Highlights
- •Clinical trials help in the formulation of an evidence-based practice of medicine which in turn ultimately promotes good health among the population.
- •Clinical trials are challenging, time consuming, intensive and need careful planning and execution.
- •The prerequisites include logistical concerns, infrastructure, appropriately trained human resources, conformity with ethical compliances and regulatory compliances as per the laws.
- •Execution of clinical trials needs the services of a robust data archival system, electronic medical record systems including PACS with regular appraisal and personnel training for good clinical practices.
- •Academic units with large clinical experience, expertise and a data rich environment are ideal to get involved in clinical trials.
Abstract
Clinical trials are conducted to evaluate the usefulness of a drug, medical treatment,
surgical intervention, radiological procedure, behavioral intervention, or preventive
health care strategy. Clinical trials are challenging, time-consuming, and need careful
planning and execution. There are certain requirements for an academic unit to be
ready for conducting quality research, especially clinical trials. These include logistical
concerns, infrastructure, appropriately trained human resources, conformity with ethical
compliances and regulatory compliances as per the laws governing the respective geographical
regions.
Infrastructure requirements include research division space, robust data archival
system, archival of imaging data, laboratory services, information technology division
and facilities for the appropriate consenting process. Human resources such as principal
investigators, data managers, clinical research assistants and biostatisticians are
needed to execute the clinical trial as per the study design. Adherence to ethical
and regulatory standards; during the conduct of the clinical trial are imperative.
Strict compliance with prevailing governing laws in the country is a prerequisite
for a department to get involved in clinical trials. The department also needs to
put in place an institutional ethics committee; the composition of which is often
governed by regulatory laws. The ethical aspects of the trial undergo a formal scrutiny
by an Institute ethics committee that ensures quality care to the patient, and safeguards
the patient's rights and privileges.
The academic unit of any department forms the core for possible research and pursuit
of clinical trials. A department with rich clinical experience and expertise in the
filed aids in the execution of quality research. The academic department must consider
grant writing and multiple center collaborative research projects in due course of
time to further enhance the quality of clinical trials and research output.
Keywords
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Article info
Publication history
Published online: January 20, 2023
Accepted:
January 18,
2023
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Ltd. All rights reserved.
