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May 26 2011

Conference Recap – 2011 ACRP Global Conference and Exhibition

 

ACRP

Image via ACRPnet.org

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA.  The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

The 6-day program included more than 125 premier education sessions covering 13 topic areas. With 159 sessions with 206 speakers there was something for all attendees. Pre-conference workshops were held on Friday, 29 April and a 9-session weekend program designed for pharmaceutical physicians and clinical investigators was held on Saturday and Sunday, 30 April – 01 May 2011.   This year, the program did seem weighted a bit more toward investigative sites and regulatory issues.

Prior to the meeting, attendees were provided a list of sessions which included their subject group ranging from business and finance to technology and innovation as well as the level associated with each presentation ranging from core (basic) to advanced.  This allowed attendees to determine which sessions to attend as the sessions did overlap.

Some of the more pertinent presentations I attended included:

  • “Drug Development- Today and Tomorrow”
  • “The Sponsor Request for Proposal and the CRO Selection Process”
  • “Seven Mistakes Commonly Made During a Monitoring Visit”
  • “You’ve Discovered Fraud – Now What Do You Do?”
  • “GCP Inspection and Audit Readiness”

Posters were also available for evaluation on Sunday and Monday.  Authors were present during the afternoon to take any questions about the posters.

On a lighter side, this year’s attendees were treated to a special “private” opening at Seattle’s Nordstrom’s department store for a fun evening of cocktails and shopping.

Two live feed plenary sessions were broadcast via the web free of charge.   One plenary session we attended focused on a Regulatory Affairs Public Forum, with representatives from both the FDA and the Office for Human Research Protection (OHRP).  This provided an excellent discussion on the viewpoints of the agency on several key current issues facing clinical research professionals.   Speaking on behalf of the FDA were Leslie Ball, MD, Director of the Division of Scientific Investigations (DSI) and Jean Toth‑Allen, PhD, Biophysicist, from the Office of Special Medical Programs.  Jerry Menikoff, MD, JD, spoke as the Director of the US Office for Human Research Protection.  Linda Strause, PhD, who currently serves as the Chair of the Regulatory Affairs Committee for the ACRP, was the moderator.     Questions of interest were submitted by the attendees to the panel prior to the forum.

Several of the issues addressed were:

  1. Sponsor oversight of the outsourced clinical trial responsibilities
  2. The increase focus on sponsor and CRO inspections
  3. FDA inspections (when and where inspections occur)
  4. The utilization of online informed consent forms
  5. The use of electronic medical records (EMRs)

Dr. Toth-Allen stated that there is an ever increasing focus of the agency in monitoring the sponsor oversight of outsourced responsibilities to vendors.  Several ways suggested to ensure adequate oversight included making sure that the sponsor has SOPs in place specifically detailing how they (sponsor) are going to oversee contracts of vendors and knowing exactly what the contracts should cover, noting of course that the sponsor is ultimately responsible. Dr. Toth-Allen also stressed the importance of having a formal auditing system in place to periodically review contracts.

Dr. Ball added that there was an increase focus within CDER specifically on sponsor and CRO inspections and that several warning letters recently issued have focused on inadequate oversight of CROs by the sponsor.  One interesting case noted was where the contract between the sponsor and CRO was not signed until the study was well underway and it was no clear which party had responsibility over which portion of the work.   All panelists agreed in the importance of the sponsor to clearly and formally outline who is responsible before any work commences.

The issue of when and where the FDA would be more inclined to conduct inspections was addressed, and what criteria the agencies are currently using to determine if a site or sponsor should be inspected.   Dr. Ball and Dr. Toth-Allen both agreed that the FDA was focusing more inspections during the actual conduct of the study and not just when a sponsor submits an application.  Dr. Ball also stated that with the shift to more sponsor/CRO inspections that the FDA inspections were increasingly looking at sponsor oversight of ongoing clinical trials; tending to focus on phase III pivotal trials. The traditional model of how sites were selected for inspection, tended primarily to address sites that were high enrolling or sites that had a high percentage of complaints.  Within the last 10 years, the FDA has revisited that system and is working to develop a “risk-based” site selection tool to help determine which sites to inspect.  This tool is a three level risk model:

  1. Application level (70% of all inspections are still conducted at submission)
  2. Trial level (generally phase III pivotal trials, though trending to all phases)
  3. Site level (protocol deviations, subject dropout rate, reported AEs, history of non-compliance)

Dr. Ball was quick to point out that this model is still in pilot phase due to the limited resources at the agencies and that the sure way to avoid an inspection was to ensure the highest quality at each site.

In terms of what the FDA is focusing on during an audit, some of the most recent findings included, not following or deviating from the protocol, inadequate subject protection (i.e., incorrect informed consent and incorrect product accountability), and inadequate record keeping.

Another interesting issue addressed was that of the industry’s use of electronic ICFs and where the agencies stood regarding them.  Generally, the view of all three panelists was that there did seem to be more a trend in the direction of electronic data, including ICFs. Regardless of whether or not we are using the paper or electronic version, the information has to be delivered correctly, it must provide an opportunity for discussion by the subject and there must be a way to verify the identification of the subject to ensure that the individual consenting is who they say they are.  Dr. Menikoff also pointed out that it also depends on the nature of the study as to the appropriateness of using an online consent form.

Lastly, the question was asked of the panel of how the FDA feels about the use of electronic medical records (EMRs).   Dr. Toth-Allen stated that the agencies know that all electronic records may not be CFR part 11 compliant, but that if a record exists, the institution has a responsibility to make those records completely accessible and available to the monitor, an auditor, or an FDA inspector should they request them.  Dr. Ball added that during an inspection, regardless whether they are paper or electronic, the medical records should be ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate.   All agreed that EMRs should have a traceable audit trail.

Overall, I was very impressed with the ACRP Annual meeting and look forward to attending it again in the future.  I do have a few tips for future conferences:

  • Register the day prior to the meetings if possible as the line for registration the first day was very long.
  • Arrive at sessions early to insure you will have a seat
  • Review program listing and objectives of each sessions carefully to pick sessions for attendance

This is a post by Shelley Sly, B.S., C.C.R.A.  Shelley is a Senior Clinical Research Associate at Cato Research.