subject testing. Clinical research is research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue that can be linked to a particular living person.The identity, physical and medical records of the individual taking part in the study is kept confidential during and after the clinical trial is completed.

How do people take part in a clinical study and how do they know it is safe? The investigators play a crucial role to answer these critical questions. An investigator is a doctor or a medical practitioner who plays an integral role in the development of medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. The investigator may be able to offer his/her patients alternatives that could only be available through their participation in clinical trials.

It is thus crucial for pharmaceutical companies to pick the right investigators for the smooth functioning of clinical trials of their investigative compound and add credibility to the clinical study. Delays in recruiting qualified investigators or in working with investigators who fail to produce their target number of patients can significantly cost pharmaceutical companies in lost product sales.

To get around this problem, most pharmaceutical companies take the assistance of comprehensive benchmarking reports that provide clinical operations staff with specific examples and recommendations on how to identify and close performance gaps with respect to not only performance metrics but also processes and best practices. Critical improvement areas include investigator selection criteria, time to identify, select and recruit investigators, investigator input to protocol design, and valued investigator services.

The ultimate goal of these efforts is to refine the working relationship with investigators to simultaneously improve their commitment to delivering patients to the trial, producing quality data and being an advocate for the developing product.

These benchmarking reports are a result of careful and thorough consultation with the important people in the clinical research business like Clinical Research Organizations (CROs), investigator sites and large pharmaceuticals themselves.

Readers of these reports will be able to forge more effective and profitable relationships with those who drive the clinical development process, investigators.

Investigators An Important Cog in the Clinical Research Machinery

By: Kirthy Shetty

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