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Case Research Weekly  
November 28, 2007  
Sponsored Projects News and Updates
New Law Enacted to Expand the Scope of ClinicalTrials.gov
A new law has been enacted to expand the scope of ClinicalTrials.gov. NIH recently provided the following information for NIH grantees on new responsibilities related to the first part of the law, the registration of clinical trials.

Public Law 110-85, which was enacted on September 27, 2007 (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf) amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov. It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance.

Which Trials Must be Registered?
The trials that must be registered are called “applicable clinical trials.” Under the statute, these trials generally include: (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance. You should review the statutory definition of applicable clinical trial to identify if any of your trials must be registered to comply with the law.

See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)). NIH encourages registration of ALL trials whether required under the law or not.

Who is responsible?
The entity responsible for registering is the “responsible party.” The statute defines the responsible party as:
  1. the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3) http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf, or
  2. the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee (provided that “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.) See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).
How do you determine if you are a responsible party?
Investigators are encouraged to consult with their sponsored research office, institutional counsel, or other partners to determine if they are the “responsible party” for registering a trial. It is your responsibility to determine if you are obligated to register any of your clinical trials.
  1. If you are the Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) holder, you may be the “sponsor” as that term is defined in the FDA regulations found at 21 C.F.R. 50.3. For studies that are conducted under an IND or IDE, the “sponsor” is identified in the course of filing the IND (commonly called the “IND holder” or the “part 812 sponsor”) OR
  2. You may not be the sponsor, but if you are the Principal Investigator you may have been delegated registration duties by the sponsor provided the other conditions for access and control over information are met. OR
  3. For extramural trials, where there is no IND or IDE holder, NIH would not be the responsible party. The funding recipient may be a “responsible party” as that term is defined in the Act, depending on the unique circumstances of the trial.
When Must I Register My Trial?
  1. Trials initiated after 9/27/2007, or trials that are ongoing as of 12/26/2007 must be registered in full by: The later of 12/26/2007 or 21 days after the first patient is enrolled.
  2. Trials that were “ongoing” as of as of 9/27/2007 and do not involve a “serious or life threatening disease or condition,” must be registered by 9/27/2008.
  3. Trials that were “ongoing” as of as of 9/27/2007, do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements.

    (“Ongoing” in this context means a trial had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome as of 9/27/2007.)
What are the penalties for failing to register an “applicable clinical trial?” Penalties for responsible parties who fail to register, or provide false or misleading information in connection with, applicable clinical trials are significant and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds. See PL 110-85, Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21 U.S.C. 331(jj)).

Obtaining Assistance from NIH: Existing mechanisms established by NIH ICs to assist funding recipients in registering trials with ClinicalTrials.gov can continue to be used to assist responsible parties with the new registration requirements. A list of IC liaisons is provided below. While the NIH anticipates the continuation of this service, it is important to remember that the IC cannot in any way substitute for the responsible party in fulfilling its statutory duties. When requesting registration assistance from an IC, you are responsible for ensuring that all necessary information is provided to the IC in sufficient time to review and coordinate before the statutory deadlines described above for submission to ClinicalTrials.gov are triggered. You will need to stay in contact with the IC liaison to ensure that your information has been registered properly. Submission of registration information to an IC is not sufficient to satisfy the statutory obligations for submission to ClinicalTrials.gov.
 
Funding Opportunities
FY2008 New Research and Development Center (NRDC) Cost Share Program
The FY 2008 New Research & Development Center (NRDC) Cost Share Program RFP has been posted on the Third Frontier Project website at http://www.thirdfrontier.com.

A program within the Third Frontier Project, the NRDC Program provides grants to assist Ohio organizations win competitions for large R&D Centers funded by the federal government, industry, foundations, and other sponsoring organizations. The NRDC Program will award grants that can be used to satisfy cost share requirements associated with the competition for the new R&D Center. To qualify, the R&D Center must be new to Ohio, funded for at least approximately $5 million, have a spending rate of $1 million or more per year, have a purpose to commercialize new technology, and have the potential to positively impact the Ohio economy. Awards will be made for 15% of the amount of the sponsoring organization award up to a total $5 million.

