ENHANCE THE NEW CLINICAL TRIAL STANDARD

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ENHANCE THE NEW CLINICAL TRIAL STANDARD

 

Clinical trials are a critical element to market new medicines. Successful studies can offer a hope of treating people. Sadly, the COVID-19 pandemic in the US caused a significant interruption in planned or ongoing non-COVID‐19 vaccine tests.

The effect is often acknowledged on the health and research spaces. There have been stories of medical studies disrupted as doctors are no longer available, health supply chains are broken and medical tools and research are difficult to access.

The pharmaceutical and regulatory industries adapt quickly to modern digital tools that empower the front-line workers and patients to pursue the work of health in the new COVID‐19 normal with patients’ lives on the line.

Modern technology adapting to change

In March 2020, the FDA published guidelines to help the ecosystem in clinical trials commute to the choppy waters of COVID‐19. These new guidelines have opened up the door for new innovative technology companies to new ways of doing traditional tasks without compromising the safety of their participants. The biggest change was the need to redesign many trials to support remote participants.

It might sound like an ordinary change, but the effect is grooved. In making this transformation possible, technology has played a significant part, including providing:

  • Ongoing patient visits are supported by virtual meetings.
  • Health monitoring medical sensors and IoT devices.
  • Smart digital coverage for the engagement of patients.
  • Low-touch approaches to manage devices and data securely.
  • Dynamic and agile methods to direct participants’ clinical supplies.

Luckily, the technology required is extremely common for such changes. Indeed, you essentially touched all the elements you required if you made a recent video call, used a fitness tracker, or ordered a product online. The safety, regulation and privacy of patients are, however, central to the clinical trial space and the difficulty is considerably higher.

The new decentralized clinical trial standard

We now know that the successful implementation of decentralized (or hybrid) clinical studies can be achieved. Will this knowledge change the way research and treatment will be carried out in the future? This new approach has significant advantages, which may not first be so apparent.

The virtual nature of remote testing and treatment permits a wider socioeconomic group of participants to be natural, ethnically diverse, geographically distributed. There are also operational and cost advantages that can lead to an exploration of rare conditions treatments which do not generally receive attention. These challenges are not addressed in traditional clinical trials, as they should be.

While this development was forced and quickly occurred, the promise of decentralized mass trials has been debated for decades. Yes, there have been challenges over the past year with implementations, but the mind and intellect have persevered. One silver lining of the pandemic is the unity, without precedent, of regulators, drugs companies and the technology industry. This unification needs to be further developed. Continue this development, bring further treatments to the market and give more people hope.

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