Oncology Pulse - Oncology Clinical Trial Design - Impact of the Latest Industry Guidelines for Pharma

Publish date: 29 Aug, 2018

Oncology Clinical Trial Design - Impact of the Latest Industry Guidelines for Pharma 

Dr. Andrew Merron, Executive Director, DRG Oncology

In August 2018, the FDA and ASCO released exciting new guidance around oncology clinical trials.


Dr. Andrew Merron, Executive Director, DRG Oncology, reviews:

- Key points of the guidance

- Why this guidance is significant for patients and the industry

- 3 takeaways for pharma


Visit DRGOncology.com for more insights from Andrew and other oncology experts.


Video transcript:

Hello. Welcome back to DRG's Oncology video series. Today, I want to talk about two key events which have occurred recently. They relate to oncology clinical trial design. The first event is that the FDA released some draft guidelines relating to how clinical trials should be designed. And the second event is that ASCO, in collaboration with Friends of Cancer Research, provided their recommendations on the eligibility criteria for trials.

So, the FDA draft guidelines are really important because they can accelerate the development of novel cancer drugs. Clearly, that has a massive societal benefit for patients, but also for pharma as well because they can get their drugs to market earlier. The intention of these draft guidelines is to provide a seamless transition between early phase endpoints such as pharmacokinetic and pharmacodynamic end points, and those more associated with Phase 2 trials, such as efficacy.

In general, the guidelines provide information on four key points: when to speak to the FDA about this clinical development pathway, what sort of drugs are eligible for this pathway, how to submit your IND and what's important in your IND, and lastly, patient safeguarding for safety. And that's really important because these types of trials are looking at novel therapies with minimal information on safety characteristics. Therefore, because they're first in human trials, with multi-cohort expansion studies, safety will be important.

The ASCO clinical recommendations provide some examples on how to broaden the eligibility of cancer clinical trials. Now, that's important because clinical trials should study patients that are representative in the real world setting. We know that trials rarely perform as well in the real world as they do in the trial setting. And that's based on strict eligibility criteria imposed on those trials.

ASCO and Friends of Cancer Research have identified five key attributes that they're looking at to broaden eligibility. They include patients with brain metastasis, patients with concurrent other malignancies, patients with organ dysfunction, patients also infected with HIV, and patients who have a minimum age criteria for entering those trials. And by modifying the eligibility criteria, we can allow more patients to enter, which has a societal benefit and it is also more representative of the real world setting.

I think there are three key takeaways that pharma can take from these pieces of news. The first is that it's important to develop your clinical strategy quickly, but don't rush it. We've seen examples where rushed clinical development fails. Instead, it's important to have an efficient clinical trial design. And that can be done through following the FDA guidelines that have recently been produced. The second key takeaway I'd suggest is not to be too restrictive in your eligibility criteria for clinical trials. Yes, it may be easier to demonstrate significant efficacy in patients without brain medicine, without HIV, for example. But think about what's really going to happen in the real world example. We need cancer drugs to be beneficial for as wide a population as possible.

And lastly, what I think is really important is that pharma needs to consider the ever-changing clinical landscape in oncology. Be ready to pivot your clinical trial design almost on a weekly basis because that's how rapidly things are changing. Thank you again for joining today's oncology video series. I hope you enjoyed the session. Be sure to check out drgoncology.com for more insights, free thought leadership, and make sure you subscribe to our channel. I look forward to seeing you again next month.


Visit DRGOncology.com for more insights from Andrew and other oncology experts.

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