Virtual (decentralized) clinical trials: definition, benefits, types and software

There are several methods to modernize clinical trials, among which decentralization stands out. Virtual clinical trials can make medical research more accessible to a broader demographic of people who may not otherwise participate in site-based studies.

Author: Jennifer Highland, Content Manager of Miiskin | Reviewed by: Jon Friis, founder, and CEO of Miiskin

Covered in this article:
Definition | Types | Benefits | Platform

There have been significant changes in how the pharmaceutical industry develops medications and conducts clinical trials. Digital health solutions have been vital in adopting patient-centricity in clinical trials.

With increased costs and time to bring new drugs to market, the demand for virtual (VCTs), hybrid, decentralized (DCTs) has risen.

Decentralized clinical trials vs virtual clinical trials

What are decentralized clinical trials?

Decentralized clinical trials are defined as clinical studies with a focus on patient-centricity where some or all of a clinical study’s activities happen at locations other than a traditional clinical trial site and are often supported by mobile or digital health technologies to collect patient-reported data and outcomes.

They can take place fully remote or hybrid, meaning patients must visit the research facility at least once. Despite the fact that the terms virtual and decentralized have been used interchangeably more often, hybrid trials are actually the ones that should be referred to as decentralized trials.

The location of the patient interaction is an important factor when defining a decentralized clinical trial.

What are virtual clinical trials?

Virtual clinical studies are conducted fully remotely. Patients use digital health technologies (DHTs) to report data from home or from a suitable location closer to their home virtually and in-home clinical visits.

A fully virtual clinical trial is defined as a completely technology-based trial. That means there are no traditional clinical trial sites, no physical locations are used, and there are no face-to-face interactions between participants and caregivers.

What are hybrid clinical trials?

Hybrid clinical trials is a kind of medical research study that combines aspects of conventional face-to-face clinical trials with remote, virtual components that are given online or through a mobile device. This hybrid type of decentralized clinical trial is ideal for sponsors and CROs who want to be patient-centric and enhance data quality but aren’t ready to go to a fully remote approach.

Types of clinical trials

There are three clinical trial types, traditional, decentralized, and hybrid. Hybrid or Virtual Dermatology Clinical Trials Meet Patients where they are.

Fully centralized clinical trials (traditional)

All clinical study procedures are conducted at the research site

Hybrid clinical trials (mixed)

Initial registration and complex procedures are conducted at the research site
Simple procedures that require in-person visits are conducted at an alternative or mobile site, while simple procedures take place remotely

Fully decentralized clinical trials (virtual)

All trial procedures take place virtually

Hybrid or virtual dermatology clinical trials meet patients where they are.

Benefits of decentralized (virtual) and hybrid clinical trials

While decentralized (virtual) and hybrid clinical trials may not be exactly the same, they do share some benefits.

Remote clinical trials in dermatology can reduce the time and resources utilized, promote patient recruitment and engagement, decrease patient attrition, and increase patient diversity¹.

The concept of meeting patients where they are when conducting clinical trials aims to increase the convenience and experience of patients.

Typically, 70% of dermatology trial participants live at least two hours from the trial site², so by decentralizing, researchers can reach a more diverse and extensive pool of patients.

Dermatology clinical research organizations and companies that have utilized a decentralized clinical trial approach have achieved a three-times faster patient enrollment and over 90% patient retention rates³.

Increase the cost-efficiency of the study

Conventional clinical trials are time-consuming and expensive since they are conducted around research facilities that employ local patients.

It is estimated that recruitment costs per patient for a clinical study are $6,500, and the average cost to recruit a new patient due to non-compliance is $19,500⁴.

According to Rosamund Round, VP of Patient Innovation Center and Decentralized Trials at Parexel

85% of all clinical trials fail to recruit enough patients, 80% are delayed due to recruitment problems⁵

Typically, dermatology clinical trials were designed around the research center where researchers could monitor the trial data of the patient pool. It was expected that trial participants travel to the facility to complete visits throughout the study, which disrupted their daily lives.

However, the long commute to the research facility represents the most significant barrier for patients to enroll in a clinical study or not⁶.

Decentralized or hybrid clinical trials in dermatology follow a patient-centric approach by using digital health tools — virtual and wearable devices — to carry out remote visits and monitor data; this is convenient for patients and saves researchers costs.

