Clinical Trial Protocols and their relevance to trials

Advancements in medical and new research are crucial to the well-being of the human population today. Those who suffer from health problems can expect to benefit from new advancements in science in the long run. To ensure an orderly process of research which facilitates new discoveries, we take the help of clinical trial protocols.

It is always a highly desired situation in which the clinical managers have access to the clinical trial protocol. This is a highly important piece of paper that has the entire game plan of the clinical trial research. Each and every trial is based on the protocols and the prescriptions therein.

Protocol takes up the task of outlining what are the goals and objectives of the clinical trial. The whole endeavour and what its underlying principles are reiterated in the protocol. The data generated during the clinical trial is also managed as per the stipulations of this protocol. Lots of information will be generated during the course of the trial and the retention of the same shall be done under the guidance of a protocol document. The use of the data generated is done under a basic formula provided by the protocol.

There are several other points that are not included in the protocol document. These can be available in another document which can be a brochure or a record that maintains all the details of the clinical trial.

The whole reason for having a protocol in clinical trials is to safeguard the well-being of the participants. The venture is to find permanent stable solutions to the health problems of individuals rather than jeopardizing their lives. Also, it must be taken care of that the participants are not forced into circumstances that will give them a low self-esteem.

The protocols can also lay down guideposts that will help the managers of the trial in executing the design. The protocol can be the decisive factor in choosing the qualifications of the participants in the trial.

  Conducting clinical trials involves certain tasks and responsibilities. There is little room for error as much is at stake. The protocol initiates the project and sustains the long-term effectiveness of the trial. Clinical trials plays an important role in Indian CRO as a part of Clinical Research. 

CROs and what it’s like working for them

In a simple frame of mind, lab based careers can be split up into options like academic research or work in industrial sector. Either of the two options, particularly the second one can encompasses a broad spectrum of roles and goals. Working in the industry does not mean you have to be employees of Glaxo or Pfizer. You can alternately work for Contract Research organizations that take part in a host of phase-1 clinical trials according to Elisabeth Allen.

Allen designs phase-1 clinical research for a living. The contract research organization she works for, Quintiles, partners with big pharma companies to hasten up the drug development process. In her estimate, a typical drug costs about nine hundred pounds to go through the developmental phases which can take up to 10-12 years. With sky rocketing costs and more stringent regulations, chunks of developmental work is increasingly being outsourced to contractors. This is where the role of CROs comes into play.

A CRO is an independent research organization that steps into the developmental process after a pharma company makes the discovery of a new molecule that holds promise. Some CROs are Quintiles, Covance, Icon, and HMR. Typically, it’s a CRO that organizes research into the effect of the new molecule on humans. In most cases, a CRO will organize and conduct clinical trials to test the effects of the new molecule on humans. 

As independent entities they facilitate an objective assessment of the new drug in clinical setting and because they have liaison with pharma companies, they offer a much broader scope of study of the effects of the drug on human subjects. If the pharma companies had themselves conducted these trials, it would have been very limited in scope because the limitations imposed by limited functionality of these companies. Elisabeth Allen describes her role as highly rewarding and playing a key part in improving the lives of many people for whom the new drug is researched into existence. Working for an Indian CRO is a job of high responsibility as it involves the lives of thousands of people.