Managing Clinical Trials: Collaborating for Success

ClinicalTrials-Doc_PatientI am attending the Financial Research Administration conference in New Orleans from March 10-12th, and while you might think that the best thing  about being in the Big Easy is the beignets (those little french doughnuts), I’m geeking out at the NCURA meeting and I’m going to be sharing the information with you on Research Administration Nation. Think of these posts as little beignets of knowledge…sweet updates.

Right now, I’m attending a workshop on Managing Clinical Trials with David Lynch (Executive Director, Office of Sponsored Research, Chicago) and Krista Harnish (Senior Research Administrator) both from Northwestern University. Full disclosure, I’m from Northwestern, too.

The workshop reviewed all aspects of CT management, and introduced a new resource which I’m really excited about and am going to purchase for my staff from NCURA: A Primer  on Clinical Trials for the Research Administrator this was published in March 2012 and is an excellent resource.

The workshop was a presentation and facilitated discussion about the cradle to grave management of clinical trials, and included a brief presentation on the types of clinical trials, case studies, and the roles and responsibilities of individuals working on trials. The majority of the workshop focused on the work that is needed to budget and negotiate agreements that are compliant and cover all study costs, and how to conduct the study and manage expenses to meet the scientific and contract requirements (while maintaining the non-profit status of colleges and universities).

The most important budgeting and negotiation points that came out of the workshop were:

  • It’s extremely important to go beyond the sponsor template when budgeting for a clinical trial, in order to ensure that you are covering all costs. An indepth cost analysis is required for each trial, which requires working directly with the investigator and the coordinators to determine the cost components of each element, how long each required aspect of the protocol takes (so that labor costs are accurate) and working with affiliates to budget each test accurately. Participants commented that the protocol analysis often takes several sources and extensive financial analysis.
  • Understanding your institution’s experience with the sponsor can assist you in analyzing the opportunity, and developing the structure of the budget (my favorite comment was “for every request we need to make for backup information we will invoice you for $X”.)
  • Documenting the budgeting and negotiating process is extremely important for success during the post-award phase.

The key discussion in the workshop came from the post-award management material, which outlined requirements for maintaining a partnership between the investigator and the administrative management that is supporting the research team.

  • The need to facilitate and maintain communication between the PI, research team (coordinators), central office, and department business administration staff, and research administration team (whether they are cradle to grave, or a separate pre-award and research finance team), is paramount. This communication needs to start when the project is awarded and be maintained through out the life of the project, as there are changes and updates that everyone should know.
  • Using a kickoff meeting allows this team to get to know each other and establish a repoire to manage this project and future projects in order to discuss questions and concerns and maintain mission focus on completing the scientific progress.
  • The team analyzes the contract and anticipates issues together – appropriately bringing roles to bear on issues that they are responsible for, and focuses on milestone acheivements together.
  • Follow up meetings are scheduled and maintained by the research administrator.
  • The meetings are maintained to report to the PI about his/her financial expenditures, receive updates on scientific progress and to manage the account and report to the sponsor.

In the post-award arena, a significant challenge that many institutions face is managing balances on clinical trial accounts. The workshop participants discussed scenarios when PI accounts have funds remaining, and institutional policies for managing those funds.

Three things to remember when managing positive balances in clinical trial accounts at the end of an award:

  1. Conduct a reconciliation of charges. Ensure that all appropriate and expected charges, including PI effort, participant remuneration, and other expenses, have hit the account.
  2. Read the contract. Do not assume that a balance can be transferred into an individual PI account. The balance should be transferred into a University account with a similiarly defined research purpose.
  3. Balances on PI accounts jeopardize the institution’s non-profit status when not properly managed and closed out into proper accounts; develop a policy at your institution and education your PIs that these funds belong to the University, not to them.

The bottom line: It’s all about collaboration for success – research administrators need to work with clinical research coordinators  and finance staff to administer clinical trials and serve investigators. When we do – clinical trial participants benefit, and that’s what its all about.

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