Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 1, Issue 2, 2014

Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) is associated with obstruction of the upper airway and occurs as a result of repeated closure of the upper airway during sleep, either by anatomical or patho-physiological factors. During these episodes, the diaphragm and chest muscles involved in breathing work actively to re-open the occluded airway and suck air into the lungs. The aim of this study is to clinically investigate the changes in inspiratory and expiratory total air when a mandibular repositioning appliance (MRA) was used for the treatment of OSAHS and to suggest possible improvement in research technology when using the MRA. A twenty three OSAHS white Caucasian male patients were randomly selected and evaluated against twenty three non-apnoeic subjects matched for race and sex from Fife region, Scotland. Anthropometric comparison is done for the body mass index (BMI) and the percentage of predicted neck circumference (PPNC). Rhinomanometer tests were used for the OSAHS patients and control before wearing the appliance and for the OSAHS group before and after wearing the MRA. Significant improvements of inspiratory and expiratory total air have resulted. MRA is useful alternative or adjunct to the use of Continuous Positive Airway Pressure (CPAP) devices in selected patients with snoring and mild to moderate (OSAHS).

A global world, with global diseases requires a global clinical research approach towards the achievement of Global Health as a principal goal. This requires collaboration among stakeholders, including inter-sponsor and intercenter/ investigator co-operation at an international level. However, this international collaboration may be challenged due to significant barriers resulting from different cultures, regulatory environment and infrastructures for research among the different countries. Professional clinical research networks could represent an extraordinary opportunity to enhance this international collaboration, and are the best way to ensure that complex clinical trials are conducted in the right way, preserving the highest quality standards, improving efficiency. Real cases of professional networks as CAIBER, ECRIN and ESPLORO network could become the new network paradigm in clinical research.

This review article discusses the current challenges and future trends on research and development (R&D) activities. Development of a new medicine becomes more complicated, challenging and expensive as well as more risky because of further obstacles during the registration. Clinical Research phases of R&D consume more than two thirds of the development cost. So sponsors will be veered towards business operations that offer cost savings, consistency, quality, and enhancements in clinical trial productivity. Gigantic changes in technology bring more challenges and opportunities to industry, clinical researchers and healthcare givers. Joint efforts by sponsors/contract research organizations, research institutes, universities and regulatory authorities are needed to shape the clinical research in the future, especially the Middle East and North Africa region.

Experiment on human for the purpose of finding new treatment of the emerging ailments is a continuous process. The regulatory bodies regulate all activities related to human experimentation. Due to increase in research activities now-a-days, it is not always possible to maintain the equal focus for all the activities through the central regulatory agency. In order to maintain the stringency, regional Institutional Ethics Committee (IEC) upholds the task of regulating human experiments in India. To maximize regulatory oversight over the regional IEC and clinical trials in India, Central Drugs Standard Control Organization (CDSCO) has recently made an amendment to its regulatory guideline (Schedule Y of the Drug and Cosmetic Act). This amendment mandates the registration of Ethics Committees which will help in the accountability of the clinical trials approved or reviewed by the IEC. Such an important step in the Indian regulatory will make a great impact on the Indian clinical research scenario.

Bioavailability and bioequivalence studies play a major role in the drug development phase for both new formulations and their generic equivalents. There are various investigations to assess bioequivalence and each regulatory authority has its own guidance for the conduction of bioavailability and bioequivalence studies before approval of generic products. Bioequivalence studies are the primary needs for generic products to enter in the market. The manufacturer’s (generic product) must be in limit with that of innovator (branded) formulation (reference listed drug). This review deals with methods of bioavailability studies and requirement of bioequivalence studies necessary for filing of data for the approval of formulation.

The objective of this paper is to provide insight and better understanding of the regulations for the scored tablet in regulated markets and World Health Organization. Splitting of tablets is done for various reasons; but is associated with certain problems such as inaccurate split resulting in change of dose, enhanced drug degradation due to atmospheric exposure, change in dissolution rate and extent. The accuracy of split is not uniform even with the use of commercial tablet cutters. Often patients with impaired vision, and lack of skilled experience have difficulty during splitting tablets. Accurate dosing may not be possible with splitting of tablets, especially with potent drugs. Tablet splitting may reduce the cost of therapy and may accommodate dose changes as required, but impact on the overall quality of medication used in therapy.

Early Childhood Caries (ECC) is a chronic, transmissible infectious disease affecting the primary teeth. The etiology of the condition is a combination of factors including frequent consumption of fermentable carbohydrates as liquids, especially when the baby is sleeping, with on-demand breast- or bottle-feeding. Other factors include oral colonization by cariogenic bacteria (especially mutans streptococci), poor oral hygiene and poor parenting. It is the most common chronic disease among children. The prevalence of ECC in infants and preschool children has been reported to vary between 3% and 94% world-wide. ECC can result in considerable suffering, pain, disfigurement and frequently compromises future dentition. This ultimately leads to a reduction in the quality of life of affected children. This paper provides an updated review of ECC. Its terminology, etiology, prevalence, clinical picture, complications and management are critically discussed and a solution to the continuing problem of ECC is suggested.

An incidence of overall oral sequelae in leukemic children of 54% has been reported in the literature. Oral complications include mucositis, fungal and viral infections, salivary gland hypofunction, dental caries, and others. Mucositis accounts for the most common complication followed by fungal infections and viral infections. It has also been reported that the quality of life of these children is affected. Dental healthcare professionals play a very important role in assessing the patient’s oral health needs before, during, and after cancer therapy. A multidisciplinary approach between the medical and dental team will help prevent, stabilize, and treat the oral and dental problems at an early stage. This paper reviews briefly the oral health problems in leukemic children as well as dental considerations and recommendations for optimal oral health care.