ACRO presents “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice” at FDA Hearing
During an April 23rd FDA hearing to gather input on ways to modernize the clinical research process, The Association of Clinical Research Organizations (ACRO) provided FDA a number of suggestions to improve the drug development process. ACRO’s main suggestion was to appoint a Chief Innovation Officer within the FDA. ACRO also recommended the following: incorporating modern regulatory science into clinical trial design, simplifying the informed consent process, and expanding regulatory cooperation and information sharing. ACRO’s Executive Director, Doug Peddicord, Ph.D was present and provided comments shared that he thought the hearing felt disorganized. at a public hearing titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.” To learn more, click here to read an article in PharmaPro, and to read ACRO’s statement, click here (insert http://www.fiercecro.com/press-releases/acro-testifies-fda-clinical-trial-modernization ). It’s not to late to provide your comments. We encourage you to submit your input to the FDA by the deadline of May 31st.
Written and electronic comments accepted until May 31, 2012. Submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
Errors Realized for Cancer Study Funding
According to a report by the Institute of Medicine (IOM), the National Cancer Institute’s (NCI) Clinical Trials Cooperative Group program was inefficient, underfunded, and filled with red tape. The NCI program contains 3,100 institutions in the U.S., Canada, and Europe and is made up of academic cancer centers, researchers and community doctors that work together to conduct trials on cancer treatment. The report found that group trials often run out of money before they can study patients’ follow up from cancer treatment. Dr. Hsien-Yeang believes that the upfront payment for these trials is the reason they run out of funding. The report also commented on the funding for industry trials. Industry trials are sponsored and give out payments as each patient hits a “milestone”.
The report also mentioned several ways to fix the current funding problem. Dr. David M. Dilts of the Knight Cancer Institute had this to say, “Perhaps it is time to consider more closely following the pharmaceutical industry model of progress payments.” Dr. Mills also said this would get rid of the habit of using new trials to fund old ones. Another option, mentioned by Dr. Seow, is to take part in fewer cooperative group trials and focus on industry-funded ones. However, she also mentioned that cooperative group trials help answer the bigger questions of how to improve cancer patients’ overall care. To read more about the current cancer study funding problem, click here.
Pearl Pathways Attracting National Exposure
PharmaVOICE has featured Pearl Pathways twice in the last year. In January 2012, Pearl President and CEO, Diana Caldwell, shared her thoughts on the expansion of Pearl’s services to meet the growing needs of their customers. In April 2012, Chief Operating Officer, Gretchen Bowker, was asked for her views on the current state of IRBs. To reads Diana’s thoughts on Pearl’s expansion, click here. To read the IRB article, click here.
IHIF Annual Meeting: Monday, May 7
Please join us at the IHIF Annual Meeting from May 7-8. Pearl will be in attendance with 3-4 teammates so be sure to look for us! The topic of the event is: “Statewide Strategic Plan for the Health Sector”. To learn more and to register, click here.
Indiana Clinical and Translational Sciences Institute: August 31, 2012
The fourth annual meeting of the Indiana Clinical and Translational Sciences Institute (CTSI) will be held on Friday, August 31, 2012. The event is free and will take place at the University Place Conference Center and Hotel on the IUPUI campus. Discussions will be run by leaders from the National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute (PCORI), the Center for Medicare and Medicaid Services (CMS), and more. Don’t miss this exciting event! To learn more and to register, click here. For questions, please contact info@indianactsi.org.
Clinical Trials Failing to Report Relevant Data?
According to an editorial published in the January edition of the British Medical Journal, researchers often do not report relevant clinical trial data. The editorialists said the problem is missing data, “We are not dealing here with trial design, hidden bias or problems of data analysis- we are talking simply about the absence of the data. This behavior, in turn, biases research, wastes health care resources and many harm patients”. Editorialist Dr. Elizabeth Loder, MD, MPH added that data is not only missing but what is reported is often times done so “inadequately”.
One study found that fewer than half of trials funded by the National Institutes of Health (NIH) are published in a peer-reviewed journal within 30 days of trial completion. The same study showed that at 51 months one-third of the results remained unpublished. The current problem is not immune to the United States. A study in 2009 showed that only 22% of drug trials subject to mandatory reporting requirements disclosed their results within one year of the trial completion date.
The lack of reporting could potentially be a violation of the FDA Amendments Act of 2007. In regards to this possible violation, Rep. Henry A. Waxman (D-Calif.) and other congressmen wrote to the heads of the NIH and the FDA. In their note, they raised several questions such as why data was not being reported and why the $10,000 penalty per day had not been enforced.
To read more about this issue, click here.
RAPS Indiana Chapter Event: May 14th, 2012
Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event. The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room. To register, click here.
Pearl Hires J. Ellen Looney as IRB Administrator
Pearl Pathways is excited to announce the recent hiring of J. Ellen Looney as an IRB administrator. Ellen is well experienced and has Pearl Pathways CEO, Diana Caldwell, excited to have her as part of the Pearl team, “Our staff and clients are lucky to have Ellen join the Pearl team. Her drive and expertise will greatly contribute to supporting our internal company growth as well as client’s needs.” To view the full press release, click here. To see the coverage of Ellen’s hiring by insideindianabusiness.com, click here.
ACRO Hopes To Educate Through New YouTube Channel
The Association of Clinical Research Organizations (ACRO) has launched a new YouTube channel to educate the public, media, and policymakers about clinical trials. ACRO believes it has an obligation to keep people informed about clinical trials, “…we have an obligation to engage and educate our curious constituencies about issues effecting clinical research. These topics range from ensuring human subject protections to cultivating favorable regulatory and economic environments that promote more efficient drug development”, said John Lewis, ACRO Vice President of Public Affairs. To read more, click here.
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