TrialSite News covers news, reports and happenings involving clinical trials, investigative sites and investigators worldwide. We identify, track, and monitor investigators worldwide. The company’s principals have decades of experience supporting the clinical trials process—from technology to professional services. The company maintains a robust, proprietary investigator database—perhaps the largest of its kind.
Investigators matter. In combination with sponsors’ capital, and entrepreneurial drives for growth and returns, they and staff drive the clinical trials engine. CROs play a key role brokering the two while taking on much of the operational work for the sponsor. Investigators are precious—especially those truly dedicated and committed to advancing new medicine, continuous improvement and patient betterment.
Sponsors are completely dependent on them to conduct their clinical trials. There is a limited supply and they are not commodities. The biopharma industry, with various consortium building endeavors, sought to share investigators for operational efficiency. This never made too much sense. They are unique differentiators for competitive advantage.
With ongoing advancement of science, precision research and drug development advancements specific expertise can be highly sought out by competitors. The market, science and research represent dynamic and unfolding pathways—conditions change. The research site and investigator used yesterday may not be the same one used tomorrow. The ongoing identification, qualification and management of investigator performance is not a trivial matter. It can be time-consuming and cause delays. Investigators are not employed by the sponsor nor by the CRO. Investigative sites are typically managed via contract. The investigative site space continues to morph with consolidation, new types of alliances and even new business models. They can work in the largest academic medical centers, health systems or private equity-owned roll-up to a physician-owned network down to a small practice. This can impact how sponsors and CROs engage with sites and investigators. A multiplicity of business dynamics and arrangements are required.
Investigators often initiate their own Investigator Sponsored Trials. In these cases, they design, finance and conduct their own studies often using sponsor drugs. The sponsors have limited control and potentially limited information.
Sponsors are rethinking their investigator engagement strategies. It has become a hot and important topic. It was easier to discount if all work was to be outsourced with efficient oversight. But life in business, especially drug development, is more complex.
Sponsors have responsibilities under ICH E6 R2 et al for oversight. If investigators are not dedicating sufficient resources to the various sponsor trials, or if performance is substandard, it can delay or even compromise the completion of clinical trials. There could be regulatory implications.
In many cases, sponsors have lost the connection to investigators with dependence on CROs. It is the CRO, not the sponsor’s staff, that understand a specific investigator’s track record-from productivity performance to adherence to cGCP procedures. If investigators spread themselves too thin they risk failure to comply with protocols for example—a grave risk to the study.
Clinical trials are in many cases, global affairs. Most sponsors don’t have the systematic and enduring relationships with investigator networks that afford the luxury of systematic risk mitigation when it comes to actual activities that can be mitigated for risk. Relationships matter, and they are costly. In many cases, biopharma sponsors must partner with other biopharma, CROs or other groups—such as specific therapeutic/disease associations—to tap into a rich vein of investigator gold. They cannot afford to do it alone.
We have learned a lot over the years. There are major biopharma sponsors we know that have no true global investigator engagement vision, let alone strategy. Many of the strategies we do hear about or observe are trite, recycled material. Do you really count on an advertising agency for how to engage?
The industry spent nearly a decade committing itself to a shared investigator database in the pursuit of efficiency and operational effectiveness. Did it work? Does a sponsor have a centralized repository for all of their investigators? Is it kept up in real time? Does it offer insight into who they are? How they have performed? What are their specialties? Importantly, do they have ongoing relationship management strategies in place? Have they assigned the right resources to engage with the investigators and staff? How are digital (social) challenges leveraged to not only grow and reinforce clinical awareness but also glean insight and intelligence with investigator networks worldwide? Investigators matter.