Sir,
In india, prospective registration of clinical trials in the Clinical Trial Registry—India (CTRI) is a mandatory requirement of Drugs Controller General India (DCGI). For the purpose of registration, International Clinical Trials Registry Platform defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials”.[1] The web site of CTRI specifies that the term “intervention” not only includes drugs and surgical procedures, but also preventive measures, educational, or behavioral treatment and rehabilitation strategies.[2] Physiotherapy (PT), an integral component of modern healthcare system, is a growing profession in India that is beginning to place greater emphasis on research. This fact is highlighted by a positive trend towards increasing clinical trials in PT research.[3],[4] Since PT research comes under the purview of DCGI guidelines on trial registration, it is imperative for physiotherapists in India to register their clinical trials in CTRI. However, not much is known about how this professional group has taken to clinical trial registration in India.
In an attempt to understand how this professional group has responded to the DCGI guidelines on trial registration, we searched the CTRI database for PT intervention trials. A search of the database using “Physiotherapy” and “Physical Therapy” as key words revealed 41 registered trials (after removal of one duplicate and eight non-PT intervention trials). There was also a progressive trend in registration of PT intervention trials since 2007. In addition to this search, we also conducted an online survey to understand the awareness and attitude of physiotherapists toward trial registration. Our survey showed that 39.3% (59/150) of physiotherapists with a postgraduate qualification were aware about trial registration and CTRI. The survey responders identified greater accountability, transparency, ethical standards, and quality of research; reduced duplication of research; increased scope for research funding, publication, developing research collaboration, and protection of intellectual property rights as advantages of prospectively registering clinical trials. Possibility of theft of research ideas, cumbersome, and time-consuming process were cited as disadvantages of prospective registration.
Research is a part of postgraduate PT education and yet the awareness about trial registration among this group of physiotherapist was low in our survey. In this era of evidence-based healthcare, DCGI has rightly made it mandatory for all healthcare professionals to prospectively register their clinical trials. With the stakeholders of CTRI attempting to encourage registration of research in medical colleges and as part of postgraduate dissertation,[5] it would be essential for them to take appropriate steps to improve awareness among all healthcare professionals involved in clinical trials. Clinical drug and surgical trials have received reasonable attention from stakeholders with regard to trial registration. We feel that it is time to reach out to healthcare professionals involved in nondrug clinical trials. This will not only ensure improved research quality and transparency in the overall healthcare research in our country, but also increase awareness about research in other healthcare disciplines and greatly increase the prospect of multidisciplinary collaborative research.
ACKNOWLEDGEMENTS
Authors Sundar K. Veluswamy and Abraham S. Babu contributed equally toward conception, design, data collection, data analysis, and manuscript preparation. Ms. Prachi Shah contributed toward design, data collection, and manuscript preparation; and Dr. Arun G. Maiya contributed toward conception, design, manuscript preparation, and approval of the final manuscript.
Sundar K. Veluswamy is supported by a 3-year Ph. D. fellowship from Manipal University.
REFERENCES
- 1.Geneva: World Health Organization; [Last accessed on 2012 Sep 25]. International Clinical Trials Registry Platform (ICTRP) [Internet] Available from: http://www.who.int/ictrp/en . [Google Scholar]
- 2.Clinical Trials Registry – India. National Institute of Medical Statistics (Indian Council of Medical Research) [Last accessed on 2012 Sep 25]. Available from: http://ctri.nic.in/Clinicaltrials/cont1.php .
- 3.Paci M, Cigna C, Baccini M, Rinaldi LA. Types of article published in physiotherapy journals: A quantitative analysis. Physiother Res Int. 2009;14:203–12. doi: 10.1002/pri.447. [DOI] [PubMed] [Google Scholar]
- 4.Coronado RA, Riddle DL, Wurtzel WA, George SZ. Bibliometric analysis of articles published from 1980 to 2009 in physical therapy, journal of the American Physical Therapy Association. Phys Ther. 2011;91:642–55. doi: 10.2522/ptj.20100267. [DOI] [PubMed] [Google Scholar]
- 5.Pandey A, Aggarwal AR, Maulik M, Seth SD. Clinical Trials Registry-5.India: Raising the veil. Natl Med J India. 2010;23:187–8. [PubMed] [Google Scholar]