the microsampling blog

In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In the US, the device is not for use with saliva samples intended for clinical DNA testing. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

2 solutions overcome the 6 top objections to clinical trials

by Neoteryx | 5 min read

clinical trialsOrganizing a clinical trial is no easy feat. Researchers must recruit a group of willing participants. The participants must meet the study criteria and be prepared to comply with all of its processes and requirements (including regular specimen collection for lab testing, filling out paperwork, etc.). Participants must be committed to participating through completion of a trial. 

It is no surprise that trial managers often have trouble finding enough qualified participants to run robust and medically useful studies and drug trials. This is especially true when volunteers with rare conditions are needed.

Common Barriers to Clinical Trials Solved with Remote Technologies 

Study volunteers cite a number of barriers to participating in clinical trials and/or reasons for abandoning them midway. Many of the same barriers or objections are raised by a majority of potential recruits and trial participants, regardless of their demographics. 

A trial design that combines the use of telehealth communications (email, telephone calls, video conferencing, and more) and remote specimen collection tools, such as Mitra® devices with VAMS® technology, can help overcome many of these barriers and make clinical study participation much more attractive to prospective volunteers. Here we take a look at the most common barriers of clinical trials.

6 Top Barriers to Patient Participation in Clinical Trials 

1. Inconvenience 

Participating in a clinical trial is not often a short-term commitment. People enrolled in a trial are expected to visit trial sites multiple times over the course of several months, or sometimes over several years. These visits can significantly disrupt participants’ lives, including travel time and the cost of travel to and from the site, which can add up over time.

2. Lost Productivity 

The site visits that clinical trials require often occur during conventional business hours, and this means that many participants are forced to take time off work or school to attend. They may lose wages or miss important lessons or exams, which can impact their work performance or grades. This is a significant deterrent for many prospective participants, especially for people who are already facing financial difficulties. 

3. Time Burdens 

Site visits for clinical studies are rarely brief. Each visit can easily take hours of a participant’s day between the time it takes to travel to the facility, wait to be seen, get the necessary specimens collected, wait for the lab results, speak to the various professionals involved, and finally exit the facility and travel back home. It can be difficult to convince participants that it is worth their while to spend so many hours on a clinical trial, even if they are receiving a small remuneration and/or are eager to play a part in advancing medical science. 

4. Paperwork 

Clinical studies are, by definition, just one phase in an academic research process. They frequently involve mountains of paperwork. Study participants are asked to complete intake papers, consent forms, and to document progress and side effects. They are also often asked to keep behavioral journals. Filling out this paperwork can take a lot of time and can be frustrating if participants are not adept at reading, writing, reporting and documenting. 

5. Specimen Collection 

Many clinical studies require participants to undergo regular specimen collection for lab testing to see how the drug or treatment on trial affects their body chemistry. It is very common for participants to become anxious at the prospect of undergoing regular specimen collection events that involve jabs with needles. For example, if blood draws are required, their stress and anxiety may be due to needle phobia or the sensations they experience following high-volume blood draws. This anxiety can be severe enough to deter people from participating in drug trials altogether.  

6. Side Effects 

It is impossible to know what side effects each individual participant will experience during a clinical trial. That’s the point of conducting the human trial phase of the research. This uncertainty frightens many people and causes them to refuse to participate. While some participants will receive benefit from a drug or vaccine on trial, with no noticeable side effects, others may be negatively impacted.

Staffing and Budgetary Considerations

Most of the challenges that trial participants face also impact researchers and the companies that employ them, albeit in different ways. Scheduling appointments, conducting in-person visits with patients, collecting samples onsite, and sorting through hundreds of pages of paperwork can take up valuable time and resources that could be put to better use. What's more, allocating space and staff to perform all this work is very costly. It’s important to consider new ways to conduct clinical studies that avoid these challenges and reduce costs. 

Overcome the Barriers with Remote Microsampling and Telehealth Solutions 

With remote specimen collection and telehealth communications technologies, clinical trials don't need to be conducted onsite at a facility using conventional processes. Instead, they can be done almost entirely remotely, offering a potential solution to most of the barriers cited by clinical trial volunteers and staff. 

Using remote methods to decentralize a clinical trial is: 

1. Convenient 

Telehealth technology allows communication between researchers and participants anywhere, even on the go. Similarly, remote microsampling frees participants from the need to visit a trial site on a regular basis. A remote approach gives participants the ability to collect samples at home or wherever they are, within the time points required by the trial coordinators. They no longer need to worry about scheduling trial appointments around other commitments, which means they won't have to miss work or school to participate. This makes them more likely to sign up for a trial. 

2. Fast 

New technologies can greatly speed up many of the steps involved in conducting clinical trials. Online portals can accelerate the paperwork process and reduce the strain of those duties for participants and staff alike. Remote specimen collection tools with easy-to-use technology can cut the sample collection process down to just a few minutes. Participants easily figure out how to use their sample devices by using the enclosed instructions or watching simple how-to videos online. 

3. Minimally Invasive 

Microsampling is minimally invasive. Collecting a "microsample" requires only a small finger-prick to the fingertip to draw a small drop of blood. This is far less uncomfortable than having several vials of blood extracted using conventional phlebotomy methods that involve puncturing a vein in the arm. Even participants with blood-test anxiety tend to react well to performing their own finger-prick sample collection in the comfort of home. 

4. Safer 

Microsampling extracts tiny samples, which places very little stress on the patient’s body, especially as compared to collection methods that require several vials of fluid. This makes it a less risky option for more fragile patients, such as children, the elderly, and those with certain medical conditions. Collecting samples this way is also less likely to cause unpleasant sensations like lightheadedness or weakness that sometimes occurs with standard blood draws. Additionally, self-collecting specimen samples at home for mailing back to the lab keeps people out of facilities where they might risk exposure to contagions, such as the novel coronavirus. People have become more aware of this safety concern in light of the highly contagious SARS-CoV-2 virus that was classified as a global pandemic in 2020. With more contagious variants circulating through the population, many people would prefer to avoid visits to medical or research facilities. 

5. Less Stressful 

All of the benefits of less invasive and remote health technologies lead to significantly improved trial participant experiences. Adopting telehealth solutions and remote microsampling is a relatively easy and effective way for research institutions and pharmaceutical companies to make participating in clinical research a much more pleasant experience for people. 

Remote, Decentralized Clinical Trials Are the Future

Improving patient recruitment could markedly improve researchers’ ability to advance groundbreaking medical treatments. It is therefore critical that clinical trial management teams investigate how remote specimen collection and telehealth technologies can drive more successful studies.

The flexibility offered by remote technologies is industry-changing, and could lead to a brighter medical future for all.  

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Originally published Mar 22, 2021 9:00:00 AM, updated on March 22, 2021

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