DIVERSITY IN CLINICAL RESEARCH: AN OPPORTUNITY FOR YOUNG CLINICAL RESEARCHERS

DIVERSITY IN CLINICAL RESEARCH: AN OPPORTUNITY FOR YOUNG CLINICAL RESEARCHERS.

The COVID 19 pandemic has given lots of opportunities to think of Clinical research.  The way clinical research is conducted, how patients are recruited and how data is analyzed, all has changed over last two years. ­ As patients started restricting their movement so it has becomes all the more critical to enroll patients and retain patient in the clinical trial. In addition to recruitment of patients, it is all the more important to complete the projects in a time bound manner. So, the number of sites will increase to increase the patient enrollment process and complete the project in a time bound manner. Once the study gets closed out at all sites, then data cleaning and data analysis is done to get the final results of the entire site.  Data from various clinical trial sites and its statistical analysis will require manpower that has necessary skills of Clinical Research.

What Skills are required in Clinical Research?

As the opportunities  for Clinical Research has increased tremendously, so is the  skilled man power for the field. Youngster from Life Science background,  Biotech & Biochemstry, MBBS, BDS, BPharma, M Pharma and Ayurvedic doctors  should enhance their skills in Clinical Research to enter into the field.

• They should enhance their skills on protocol writing. It is important to see what is inclusion criteria, exclusion criteria, Primary and Seconday objective and corresponding end points,  and statistical points for the study
• They should know about hospital supplies, where those have reached the site or not. The hospital supplies may include Investigation Product, Comparator Products, CRF, ICF, site master file etc.
• Informed consent form and process must also be very clear, concise and in simple language. During the current Informed Consent Process, the patient should be checked and asked about if he has understood each and every point in the process.
• CRF data should be filled and must be checked with source data. There should not be any error in the sheets.
• Data from all the site must be correctly filled in statistical software and data must be cleared

So, as the opportunities in clinical research has increased after COVID-19  pandemic, then it must be power of CRC/CRA to execute the project in time bound manner with bare minimum correction.

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