Question

Identify someone who is currently involved in the drug development process. This person could be any of the following:

A physician, nurse, or study coordinator who is doing or has done clinical research

An employee of an IRB, Pharmaceutical Company, Biotechnology Company, or CRO

Employee of the FDA

Request to set up a meeting (in person or via teleconference) to discuss their job/experience as it relates to the drug development process.

n two pages summarize your interview, include information such as the persons background prior to working in clinical trials, therapeutic areas they have worked in and the challenges of that area, their role in the research (i.e. project manager, CRA, etc.), what type of ethical issues arose while conducting their research

Answer 1

I would like to choose a physician who is involved in the drug development process.

The background:

The physician is medical degree holder with a valid licence. The physician has a working experience of 5 years. Prior to working in clinical trial, the physician was working as a resident doctor in hospital in the cardi0vascular department. He also has prior experience as an Invetigator.

Therapeutics areas they worked: The therapeutic area the physician worked was cardio-vascular department. There were lot of challanges involve in diagnosis and managing the treatment of cardiovasular patient. Physician has to put lot of effort for electronic documentation and other administrative works and ultimately left with very less tiem with patients. They need to fulfil lot of regulatory requirements while working in cardiovascular departments. Physician sometime has to depend on the third party for the funding. The cardiovascular physicians are always over burden because of the increasing no of patient with increase incidence of diseases with time.

The role in clinical research:

The physician role was as an investigator while was involved in clinical trial. Being a investigator he need to conduct the clinical investigation of the patient taking the investigational drug. He is the responsible leader of the individuals working in the particular clinical trial. The physician is responsible for conducting the clinical trial as pr regulatory guidance and as per ICH-GCP. The physician is responsible for recruitment of the patients in the clinical trial as per the inclusion and exclusion criteria. The physician has to ensure that the objective, procedure and the test involved in the clinical trial, potential risk and anticipated benefit are well explained to each subject/patient involved in the clinical trial. The physician has to provide trial related medical care to the patients. Maintain accurate records for the each patients.

The ethical issues erose while conducting clinical research:

The ethical issue that usualy arises while conducting a clinical trial is not respecting the human right. The subjects has to be explained the complete procedure which their potential risk and antiiapated benefit and then has to povide then the right to choose whether they want participate in the clinical trial. Beneficence is also an ethical issue. The Clinical trial staff should always consider this aspect while conducting clinical trial. The decesion has to make accrdingly if the trial is actually benefiting others. The third issue is 'Justice'. The reason for including a patient in clinical trial should justify the inclusion. The fourth ethical concern is not being faithful. The organization and the staff involved in clinical trial has to be faithful because it involve human subjects.