With decentralized clinical trials, patient monitoring and data collection are conducted remotely, so they do not need to commute to the site, eliminating this participation barrier constantly.

Get more accurate outcomes

Individuals experience the same disease and treatment differently. Clinical trials must include people with various characteristics, such as age, ethnicity, sex, eating habits, living conditions, and behaviors. This way, the clinical trial will consider the outcomes of all participants, and all communities will benefit from the scientific advances.

However, clinical trials usually have inadequate recruitment of minority populations. Decentralized or hybrid clinical studies can potentially increase patient diversity due to the convenience they bring.

For example, recruiting minorities is so challenging because traditional clinical trials often require patients to take time off from work, have a car, and navigate other inconveniences.

Therefore, it is not surprising that these factors make clinical studies inaccessible to the individuals and communities who need them the most. Hybrid clinical studies in dermatology can remove these burdens.

Reduce the drug time to market

Virtual clinical trials in dermatology and other medical specialties can significantly reduce patient attrition. On average, clinical trial participants have a dropout rate of 30% to 40% percent⁷. When participants perceive a high patient burden, the likelihood of dropping out of the trial is higher.

Frequent visits to the trial site increase dropout rates, whereas reduced site visits can help retain patients until the end of the trial.

Decentralized dermatology trials focus on the patient experience and aim to relieve such burdens by utilizing remote patient monitoring technologies to collect patient data virtually.

With a digital patient engagement solution, it is easier to keep dermatology patients engaged and motivated to remain in the trial until completion.

A virtual clinical trial platform (software) for skin diseases

A big challenge for dermatology researchers looking to conduct a virtual or hybrid clinical study can be finding the right digital health platform for the trial that can do everything they need —securely gather patient-reported data, act as a communication channel between patients and researchers, and keep patients engaged— during the entire duration of the trial.

Miiskin is a skin health platform that enables patients to share information and high-resolution images of skin conditions, skin location, and the condition on a body map and fully customizable clinical questionnaires filled out by patients.

The Miiskin platform consists of the Miiskin app for patients and a web portal for dermatological researchers.

The platform can be used for dermatology research and clinical studies that require digital patient-provider interventions and workflows using a high-quality skin imaging app in the hands of the patient.

The platform and app can be used for patient intervention research within the most common skin conditions such as melanoma, skin cancer, moles and lesions, rosacea, wound care, acne, psoriasis, and eczema, among others.

Therefore, the Miiskin platform can be a valuable asset for both hybrid and virtual clinical trials and dermatology research.

What type of patient-reported information can you include in your research?

Miiskin is fully customizable and can be configured to include all the information needed for clinical research.

The Miiskin app is powered by artificial intelligence, and it helps users document and track moles, lesions, and other chronic skin conditions over time. The app creates a photo log with the subject’s face and body photos allowing users and researchers to view the photos side by side on a screen.

The Miiskin digital platform for dermatology research offers the following:

Automatic Skin Imagining to take full-body images
Face Tracking to take full-face images
Skin Mapping to visualize all the lesions and marks on the Skin
Mole Sizing to digitally measure and keep track of individual moles or skin lesions

Miiskin PRO taking a front picture using artificial intelligence

Researchers can, for example, view the following information on the Miiskin digital platform:

Type of medication
Symptoms
Side effects
Patient images

The digital health platform can also be customized to capture additional information related to the specific research.

Does the platform provide patient consent?

Yes, the Miiskin app also ensures that patients consent to share their photos and patient-reported information with the study’s researchers.

Is the digital health platform easy to use?

The Miiskin app and the web portal are extremely easy to use for patients and researchers. It has an intuitive user interface and is fully customizable to fit your research or study.

Is the platform secure and compliant?

Miiskin PRO is a secure and HIPAA-compliant digital healthcare platform. All information and images in the Miiskin app are encrypted so that no other app can access the information (PHI data) and pictures in your research. Besides, a PIN code can protect the patients’ photos. Researchers and providers can only access the encrypted PHI data through a personal provider login on our provider interface.

References:
¹https://www.appliedclinicaltrialsonline.com/view/5-ways-dcts-can-positively-impact-trial-diversity
²https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
³https://www.outsourcing-pharma.com/Article/2021/03/24/Advisory-council-works-to-amplify-patient-voice-inclusivity
⁴https://pubmed.ncbi.nlm.nih.gov/30264133/
⁵https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/
⁶https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5975097/
⁷https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568443