Factors influencing inclusion of patients with malignancies in clinical trials

Cancer ◽  
2006 ◽  
Vol 106 (2) ◽  
pp. 258-270 ◽  
Author(s):  
Caroline Tournoux ◽  
Sandrine Katsahian ◽  
Sylvie Chevret ◽  
Vincent Levy
Keyword(s):  
Clinical Trials ◽  
Factors Influencing

Factors Influencing Enrollment in Clinical Trials for Cancer Treatment

1999 ◽  
Vol 92 (12) ◽  
pp. 1189-1193 ◽  
Author(s):  
CARRIE N. KLABUNDE ◽  
Bethesda ◽  
BRIAN C. SPRINGER ◽  
BELINDA BUTLER ◽  
Winston-Salem ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Factors Influencing

Classes of Antiretrovirals

2019 ◽  
pp. 225-238
Author(s):  
David E. Koren
Keyword(s):  
Clinical Trials ◽  
Human Services ◽  
Health And Human Services ◽  
Department Of Health ◽  
Factors Influencing ◽  
The Us

Upon completion of this chapter, the reader should be able to • Describe the classes of antiretroviral (ARV) medications and the factors influencing treatment dosing. • Understand the US Department of Health and Human Services panel’s recommended initial HIV treatments and relevant clinical trials. •...

Recruitment of Infants with Sickle Cell Anemia to a Phase III Trial:Data from the BABY HUG Study.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1429-1429 ◽  
Author(s):  
Lynn W Wynn ◽  
Lane Faughnan ◽  
Daner Li ◽  
Winfred Wang ◽  
Brenda Martin ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Clinical Care ◽  
Phase Iii ◽  
Screening Tests ◽  
Investigational Drug ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Screening Process ◽  
Factors Influencing

Abstract Background: Factors influencing participation in clinical trials have been reported, but few studies analyze the combination of issues which affect overall patient accrual. When designing clinical trials, investigators are aware that some potential subjects may not be candidates for research participation and other subjects will decline. Total sample size is further affected by protocol-defined eligibility. BABY HUG (NCT00006400) is a randomized, double-blind, placebo-controlled Phase III clinical trial of hydroxyurea (HU), which had an enrollment goal of 200 infants, age 9–17 mo, with Hb SS or Sβ0-thalassemia. A number of screening tests (spleen scan, 99mTc-DTPA renal clearance, abdominal sonogram, transcranial Doppler ultrasound, neuropsychological testing, blood analyses) were required prior to study entry and at exit, with at least monthly follow-up visits during the 2-year study period. To enhance recruitment, an anonymized registry of potential subjects was created to identify factors affecting enrollment. Methods: BABY HUG study coordinators considered all infants with an FS/SS diagnosis on newborn screening who were less than age 17 mo. The coordinators developed an IRB-approved spreadsheet to record the number of potentially eligible subjects; whether parents were approached and, if not, why not; and reasons of those approached for participating or declining. Most of these reasons could be categorized into one of several common themes. Results: Of 1107 potential participants (23–132/center) identified between October 2003 and June 2007, 239 (22%) entered the screening process and 193 (17%) were randomized. More than 25% were not approached for various reasons, including poor adherence to standard clinical care or failing to meet eligibility criteria. Factors influencing enrollment decisions are shown in the figure. The willingness to contribute to medical knowledge, the hope of being randomized to receive the investigational drug (HU), and the desire for closer clinical care were the most common reasons for participating in BABY HUG. Conversely, fear of research, transportation problems, parental work schedules and the demanding nature of the study (with frequent blood samples and clinic visits) were the primary reasons for parents declining. Disease severity had less impact on decision-making, perhaps reflecting the often asymptomatic history of potential subjects. Conclusion: The time and effort required by multiple screening tests and frequent visits impact the willingness of eligible subjects to participate in a study. Similar trials may require a larger pool of potential participants than expected to meet accrual goals. Factors that influence subject availability and the decision-making process of participating families must be considered for successful recruitment. Figure Figure

scholarly journals Factors Influencing Physician Referrals of Patients to Clinical Trials

2008 ◽  
Vol 100 (11) ◽  
pp. 1298-1303 ◽  
Author(s):  
Arch G. Mainous ◽  
Daniel W. Smith ◽  
Mark E. Geesey ◽  
Barbara C. Tilley
Keyword(s):  
Clinical Trials ◽  
Factors Influencing ◽  
Physician Referrals

Room G, 10/16/2000 9: 00 AM - 11: 00 AM (PS) Consenting Patients for Clinical Trials in Anesthesia - A Randomized Study on Factors Influencing the Patients' Acceptance 

2000 ◽  
Vol 93 (3A) ◽  
pp. A-1135
Author(s):  
Tanja A. Treschan ◽  
Thomas Scheck ◽  
Alexander Kober ◽  
Edith Fleischmann ◽  
Franz X. Lackner
Keyword(s):  
Clinical Trials ◽  
Randomized Study ◽  
Factors Influencing ◽  
Patients Acceptance

Factors influencing patient evaluability in anti-infective clinical trials

1986 ◽  
Vol 7 (3) ◽  
pp. 251
Author(s):  
Jean A. Hosutt ◽  
George I. Moonsammy ◽  
Joseph T. McDevitt ◽  
Barbara T. Nagle ◽  
Sean A. Reade
Keyword(s):  
Clinical Trials ◽  
Factors Influencing

Factors Influencing Patient Evaluability in Anti-Infective Clinical Trials

1985 ◽  
Vol 3 (4) ◽  
pp. 441-442
Author(s):  
Jean A. Hosutt ◽  
George I. Moonsammy ◽  
Joseph T. McDevitt ◽  
Barbara T. Nagle ◽  
Sean A. Reade
Keyword(s):  
Clinical Trials ◽  
Factors Influencing
Sign in / Sign up

Export Citation Format

Share Document