Linking databases has value, can raise regulatory questions

October 2009
Clinical Trials Administrator;Oct2009, Vol. 7 Issue 10, p115
This article focuses on the use of clinical data registries by clinical trial sites and investigators in the U.S. According to Rachel Dokholyan of Duke University's Duke Clinical Research Institute, a lack of long-term follow-up is one of the main drawbacks of these databases. It notes the potential value of an administrative claims database linked with registry data in addressing the follow-up dilemma. Dokholyan says there are obstacles to linking the two kinds of databases.


Related Articles

  • Effects of folk medicinal plant extract Ankaferd Blood Stopper� in vital primary molar pulpotomy. Yaman, E.; G�rken, F.; Erdem, A. Pinar; Sepet, E.; Aytepe, Z. // European Archives of Paediatric Dentistry;Aug2012, Vol. 13 Issue 4, p197 

    Aim: To compare the clinical and radiographic success rates of two vital pulpotomy agents: formocresol (FC) and Ankaferd Blood Stopper� (ABS), in primary molars during a 12-month follow-up period. STUDY DESIGN: A randomised, single-blind study design was used in a sample of 30 healthy 6-9...

  • Clinicopathological and immunohistochemical analysis of six cases of gastric globoid dysplasia. Lino-Silva, Leonardo Saúl; Salcedo-Hernández, Rosa Angélica; Molina-Frías, Ernesto; Herrera-Goepfert, Roberto; Padilla-Rosciano, Alejandro // Revista Española de Patología;ene-mar2013, Vol. 46 Issue 1, p26 

    Background: The pre-invasive lesions of Lauren's intestinal type of gastric cancer are well rec-ognized but those of signet ring cell carcinoma (SRCC) have not been studied in detail. The putative precursor lesion of SRCC is poorly and ambiguously described as 'tubule neck dyspla-sia',...

  • Estimating treatment effects from a randomized clinical trial in the presence of a secondary treatment. Zhang, Min; Wang, Yanping // Biostatistics;Sep2012, Vol. 13 Issue 4, p625 

    In randomized clinical trials involving survival time, a challenge that arises frequently, for example, in cancer studies (Manegold, Symanowski, Gatzemeier, Reck, von Pawel, Kortsik, Nackaerts, Lianes and Vogelzang, 2005. Second-line (post-study) chemotherapy received by patients treated in the...

  • "Case-control" studies. GALANIS, P. // Archives of Hellenic Medicine / Arheia Ellenikes Iatrikes; 

    Epidemiological studies include experimental and non experimental studies. Experimental studies include clinical trials, field trials and community intervention trials, while non experimental studies include quasi experimental studies, follow-up studies (in which subjects are selected with...

  • Impact of stroke-associated infection on long-term survival: a cohort study. Kwan, Joseph; Pickering, Ruth Mary; Kunkel, Dorit; Fitton, Carolyn; Jenkinson, Damian; Perry, V. Hugh; Ashburn, Ann M. // Journal of Neurology, Neurosurgery & Psychiatry;Mar2013, Vol. 84 Issue 3, p297 

    Background and objective; The effects of strokeassociated infection (SAI) on long-term survival are unclear. We performed a prospective evaluation to explore risk factors of SAI, and compared survival status over the 3 years following stroke onset between those who experienced SAI and those who...

  • Ensuring balanced groups in surgical trials. Farrokhyar, Forough; Bajammal, Sohail; Kahnamoui, Kamyar; Bhandari, Mohit // Canadian Journal of Surgery;Dec2010, Vol. 53 Issue 6, p418 

    The article offers tips on how a researcher can create balanced groups in surgical trials. It says that the researcher should be prepared in consulting with study investigators to deal with potential protocol violations during the enrolment stage of the trial. It adds that the patients must be...

  • Recommendations for a uniform assessment of publication bias related to funding source. van Lent, Marlies; Overbeke, John; Out, Henk J. // BMC Medical Research Methodology;2013, Vol. 13 Issue 1, p1 

    Background: Numerous studies on publication bias in clinical drug research have been undertaken, particularly on the association between sponsorship and favourable outcomes. However, no standardized methodology for the classification of outcomes and sponsorship has been described....

  • Quality of life monitoring in ambulatory heart failure patients: temporal changes and prognostic value. Lupón, Josep; Gastelurrutia, Paloma; de Antonio, Marta; González, Beatriz; Cano, Lucía; Cabanes, Roser; Urrutia, Agustín; Díez, Crisanto; Coll, Ramón; Altimir, Salvador; Bayes-Genis, Antoni // European Journal of Heart Failure;Jan2013, Vol. 15 Issue 1, p103 

    Aims Heart failure (HF) is a chronic condition that typically affects a patient's quality of life (QoL). Little is known about long-term QoL monitoring in HF. This study aimed to evaluate the temporal changes and prognostic value of QoL assessment in a real-life cohort of HF patients. Methods...

  • Relative versus absolute change in forced vital capacity in idiopathic pulmonary fibrosis. Richeldi, Luca; Ryerson, Christopher J.; Lee, Joyce S.; Wolters, Paul J.; Koth, Laura L.; Ley, Brett; Elicker, Brett M.; Jones, Kirk D.; King Jr., Talmadge E.; Ryu, Jay H.; Collard, Harold R. // Thorax;May2012, Vol. 67 Issue 5, p407 

    Background Decline in forced vital capacity (FVC) over time reliably predicts mortality in patients with idiopathic pulmonary fibrosis. The use of this measure in clinical practice is recommended by current evidence-based guidelines. It is unknown if the method of calculating decline in FVC...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics