Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks

• Home
• Organization
  • Governance Structure
  • Executive Committee
  • Board of Advisors
  • Consortia and Collaborations
  • Working Groups
• Meetings
  • ADEPT
    March 2011
  • ACTION-1
    June 2011
  • ACTTION-2
    October 2012
• Resources
  • Publications
  • Pain Database Standards
  • RReACT Database
• Partnership with FDA
  • Letter from Drs. Rappaport and Woodcock
  • Dr. Rappaport slide presentation
  • FDA ACTTION webpage
• Other
  Partners
• IMMPACT
• Contact Us

Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomaki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath P, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve B, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010;149:177-193.

Dworkin RH, Turk DC, Peirce-Sandner S, McDermott MP, Farrar JT, Hertz S, Katz NP, Raja SN, Rappaport BA. Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database. Pain 2010;150:12-16.

Rappaport BA, Cerny I, Sanhai WR. ACTION on the prevention of chronic pain after surgery. Anesthesiology 2010;112:509-510.

Dworkin RH, Peirce-Sandner S, Turk DC, McDermott MP, Gibofsky A, Simon LS, Farrar JT, Katz NP. Outcome measures in placebo-controlled trials of osteoarthritis: responsiveness to treatment effects in the REPORT database. Osteoarthritis Cartilage 2011;19:483-492. (Corrigendum: Osteoarthritis and Cartilage 2011;19:919).

Dworkin RH, Turk DC. Accelerating the development of improved analgesic treatments: the ACTION public-private partnership. Pain Medicine, 2011;12:S109-S117.

Dworkin RH, Turk DC, Katz NP, Rowbotham MC, Peirce-Sandner S, Cerny I, Clingman CS, Eloff BC, Farrar JT, Kamp C, McDermott MP, Rappaport BA, Sanhai WR. Evidence-based clinical trial design for chronic pain pharmacotherapy: a blueprint for ACTION. Pain 2011;152(suppl):S107-S115.

Comer SD, Zacny JP, Dworkin RH, Turk DC, Bigelow GE, Foltin RW, Jasinski DR, Sellers EM, Adams EH, Balster R, Burke LB, Cerny I, Colucci RD, Cone E, Cowan P, Farrar JT, Haddox JD, Haythornthwaite JA, Hertz S, Jay GW, Johanson CE, Junor R, Katz NP, Klein M, Kopecky EA, Leiderman DB, McDermott MP, O'Brien C, O'Connor AB, Palmer PP, Raja SN, Rappaport BA, Rauschkolb C, Rowbotham MC, Sampaio C, Setnick B, Sokolowska M, Stauffer JW, Walsh SL. Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations. Pain, 2012;153:2315-2324.

Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, Jensen MP, Katz NP, Raja SN, Rappaport BA, Rowbotham MC, Backonja MM, Baron R, Bellamy N, Bhagwagar Z, Costello A, Cowan P, Fang WC, Hertz S, Jay GW, Junor R, Kerns RD, Kerwin R, Kopecky EA, Lissin D, Malamut R, Markman JD, McDermott MP, Munera C, Porter L, Rauschkolb C, Rice ASC, Sampaio C, Skljarevski V, Sommerville K, Stacey B, Steigerwald I, Tobias J, Trentacosti AM, Wasan AD, Wells GA, Williams J, Witter J, Ziegler D. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain, 2012;153:1148-1158.

Greene K, Dworkin RH, Rowbotham MC. A snapshot and scorecard for analgesic clinical trials for chronic pain: the RReACT database. Pain, 2012;153:1794-1797.

Smith SM, Chang RD, Pereira A, Shah N, Gilron I, Katz NP, Lin AH, McDermott MP, Rappaport BA, Rowbotham MC, Sampaio C, Turk DC, Dworkin RH. Adherence to CONSORT harms reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review. Pain, 2012;153:2415-2421.

Turk DC, O’Connor AB, Dworkin RH, Chaudhry A, Katz NP, Adams EH, Brownstein JS, Comer SD, Dart R, Dasgupta N, Denisco RA, Klein M, Leiderman DB, Lubran R, Rappaport BA, Zacny JP, Ahdieh H, Burke LB, Cowan P, Jacobs P, Malamut R, Markman J, Michna E, Palmer P, Peirce-Sandner S, Potter JS, Raja SN, Rauschkolb C, Roland CL, Webster LR, Weiss RD, Wolf K. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations. Pain, 2012;153:1997-2008.

Dworkin RH, Allen R, Kopko S, Lu Y, Turk DC, Burke LB, Desjardins P, Etropolski M, Hewitt DJ, Jayawardena S, Lin AH, Malamut R, Michel D, Ottinger J, Peloso P, Pucino F, Rappaport BA, Skljarevski V, St. Peter D, Timinski S, West CR, Wilson HD. A standard database format for clinical trials of pain treatments: an ACTTION–CDISC initiative. Pain, 2013;154:11-14.

Related Publications

Dolgin E. Fluctuating baseline pain implicated in failure of clinical trials. Nat Med 2010;16:1053.

Hamburg MA. Innovation, regulation, and the FDA. N Engl J Med 2010;363:2228-2232.

Hamburg MA, Collins FS. The path to personalized medicine. N Engl J Med 2010;363:301-304.

Institute of Medicine. Transforming clinical research in the United States: challenges and opportunities. Washington, DC: The National Academies Press, 2010.

Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press, 2011.

United States Food and Drug Administration. Advancing regulatory science for public health. Bethesda, MD: Department of Health and Human Services, 2010.

Woodcock J. The prospects for "personalized medicine" in drug development and drug therapy. Clin Pharm Ther 2007;81:164-169.

Woodcock J. A difficult balance: pain management, drug safety, and the FDA. N Engl J Med 2009;361:2105-2107.

Woodcock J, Witter J, Dionne RA. Stimulating the development of mechanism based individualized pain therapies. Nat Rev Drug Discov 2007;6:703-710.