PMID- 20213475
OWN - NLM
STAT- MEDLINE
DCOM- 20100908
LR  - 20181113
IS  - 1435-702X (Electronic)
IS  - 0721-832X (Linking)
VI  - 248
IP  - 7
DP  - 2010 Jul
TI  - Risk factors for subject withdrawals in clinical trials evaluating glaucoma 
      medications.
PG  - 1007-12
LID - 10.1007/s00417-010-1339-4 [doi]
AB  - BACKGROUND: To evaluate risk factors for subject withdrawals from multicenter 
      clinical trials evaluating glaucoma medications. METHODS: An analysis of 
      prospective, randomized, multicenter, parallel, active-controlled clinical trials 
      with 70 subjects/treatment arm published from 1996-2008. RESULTS: We analyzed 36 
      glaucoma studies including 17,511 subjects at 1,294 clinical sites. There were 
      2,060 (12%) subject withdrawals with 669 (32%) for administrative errors, 945 
      (46%) for adverse events (AEs), 197 (10%) for inadequate intraocular pressure 
      (IOP) control and 249 (12%) for unknown reasons. By multilinear regression 
      analysis, no positive risk factors for early subject withdrawals were observed 
      following a Bonferroni correction (p > or = 0.01). A positive correlation was 
      observed for medication errors and protocol violations to withdrawals due to 
      ocular AEs and total administrative errors (p < 0.0001). Protocol violations 
      alone were correlated to subject withdrawals for any AE (total/month) and 
      systemic AEs (p < 0.0001). Females and Caucasians were correlated to medication 
      errors (p < 0 .0001). Among medical therapies, alpha-agonists, beta-blockers, the 
      carbonic anhydrase inhibitor/beta-blocker fixed combination and prostaglandins 
      were correlated with systemic AEs (p < or = 0.005) while the alpha-agonists were 
      correlated with withdrawals for poor IOP control (p = 0.00056). CONCLUSIONS: 
      Subject withdrawals from clinical trials for total administrative errors or AEs 
      potentially might be reduced by choosing sites with lower historical rates of 
      protocol violations or medication dispensing errors. Drug class choice also may 
      influence subject withdrawals for AEs and poor IOP control.
FAU - Stewart, William C
AU  - Stewart WC
AD  - PRN Pharmaceutical Research Network, LLC, Charleston, SC, USA. info@prnorb.com
FAU - Demos, Christina M
AU  - Demos CM
FAU - Turner, Meredith K
AU  - Turner MK
FAU - Stewart, Jeanette A
AU  - Stewart JA
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20100309
PL  - Germany
TA  - Graefes Arch Clin Exp Ophthalmol
JT  - Graefe's archive for clinical and experimental ophthalmology = Albrecht von 
      Graefes Archiv fur klinische und experimentelle Ophthalmologie
JID - 8205248
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Carbonic Anhydrase Inhibitors)
SB  - IM
MH  - Adrenergic beta-Antagonists/*administration & dosage/adverse effects
MH  - Antihypertensive Agents/*administration & dosage/adverse effects
MH  - Carbonic Anhydrase Inhibitors/*administration & dosage/adverse effects
MH  - Controlled Clinical Trials as Topic/statistics & numerical data
MH  - Glaucoma/*drug therapy/*epidemiology
MH  - Humans
MH  - Multicenter Studies as Topic/statistics & numerical data
MH  - Patient Dropouts/statistics & numerical data
MH  - Risk Factors
RF  - 13
EDAT- 2010/03/10 06:00
MHDA- 2010/09/09 06:00
CRDT- 2010/03/10 06:00
PHST- 2009/11/11 00:00 [received]
PHST- 2010/02/14 00:00 [accepted]
PHST- 2010/02/06 00:00 [revised]
PHST- 2010/03/10 06:00 [entrez]
PHST- 2010/03/10 06:00 [pubmed]
PHST- 2010/09/09 06:00 [medline]
AID - 10.1007/s00417-010-1339-4 [doi]
PST - ppublish
SO  - Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):1007-12. doi: 
      10.1007/s00417-010-1339-4. Epub 2010 Mar 9.