What Does Covid-19 Mean for Patients in Clinical trials?
Many of you will be directly affected by this pandemic even if you never test positive for Covid-19. Some of you already are. The last couple of weeks had us write many emails to patients applying for clinical trials informing them that the trial they are interested in has been suspended. This is heartbreaking for the FindMeCure team because we started our company with one mission: to help patients find treatments.
We understand it’s even more disheartening for you to find out that the trial you were hoping would help you is not moving forward. The frustration of fighting for your health every day and the anxiety of the current situation only make matters worse.
We firmly believe clinical research must go on – too many patients rely on clinical trials and the outcome of them which translates to better treatments available to everyone. However, right now researchers are still trying to make sense of the way social distancing is going to impact clinical trials in order to plan for the future. We’re sorry the trial you applied for is on hold but if you can wait and are still interested it will eventually be an available option again.
And let us reassure you – it’s not all bad news! In fact, Covid-19 might just spell a very positive shift in the way clinical trials are conducted in the future. Which means more innovative treatments will make it to FDA approvals. Here’s how.
Virtual and remote clinical trials
One of the main barriers between new treatments and the patients who need them, apart from limited awareness about clinical trials, is not enough patient participation in research. Many promising new drugs never get to the market not because they’re ineffective or unsafe but because clinical trials fail to recruit enough participants.
Decision-makers have been trying to bridge this gap by making trials more patient-centric. Some sponsors realize that not every patient who is interested in participating lives near a trial site, so they reimburse the cost of travel and sometimes accommodation as well.
It would be so much easier, however, to bring the trial directly to the patient at their home. Not only can trials reach new demographics and enrich the data they collect (which in turn leads to more relevant and reliable scientific knowledge) but they can also help patients who want to participate but live too far to travel even if the cost was not an issue.
Completely remote trials are possible with the technology we now have and they could solve the issue of recruitment. They’re also more convenient for patients who can receive their treatment at home either by a visiting nurse or by direct shipment of the drug and virtual guidance on how to administer it by themselves. This would be a win for all of us because efficient recruitment means more treatments will go through trials – some of them won’t prove to be an improvement upon standard medications but many of them will get to the final stage and be approved by the FDA.
Not all trials can go completely virtual. Trial sites serve an important purpose and just like not everyone is going to work remotely now that we know it’s a possibility, not every trial will be siteless as well. However, the current trends in research paint a future of increased patient-centricity.
Taking trials to the patients desn’t just mean conducting protocol visits in their homes or via modern technology. Crises make us understand the importance of taking the whole patient experience into consideration when designing a trial. Understanding patient needs, hopes and expectations is crucial not only to recruitment but also to retention and as the current situation shows – to planning for the unpredictable.
Designing a trial with the patient in mind is the best way to ensure recruitment, meet timelines and stay on track. This also means that patients need to become more vocal about their needs and expectations and take their health into their own hands.
Receiving a treatment that only barely manages your symptoms should not be an option when there are clinical trials developing increasingly more sophisticated drugs. Some prognostics predict that soon finding the right treatment will be like finding a good pair of shoes to fit you – as medicinal products are developed with more particular indications in mind we’re moving closer to personalized treatments.
These changes won’t occur overnight but it’s clear that the current crisis is shaking things up and for the better.
There will be a delay
Screening for clinical trials is put on hold for the time being and enrollment will be delayed for many research studies. For those of you already enrolled in a clinical trial, other questions appear. Some patients only found options in another country and as the time for their first visit approaches travel bans make the situation more complicated and uncertain. Others are reluctant to visit the research centre they applied for because of the risk of being infected.
Many patients seeking trials fall into the risk group of people who fight diabetes, autoimmune diseases, cancer or other chronic conditions. For them, staying home is likely the best course of action.
It will take some time for the teams behind clinical trials to come up with solutions. Unfortunately, this means many of you who are strongly motivated to participate and are hoping for a better treatment will have to wait with no clear end in sight. We remain committed to our mission and you can still apply for one (or a few) of the many trials on our platform. As of now, we don’t have any more information than the rest of the world – we don’t know how long the quarantine will go on and we can’t tell you for sure when your chosen trial will move forward. Some of the trial coordinators give us a timeline while others are uncertain.
What we do know is that this crisis will bring about some positive changes in the long run. If you can wait for your chosen trial to start again we will inform you when the trial coordinator reaches out to us.