AbstractBackground: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary: VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research. © 2020 S. Karger AG, Basel
Clinical drug development is a time-consuming and complex process that takes around 6–15 years . The cost of developing a new drug, from research and development to marketing approval, is approximately USD 2.6 billion . Approximately 85% of therapies fail through early clinical development, and only half of those reaching phase 3 are approved . Over two-thirds of the total cost, in both money and time, of the discovery and development of a new drug is embedded in the clinical-testing phase . Patient recruitment is the single biggest cause of clinical trial delays, and 30% of phase 3 study terminations are due to enrollment difficulty. Approximately 80% of trials fail to meet the initial enrollment target and timeline . These delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Additionally, nearly USD 6 billion annually are spent on patient recruitment. Moreover, only 2% of the eligible population in the USA participate in clinical trials, and those who do participate attend an average of 11 visits at the trial site in 6 months .
Virtual clinical trials (VCT) are a relatively new and underutilized method of conducting clinical research using technologies (apps, electronically monitoring devices, etc.) and online social engagement platforms. Making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Thus, VCT are in many ways made for dermatology.
Herein we discuss advantages and challenges of VCT and outline the implications of VCT for dermatological research.
This narrative review was conducted using PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov. The searches were carried out using the following terms: “virtual clinical trial,” “remote trial,” “web-based trial,” “decentralized,” “hybrid study,” and “hybrid trial.” For the present paper interventional studies including the words “virtual,” “remote,” “hybrid”, or “decentralized” were selected. Studies not including any intervention or virtual/remote element were excluded. Further, telemedicine and teledermatology studies were excluded. Updated information on trials was found in the press release from the pharmaceutical companies sponsoring the trial.
Virtual Clinical Trials
VCT are not a new or separate type of clinical trial but a modification of clinical trials that makes trials cost-effective, timesaving, and easier for the participants . With the use of digital health technologies, VCT manage to recruit faster, improve retention, and increase participant diversity and representation . Further, VCT overcome the challenges faced in conventional clinical trials like many long appointments during working hours .
In conventional clinical trials participants are recruited through hospital visits, medical clinics, or using media such as newspaper/radio/television ads. Moreover, the target populations are often limited by their geography. In VCT recruitment is targeted directly to the patient by web-based platforms (e.g., Google search engine) and social media (e.g., Facebook, Instagram), without geographical limitation, reaching potential eligible patients worldwide. Patients can sign up, add additional information, and answer questionnaires about demographics, disease history, and geographical location on specific websites. To fulfil the inclusion criteria and to confirm the diagnosis some online recruitment platforms require image upload of target lesions, i.e., photos of body parts affected, for example, by acne, atopic dermatitis, or psoriasis. This kind of recruitment initiative is very appealing as 80% of internet users are seeking healthcare information and within eczema alone there are 4,343,000 searches/month (searches on Google, USA, November 2018). Furthermore, running online campaigns compared to newspaper/radio/television ads, allows: flexibility as one can turn a campaign on or off at a moment’s notice, proper tracking in place can specifically target actual leads (i.e., atopic dermatitis searches only), and it may be cost efficient with a lower cost per patient than traditional media. Informed consent is given remotely if allowed by the national/state ethical review board . An online questionnaire can test the participants’ understanding of the informed consent. In addition to the online information the participants have the opportunity to ask questions and discuss relevant topics with the investigator through a phone or online call before giving the consent [11, 12]. Furthermore, a limited number of study sites are involved in VCT. There is often only a single site, or one site in each country in global studies, led by a principal investigator whose team review all the data as they are reported in real time to monitor the health and safety of the participants. Studies are managed centrally by a remote study coordination center facilitating all research activities. This is different from conventional clinical trials with many study sites and study teams which contribute to the increased expense. VCT also allow data collection from multiple sources and reporters, e.g., mobile devices like phone, apps, watch, electronic patient-reported outcomes, and e-diaries . This is in contrast to conventional clinical trials where the data collection is made by the study team. (Table 1).