Applied Bimatics - An Informatics & eHealth Blog

I am a clinician with a passion for informatics. This blog is about my eHealth journey exploring interoperability in Electronic Medical Records (EMR/EHR), Patient Safety, Pharmacovigilance, Data Analytics, Clinical Research and Bioinformatics in a clinical context. Comparing Canadian, Indian and Middle Eastern healthcare systems and services. Join our open facebook group here: https://www.facebook.com/groups/clinical.bioinformaticians/


Clinical trials in cosmetic dermatology

Dr. Philip C Anderson in Dermatology Departmen...
Dr. Philip C Anderson in Dermatology Department circa 1967 (Photo credit: Wikipedia)
We are again having an interesting discussion on new generation hairloss treatments in the Dermatologists Sans Borders facebook group. We have discussed about the inconsistencies in the claims of the so called biomimetic peptides before.(Beauty born out of Bioinformatics) So we will not go back into that again. One of the senior members pointed out the two fundamental limitations in conducting a proper clinical trial in a non-critical intervention like hairloss remedies. Cost and time. So this post is basically to explore the challenges and the probable solution in this scenario. I am not a subject expert and the intention is just to offer few breadcrumbs from other fields to ignite thinking amongst this group.

Historical control data:[1]
Historical control data consists of a wide range of data gathered from diverse experiments performed under widely differing conditions. Though historical control data is not as reliable as concurrent controls, it may suffice in this situation as the intervention is non-critical. Use of historical control data may significantly reduce the overall trial costs.

Single-Subject design:
Single-subject design is a research design in which the subject serves as his/her own control, and is sensitive to individual organism differences important in cosmetic interventions. It may also reduce the interpretation bias and reduce the time required to arrive at a preliminary conclusion.

Equivalence / Non-inferiority trials:[2]
Equivalence trials are designed to demonstrate that one treatment is as effective as another. This is especially important here as exotic and expensive treatments bust into the scene all the time. In my cynical view, most of these interventions may not even clear a non-inferiority trial

Systematically reviewing and synthesising evidence from conversation analysis.
This is a new concept that is emerging and may become more and more significant in the new digital age of social networking. To quote from an article in BMC Medical Research Methodology:

Healthcare delivery is largely accomplished in and through conversations between people, and healthcare quality and effectiveness depend enormously upon the communication practices employed within these conversations. An important body of evidence about these practices has been generated by conversation analysis and related discourse analytic approaches, but there has been very little systematic reviewing of this evidence.
Parry, RH. "Systematically reviewing and synthesizing evidence from ..." 2013. <http://www.biomedcentral.com/1471-2288/13/69>

The Dermatologists sans Borders facebook group was used as a cohort for research couple of years back. Hope this strictly curated group of dermatologists contribute to the corpora of knowledge by active discussions like this.

References:
1. Haseman, Joseph K. "Data analysis: Statistical analysis and use of historical control data." Regulatory Toxicology and Pharmacology 21.1 (1995): 52-59.
2. D'Agostino, Ralph B, Joseph M Massaro, and Lisa M Sullivan. "Non‐inferiority trials: design concepts and issues–the encounters of academic consultants in statistics." Statistics in medicine 22.2 (2003): 169-186.


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Rational Drug Design

Rational drug design is at present based on docking studies. Docking predicts the binding orientation of the candidate drug molecule to its target protein that in turn predicts its affinity and activity. Docking algorithms are constantly being improved to make the predictions more reliable. However the pharmaceutical relevance of docking studies are constrained by the inability to predict the extent to which the drug molecules actually reach the target protein. Besides predicted affinity and activity may not be demonstrable in vitro. Hence most promising molecules on the drawing board fail to impress during clinical trials.

English: Drug overdose
English: Drug overdose (Photo credit: Wikipedia)
But this is about to change! Researchers at Karolinska Institutet in Sweden have developed the first method for directly measuring the extent to which drugs reach their targets in the cell. They have developed a new tool called CETSA (Cellular Thermal Shift Assay), which utilise the concept that target proteins usually get stabilised when drug molecules bind.

The tool may also be useful in individualised treatment of certain conditions, especially malignancies based on the protein profile. Hope this technology does take off one day  and introduce a paradigm shift in drug designing protocols.

Reference:

1. Karolinska Institutet (2013, July 5). Technological breakthrough paves the way for better drugs. ScienceDaily. Retrieved July 16, 2013, from http://www.sciencedaily.com­ /releases/2013/07/130705101541.htm

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About Me

As a Dermatologist and Informatician my research mainly involves application of bioinformatics techniques and tools in dermatological conditions. However my research interests are varied and I have publications in areas ranging from artificial intelligence, sequence analysis, systems biology, ontology development, microarray analysis, immunology, computational biology and clinical dermatology. I am also interested in eHealth, Health Informatics and Health Policy.

Address

Bell Raj Eapen
Hamilton, ON
Canada