One thing I have been wondering about recently is to what extent consulting firms are exploring the clinical trial sector of academic medical centers (AMCs). While conducting an assessment of just one (small) department within an AMC in a previous consulting engagement, I learned how weary everyone around me was of the academic bureaucracy and lacked any faith that a change can come about. During our assessment, my teammates and I learned about two types of organizations that can be set up inside an AMC to boost its competitiveness in the clinical trial landscape.
Organization Types
One is a Site Management Organization (SMO) that helps sponsors manage multiple sites for clinical trials, including private sites in the AMC’s own vicinity. An SMO can help an academic medical center not only boost clinical trial revenues with more sites under its belt but also cut costs on research and resources by sharing them with its sites. The only drawback is that a SMO cannot conduct its own Quality Assurance, which would be resolved if the AMC can use its university’s Institutional Review Board (local IRB) to gain approval for all its clinical trial sites. However, the fact that local IRBs can take somewhere from two to six months to approve one study, as they are often underfunded and understaffed, really means that by the time a study gets approved it is over. Other clinical trial sites have picked up patients, reaching the maximum goal set by the sponsor. Thus, an SMO within an AMC has no choice but to contract with an independent IRB (central IRB) or partner with a Contract Research Organization (CRO) to keep up the pace. While the former partnership is necessary to gain fast approval for clinical trials (within one business week), the latter is not in an AMC’s best interest because a CRO is a direct competitor who can manage clinical trial sites, conduct Quality Assurance, and compile the findings to meet sponsors’ requirements. In a partnership with a CRO and a sponsor, the AMC SMO would be just another, bigger, clinical trial site.
AMC Advantages
One very crucial thing that an AMC has going for it, and that a CRO cannot boast, is the research minds and expertise of its world-renowned physicians as well as the research funding and resources that come with being part of a large state university. Sponsors like to see more AMCs in their clinical trials because results from these sites provide the credibility that a CRO cannot provide by simply compiling the results. Further, from our research, my teammates and I found that sponsors WANT to work directly with AMCs instead of going through a CRO. However, CROs have become a major force in the clinical trial landscape as the main “middlemen” between sponsors and sites because they can manage an entire clinical trial for sponsors on one budget from start to finish. This may offer convenience but may be not always provide the best expertise or the best product for the price.
Now, if you combine the competitiveness of a CRO with the resources that come with being an AMC, you can build a very strong clinical trial competitor who can do more just conduct a lot of clinical trials. An AMC CRO can work directly with sponsors on clinical trials and medical research to improve the healthcare that is provided not only in the AMC’s immediate area but also to patients worldwide by backing up the findings with the expertise of world-renowned physicians who are trusted for their opinions and experience. This will benefit the AMC by attracting the best medical talent there is, meaning the best residents who want to train and the best physicians who want to be researchers, and also by improving its outreach in its immediate community.
I wonder why I don’t see more and more consulting firms working with AMCs on reaching these heights by helping them become major sources of clinical research as well as the best medical care that members can get no matter what their healthcare affordability. I am hoping to gain insight from healthcare consulting experts through my blog.
