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COVID-19 pandemic and the rise of Complex Innovative Design trials

Complex Innovative Design (CID) trials have the potential to increase efficiency and lower the costs of drug development. This type of trial has been around for over 15 years but, until recently, they have yet to make an impression. Now, with the ongoing COVID-19 pandemic, the urgent search for an effective therapeutic treatment has led to a surge in applications for CID trials. But what are CID trials?

CID trials

The FDA defines CIDs as designs that are intended to advance and modernise drug development. Their recent guidelines emphasise that there is no fixed term of what constitutes a CID. This is because what people consider innovative or novel will naturally change over time. The FDA says its focus is on trial designs that have rarely or never been used. In doing this, it will provide substantial evidence of effectiveness in new drug applications.

In CID trials, you can efficiently combine multiple research questions into a single study. There is also flexibility to add new or stop existing parts of the study whilst its ongoing. It is a rapidly expanding area of research, which has the potential to get new therapies to patients faster.

In the time of COVID-19

The NHS Health Research Authority (HRA) has recently reported a surge in CID applications since the pandemic hit. The urgent need for an effective treatment – and at a quick pace – has turned researchers’ attention to CID trials.

While there are several different methodologies used in CID trials, the team report that platform as the methodology of choice for COVID-19 clinical trials. This methodology allows for a single master protocol that evaluates multiple treatments simultaneously. This approach enables different treatments to be added into trials, allowing them to be accurately assessed in a single population. Each platform trial only needs to include one control group who will receive the normal treatment.

Examples of promising COVID-19 CID trials include:

  • PRINCIPLE (Platform Randomised trial of Interventions against COVID-19 In older peoPLE): This platform trial is evaluating the effectiveness of hydroxychloroquine, an existing antibiotic that has antiviral properties. The flexible platform trial will allow the addition of further interventions while it is in progress.
  • RECOVERY (Randomised Evaluation of COVID Therapy): This trial will determine whether a number of possible treatments available for COVID-19 are better than treatments currently given in hospital. The trial is designed so that other possible treatments can be tested should they become available.
  • REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia): This trial aims to determine the best range of treatments for patients who become severely ill with COVID-19. This will look at existing drugs in combination, with additional treatments being added over time.

Trials are being designed, funded, approved and rolled out across the NHS at an unprecedented rate. This will ultimately provide a key learning experience in the application of CID trials in developing safe and effective treatments in a time of great uncertainty.

Image credit: Image by Muhammad Naufal Subhiansyah from Pixabay

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