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Updates in dermatology trials.
Skin is the largest organ of the human body, and its complex and sensitive nature toward various foreign and internal factors makes it highly susceptible to a number of diseases and disorders.
The result of these foreign and internal factors (environmental, physical, microbial, hormonal, and others) is critical conditions and related symptoms.
Pharmaceutical companies conduct clinical trials based on factors such as a promising therapeutic area, unmet needs for a particular indication, and the presence of a significant patient population.
The number of patients recruited for major indications from 2000 to 2010.
Currently, there are many indications for which no appropriate treatment is available. Therefore, pharmaceutical companies are currently analyzing the potential of launching new therapies and tapping the potential market.
An analysis of patients recruited for clinical trials which were "completed," "ongoing," and/or "started" during 2000–2010, showed that patient recruitment, among all the major indications under dermatology, was highest for acne vulgaris.
GBI Research discovered that the highest number of patients were recruited for clinical trials for acne vulgaris, atopic dermatitis, candidiasis alopecia, and herpes zoster—the figure depicts the results.
A study conducted on the number of patients recruited for clinical trials in dermatology shows that the total number of patients recruited for acne vulgaris clinical trials accounted for 48% of the total dermatology clinical trial recruitments, which accounted for a greater patient share than that of atopic dermatitis with 25%. The numbers of patients recruited for herpes zoster were 17%, followed by candidiasis with 9%, while alopecia clinical trial recruitment accounted for 1% of the total dermatology clinical recruitments.
In the dermatology sector, most companies coordinate their research and development (R&D) activities to constantly expand their product pipeline with innovative drugs.
Although there is a consistent and continuous threat from generics and other alternatives, companies in the dermatology therapy area are not reluctant to invest in R&D and are focused on offering new products to the market.
In addition to the threat from generics, patient recruitment is another major challenge for clinical research organizations. Patient recruitment is the most time-consuming process involved in clinical trials. Recruitment of patients is more difficult than treating them.
High competition is observed among the companies recruiting subjects with similar dermatological conditions. However, to achieve better results and easy determination of drug efficacy, the selection of subjects should be based upon the variability in dermatological symptoms/specification of the disease in patients.
This can be achieved by following physician referral, advertisements, and by conducting patient awareness programs through seminars and other means.
Adequate patient recruitment is necessary to ensure a successful trial within the scheduled time limit. Patient recruitment and enrollment within the proposed time limit enables the company to launch new products ahead of its competitors and maximize revenues from them.
Following the ethical guidelines established by the relevant regulatory authorities is one of the more important requirements in avoiding external barriers to the progress of trials.
— Syed Faiyaz Razvi is a Clinical Trials Analyst at GBI Research