How to enhance clinical trials
A common misconception is that clinical trials are done so big pharma can experiment on humans; this could not be further from the truth. Clinical trials are there so that healthcare professionals, medical doctors, and scientists can determine if a new pill, medical device, or surgery will be the one that cures or fixes a life-threatening disease or health issue. And because there are organizations like Clinical Ink, you can rest assured that clinical trials are all conducted above board and with the best digital tools.
The standard protocols in clinical trials are usually set in stone before the first patient even joins the trial. Desired outcomes, dosage for patients, criteria for the correct candidate, etc., are all set out in advance, and the clinical trial will be executed without any change. You know the saying, “if it ain’t broke, don’t fix it,” and to some extent, we can agree with this, but with new technology comes new methodologies and processes aimed at enhancing the entire experience for all parties.
Adaptive design clinical trials are one way to be flexible. Rob Lenz, Senior Vice President, Global Development, Amgen, says: “With adaptive designs, you can monitor the incoming data and modify the protocol based on what you’re learning as the study unfolds.” We also have to understand that even before a clinical trial can begin, any changes that might occur must be discussed and determined beforehand. And if predetermined criteria are met, you can make adaptations which include:
- Increase or decrease doses: You can exclude doses that aren’t working and add more value to the study by allocating more patients to more informative doses.
- Increase the size or the length of the trial: Allowing more time and even increasing your patient pool gives the drug a better chance to work.
- Diversify your study population: Add in different types of patients.
Organizations often feel as though improving on processes, specifically when it comes to efficiency and speed, will likely be a costly exercise. There will always be tradeoffs if you want to prioritize speed which will, in turn, increase your success, and paying for something now to improve your system will benefit you in the long run and reduce costs. Optimizing your systems for success means you will stack data making your program slower; on the other end, optimizing for cost by staging your investment also slows you down, and optimizing for speed increases costs. So, what is the solution? Adaptive design. With this, it is possible to increase success, reduce spending, AND get to an answer much faster. The industry is quite clear on clinical studies and stresses that when clinical studies are designed, there needs to be some level of assumption at play. An example would be that we assume that a patient will look a certain way (some studies require a specific person of a specific race, age, gender, etc.); the disease or illness will progress in a predetermined way; doses will perform in a certain way and the treatment effect. Some assumptions will most definitely be wrong, but this is exactly why clinical trials are conducted, to be accurate!
Quite a few factors must be taken into consideration in making adaptive design practical and attractive. Data needed for accurate simulations come from two sources – including real-world data collected from electronic health reasons and patient data acquired from past clinical trials. While the challenges organizations face include downtime and inaccuracies, it’s still difficult to engage with organizations to get involved in significant changes like adaptive design. It’s been noted in the industry that it is much easier for smaller organizations to move quickly; however, they might not always have the resources and the expertise on hand.
The Food and Drug Administration is now required to provide updated guidance on how companies can use adaptive trial designs. There is also regulatory guidance on how companies can use adaptive clinical trial designs that satisfy their needs and those industry standards. Over and above this, the FDA is open to simple adaptive designs while their interest in more complex designs is growing as they arise. All this leaves little margin for error, and organizations can feel assured that they are following the correct procedures and standards.