Virtual clinical trials are an increasingly popular and cost-effective way to conduct drug research, but they are not without their challenges. This article will explain what a virtual clinical trial is and why there might be a need for such a trial. What are the pros & cons of a virtual clinical trial, how is it different from a regular clinical trial, and what are some potential challenges with virtual clinical trials. This article will also answer any other questions you may have about Virtual Clinical Trials so you can make an informed decision on whether or not you would like to use them in your next clinical trial.
Defining Virtual Clinical Trials
Virtual clinical trials rely on advances in technology and research to recruit patients that fit specific criteria to participate in experiments using those patients’ data, as opposed to having human participants meet face-to-face with researchers. The goal of virtual patient recruitment is for their findings to be more accurate.
Some drawbacks to virtual recruitment include costs and limited access to specific groups. But, there are also many benefits associated with recruiting patients via video or remote technologies including increased geographic diversity and reduced time between screening and enrollment. Virtual patient recruitment is especially useful when there isn’t a large enough population within close proximity of a medical center.
Advantages to virtual recruitment include an increase in geographic diversity and reduced time between screening and enrollment. Studies show that virtual trials that are conducted via video or through remote technologies tend to involve patients from diverse backgrounds than traditional face-to-face recruitment techniques. Because you can recruit patients from around the world, it is possible to draw from a wider range of subject populations by eliminating language barriers during evaluation, which could potentially lead to groundbreaking findings.
Also, because there is no travel involved for patients who participate in virtual clinical trials, there is less waiting time between screenings and enrollments. This means that patients will be able to start treatment sooner rather than later if they do qualify for a study.
For sponsors who are worried about only getting biased opinions from participants in a small, geographic area, a virtual trial may be your solution because it removes these physical factors from participants’ decision making processes
One disadvantage associated with recruiting participants using technology includes the cost. Conducting any type of study costs money and recruiting participants using technology can add up quickly due to additional costs such as paying researchers or hiring IT professionals.
Another potential challenge with conducting virtual clinical trials involves reaching specific groups of people, like those who may not have access to computers or other technological devices necessary for participation in certain types of studies.
How Does A Virtual Trial Differ From A Regular Trial?
In a virtual trial, subjects are randomly assigned to different groups then study interventions are administered over some form of digital media (web, mobile app). The subjects may have been recruited for other reasons such as being at risk for certain diseases or just having access to technology. In general, these people have been given no information about the nature of their participation.
With regular clinical trials, recruitment can occur from specific populations that participate in research studies because they already had an interest in research. Unlike virtual trials, which generally recruit from a wide range of populations with no indication that they would be eligible for participating in a clinical trial or already had an interest in clinical trials or medical research.
A virtual trial allows for more people to be involved, it can be done at scale, and does not require that every patient who participates in a study leave their normal routine. In theory, a virtual trial allows for wider access to patients who might not otherwise have an opportunity to participate. Patients are able to participate from any location where they have Internet access and can complete assessments at times convenient for them without having to travel or miss work or family obligations.
It is important to note that a virtual trial has some inherent limitations. One major limitation is subject engagement. In regular trials, patients have multiple points of contact with their research team and they are able to participate in study activities at sites convenient for them, such as study clinics or other locations close to home.
This makes regular clinical trials more effective because it encourages patient engagement since there are often several opportunities to interact with a patient throughout a trial and make sure they understand what is expected of them and respond in ways consistent with good clinical practice guidelines.
The Pros And Cons Of A Virtual Trial
Anyone who has been on a medical trial will tell you that there are always pros and cons to participating in such a trial.
Pros
- Patients can participate with limited travel
- Administrative paperwork can be filed digitally, reducing admin costs
- Reduced cost for researchers to secure testing facility
- Reduced cost for patients that don’t need to travel to the testing facility
- Drugs can be administered by a professional when the patient is on site
- Larger area to source participants from, participants can be from all over the world
Cons
- Patients are responsible for observing themselves for any side effects and may not be as accurate as a medical professional
- Patients may need additional assurance that their information is being handled confidentially
- Researchers may need to purchase software to meet with patients during the trial
- Participants may feel more nervous about a virtual trial than one in which they actually give themselves injections or infusions
Another challenge with a virtual trial is how to ensure that patients are taking their medications and don’t alter them in any way. This can be overcome with proper monitoring of patients with blood tests and other physical checks before and after administering treatment.
It will also be important to give you or your office staff training on how to manage these types of cases appropriately so that you’re able to identify if a patient is cheating or not. Proper tracking software can also help make sure that patients are adhering to their schedule as well, like keeping track of when they should take their medications or if they have missed any appointments.
Challenges With Running A Virtual Trial
Not everyone has access to a computer and they may be too ill or otherwise disabled to go online. Because of these challenges, a virtual trial might not reach everyone that it needs to participate, making it harder for researchers to get accurate results.
While it’s true that some people don’t have access to a computer or can’t go online, most Americans do have access to a computer. According to a recent study, over 90% of Americans have access to the Internet. It’s likely that most of your patient base will have access to the Internet, however you may want to confirm with applicants that they will be able to interact with your study digitally. You may need to include training material.
Seniors or people in rural areas may have more trouble participating in a virtual trail. That might cause issues with cost and those groups may be less likely to enroll in an online program than younger or urban dwellers. With a virtual trial, it is also more difficult to ensure that patients are taking their medications properly.
These challenges might not be too difficult to overcome. For instance, you can create a program for use on smartphones or tablets, which many Americans have access to, and may be easier for seniors to use.
What are the 4 types of clinical trials?
