Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 620Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  

 Table of Contents      
Year : 2011  |  Volume : 2  |  Issue : 3  |  Page : 84-85

Challenges in clinical research

Novartis Healthcare Private Limited, #6 Raheja Mindspace, Madhapur, Hyderabad, India

Date of Web Publication27-Jul-2011

Correspondence Address:
Ashwini Mathur
Novartis Healthcare Pvt. Ltd., #6 Raheja Mindspace Hitec City, Madhapur, Hyderabad
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.83223

Rights and Permissions

How to cite this article:
Mathur A. Challenges in clinical research. Perspect Clin Res 2011;2:84-5

How to cite this URL:
Mathur A. Challenges in clinical research. Perspect Clin Res [serial online] 2011 [cited 2023 Mar 24];2:84-5. Available from: http://www.picronline.org/text.asp?2011/2/3/84/83223

For conducting good clinical research, certain principles need to be followed. In this article, the principles of Ethics, Transparency and Scientific Unbiasedness are laid out and argued for becoming the basics of planning, conducting and reporting clinical research.

India is an important hub for conducting clinical research. Large customer base, a big treatment naive patient population and talent pool of clinical researchers make India an attractive destination for clinical research. [1],[2] One aspect that will contribute to success in this endeavor would be how clinical researchers plan, conduct and report research. Good research needs to be driven by three basic principles.

The first principle of Ethics should be the bedrock of all clinical research. Every clinical research endeavor (single case studies, randomized clinical trials, observational studies, etc.) needs to adhere to ethical tenets of Respect, Beneficence and Justice. Respecting individuals participating in clinical trials by treating them as autonomous agents, conducting clinical research that intends well-being and thereby ensuring Beneficence, and planning clinical research in such a way that the associated benefits and burdens are clearly accounted for need to be adhered to. [3],[4],[5] The second principle of Transparency tasks researchers to be factual about the planning, conduct and reporting of research. Reporting guidelines like CONSORT [6] and STROBE [7] are propagating this through use of checklists. Reporting is the end point of an endeavor which starts with proper planning and continues with proper conduct of the experiment. The principle of Transparency will ensure that each step that is taken during the planning, conduct and reporting is taken only after due thought process has gone into justifying the step that was taken. Transparency will create confidence in the consumers of the clinical research endeavor. The third principle of Scientific Unbiasedness is based on scientific and communication excellence. This is achieved by evaluating the clinical research endeavor holistically. By holistically, we mean that the final interpretation is not only based on internal validity of the clinical research but also on generalizability. The end result should ensure that clinical researcher and consumers of this research are closer to the truth. Note that a particular clinical research endeavor might be biased but with proper communication (e.g. by acknowledging this bias) it could result in coming closer to the truth and as such becoming scientifically unbiased.

These principles are universal and all existing and future guidelines can be framed under them. Statistical principles can play a role in ensuring that clinical research is aligned along these principles. Ideas like hypotheses testing, confidence intervals, sample size, randomization and blinding, bias and bias reduction, design of experiments, statistical interpretation of data and meta-analyses can be applied to make the clinical research ethical, transparent and scientifically unbiased. [8]

The challenge this year and going forward is to embed these principles within the clinical research fraternity. This can be achieved by having these principles as a central theme of workshops and trainings associated with clinical research. Personally, I will take up this challenge by training clinical researchers working in colleges, universities, research institutes, corporations and government agencies. I will hold workshops on Research Methodology and Statistical Concepts for Clinical Research, and both these workshops would have Ethics, Transparency and Scientific Unbiasedness as central themes. The workshops would be held at academic institutes and at meetings organized by professional societies and associations.

   References Top

1.Strengthening clinical research in India. Lancet 2007;369:233.  Back to cited text no. 1
2.Available from: http://www.bw.businessworld.in/PDF_upload/Indian_Pharma.pdf [Last accessed on 2011 Mar 18].   Back to cited text no. 2
3.World Medical Association Declaration Of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. Available from: http://www.wma.net/en/30publications/10policies/b3/17c.pdf [Last accessed on 2011 Mar 18].  Back to cited text no. 3
4.Beauchamp TL, Childress JF. Principles of Biomedical Ethics. New York: Oxford University Press; 2001.  Back to cited text no. 4
5.Health, Ascension. "Principle of Distributive Justice." Available from: http://www.ascensionhealth.org/ethics/public/key_principles/distributive_justice.asp [Last accessed on 2011 Mar 18].  Back to cited text no. 5
6.Schulz KF, Altman Dg, Moher D; Consort Group. Consort 2010 Statement: Updated guidelines for reporting parallel group randomized trials. BMJ 2010;340:c332  Back to cited text no. 6
7.von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology statement: Guidelines for reporting observational studies. J Clin Epidemiol 2008;61:344-9.  Back to cited text no. 7
8.Statistical Principles for Clinical Trials, E9 Ich Harmonised Tripartite Guideline. Available From: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf [Last accessed on 2011 Mar 18].  Back to cited text no. 8

This article has been cited by
1 Overview of health-related quality of life and toxicity of non-small cell lung cancer patients receiving curative-intent radiotherapy in a real-life setting (the REQUITE study)
van der Weijst Lotte, Aguado Barrera E. Miguel, Azria David, Berkovic Patrick, Boisselier Pierre, Briers Erik, Bultijnck Renée, Calvo-Crespo Patricia, Chang-Claude Jenny, Choudhury Ananya, Defraene Gilles, Demontois Sylvian, M. Dunning Alison, M. Elliott Rebecca, Ennis Dawn, Faivre-Finn Corinne, Franceschini Marzia, Gutiérrez-Enríquez Sara, Herskind Carsten, S. Higginson Daniel, L. Kerns Sarah, Johnson Kerstie, Mollà Meritxell, Lambrecht Maarten, Ramos Mónica, Rancati Tiziana, Rimner Andreas, S. Rosenstein Barry, De Ruysscher Dirk, Salem Ahmed, Sangalli Claudia, Seibold Petra, Sosa-Fajardo Paloma, Sperk Elena, Stobart Hilary, Summersgill Holly, Surmont Veerle, Symonds Paul, Taboada-Lorenzo Begoña, J. Talbot Christopher, Valdagni Riccardo, Vega Ana, Veldeman Liv, R. Veldwijk Marlon, Ward Tim, Webb Adam, M.L. West Catharine, Lievens Yolande
Lung Cancer. 2022;
[Pubmed] | [DOI]


    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

  In this article

 Article Access Statistics
    PDF Downloaded628    
    Comments [Add]    
    Cited by others 1    

Recommend this journal