Phase II - IV Clinical

Navigating Your Trials Through Principal Investigators - December, 2012

Introduction

Today planning and executing clinical trials requires precise clinical expertise, in addition to ample facilities and abundant resources.Often the first partner to be consulted when setting up a clinical trial is the Principal Investigator(PI).

The principal investigator, or PI, is a physician who serves as the leader for the research team. The PI takes up a special role throughout the course of a study, and is responsible for overseeing that the conduct and quality of the trial stays within regulatory and sponsor requirements, as well as to ensure good clinical practice (GCP) and perhaps most importantly patient safety.

A good PI requires a great deal of experience and expert knowledge of clinical trials to create the foundation of a strong, positively focused clinical trial.

The Principal Investigator– A Crucial Link

The PI is accountable for maintaining the scientific integrity of the protocol as well as regulatory and reporting compliance.The PI oversees a number of functions likeprotocol submission, participant recruitment, informed consent, protocol adherence, data collection and analysis.In a multi-centre trial, the Lead PI is responsible for all regulatory reporting requirements, regular communication with all sites, timely review of all SAE reports from every site to ensure the safety of participants, and review of all study data submitted for analysis.

One of the major challenges of any CRO including QPS is to recruit the required number of patients for a study within the given timelines, thereby lowering the cost of conducting a clinical trial. PIs who have known patients at a clinical site can accelerate recruitment by screening patient records.

A PI is responsible for oversight of clinical trials but can delegate research tasks to appropriately trained staff. However the PI must be available on a daily basis for the clinical trial and is ultimately accountable for all the documentation to be maintained at the study site.

Fostering relations with Principal Investigators

Structured business processes that facilitate rapid performance and internal and external communication are the key to ensuring smooth operations during clinical studies.Considering the indispensable role played by the PI in the smooth functioning of a clinical trial, QPS is employing various strategies to develop stronger relationships with PI’s.

Periodical meetings with the PI for e.g. a conference with a brief lunch where QPS officials and sponsors can hear out the views of PI’s on how the study could be improved is one such instance. This serves as affirmation by QPS that we appreciate the PI’S views and can go a long way in strengthening relationships.

QPS engages in regular relationship building exercises with PI’s from time to time as a healthy relationship with PI’s before during and after the trial helps enhances the quality of studies and aids effective resolution of several functional and operational issues that might come up during the course of a trial.

back
top
20 years in pharma R&D navigation