For more on the NRDC Program RFP requirements and forms, please visit the thirdfrontier website above. Questions regarding the NRDC RFP should be addressed to 2008_NRDC_RFP@odod.state.oh.us.

 
Tech Transfer News
Case Western Reserve University spinoff partners with Medtronic to produce, distribute adult stem cell technology
Case Western Reserve University's spinoff Arteriocyte Inc. is joining forces with Medtronic of Minneapolis to acquire and exclusively distribute a drug delivery system with the potential to accelerate wound healing and reduce infection following surgery.

Arteriocyte, through its new medical device company Arteriocyte Medical Systems Inc., has formed a strategic partnership with Medtronic, beginning with the immediate acquisition of the Magellan Platelet Gel Business. Arteriocyte Inc.—a partner of the National Center for Regenerative Medicine—recently teamed with the private equity firm DW Healthcare Partners of Salt Lake City to create Arteriocyte Medical Systems Inc.

As part of the partnership with Medtronic, Arteriocyte Medical Systems Inc. has signed an exclusive distribution agreement for Medtronic to continue to promote the Magellan gel technology into cardiac surgery. The agreement also provides for Medtronic to continue to manufacture the product for Arteriocyte Medical Systems Inc.

For more information about this development, please go to: http://blog.case.edu/case-news/2007/11/08/magellan.

 
Funding Opportunities
The National Research Council of the National Academies has announced the 2008 Postdoctoral and Senior Research Associateship Programs
The National Research Council of the National Academies has announced the 2008 Postdoctoral and Senior Research Associateship Programs. The Research Associate Awards are open to doctoral-level scientists and engineers (US and Foreign Nationals).

Full-time Associateships will be awarded on a competitive basis in 2008 for research in fields of chemistry, earth and atmospheric sciences, engineering, applied sciences and computer science, life and medical sciences, mathematics, space and planetary sciences, and physics.

Awards are available for Postdoctoral Associates (within 5 years of the doctorate) and Senior Associates (normally 5 years or more beyond the doctorate). Postdoctoral awards are made for one or two years, renewable for a maximum of three years; senior applicants may receive awards for shorter periods. Annual stipends for recent PhD recipients for the 2008 program year range from $41,000 to $70,000 depending upon the sponsoring laboratory, and are appropriately higher for senior award recipients.

Financial support is provided for allowable relocation expenses and for limited professional travel during the duration of the award. The host laboratory provides facilities, support services, necessary equipment, and travel necessary for the conduct of the approved research program. Contact with the research adviser/mentor at the proposed sponsoring laboratory, including discussion of the proposed project, is necessary prior to submitting a formal application to the NRC.

Application deadlines are February 1, May 1, August 1 and November 1 for reviews in mid-March, mid-June, mid-September and mid-January respectively. Initial awards will be announced immediately following each review with the notification of alternate candidates at a later time.

For detailed program information, including instructions on how to apply, visit http://www.national-academies.org/rap.

 
Sponsored Projects News and Updates
Seminar Reminder - Electronic Research Administration Update
Wednesday, December 5
9:00 - 10:30 am
Crawford Hall, Room 9A and 11B

Eric Cottington, Case's Associate Vice President for Research, will present an update on internal and external information systems for the administration of grants and contracts including the electronic University Review Form (eURF version 2.0), grants.gov, and the eRA Commons. These systems are used increasingly to route applications internally for review and approval and for submitting applications, progress reports and other materials needed by federal agencies, particularly NIH, to issue an award and for the on-going administration of sponsored projects. Recent changes to these systems and future plans will be highlighted.

To register for this seminar, please go to: http://ora.ra.cwru.edu/research/orc/education/onlinecalendar.cfm.

 

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