CSSi Blogs

A Brave New World: Recruiting Patients for DCTs and Hybrid Trials

  • By Myra Zerr-Korolev
  • 27-Jul-2022

Image of telemedicine used for patient clinical study recruitment solutions

During the COVID-19 pandemic, many clinical trials were halted or stopped altogether due to the inability to recruit and screen patients. Much of this was due to a centralized study set up, where patients were required to appear in person for screening and secondary study visit activities. As the pandemic progressed, the need for an alternate approach was high. This is where the decentralized clinical trial model came in.

Decentralized clinical trials, or DCTs, refer to the model of research studies that incorporates technological advances and alternate methods (like telemedicine, mobile patient intake) rather than traditional centralized methods such as required in-person visits. DCTs have always been in the background, ready to be implemented, but came to the forefront during the pandemic. While this model has come into play earlier than planned for the clinical trial industry, there are several benefits to using DCTs or hybrid trials. We expect DCTs and hybrid trials will only increase in prevalence in the research space.

How do we best transition to the DCT approach? Patient recruitment in the traditional space can be tricky, let alone in the new frontier that is DCTs. CSSi continues to evolve, adapt, and strategize for the ever-evolving landscape of clinical trials. Here are some general recommended utilizations for recruiting patients in a DCT or hybrid trial.

1. Digital Media

As most DCTs are not paired with or only have loose ties with site locations, the ease of local advertising is no longer applicable nor effective. Digital media, especially in the form of social media advertising and search engine advertising, holds the most weight in terms of best use of budget and highest patient reach. As of 2021, there are: 5.22 billion global individual mobile users, 3.96 billion global individual social media users, over 5.4 billion global Google searches a day and over 232 million American streaming users. Not only are more prospective patients being reached, but more diverse populations are also being included in the narrative as well.

The lack of diversity in clinical trials continues to be a concern for the community, and advertising your clinical trials in the digital space can assist in increasing diverse patient populations in clinical trials. Around four-in-ten White (42%) and Black adults (40%) say they have a smartphone, broadband at home, a desktop or laptop computer and a tablet1. In terms of social media usage as of 2020, around 80% of Hispanic adults and 77% of Black adults reported using at least one social media platform2. This more equitable access and platform use can allow increased participation from diverse groups.

CSSi, and its specialist media planning partner Patient Advertising Guru, are experts in creating digital media content and placement. Only the most qualified prospective patients are referred through our digital media services.

2. Online Advocacy Groups

Patient advocacy groups are communities with support and goal-focused members that include patients, friends and families of loved ones, medical professionals, and patient activists. The rise of online meetings, video conferences, and social media has allowed online advocacy groups to flourish. With the additional measure of safety, especially for those who are immune-compromised (or… most recently, trying to avoid contracting COVID-19), online advocacy groups may be the only group some patients revolve in.

Clinical trials and advocacy group have a historic collaboration that is mutually beneficial to both parties. Patient advocacy groups assist in the recruitment process by disseminating information to their community members, further spreading awareness of the recruiting trial3. Many of these online advocacy groups exist in social media, advocacy website forums, and more. By joining and participating as a sponsor/trial stakeholder, not only are you building a relationship with the patients you are trying to help but are improving your trial’s patient recruitment.

CSSi’s Local Enrollment Specialists (LES) provide advocacy group interaction and clinical trial awareness on behalf of the sponsor. From virtual (or in-person) patient community and advocacy groups and events, our LES are fully engaged and facilitate relationships between the patient network and the sponsor.

3. Virtual Patient Databases

Chart reviews available through databases and registries are valuable assets for both DCTs/hybrids and sites who do not have the time to carefully review databases to determine patient eligibility. Registries and databases can identify large patient pools of potential subjects for screening for eligibility and enrollment in your clinical trial. This can lead to more timely recruitment in the DCT and hybrid trial space4.

CSSi’s Local Enrollment Specialists (LES) review patient charts of thousands of possible patients each year, which often assists in meeting (or beating) recruitment deadlines. In a recent trial, we deployed one of our expert LES to assist with patient review. In a matter of hours, our LES was able to perform a Sponsor-provided service of a comprehensive chart review from thousands of potential patients. They identified 65 patients that met the inclusion and exclusion criteria, and of those, 10 were marked as a priority to screen. Of those 10 priority patients, 4 went on to screen into the study – all identified by our LES!

4. Pre-screening and Secondary Screening

While many prospective patients may be interested in a clinical trial, not all will be eligible. The time to handle a full-length screening for a non-qualified patient is frustrating for both the patient and the study staff. For hybrid and DCT trials who cannot afford the time for unqualified patient screenings, this is even more concerning as it also affects study resources. Pre-screening and secondary screening technologies filter out the prospective patient pool so only patients with the highest chance of eligibility and enrollment are referred to the study staff. For those DCTs and hybrids that do have a tie with a site, connecting only the most qualified patients to the site via telemedicine, in-home visit, or otherwise can improve trial outcomes overall.

As a full-service recruitment partner, CSSi can provide pre-screening and secondary screening technologies. Pre-screening, typically consisting of a questionnaire developed by our team using your unique protocol, which is the first step in focusing in on qualified prospective patients. After passing the pre-screening phase, our LES further qualify remaining patients with secondary screening (also developed by our team via your protocol). Secondary screening is typically done virtually or over the phone, further implementing DCT and hybrid trial methods. The remaining patients have the highest possible chance of screening and enrolling successfully into your study!

5. Virtual Medical Practitioner Outreach

On a recent poll, 91.9% of Americans trust their doctors. Many patients rely on the advice and medical opinion of their physicians, and this follows true when discussing a possible fit into a clinical trial. As telemedicine, virtual visits, and e-charts have been an increasing favorite for patients for accessibility – it can be for physicians too! Physicians and patients can communicate in more ways than ever, including passing along information for clinical trials that may benefit patients in their practice. Sponsors and physicians work hand in hand for referral networks, which assist prospective patients being included into the study. Though with DCTs and hybrid trials, the common in-office visit to discuss your clinical trial may not be an option.

Virtual Lunch-n-Learns, Zoom Coffee Discussions, etc. offer medical professionals new ways to be introduced and made aware of your clinical study. Arranging, organizing, and scheduling these events can be a difficult task both in-person or virtually! CSSi has hosted numerous digital events for medical professionals on the behalf of sponsors and CROs, which in turn has increased study awareness for both physicians and their patients.

Citations:

1https://www.pewresearch.org/fact-tank/2021/07/16/home-broadband-adoption-computer-ownership-vary-by-race-ethnicity-in-the-u-s/

2https://www.pewresearch.org/internet/fact-sheet/social-media/?menuItem=c14683cb-c4f4-41d0-a635-52c4eeae0245

3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4870759/

4https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4380621/

 

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