We all know there is an issue surrounding investigator participation in industry-sponsored clinical trials. Tufts University puts the figure for doctors declining to return for a second study at approximately 40%. At the same time, the number of global clinical trials continues to rise and increase in complexity. We’ve all read articles and attended conferences that expound the passionate view that investigators who commit their time and expertise need our help and encouragement. But if that’s the case, why do we as an industry fail to address the administrative burdens driving them away?
One technology solution that was designed to decrease the burden associated with feasibility and startup is online profiles. Online profiles allow sites to enter information about themselves and their facility once, instead of for each feasibility survey and at the start of every new trial.
Sites know that there are many advantages to completing online profiles. In fact, the DrugDev 2016 Global Investigator Survey found that approximately 80% of sites maintain at least one online profile. For investigators, online profiles typically capture information about a person such as their facility affiliation, medical specialty, education, experience and medical licensure. Some systems offer the added benefit of generating a CV that can be shared with any CRO or sponsor. In addition, online profiles help make investigators visible for study opportunities. This can potentially ease the business development process of looking for new studies and avoid the need for outside study brokers. Finally, more advanced systems also enable investigators to view their study history and metrics, including the ability to download enrollment information for sharing with potential study sponsors.
On the facility side, profiles often capture basic information asked during feasibility. This includes facility contacts, access to diagnostics, IRB details, patient population, EMR/EHR use and IP handling. Similar to individual profiles, facility profiles allow investigators to share their standard information with those who need it. This enables investigators to answer protocol-specific questions during feasibility and startup instead of repeatedly providing basic information.
However, this is not to say that online profiles do not have potential drawbacks. Sites should be aware of the cost of creating and maintaining online profiles, as some providers charge for services. In addition, investigators and sites should take note of where and with whom their profiles are being shared. Is the profile with one provider, or is it shared across the industry, supporting collaboration between many sponsors and CROs?
Despite the fact that there are, online profile systems in existence, there is no single, free, standardised solution for investigators and sites. This means investigators and sites are still burdened with maintaining multiple online profiles. The DrugDev 2016 Global Investigator Survey found that 35% of sites have at least three online profiles, and nearly 10% maintain 11 or more profiles. While those in developing countries were least likely to have online profiles, a sizeable proportion still maintained multiple profiles, with 28% of sites in India and 19% in South Africa having three or more.
Increasing industry-wide collaboration is critical to fully realizing the benefits of online profiles. After all, how many times do we need to ask sites if they have a -70 degree freezer, or whether they have an ECG available to support clinical trials?
The rewards for collaboration and standardization are great. Consolidating on a single, online profiles system accessible by all CROs and sponsors would significantly reduce the number of basic information requests. This would allow investigators to spend less time on repetitive administrative tasks and more time on clinical activities. It would also allow CROs and sponsors to better target study opportunities toward the right sites.
We don’t underestimate what it will take to achieve a single online profile. The first step in the process is establishing an industry-wide acceptance that information about investigators is not proprietary. Instead, it rather belongs to investigators and sites. Once there is philosophical alignment, full realization of a single online profiles solution will still require standardization on a single consent and data controller that has the ability to broadly share profiles data contributed by investigators and sites.
While the road ahead is difficult, it’s worth it. As an industry, this is the chance for us all to be musketeers on the crusade for decreasing site burden by saying, “All for one and one for all!” Only then can we truly achieve the goal of allowing sites to “give information once and share with many.”
Elisa Cascade is an expert in clinical trial innovation and technology with over 25 years of industry experience. She leads DrugDev’s Data Solutions business working with sponsors, CROs, and sites to improve clinical trial operations through standardization, industry-wide collaboration (including TransCelerate’s Investigator Registry and Investigator Databank), and a beautiful technology experience. Email firstname.lastname@example.org or tweet DrugDev at @drugdevinc.
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