What Happened to Clinical Trials during the Pandemic and How to Resume Them
Data by ClinicalTrials.gov show that, in March 2020, 262,370 randomized laboratory trials of drugs and methods for behavioral and surgical treatments were conducted in the world. A sudden pandemic outbreak has created serious obstacles to research activities, suspending thousands of clinical trials. In this article, we will consider how custom healthcare software is helping to keep trials going in the changed environment.
Difficulties in carrying out trials
Practices for combating the coronavirus infection spread include restricting visits to clinics and medical centers, on the basis of which randomized trials are conducted.
During the pandemic, trial participants may catch the coronavirus, given the fact that some of them belong to a risk group. Also, restrictions affect trial conditions and result collection. Thus, scientists were faced with the question of how to organize clinical trials in the context of the coronavirus pandemic.
Medidata – a platform that supports clinical trials – surveyed around 10,000 research center employees from America, Asia, Europe, and Africa. Participants of this survey included coordinators, researchers, and medical personnel. The majority of respondents (69%) noted that the pandemic had an impact on their scientific work: limited their abilities, made it difficult to find and recruit patients, and led to financial losses. Under these conditions, the respondents were forced to temporarily suspend their work until the situation stabilized.
Challenges in organizing clinical trials
When clinical trials of drugs are carried out, institutions and pharmaceutical companies invest around $20-50 million per experiment. Typically, large research centers conduct several experiments simultaneously, recruiting thousands of participants worldwide. The pandemic has created the following difficulties:
- visits to medical facilities are restricted;
- fewer people are willing to take part in clinical trials;
- trial participants are at risk of catching the coronavirus;
- sponsors are not always able to provide the necessary materials and equipment;
- deviations from the trial dates can affect the data integrity due to delayed evaluation and monitoring.
In view of the above problems, some of the trials break down right at their start because of the inability to recruit the required number of participants and the lack of resources.
Michael Lauer, Deputy Director for Extramural Research at the US National Institutes of Health, says that the pandemic’s impact has been huge – nearly 80% of clinical trials unrelated to the coronavirus have been suspended or interrupted. For example, experts reported the halt of 95% of cancer trials.
How to conduct trials during the pandemic
Some scientists called for the suspension of randomized trials that don’t produce immediate results. But in most cases, the effect of using the drug is unknown until the end of the trials, and these trials mustn’t be interrupted.
Continuing clinical trials will give people a chance to deal with their diseases without waiting for the end of the pandemic. Experts have made suggestions on how to proceed with randomized clinical research without endangering their participants.
- Remote monitoring
In its guidance on the conduction of clinical trials, the FDA states how they must proceed during the pandemic, highlighting the importance of ensuring the safety of participants and maintaining maximum research integrity.
When studying the results, researchers must consider the possibility of the virus affecting the condition of people. It is recommended to use remote methods of obtaining data – for example, remote questioning. Also, it is essential to take into account the cases when getting a high-priority result at home is impossible.
- Modification of trial conditions taking restrictions into account
Clinical trials must be as safe for their participants as possible. Scientists should anticipate the likelihood of participants falling ill during the trial. In this regard, it is necessary to adjust parts of the trials (for example, taking medications or doing controlled exercise) and monitor trial subjects remotely.
- Elimination of deviations in trial results
Quarantine restrictions can lead to deviations in research results. For example, if a participant is unable to attend an appointment before the end of the trial and misses a dose of a drug, this mustn’t do any harm to them. The safety of research participants is above everything.
- Additional measures
There is no definite answer to whether people with coronavirus symptoms may continue to take certain medications. On one hand, it can mitigate the course of the disease – for example, the cardiovascular consequences of an acute inflammatory condition. On the other hand, if a clinical drug poses certain risks, it is better to temporarily stop taking it.
Researchers have the right to choose what procedures they can carry out during a pandemic: registration, study visits, data collection and analysis, etc. The decision to suspend a particular study is to be made by the institutional review board.
- Healthcare software solutions
The value and effectiveness of clinical trials can be preserved with the help of devices for contactless monitoring of their participants. The latter use them to independently collect the necessary data and transmit it to scientists without visiting the clinic.
These devices are based on Artificial Intelligence and Machine Learning and are connected to the study participants’ mobile apps and the clinic’s platforms. In this way, a healthcare software development company can help in continuing remote clinical trials without sacrificing quality.
Clinical trials are of paramount importance for promoting and developing new drugs and therapies and for reducing their cost. The complex structure of some clinical trials meant that they had to be suspended amidst the pandemic. Many organizations have faced the challenges of funding, close monitoring of results, and safety of research participants.
It takes years to develop a drug, test it, and bring it to the market. Therefore, continuing research is important even during the pandemic, provided isolation conditions are observed and contactless patient monitoring methods are used. TeleMedicine and remote monitoring solutions are what can help scientists with this.