Virtual trials may be the key to increasing patient diversity
The diverse clinical trials participants are a key factor in fostering better health outcomes and improving care for a wide range of populations. According to a study in Clinical Pharmacology & Therapeutics from 2014, the differences between participants often lead to a difference in the way different people respond to the same treatment. Characteristics like age, genetics, gender, weight, ethnic origin, even geographic location may influence how the treatment work or how safe it is. For example, as stated by Pfizer, in some cases African Americans might need a different dosage – or a completely different treatment than white, Asian, or Hispanic patients with the same disease. With the rise of precision medicine with therapies targeting specific genes, the diversity in clinical trials become even more crucial. Still, a huge percentage of the clinical trials, lack diverse participants. Insufficient clinical trial representations of all populations can leave minority groups vulnerable due to the lack of subgroup-specific data.
However, how can clinical research organizations increase the diversity of their trials?
Can the answer to this question be in decentralized and virtual trials?
The concept of decentralized and virtual clinical trials, which continuously increase its popularity, can help research organizations to reach more participants in rural communities. One of the major barriers to clinical trial diversity is accessibility. The need to regularly travel visit a central study site might be a huge problem for people who are parents or hourly workers, health issues preventing traveling, or just busy schedules. The cost for traveling, childcare, and time off work is also a showstopper when it comes to people with lower socioeconomic status.
Virtual and decentralized clinical trials however often can be conducted in a location and timeslots convenient to the participants.
Some decentralized trials let patients submit the needed data through apps, telehealth visits, or wearable devices. Others provide the possibility to visit local clinics and pharmacies. In addition, the recruitment may cover underserved areas that do not always have access to information about the clinical trial and thus increase the possibility for a more diverse population.
Another important challenge that virtual clinical trials are addressing is the language barrier.
For example, Spanish-speaking people may be resistant to participating in a clinical trial if all documents and communication are in a language they don’t really understand. The virtual clinical trials technology makes it much easier to provide all documentation in several different languages. Furthermore employing more Spanish speakers can help the research sites to recruit more Latin Americans as participants.
But distance and communications are not the only barriers for people to participate in clinical trials.
Some representatives of diverse communities would not participate in clinical trials because they don’t trust medical research organizations.
Decentralized trials often let participants visit local doctors and pharmacists they already trust and thus allow people to overcome the lack of trust. Even if the participants need to interact with clinical research staff, research sites can help participants feel more secure by employing a diverse research team. Seeing themselves represented among the people running the trial may help potential participants feel more confident about participating in the clinical trial.
What is next?
And when we have diverse trial participants ready to be enrolled, the next step would be to ensure balanced randomization of patients through different groups. Clinicubes provides flexible randomization capabilities, which self-adapt to the study needs, no matter the expected number of subjects or how many covariates will be controlled. Clinicubes’ randomization model is based on the covariate adaptive randomization method but enhances its advantages with a combination of randomization methods that automatically adapt and ensure balanced groups regardless of the sample size. Another key advantage of the randomization tool is that is fully unpredictable. Unlike other randomization models, with Clinicubes you always will receive different results no matter how many times you do the same randomization simulation.
Read more about the alternative approach to patients’ randomization to explore Clinicubes randomization capabilities or contact us to request a demo.