- Phase I clinical trials are performed on a small group of 20-80 healthy volunteers (healthy means no signs or symptoms of disease) and are used to evaluate if a new drug is safe enough to be given to larger groups.
- Phase II clinical trials involve approximately 100-300 participants and determine if a drug is effective at treating cancer by monitoring its effect on tumor growth.
- Phase III clinical trials are performed on several hundred patients who have similar types of cancer in order to confirm that a particular drug works well enough, has few enough side effects, and is safe for general use.
- Phase IV clinical trials are also known as post-marketing studies. After a drug has been approved for general use, many questions can remain unanswered about its long-term effectiveness and side effects. In these studies, doctors continue to gather information from patients who have used new drugs. This data is then used to make additional safety determinations and to examine factors like
What are hybrid clinical trials?
A hybrid clinical trial is one in which participants are exposed to an investigational drug or intervention by two or more different routes of administration. The most common route of administration for a pharmaceutical agent is oral, but some drugs are better suited for other delivery methods, such as intravenous injection or application to a skin lesion.
Because most pharmaceuticals only have extensive human exposure and testing data for their single primary route of administration, using two different routes of administration helps provide more complete safety and efficacy information about investigational compounds. This can speed up clinical development and lessen risks from any unknown side effects.
One of the biggest benefits of a virtual clinical trial is that it allows researchers to conduct clinical research on more people at once. In addition, with a virtual trial, participants don’t have to travel as far or take time off work. Using digital communications platforms like web and mobile apps and video conferencing reduces delays and offers additional ways for participants to communicate with their physicians and each other.
Direct, digital communication can improve adherence to treatment regimens and overall participant experience in online studies. While virtual trials have an enormous amount of potential for speeding up clinical development.
As with any clinical trial, virtual trials have risks and limitations that have already been discussed in this article. Despite these challenges, however, hybrid clinical trials present great opportunities for accelerating drug development and bringing new drugs to market quickly. Hybrid trials can combine the best of both worlds to make your patients feel comfortable while also ensuring accuracy in your study.
What is Remote Patient Monitoring in Virtual Clinical Trials?
Remote patient monitoring is used in most virtual clinical online trials today. It includes any remote patient-generated physiological or behavioral health data (including observations) collected during a clinical trial that is transmitted to research sites where it is monitored, analyzed, and reported back to researchers. In virtual clinical trials, all participants are remotely located throughout a network of study sites; they do not all need to be located at one single site as long as there are enough participants at each study site.
The ability to remotely monitor and record data has been a game-changer in clinical trials, but that doesn’t mean it’s without its challenges. Since virtual clinical trials often involve patients who are more vulnerable to many factors, including changing environments like home settings and network connectivity issues, it can be difficult to ensure that data is being collected consistently and accurately throughout all study sites. Furthermore, given their unique nature, there aren’t any standards in place for today’s virtual clinical trials yet companies often must invest time into developing their own standards or risk substandard data.
The nature of virtual clinical trials makes them an effective solution for expediting new drugs and treatments. They provide access to patients who may not otherwise have been able to participate in a trial due to travel barriers or other factors. Furthermore, virtual trials are easier and can be less expensive than traditional ones, which means companies can bring more treatments to market sooner.
With more products in development, society stands to benefit as well. With drugs being developed and tested faster thanks to modern technology, patients with cancer and other life-threatening illnesses stand a better chance of finding treatments that will work for them sooner rather than later.
How Do Virtual Trials Benefit the Clinical Trial Industry
Virtual trials can potentially speed up clinical trial enrollment times and reduce overall costs. One of the biggest benefits of virtual trials is that patients with many conditions can be treated at one time instead of having to treat each patient individually.
This is especially beneficial for rare diseases where there are only a small number of patients with those diseases available for clinical trial participation. Another benefit to using a virtual trial is that you are able to recruit patients globally instead of just in a small geographic area like a physical clinic can provide. This will increase your reach and also allow you to recruit more people from different cultures into your trial who might not have otherwise participated because they were uncomfortable going to a physical clinic that they had never been to before.
One of the biggest challenges that some patients have in doing a physical clinical trial is traveling to their clinic for appointments on time. With virtual trials, patients don’t need to travel far and there aren’t any issues with scheduling due to distance.
How to Do Virtual Patient Recruitment
Patient recruitment is just like it sounds; it involves advertising and finding participants for your clinical trial. Recruiting for virtual trials is no different. Even though you will not be physically screening your virtual participants, you will still need to bring them into your trial office.
There are many different methods to achieve patient recruitment including advertising online, promoting through clinics and hospitals, etc. Here are some additional ways of recruitment that may be beneficial to your study:
- Advertisements: A popular way to recruit patients is using online advertisements. These can be very cost-effective and easy to implement. The only downside is that it can take quite a bit of time before you have enough responses from potential participants.
- Purchasing Data: Another option would be purchasing data from a vendor such as OptumInsight or eTMFHealth (formerly Trial Master File). Both of these companies offer recruitment services targeted toward clinical trial sponsors who are in need of patient populations for their next study. There are many other health data sets that you can use.
Recruiting for a virtual trial is not an easy process, but it can be quite rewarding. Knowing how to recruit for virtual trials takes a lot of preparation and sometimes trial and error. Just remember to never give up and always do your best.
A virtual trial is basically a clinical trial that requires participants to interact over electronic devices. It can still be seen as a type of live study, but all of its procedures are done through computers and/or phones instead of in person at a clinic or hospital. There are pros and cons to using a virtual trial. It is up to you and your research team to determine if a virtual trial would be beneficial for your research goal.
