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3. Thompson AA1, Kim HY, Singer ST, Vichinsky E, Eile J, Yamashita R, Giardina PJ, Olivieri N, Parmar N, Trachtenberg F, Neufeld EJ, Kwiatkowski JL; Thalassemia Clinical Research Network. Pregnancy outcomes in women with thalassemia in North America and the United Kingdom. Am J Hematol. 2013 Sep;88(9):771-3. Co-author

Abstract
Improved survival in thalassemia has refocused attention on quality of life, including family planning. Understanding the issues associated with infertility and adverse pregnancy outcomes may impact clinical care of patients with thalassemia. We report the number and outcomes of pregnancies among subjects enrolled in Thalassemia Clinical Research Network (TCRN) registries and examine variables associated with successful childbirth. We identified 129 pregnancies in 72 women among the 264 women, age 18 years or older in our dataset. Over 70% of pregnancies resulted in live births and 73/83 (88%) of live births occurred at full term. Most pregnancies (78.2%) were conceived without reproductive technologies. Most (59.3%) pregnancies occurred while on chronic transfusion programs, however only 38.9% were on iron chelation. Four women developed heart problems. Iron burden in women who had conceived was not significantly different from age- and diagnosis-matched controls that had never been pregnant. There was also no difference in pregnancy outcomes associated with diagnosis, transfusion status, diabetes or Hepatitis C infection. Pregnancies occurred in 27.3% of women with thalassemia of child-bearing age in the TCRN registries, a notable increase from our previous 2004 report. With optimal health maintenance, successful pregnancies may be achievable.

2. Roberts DO1, Covert B, Rodeghier MJ, Parmar N, Debaun MR, Thompson AA, Liem RI. (2014) Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia. Pediatr Blood Cancer. 2014 Apr 22.Co-author

Abstract
BACKGROUND:
Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials. The Silent Cerebral Infarct Multi-Center Clinical (SIT) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children. Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease (SCD) and silent cerebral infarct (SCI) in the SIT Trial after initial consent.
PROCEDURE:
Differences in socio-economic and demographic variables, family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent. Head of household educational level and family income were examined separately for US versus non-US sites.
RESULTS:
Of 1,176 children enrolled in the SIT Trial, 1,016 (86%) completed screening. Of 208 (20%) children with qualifying SCI on pre-randomization MRI, 196 (94%) were successfully randomized. There were no differences in socio-economic, demographic, or disease-related variables between children who were or were not randomized. Participants from non-US sites were more likely to be randomized (22% vs. 12%, P = 0.011); although, randomization by country was associated with neither head of household education nor family income.
CONCLUSION:
In the SIT Trial, acceptance of random allocation was not associated with socio-economic or demographic factors. Although these factors may represent barriers for some participants, they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation.

1. Parmar N (2014) Ethical Considerations and Challenges in Pediatric trials in Developing Countries.  SOCRA Source. Journal of Research Excellence. May 2014. Principal author

This article provides an overview of key ethical issues such as consent process, role of ethics committees, fair selection, and social norms that are often observed in pediatric studies.  The regulations and guidelines that govern human subjects in developing countries will be discussed. The key challenges associated with pediatric studies in developing countries are also identified.