Decentralized Clinical Trials: Five Questions Answered by an Expert

Decentralized Clinical Trials: Five Questions Answered by an Expert

Despite the many advantages brought by the popularization of decentralized clinical trials (DCTs), we are aware that many people, including researchers and medical professionals, still have many questions about this innovative approach to clinical research. This is natural and it happens every time new technologies replace traditional methods.

However, as an expert CRO with experience in implementing digital health technologies, we would like to give our contribution in easing some of the main concerns about implementing DCTs. In this article, we answer five questions about decentralized trials, with a special focus on regulations and the Food and Drug Administration (FDA)’s position on the matter. Keep reading to learn what are DCTs, if they are accepted by regulatory authorities, requirements and considerations to implementation, and also what you can expect from the future of DCTs.

#1 What are Decentralized Clinical Trials?

Before addressing more specific questions, we should clarify what a decentralized clinical trial is and what it involves. As the name indicates, this is a kind of trial that is not “centralized”, meaning it does not rely on a single location to conduct its activities. Many of the trial’s activities are conducted in places that are not traditional clinical trial sites.

In DCTs, the patient’s home, a local health care facility and a laboratory in the participant’s living area, for example, may be considered part of the clinical trial facilities. This is enabled by the implementation of digital health technologies, which allows many tasks to happen remotely.

Decentralized clinical trials rely on the collection of patient’s information as much as traditional clinical trials, but in DCTs the data can be collected directly from participants, who do not need to travel to a study center. Some examples of instruments and devices used in DCTs are activity trackers, blood pressure monitors, glucose monitors and spirometers.

Decentralized clinical trials and the future of drug development

#2 Are Decentralized Clinical Trials Accepted by Regulatory Authorities?

The short answer to this question is “yes”. However, we understand that many people might wonder how DCTs comply with regulatory requirements, as they are conducted using different methodologies and rely on other kinds of equipment. This is easily explained if we take into account that regulations exist, ultimately, to ensure the patient’s safety. If this is being done, there is no reason to not accept a different trial methodology.

Taking the FDA as an example, we understand that the regulations issued by the agency do not tell sponsors specifically how to design their trials. As long as the clinical trial follows Good Clinical Practice Guidelines, keeps patients safe and reports high quality data, the FDA is not concerned whether it is a traditional or decentralized clinical trial.

The agency has, in fact, being supportive of DCTs and issued a draft guidance called “Digital Health Technologies for Remote Data Acquisition in Clinical Investigation: Guidance for Industry, Investigators and other Stakeholders”. The paper does not create a new regulatory framework for DCTs: it helps researchers to best adapt to the implementation of digital health in clinical trials and it gives examples.

#3 Is there Any Special Recommendation to Implementing DCTs?

Having answered the question above, we acknowledge that a company that is implementing DCTs for the first time might still ask what they should be doing differently, if regulatory agencies do not have separate rules for DCTs. Common sense tells that procedures will indeed be a bit different, if the tools used and relationship with patients are not the same as in traditional trials.

Based on the FDA’s draft guidance that we mentioned above, we can answer this question by giving a summarized checklist that can help to ensure that a DCT complies with regulations. These are not mandatory requirements, but important points of attention.

  • Informed consent is as important as it is in traditional trials. DCTs usually obtain patient’s consent through eConsent forms, in which case the patient’s identities should be authenticated with secured logins and all personal data should be managed with robust data security systems
  • Digital health technology equipment must be carefully selected. DHTs used in clinical trials do not need to obtain marketing approval or clearance, if they are not deficient, but the clinical team is responsible for its validation and ensuring that they do not compromise the patient’s safety.
  • It is highly recommended that researchers and other trial personnel receive training on how to use the tools and software that enable remote monitoring
  • In DCTs, special attention should be paid to the way the data is handled, as there are many data management solutions available on the market. Choosing a reliable and safe one might not be as simple as storing paper documents on files, but, with the right provider, the patient’s information will be a lot safer.
  • While patients may use their own devices to collect and share health related data with researchers, technical support to the other tools used in DCTs must be available all the time. Difficulties in operating the devices and device malfunctioning should not hinder the trial conduct.

#4 What Should I Consider Before Implementing Decentralized Clinical Trials?

This question usually comes from companies that already have some experience in conducting traditional clinical trials and decide to switch to a decentralized method. Some sponsors might already know that there are no regulatory impediments to implementing DCTs and be aware of the points of attention that we mentioned in the previous section, but still think they could benefit from recommendations on how to get started. We suggest 3 essential steps to make a company ready to work with DCTs:

  1. Find a Contract Research Organization (CRO) to partner with. This should be a careful selection that considers not just the need to implement a DCT, but also the therapeutic area you are working in, the relevant regulations you need to comply with and the kind of product you are developing. The chosen CRO will have proven experience in all those areas
  2. Start working with regulatory bodies as soon as possible. While there are no special laws to implement DCTs, it is recommended that discussions start early to ensure complete transparency about a process that is relatively new.
  3. Search for decentralized trials similar to the one you are about to implement and study the methods and the results. Also because DCTs are something that is just starting to become popular, your study planning can also benefit from previous ones.
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#5 Should I Expect Changes in the Implementation of DCTs?

It is expected that the popularity of decentralized clinical trials will only grow, as researchers grow more confident to implement it and more successful trials yield results. However, as we mentioned earlier, it is still something relatively new and with a lot of space for development. There are three major changes we may see in the next few years:

  1. Regulatory agencies such as the FDA will probably develop more detailed guidance and maybe even regulations regarding digital health technologies such as medical mobile apps and clinical software.
  2. DCT methods will be more used in post-market surveillance as well, as they have proven to be cost-beneficial in pre-market clinical trials
  3. DCTs will help increase the diversity of clinical trials, as it fosters enrollment of participants from underrepresented groups.