- •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.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- An introduction to clinical trial design.Paediatr Respir Rev. 2019; 32: 30-35
- Evidence based medicine: what it is and what it isn't.BMJ. 1996; 312: 71-72
- Health Professions Education: A Bridge to Quality (Quality chasm series).National Academies Press, 2003
- Handbook for good clinical research practice (GCP): guidance for implementation.World Health Organization, Geneva, Switzerland2005
- Data management in clinical research: An overview.Indian J Pharmacol. 2012; 44: 168
National ethical guidelines for biomedical and health research involving human participants Indian Council of Medical Research https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
- Quantitative Imaging of Musculoskeletal Tissue.Annu Rev Biomed Eng. 2008; 10: 369-390
- DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials.J Digit Imaging. 2015; 28: 558-566
Specific Criteria for Accreditation of Medical Laboratories National Accreditation Board for Testing and Calibration Laboratories (NABL) https://www.nabl-india.org/wp-content/uploads/2019/02/NABL-112_Issue-No.-04.pdf
- Collection, transport, preparation, and storage of specimens for molecular methods: approved guideline.NCCLS;. 2005;
- The Influence of Serum Sample Storage Conditions on Selected Laboratory Parameters Related to Oxidative Stress: A Preliminary Study.Diagnostics. 2020; 10: 51
- Investigator Responsibilities in Clinical Research.Ochsner J. 2020; 20: 44-49
- Guidance for biostatisticians on their essential contributions to clinical and translational research protocol review.J Clin Transl Sci. 2021; 5: e161
- The role of the clinical research coordinator – data manager – in oncology clinical trials.BMC Med Res Methodol. 2004; 4: 6
- Informed consent in human experimentation before the Nuremberg code.BMJ. 1996 Dec 7; 313: 1445-1449https://doi.org/10.1136/bmj.313.7070.1445
- World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.JAMA. 2013; 310: 2191
- Development of Pharmacovigilance System in India and paradigm of pharmacovigilance research: an overview.Curr Drug Saf. 2022 Sep 30; https://doi.org/10.2174/1574886317666220930145603
- Ethics committees in India: Facing the challenges!.Perspect Clin Res. 2012; 3: 50
- Reviewing clinical trials: a guide for the ethics committee.Hong Kong, 2010
- Conducting a clinical study: A guide for good research practice.Indian J Orthop. 2007; 41: 27
- Regulatory requirements for clinical trials in India: What academicians need to know.Indian J Anaesth. 2017; 61: 192
- Developing a clinical trial unit to advance research in an academic institution.Contemp Clin Trials. 2015; 45: 270-276
- Patient involvement in clinical research: why, when, and how.Patient preference and adherence. 2016; 10: 631