Clinical Research Basics and Job Opportunities
What is clinical research?
Clinical research is a research study of drugs through the use of human subjects. Clinical studies do not necessarily all involve medical treatments or experimental therapies. It can include observational studies, in which people are followed over a period of time to determine health outcomes.
Clinical research may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. In clinical practice specific predefined treatments conducted during are used, while in clinical research evidence is collected to establish a treatment. It may also be used to determine the efficacy & safety of a new diagnostic procedure or drug treatment. Clinical research is a pre planned activity and it follows a defined protocol. Clinical trials are one important type of clinical research.
What are clinical trials?
Clinical trials are a form of clinical research which follows a defined protocol that has been carefully developed to evaluate a clinical study of a drug. There is one more definition of clinical research proposed by National Institutes of Health (NIH) of United Status – “A prospective biomedical or behavioural study of human subjects that is developed to evaluate specific investigation about biomedical or behavioural interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).”
Job Opportunities Available in different levels of Clinical Research
In five phases of drug development Clinical research there are many ranges of job opportunities. There are the different stake holders who serve the major role in clinical trials /research
Sponsor –Any pharmaceuticals company who formulate or discovers the molecule/formula which is being a new developed drug for clinical trials.
CRO (contract research organizations) – this is the organization who takes the responsibility to conduct the trial activities with help of well equipped facilities and investigators. The major role of CRO is to conduct a trial which is compliance to the guidelines and they perform all the activities regarding trial recruiting staff under them also co ordinate and handle the whole trial project for particular trial. Clinical Research coordinators are usually working with CRO.
SMO (site management organizer) – SMO is responsible to perform and record all the activities conducted at the site / hospital. Clinical Data management team plays important role at this stage.
PI (principal investigator) – The PI is the main stake holder who is responsible for the all activity conducted and perform during a trial he is only person who is designated as principal investigator which is the qualified as well as experienced doctor. Clinical Research associates and managers are responsible to manage all these activities.
CDSCO, DCGI, FDA these all are the regulatory bodies who approves the trial regarding documentation and practical implementation with the help of ICH-GCP guidelines.
Data Management Team – The data management people are mainly IT based organization who serves the major role during trial.
At the time of trial the activities to be performed should be documented and recorded this is the major task of data management team. There clinical data falls under following types electronic data, Administrative data, Healt6h surveys, trial data, disease registries. After this data management following activities should be performed like medical coding, medical summarization, medical writing, medical reviewing etc.
Pharmacovigilance- There might be some adverse events and serious adverse events occur during trial, in such a case the PV team can perform all the activities from reporting to resolution of this AE/SAE.
Who can participate in clinical trial?
Each trial has specific inclusion and exclusion criteria to determine the patients who match the exact criteria may participate. Individuals with exact match the predefined and preapproved inclusion criteria for a trial may participate if the trial is currently accepting participants. Inclusion criteria is decided on factors such as patient age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Some clinical trials require participants with illnesses or conditions to be studied in the trial, while others need healthy participants.