Career in Life Sciences: What is Clinical Research?

By Khushnoor Dastoor

Interested in the area of Clinical Research? Read this article to get a clear idea of what it is all about and how can you be a part of this industry.

Let's start with understanding - What is clinical research? Pharmaceutical companies have a requirement to provide evidence to regulatory authorities that their drugs are safe and effective enough to be distributed in the market.  Before a drug is approved for marketing, it is known as a research molecule. 

To provide such evidence, they first conduct pre-clinical studies on animals. 

When the pre-clinical study is complete, the company must conduct a Clinical Study or Clinical Trial, upon a sample population of subjects in order to study the effect of the drug on these subjects. 

Pharmaceutical companies outsource the process of Clinical trial to Contract Research Organizations (CROs) who have experience in conducting such trials, preparing documents for necessary approvals and other related activities.  The pharmaceutical company is referred to as the Sponsor of the trial, since all study costs are borne by it.  

Clinical Study trials can take up to 15 years and cost millions of dollars, so it is essential that they are conducted in an effective manner, in compliance with national and international regulations, in order to facilitate approval of the molecule. 

What are Trial phases?

Clinical Trials are conducted in different phases: 

Phase 1 is carried out on a small population of between 20 and 100 healthy volunteers. The primary purpose is to establish the safety of the drug in human beings and the dosage limits. 

Phase 2 is carried out on a larger population of volunteers, with the objective of establishing effectiveness of the drug.  (Some companies split this up into Phase 2A and 2B trial stages.)

Phase 3 is carried out on a larger sample of subjects and can include thousands of patients depending on the scale of the trial. Based on whether Phase 3 can prove that the drug is both safe and efficacious, regulatory authorities will give permission to market the drug.

Phase 4 is then carried out after the drug is available in the market to provide evidence of its safety and efficacy in the public at large and to report any side effects that were not reported in the samples of volunteers from previous phases. 

There have been times when the drug has been removed from the market after marketing approval was given in Phase 3, so this phase must be carried out as stringently as any other phase.

What steps are involved in the conduct of a Clinical Trial?

After a regulatory authority authorizes a sponsor to go ahead with conducting a clinical trial:

A. Site operations

The CRO will begin with Site Operations.  This means that doctors who have been allocated as Investigators for the purpose of the study trial, will begin to administer the molecule which is to be approved as a drug, according to the requirements listed in the Study Protocol.  Administering of molecules can only begin after an Informed Consent Form has been received by each subject, which is to be signed after the subject is informed of all the risks, benefits and expected outcomes of the trial.  Confidentiality and privacy of subject data is of utmost importance during a clinical trial. 

The location where the investigator operates out of (hospital, clinic) is known as the site.  Investigators are responsible for documenting all subject cases on paper Case Report Forms (CRFs), or electronic CRFs where information is fed directly into a computer. 

B. Data Management 

The information from Case Report Forms will be received by the Data Management team which is responsible for compiling all data for each individual patient into analyzable lists of data, such as vital statistics, laboratory test results and adverse events.  Data Management is responsible for the accuracy, adequacy and cleanliness of data in order to ensure that analytics reveal fair and accurate results with respect to safety and efficacy parameters for the drug.  It involves data validation, clinical coding and transfer of clinical trial data.  The Data Management team is also responsible for collating data according to required standards, such as CDISC-SDTM requirements. 

C. Biostatistics

Collated data shall then be extracted and transferred into tables, listings and figures, to be used by Biostatistics to analyze the data according to end points specified in the study protocol.  This step is critical in identifying whether the safety and efficacy parameters, that the trial was expected to provide evidence of, have been successfully met. 

D. Medical Writing

Based on the output from biostatistics, a specialized Medical Writer must produce scientific documentation regarding the outcome of the trial.  The medical writer will, describe the trial results, requirements for usage of the drug and other medical information.  Such documentation must comply with regulatory and other guidelines required for approval and publishing. 

Besides these basic activities, there are many operations that go hand-in-hand with these main processes, such as pharmacovigilance activities where a safety database is maintained in order to keep a close eye on any side effects of the drug that may endanger the subjects in any way, throughout the duration of the study trial.  

How can you be a part of the Clinical Research industry?

Ruby Hall Clinic and Phoenix Progressive Certifications Enterprise Pvt. Ltd. (PPCE) conduct a six-month Post-graduate Diploma Course in Clinical Research and Data Management.  This course is designed to cater to the needs of students who want to enter the promising arena of clinical trial management; as well as for students who want to stay abreast of evolving industry trends in the Life Sciences sector. The course is designed to give you a deep insight into this rapidly growing industry and allow you to demonstrate your knowledge of best practices in any Life Sciences/Healthcare domain; therefore increasing your employability.

About the author:

Khushnoor Dastoor is Executive Director & Head – QA at Phoenix Progressive Certifications Enterprise Pvt Ltd (PPCE).