References
- Demonaco HJ, Ali A, Hippel E. The major role of clinicians in the discovery of off-label drug therapies. Pharmacotherapy26, 323–332 (2006).
- Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch. Intern. Med.166, 1021–1026 (2006).
- Fee R. The cost of clinical trials. Drug Discov. Dev.10(3), 32 (2007).
- Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B. Patient-reported outcomes: conceptual issues. Value Health10, S66–S75 (2007).
- Sprangers MAG. Disregarding clinical trial-based patient-reported outcomes is unwarranted: five advances to substantiate the scientific stringency of quality-of-life measurement. Acta Oncologica49, 155–163 (2010).
- Hufford MR, Shiffman S. Methodological issues affecting the value of patient-reported outcomes data. Expert Rev. Pharmacoeconomics Outcomes Res.2(2), 119–128 (2002).
- Turner CF, Ku L, Rogers SM, Lindberg LD, Pleck JH, Sonenstein FL. Adolescent sexual behavior, drug use, and violence: increased reporting with computer survey technology. Science280, 867–873 (1998).
- Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur. J. Cancer45, 347–353 (2009).
- Basch E, Jia X, Heller G et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J. Natl Cancer Inst.101, 1624–1632 (2009).
- Baiardini I, Bousquet PJ, Brzoza Z et al. Recommendations for assessing patient-reported outcomes and health-related quality of life in clinical trials on allergy: a GA2LEN taskforce position paper. Allergy65, 290–295 (2010).
- Rammohan KW, Rosenberg JH, Lynn DJ, Blumenfeld AM, Pollak CP, Nagaraja HN. Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre Phase 2 study. J. Neurol. Neurosurg. Psychiatry72, 179–183 (2002).
- Frost J, Okun S, Vaughan T, Heywood J, Wicks P. Patient-reported outcomes as a source of evidence in off-label prescribing: analysis of data from PatientsLikeMe. J. Med. Internet Res.13, E6 (2011).
- Forshew DA, Bromberg MB. A survey of clinicians’ practice in the symptomatic treatment of ALS. Amyotroph. Lateral Scler. Other Motor Neuron Disord.4, 258–263 (2003).
- Fisher JA. Practicing research ethics: private-sector physicians and pharmaceutical clinical trials. Soc. Sci. Med.66, 2495–2505 (2008).
- Horrobin DF. Are large clinical trials in rapidly lethal diseases usually unethical? Lancet361, 695–697 (2003).
Websites
- Goldfarb N. Review of ‘Clinical operations: accelerating trials, allocating resources & measuring performance’. J. Clin. Res. Best Pract. 2(12) (2006) www.firstclinical.com/journal/2006/0612_Clinical_Operations.pdf
- MediGuard www.iGuard.org
- RateADrug www.RateADrug.com
- edrugsearch www.edrugsearch.com
- Health Tracker www.healthtracker.com
- Nike www.nike.com
- TRACK www.trackfitness.com
- PatientsLikeMe www.PatientsLikeMe.com
- Pew Internet: The Social Life of Health Information www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information.aspx