There is a lid for every pot and for every protocol there is an optimal patient recruitment strategy.

Over the last two years, we have recruited patients in different settings in Germany and Austria. We have covered studies from first-in-man to phase IV, from Asthma to Parkinson’s.

What we have learned is that digital patient recruitment does not save every trial and does not work for every protocol. Obviously, that’s no news.

Through our ongoing collaboration with sponsors, sites and patients, we can now identify protocols where digital patient recruitment delivers. Because when it does, it has a significant impact on timelines and budgets.

As more and more Sponsors and CROs realize the opportunity of digital patient recruitment, we feel the need to share our insights, in order to move the whole industry forward.

Over time, we have established a very experienced medical team. At this point, we have several MDs and study nurses with deep expertise in medical research and trial management in our team.

Together, we have screened close to 100 protocols and established internal SOPs for our own protocol feasibility.

But why do we, as a recruitment vendor, need to conduct our own feasibility analysis?

Because we take on the recruitment risk. Viomedo was the first vendor in the DACH region to offer a success-based payment model. We are paid for every patient we recruit into the trial.

There are several types of risk that need to be considered for direct-to-patient recruitment campaigns.

1. Distribution Risk:

The risk of not being able to reach the specific patient population in time.

2. Investigator Site Risk:

The risk that investigator sites are not ready to effectively handle referred patients.

3. Protocol Risk:

The risk of not being able to match patients to the protocol.

Let’s dive into the protocol part in order to identify adequate protocols for direct-to-patient campaigns.

Be it umbrella or platform trials, the frequency of including several cohorts in one clinical trial is increasing.

We have conducted trials where the recruitment flow algorithm included 6 distinct cohorts specified by certain lab results.

Phase Ib trials are often structured around several cohorts with escalating doses. Usually, these trials start with a very small number of patients and a small dose (Cohort A). For safety reasons, the next cohort (Cohort B) only opens, once the results from Cohort A are in and positive.

Recruitment challenge

Cohorts add a significant overhead for patient recruitment. When cohorts close, the targeted patient population changes.

In early stage studies, the analysis of cohort data introduces breaks in the recruitment flow. During these times, patients cannot be included in the trial.

The main challenge is to keep all parties informed in real time on the status of the cohorts and forecast their development.

Solution

Close communication between Viomedo and the Sponsor: Timely information on the cohort status as well as on the anticipated changes and when these are expected to occur are necessary to effectively manage the patient flow and patient expectations. This assures that the right patients can be matched consistently and correctly.

Close communication between Viomedo and the patient: Keeping the patient in the loop at all times, especially when recruitment is paused in order to manage expectations and motivation.

Close communication between Viomedo and the site: Align on when the site will continue recruiting (e.g. which days patients will be invited for screening) and discuss when it would be best to refer patients (in some cases before the next cohort actually opens).

Recruitment transparency: Real time reporting on the patient status per site and creating close alignment between Monitors / CRAs, site and patients.

Time is a crucial component in our feasibility analysis. It has several dimensions.

First, there are protocols that require that patients start with the study just after a certain event has occured. Often, clinical trials in oncology are recruiting non-responders.

A common example is that the trial is initiated directly after e.g. the standard chemotherapy fails. This situation does not represent a good fit for a direct to patient approach.

First of all, these patients are in a critical condition and under direct care of an oncologist. After a treatment failure, the decision on how to proceed needs to be taken rapidly. If that patient is not at the site already it is often not feasible to switch to a study site in time.

In acute indications, time is of essence. Sometimes the patient has no autonomy (see next section). In other cases, the hard part is to connect patient and site fast enough, e.g. when herpes breaks out or sudden hearing loss occurs.

Solution

We carefully evaluate indications and protocols and match them to existing patient profiles in our database. This trial specific in-depth analysis shows, if Viomedo recruitment support will be beneficial.

Engage patient and MD in advance: When time plays a role, it is even more important to get the recruitment vendor involved from the get go. If we participate in a trial from the beginning, we can follow the patient across her journey. This allows the patient to engage her MD and inform her about the study, creating the ideal situation where both, patient and MD are aligned. They can openly discuss if participating in that trial might make sense and revisit that decision should e.g. the patient not respond to the standard therapy.

Make the trial easy to find for patients and potentially referring MDs: Listing the trial on Viomedo provides awareness and visibility for patients, patient organizations and MDs.

Position site as ideal destination: Especially when it comes to outpatient indications where patients have many options, it is important to position the site well. The site can provide out-of-hours services, such as screening appointments on Saturdays for added benefit. The site also needs to be easily found, e.g. by being listed on Viomedo.

If time is an issue in the protocol, then a good preparation is everything. As Benjamin Franklin said:

In acute conditions, such as stroke, the patient is not in control. Therefore, engaging the patient directly does not work when there is a short time interval between incident and start of study-treatment.

We support Sponsors in connecting directly with patients during the planning phase. Sponsors can interview individual patients or run surveys to assess the patient burden better.

The patient’s voice and expert experience as a patient can be used to design better trials and make it easier for patients to participate.

In our own feasibility analysis, we always evaluate the protocol from the patient’s perspective. We are very transparent with our findings and communicate concerns to the sponsor. When we are involved in the protocol design phase, we help to anticipate and address potential problems.

If we get engaged later in order to rescue the trial, then changing the protocol is usually not feasible. In these cases, we might reject a protocol, if our assessment is negative with respect to patient burden.

Given that we have anonymous usage data on over 1m patients, we can predict in advance the likelihood of finding a specific patient in a specific region.

This kind of data is necessary in order to analyze the potential for patient recruitment.

We communicate to Sponsors in advance, if we find that a particular eligibility criteria excludes the majority of patients. This allows us to align expectations with everybody involved. Sometimes we can work together to adjust the protocol in order to address this issue.

Sponsors who have not worked with us from the beginning, sometimes develop protocols that are not considering referred patients.

In these cases, the protocol might ask for a certain lab result to be available at screening. Referred patients sometimes don’t have these lab results at hand.

Given the lack of EHRs in Europe, it can be challenging or costly for the patients or investigator to obtain these lab results. We look out for these cases and discuss them with the Sponsor, if adjusting the protocol, by e.g. including this lab work at the screening visit is an option.

The last but potentially the most important factor we need to consider is the potential benefit for trial participants and all other patients with the disease.

The clearer the potential of the therapy can be communicated to the patient, the better do direct to patient campaigns work. Obviously, it’s critical not to generate wrong expectations on the patient side.

After listing well over 100 trials on Viomedo and translating them for the patient, we are experts in communicating trial details to patients.

We’re always happy to provide a free and confidential assessment of study protocols. Just contact us. We’re happy to help.

What other factors do you consider when planning a recruitment campaign? Discuss with us on Twitter or contact us.