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What is a complex innovative clinical trial?

Researchers from the U.K. have developed new recommendations for complex innovative clinical trials.

In a given year, around 18 million people are diagnosed with cancer worldwide and that number is expected to rise to 29.5 million in 2040.

Recent discoveries in cancer biology have led to an increase in the development of new cancer therapies.

However, many of these therapies do not end up reaching the patients.

The traditional drug development pathway – involving clinical trials with four phases – is slow and takes around twelve years to develop novel therapies.

Adopting the complex innovative clinical trial design

Researchers are increasingly adopting the complex innovative clinical trial design, considered to be faster and more efficient than the traditional drug development pathway.

Complex innovative clinical trial designs enable researchers to address multiple clinical questions within a single study.

With this trial design, a novel drug can be assessed for safety and effectiveness at the same time and patients are selected based on biomarkers rather than the origin of the tumor.

In some complex innovative clinical trials, patients with different cancer types have the same biomarker and in others, patients with the same cancer type are assigned to different cohorts based on specific biomarkers.

The trials can be adapted to add or discontinue cohorts and treatments while the study is still running.

Although complex innovative clinical trials can accelerate the traditional development process to drug licensing, they are challenging to design and conduct.

Addressing the challenges of complex and innovative clinical trials

The Experimental Cancer Medicine Centre (ECMC) network convened a working group, comprised of researchers, funders, pharmaceutical industry representatives, regulators, and patients to address the challenges pertaining to complex innovative clinical trials.

In the review, published in the British Journal of Cancer, the group developed ten key recommendations for each stage of the clinical trial process.

Each recommendation addresses a specific stage of the clinical trial process.

The stages of the clinical trial process include trial planning and design, protocol development, patient-facing documentation, statistical analysis, defining leadership and oversight, dissemination of results, staff training, the approval and reimbursement process, and evaluating the impact on public health.

Researches recommendations

According to the researchers, the recommendations could improve the quality, conduct, and acceptability of oncology complex innovative clinical trials, as well as accelerate the process by which new and innovative treatments reach patients.

The review suggests that improving the way in which different stakeholders interact and share their knowledge from these trials will help foster a clinical research environment that could enable complex innovative clinical trials to be conducted in new therapeutic areas.

According to study author, Dr. Lemoine, it can take some time to deliver promising treatments to patients who need them the most, so speeding up the drug development process through complex innovative clinical trials is a priority.

Conclusion

Study author, Dr. Kearns, suggests the recommendations will ensure there are good quality complex innovative clinical trials in place to deliver more effective treatments to the clinics as quickly as possible.

The researchers suggest that clinicians, funders, regulators, and the pharmaceutical industry adopt these recommendations and work together to quickly implement them.

Although the recommendations were focused specifically on cancer research, they could be applicable to other diseases as well.

Written by Ranjani Sabarinathan, MSc

References:

Blagden SP, Billingham L, Brown LC, et al. (2020). Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement. British Journal of Cancer. doi: 10.1038/s41416-019-0653-9

Complex Innovative Trials: New guideline adoption could get medicines to patients faster. (2020, January 5). Retrieved from https://www.eurekalert.org/pub_releases/2020-01/cru-cit010220.php

Image by mohamed Hassan from Pixabay

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