Nov 10, 2020
At the heart of it, clinical trials are about data. By testing treatments and drugs, researchers seek to measure how well they work and quantify possible side effects. Regulators need data to make informed decisions about which treatments and drugs they will approve – and for what specific indications.
As we are all acutely aware, researchers around the world are working on COVID-19 treatments to lessen the severity if you get the virus and vaccines to put an end to the pandemic. In this extraordinary time, everyone is trying to move quickly. But even if time is of the essence, we need to balance safety with speed. There’s just too much at stake to rush decisions that aren’t supported by data. And the data should be transparent so healthcare professionals and the public in general have access.
At the risk of stating the obvious: clinical trial data needs to be made available sooner rather than later.
In a positive step for data transparency, the European Medicine Agency (EMA) decided to publish clinical data for COVID-19 medicines. The first results published were the data that supported the authorization of Veklury (remdesivir). EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force.
Data sharing means that the whole research community can be involved. This can be especially useful when pandemics occur. For example, during the Ebola epidemic six years ago, data sharing meant that the virus was rapidly able to be controlled. Additionally, research duplication can be reduced when resources are pooled through data sharing.
As it stands, FDA rules require clinical trial sponsors to post results to Clinicaltrials.gov one year after a study has finished. Yet, research earlier this year from Science shows that sponsor organizations continue to miss the reporting deadline.
Some have downplayed concerns about missing deadlines for ClinicalTrials.gov, saying that instead researchers, doctors, and patients can learn about trial outcomes from peer-reviewed publications. But the reality is that thousands of trials are never published, particularly when treatments are found not to be effective.
Over the last few years, we have seen efforts to tackle the missing data. For example in 2013, The BMJ announced that it would “no longer publish any trial of drugs or devices where the authors did not commit to making the relevant anonymized patient level data available, on reasonable request.”
And in February 2020, hundreds of universities, drug companies and medical device manufacturers were ordered by a federal judge in New York to post missing trial data for trials conducted on drugs and devices over the last 10 years.
Maybe it sounds ambitious to expect reported results for all clinical trials. But as we are seeing backlashes now from people who either don’t want to participant in COVID-19 clinical trials or are already gearing up to reject a vaccine – it is critically important that clinical trial findings are transparent.
But if we look at the way trials are run today, there are so many parts where data transparency just isn’t there. We need to look at building data visibility into the entire process of clinical trials – not just the reporting of completed trials.
This is why we founded Teckro: on the belief that clinical research must be simpler, more accessible and transparent. In the current climate, data openness is no longer a “nice-to-have” but a “must-have.” During the clinical trial process, our technology ensures that there’s full transparency for all stakeholders – from sponsors, to monitors, to physicians and research staff.
In the end, everyone benefits if they have greater insight and visibility into study activity. What I’m talking about is bigger than simply the “traditional” clinical trial data that is documented with each patient and each visit. I’m talking about the data – the visibility – into the trial itself. This ranges from what sites are engaged with the protocol to what kind of questions research staff have about specifics in the protocol.
You may not think of questions as data. But the reality is that each site question contributes to a pool of questions. And what if the sponsor could identify a pattern that multiple sites are looking for information because of an adverse event, say a skin reaction. Taken together, these individual questions form a pattern that can be an early indicator of a potential safety risk.
This transparency just isn’t possible when the protocol is a static paper document.
Not only does this greatly improve the relationship between physicians and sponsors – ensuring more confidence and honesty – it also can make trials safer and more efficient. Fewer protocol deviations mean better trial quality. And greater data transparency speeds up the drug-to-market timeline. Everyone benefits.
Over the next few years clinical trial transparency needs to be an urgent focus for both governments and the wider industry. The pandemic demonstrates that it is of the utmost importance that public health institutions can act at speed during times of crisis. As well as this, the public needs to feel they can have faith in the clinical trial process.
With data transparency, patients and doctors are more confident because they can see the results for themselves. For those patients participating in research, it is important that they know that the data they helped contribute to is made widely available.
The pandemic is pushing the industry to change on several levels. Greater transparency and a more modern approach to clinical trials are good for everyone. Once we are past COVID-19, these changes will hopefully be entrenched and there’s no going back.