Looking abroad: Clinical drug trials

Food and Drug Law Journal

Volumn 63, Issue 3, 2008, Pages

  Hathaway, Carolyne R ^a   Manthei, John R ^a   Haas, J Ben ^a   Scherer, Cassie A ^a  

^a Latham Watkins   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CLINICAL RESEARCH; DRUG INDUSTRY; DRUG LEGISLATION; DRUG RESEARCH; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL RESEARCH; PATIENT PARTICIPATION; PRIVACY; REVIEW; RISK BENEFIT ANALYSIS; SAFETY;

CLINICAL TRIALS AS TOPIC; EUROPEAN UNION; FORECASTING; GOVERNMENT REGULATION; HUMANS; INTERNATIONAL COOPERATION; INTERNATIONALITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 50949120011     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (41)

1. Press Release, PhRMA, R&D Spending by U.S. Biopharmaceutical Companies Reaches Record $58.8 Billion in 2007 (Mar. 24, 2008), available at http://www.phrma.org/news_room/press_releases/ us_biopharmaceutical_companies_r&d_spending_reaches_record_$58. 8_billion_in_2007/.
2. Faiz Kermani, CROs Stand to Benefit from Dramatic Rises in Pharma R&D Spending, CLINICAL TRIALS TODAY, (NOV. 6, 2006), available at http://www.clinicaltrialstoday.eom/2006/11/ cros_stand_to_b.html.
3. The CEE includes, among others, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania and Slovakia.
4. Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application, 73 Fed. Reg. 22,800, 22,813 (Apr. 28, 2008).
5. Sonia Shah, Globalizing Clinical Research, THE NATION (July 1, 2002), available at http://www.thenation.com/ doc/20020701/shah.
6. Id.
7. Ted Agres, Clinical Trials Trickling Away, DRUG DISCOVERY & DEVELOPMENT, (July 05, 2005), available at http://www.dddmag.com/clinical-trials-trickling-away.aspx.
8. Kenneth A. Getz, Global Clinical Trials Activity in the Details, APPLIED CLINICAL TRIALS Online, (Sept. 1, 2007), available at http://http://appliedclinicaltrialsonline.findpharma.com/ applied-clinicaltrials/Regulatory/Global-Clinical-Trials-Activity-in-the- Details/ArticleStandard/Article/detail/453243?contextCategoryId= 37194&searchString= global%20clinical%20trials%20activity%20in%20the%20details.
9. Agres, supra note 6.
10. Press Release, Tufts Center for the Study of Drug Development, Despite Development Challenges, Drug Developers Have Reason to be Optimistic (Jan. 3, 2007), available at http://csdd.tufts.edu/NewsEvents/NewsArticle.asp? newsid=75
11. Kirsty Barnes, CROs March Towards Eastern Europe, OutSourcingPharma, (Jan. 31, 2006), available at http://www.outsourcing- pharma.com/Clinical-Development/CROs-march-towards-Eastern-Europe. In 2006, the pharmaceutical market in CEE countries has been estimated to be $9.20 billion. It has grown rapidly over the past few years and is likely to reach around $14 billion by 2010.
12. Sylvia Miriyam Findlay, Central and Eastern EuropePharmaceutical Industry - An Overview, PHARMALICENSING, (Jan. 18, 2007), available at http://pharmalicensing.eom/articles/disp/ 1169475631_45b4c82f37694.
13. Phillip Ward, European Clinical Trial Regulations Undergo a Slow Revolution, PHARMACEUTICAL REGULATORY GUIDANCE BOOK (July 2006).
14. See generally Id.
15. See generally David Concar, A Bitter Pill: Exporting Drug Trials to the Developing World, Amnesty International Magazine (Summer 2003), available at www.amnestyusa.org/page.do?id=1105438.
16. 21 C.F.R. § 312.21 (2008).
17. 21 C.F.R. § 312.21(c).
18. See generally 21 C.F.R. pt. 312.
19. 21 C.F.R. § 312.23.
20. 21 C.F.R § 312.40.
21. 21 C.F.R. pt. 312, see subpt. D.
22. See 73 Fed. Reg. 22,800 (amending 21 CFR § 312.120 and 21 C.F.R. § 312.3) (Apr, 2008).
23. Id.
24. 21 C.F.R. § 312.120.
25. See 73 Fed. Reg. at 22,801.
26. 21 C.F.R. § 312.120.
27. 21 C.F.R. § 312.120(a).
28. 21 C.F.R. § 312.3.
29. 45 C.F.R. pts. 160 and 164 (2008).
30. See, e.g., Cal. Civ. Code § 56.10.
31. Detailed Guidance on the European Clinical Trials Database (EUDRACT Database) (Apr. 2003), available at http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-10/13_cp_and_guidance_eudract_april_04.pdf; Detailed Guidance on the European Clinical Trials Database (EUDRACT Database) Amendment Describing Deployment of EudraCT- Lot 1 for 1 May 2004, available at http://www.meduni-graz.at/ethikkommission/Forum/Download/Files/CT_5_1. pdf.
32. Official Journal of the EU, Commission Directive 2005/28/EC of 8 April 2005 (Apr. 9, 2005), available at http://europa.eu.int/eur-lex/lex/ LexUriServ/site/en/oj/2005/1_091/1_09120050409en00130019.pdf.
33. Official Journal of the EU, Commission Directive 20031941 EC of 8 October 2003 (Oct. 14, 2003), available at http://ec.europa.eu/ enterprise/pharmaceuticals/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf;
34. European Medicines Agency, Inspections - Good Manufacturing Practice, http://www.emea.europa.eu/Inspections/GMPhome.html (last visited June 18, 2008).
35. World Medical Association Declaration of Helsinki (2004), available at http://www.wma.net/e/policy/pdf/17c.pdf.
36. Id.
37. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice E6(R1) (June 10, 1996), available at http://www.ich.org/LOB/media/MEDIA482.pdf.
38. Id.
39. Id.
40. Sponsors spent 17 percent of their total development budget on CRO services in 2007, up from 14 percent in 2001. Kenneth Getz & Rachael Zuckerman, Clinical Research Outsourcing: Moving from Transactional to Strategic Partnership-Based Outsourcing (June 2008), available at http://www.contractpharma.com/articles/2008/06/clinical-research-outsourcing.
41. 21 CFR 312.52.