This article is based upon a presentation at the Onsemble 2012 Fall Conference.
The concept of conducting clinical trials in a consortium is gaining greater prominence in the industry – more and more institutions are considering it as a method of pooling resources to compete more effectively. It takes a few special conditions, including institutions that agree to function as if they are a single organization and leadership that is determined to overcome obstacles. Though the model does present challenges, the benefits of institutions coming together to conduct research far outweighs independence.
Why is there such a buzz around consortia?
There are several reasons why the idea of conducting clinical trials in a consortium has garnered more and more discussion, and it largely revolves around the benefits experienced by institutions that are involved with such a model. They include the ability to build on complementary research strengths, tap into a larger patient base, serve a broader geographic region, build upon existing collaborations, respond to external pressure, and compete more effectively.
Dana-Farber/Harvard Cancer Center Model
Let’s look at the organizational structure and experience at the Dana-Farber/Harvard Cancer Center as a consortium that conducts cancer-related clinical trials.
Dana-Farber/Harvard Cancer Center evolved from the Dana-Farber Cancer Institute and was first designated as a comprehensive cancer center in 1974. In the late 1990s, DFHCC was mandated as a consortium by the National Cancer Institute. The consortium was built upon pre-existing relationships:
- DFCI/Brigham and Women’s Hospital adult cancer program
- DFCI/Boston Children’s Hospital pediatric cancer program
- DF/Partners Cancer Care clinical trials organization
There have been many advantages to the consortium model in our experience. It has brought together the tremendous talent and resources of the Harvard cancer community; it provides the organizing framework and leadership needed to overcome institutional barriers; enables scientific collaboration that would otherwise not have occurred; and it maximizes each institution’s abilities in cancer.
The Clinical Trial Infrastructure
The Clinical Trial infrastructure is one that supports all cancer research. It uses a single Internal Review Board (IRB) and Protocol and Review Monitoring System (PRMS), as well as integrated clinical trial informatics.
Research is conducted with common policies and procedures. There is unified data and safety monitoring, auditing, analytics, and registration, as well as programs for unified education and training.
There are common pharmacy SOPs and QA practices. There is also coordinated budgeting and contracting operations. The value of having a centralized clinical trial infrastructure has been tremendous for us for the following reasons:
- Takes advantage of collective expertise by disease
- Provides access to specialty expertise and resources at other institutions
- Taps into broader patient base for trials
- Sets a single standard for the review and conduct of trials across multiple institutions
- Reduces duplication in infrastructure
Certainly, the benefits cannot be realized without overcoming the many obstacles posed by consortia — and the obstacles are not trivial. The following are the day-to-day considerations for conducting clinical trials in a consortium.
- Selecting best talent for leadership and committee membership, while retaining institutional balance
- Keeping decision making timely and fair
- Recognizing that all faculty are not equally talented in conducting clinical research
- Understanding institutions are not equally willing to invest in their infrastructure
Selection of trials:
- If accrual for a high-priority trial is small, PI may only want to open at their site
- PI may not feel that other sites have requisite skill
- Faculty at sites may not be interested in some trials
- Some do not want to collaborate with other institutions
- There may be pressure to open a trial in support of young investigator’s academic career
Conduct of trials across a consortium:
- While sites may open trials led by colleagues at other institutions, they tend to enroll more on their own trials
- Hard to access data on a regular basis
- Difficult to establish policies that can be implemented across different performance sites
Oversight and compliance:
- Takes time to develop trust and respect by sites
- Difficult to ensure quality at performance sites that don’t report to you
- Politically challenging to take needed actions
- e.g., closure of trial, PI sanctions, widespread audit
- Institutional IRBs are reluctant to cede responsibility
- Selecting products that are acceptable to multiple institutions
- Interfacing with different IT systems and processes
- Sponsor may prefer working with one institution
- Sponsor may want single signature contract
- Institutions may differ on legal terms
- Different charges for same service
- Variation in willingness to negotiate fees
Evidence of Success at DFHCC
The success at the Dana-Farber/Harvard Cancer Center is in the numbers: It has sustained its model for more than a decade with more than a 1,000 members, 18 research programs, and 21 shared resources. We have been awarded more than $623 million in research grants and have 3,000 publications annually. There have been 3,400 therapeutic accruals per year, which is one-third more than in the past five years. We also received the highest-possible Cancer Center Support Grant score in 2005 and 2011.
Secrets to Consortium Success
To sustain a consortium, we’ve learned that it’s extremely important to demonstrate the successful results. These could be an increase in grant funding and the number of clinical trials, more collaborative publications, and outstanding joint discoveries, to name a few.
Secondly, it’s important that all voices are heard across the organizational structure. And last, but certainly not least, persistence is essential. You can’t give up; even if you are challenged, you have to show that it’s working — because it’s worth it.