Clinical Trials – The Elephant In The Room


The more I study the world of clinical trials and read the comments of the brightest minds who comment on them, the more I notice the absence of agreement on two important subjects. These subjects are “patient engagement” and “patient sustainment”. The issue is certainly not that there is a lack of comment in our literature, because these two terms have become buzzwords that one can find in almost any article written about trial processes.

However, the differences in philosophy regarding patient engagement and sustainment are vast. At one extreme are those sites and centers that suggest the gold standard for both terms is a face-to-face engagement between those on whom the research is being conducted and those who are conducting the research. This camp is adamant about their belief that “The Face-to-Face model has always worked, and there is, therefore, no reason to change it”!

In the other corner are the progressivists within the research who claim that innovation is necessary and long overdue, especially so, given the struggles that almost every site is experiencing to engage the number of patients they have committed. To further make their case, they point to the available statistics that describe the growing rate of patient dropout that most sites currently experience (15-30% depending on who you read). Therefore, this problem is immensely expensive for both pharma and those conducting their research.

As a company, we do not defend either approach for dealing with engagement and sustainment in clinical studies. Rather, we have concluded that it is not so much a company philosophy that will rescue patient selection and sustainment difficulties for trials, but rather there is a separate variable that powerfully affects each of these. That variable turns out to be the ability of a company to be flexible in its approach, which in turn requires that a company can adapt to new market needs without spending months “going through channels” to obtain approval. These internal hurdles exist with legal, IT, operations, and marketing. In our experience observing very large companies, many wonderful ideas have been killed by delay—a sort of death by committee approval.

Working for a company where significant decisions can be made quickly and correctly is extremely satisfying. For instance, when we developed our ACTM (Automated Clinical Trials Matching System), it was immediately evident that we could offer customers the ability to improve communication with their patients, regardless of whether they were drawn from a data pool of previous trials, social media, or direct online invitations. Either way, our customers now had access in real-time to the status of patient progression through the entire study. A by-product of this was that communication with the patient also improved as they could now select how they wished to connect with the staff at the required study intervals.

Another piece of our development that has been equally rewarding is our Chatbot system, in which large savings in time were achieved for identifying patients for study inclusion. Using this system, a patient can gain a broad understanding of most parts of a study as they determine whether they wish to participate. It also can answer a large store of FAQs common to potential patients for any given study.

The reward for our company is that we have been able to assist customers in addressing critical issues such as patient selection, sustainment, and improved communication. More importantly, due to our size and agility, we can address client concerns quickly as their needs change over time. We believe that there is a role for existing large companies to serve certain markets. However, there is also a well-documented need for a company whose primary customer is within the mid-sized market, such as those who lack unlimited budgets and yet require agile service delivery. We’ve been delighted with the response we’ve received from this market segment.

As always, we’d like to hear your thoughts about these difficult topics including patient engagement and sustainment and the optimal method of patient communication during a trial.

Best—Dr. Lanny Turner