As a relatively young industry, it’s no wonder that the clinical trial industry tends to undergo rapid change. Although you may hear some argue that with regulations catching up, and a few COVID-19 setbacks and challenges, change isn’t happening fast enough, these 6 trends we’ve identified in clinical research will prove to you that change in the clinical trial industry shows no sign of slowing down anytime soon. Because setbacks in one part of the industry leave room for exponentially accelerated growth in another. Let’s look at the trends.
Decentralized Clinical Trials
Decentralized Clinical Trials (DCTs) are clinical trials that remove reliance on central research sites for clinical studies. This makes it possible to increase the remote monitoring of trial data, and for trial participants to take part in clinical trials from various remote and alternating locations. This approach is heavily reliant on technological applications. Read more details here.
While Decentralized Clinical Trials have existed before, the advent of the pandemic has propelled them to industry-shaping-trend status. And though many of the pandemic restrictions which initially accelerated the trending rise of DCTs are now relaxing, the progress made in improving the applicability of Decentralized Clinical Trials promises the continued rise of the trend, despite a possible reduction in the degree of the trend’s rise in the immediate future.
That is because some investigations which recently took place through DCTs through regulatory necessity may be fated to make at least a temporary return to conventional clinical trials until the transient nature of some of the emergency COVID-19 regulations gets sorted out. But ultimately, the trend will continue to rise, even if the rise briefly slows down in the immediate aftermath of an economy and regulatory atmosphere that are fully recovered from COVID-19 practices.
Another reason for the reduction of the rise in this trend’s degree in the immediate future is conservative backpedaling, which may have some industry leaders increasing their reliance on methods they are more familiar with, even when the investigations in question are not necessarily more suited to conventional clinical trials. Still, DCTs remain a strong upcoming trend in the clinical trial industry and are here to stay. Having majorly come to the forefront during the pandemic and with an expectation of minorly receding from the scene in the immediate aftermath, the DCT trend is expected to sustainably grow in the foreseeable future, having demonstrated considerable progress in applicability during the pandemic.
Personalized medicine is a therapeutic approach that enables researchers and clinicians to tailor medications more towards individual needs, rather than via general approach. It relies on a detailed understanding of individuals’ genetic profiles, grouped with other relevant data about them, and is a special area of interest for the treatment of cancer in particular.
While the percentage of clinical trials featuring personalized medicine does not dominate the total number of annual clinical trials, clinical trials investigating the personalized medicine approach are still definitely a strong trending interest in 2022 that will affect the clinical trial industry in the future. The reason for this interest, outside of potential therapeutic benefits, is that clinical trials for personalized medicine appear to promise a radical cost reduction as compared to clinical trials which test for generalized treatment approaches. This is because the required number of patients for an effective trial is much less. At the same time, the projected trial withdrawal rate is also radically reduced due to the increased treatment benefit for prequalified patients and the decreased possibility of extreme side effects. Radically lower cost-reduction along with radically lower trial withdrawal rates come together to yield nearly optimum cost-efficiency in clinical trials.
Slower than other trends but steadily gaining momentum is the rise of Expanded Access programs. When patients who aren’t eligible for clinical trials investigating a particular treatment suffer from severe diseases which may endanger their lives and have no recourse to any viable alternative treatments, they may be given access to the treatment being investigated outside of a clinical trial.
This shapes the clinical trial industry in more than one way. On the one hand, some have expressed concern that expanded access programs may de-incentivize people from enrolling in clinical trials. On the other hand, expanded access may provide very valuable supporting data in the future. While obtaining this data outside of a formal study may not qualify it as conclusive research, its indicative supporting function is invaluable and it may help clarify preferred clinical research directions in the future.
Post-trial follow-up of trial participants is sometimes indicated for participants who consent to it and is another growing trend that shapes the clinical research industry. One particular type of post-trial follow-up is that which is done for clinical trial participants who continue with their experimental treatment after concluding their participation in the trial. The European Medicines Agency empowers this particular scenario for some trial participants. Specifically, participants who wish to carry on with their experimental treatment after they conclude the clinical trial. There are other post-trial follow-up scenarios. For example, patients who do not continue an experimental treatment may also undergo post-trial follow-up.
Post-trial responsibilities are in general growing for sponsors, but whether post-trial follow-up is carried out by the sponsors voluntarily or whether they come to do so in compliance with future regulations, it makes for another interesting trend to observe the participants continue the same treatment after the trial ended. The reason for this interest is because those participants were eligible for the original trial, so the data for long-term usage in eligible participants may become available in a supporting capacity, even if not acquired in a formal trial. This is distinctly different from the data available from Expanded Access programs that offer the experimental treatments in question to patients who were not eligible for the relevant clinical trials.
Electronic consent mediums, forms, and procedures were already highly trending before COVID-19, but their use has multiplied exponentially since then, making eConsent one of the most burgeoning trends to shape clinical trials in the upcoming year. eConsent naturally has applications in both clinical treatment contexts as well as clinical research contexts. It is of particular interest to investigators and sponsors since it occupies less physical storage space and can generally be less costly to maintain in record keeping. eConsent records are also considerably easier and quicker to locate for access than physical records and can be done by authorized personnel far more conveniently. It is also easier to verify when integrating different categories of the same consent together into one file, such as signed consent and filmed consent.
An additional factor that caused this trend to precede the COVID-19 crisis and grow throughout it relates to trial participants. eConsent is also beneficial for patients and trial participants in that it allows them to read the terms which inform their consent at their convenience before signing from any location where they have secure internet access. Depending on the eConsent solution used, participants may also be able to access all their electronically signed forms and the documents relating to them more easily. Some eConsent solutions can be accessed from almost any smartphone, tablet, desktop, or laptop. The eConsent solution used may also allow for patients and participants to be better informed before documenting their consent, through the use of interactive elements, such as short quizzes.
Deeper HBSM Software Integration
HBSM is one of the few fields related to clinical research in which the acceleration of digitalization has been almost completely organic, notwithstanding the general socioeconomics which drove technological development as a whole in the past few decades. It is organic in the sense that it wasn’t really waiting for a crisis to accelerate its digital framework. Deeper integration of HBSM software happens almost as soon as reliable, innovative HBSM software becomes available. Because Human Biosample Management is very hard work, dominated by thoughts like “I wish I could record this data faster”, “I wish chain of custody records were easier to locate”, and so on. So it’s no wonder that as better, more efficient HBSM software develops, it continues to drive the trend for deeper software integration in all HBSM levels.
These are 6 of the clinical trial trends to watch out for in 2022 as they’re likely to be active in shaping the clinical trial industry. There are more trends to look out for, though. Stay current throughout 2022 and keep abreast of new developments. Make sure to subscribe to the Cloudbyz newsletter for updates on all things clinical research in the upcoming year.