Did you know that a clinical trial for Botox from 1989 is still ongoing? The trial, sponsored by the National Institute of Neurological Disorders and Stroke, aims to study the efficacy of Botox in treating various movement disorders. It requires at least 2,000 male and female participants, yet the researchers are still recruiting.
You can check the trial’s details on this ClinicalTrials.gov entry, but this lengthy timeframe isn’t that uncommon. Clinical trials are perhaps the most time-consuming part of creating a new drug, with the average being around a decade. More people suffer or succumb to the disease with each year that the study remains in progress, and researchers know this too well.
No scientist wants to rush a drug, lest they risk creating a new problem on top of the current one. Fortunately, there are ways to accelerate clinical trials without compromising safety or quality.
- Reuse Data
‘Reusing’ in this context means using health-related data for purposes other than the function it initially served. Researchers rely on patient data, primarily used for general care, to conduct their respective research or analysis.
Reusability is more crucial than one gives it credit for. It forms the ‘R’ under the World Health Organization’s FAIR Principles in health-related data management and sharing (the other three being findability, accessibility, and interoperability). It accelerates drug development by making the most out of the data, reducing the risk of duplicate trials, and fostering new research ideas.
When paired with governance compliant software, storing and retrieving health-related data can be streamlined. Case report forms, electronic health records, data capture—researchers can have all the data they need in one platform, reducing search times.
- Automate Some Functions
Some life science experts say a major reason clinical trials take years to complete is the immense manual effort involved. One expert even says that researchers today still work with methods used about 50 years ago, from recruiting patients to reworking databases. It leads to inefficiencies and, in some cases, discrepancies in results.
Many experts agree that clinical trials should leave repetitive tasks to automated solutions. One key area that can benefit from them is registration screening, wherein automation can keep trial data up-to-date. Since new evidence comes in almost instantly in many fields, researchers want to keep their studies as timely as possible.
Automation also has a hand in making every aspect of clinical trials as transparent as possible. It isn’t unusual for partners, particularly large companies, to invest in these studies. Automating the funding process goes a long way in ensuring every penny of investment goes into the trial.
- Go Beyond The Hospital
The traditional, if not pre-pandemic, way of conducting clinical trials requires volunteers to go to their nearest hospital or medical research center. However, many potential participants live more than two hours from their local medical center, and COVID has shown how a pandemic can stop them from participating.
As a result, various scientific circles have called for more decentralization in future clinical trials. It means the venue goes beyond the hospital, communicating with participants via telehealth and having the drugs delivered to their doorsteps. Researchers and sponsors have shown that they’re more amicable to decentralized trials than before the pandemic.
Such trials wouldn’t have been possible decades ago, but now they’re here to stay. It accelerates trials by reaching out to more people regardless of where they live, helping researchers finish in less time. If it isn’t possible, researchers should at least consider them during planning.
- Cut Costs Wherever Possible
For researchers, nothing’s more frustrating than their idea for a study never advancing beyond the drawing board. There are several reasons for this, perhaps the most major being the lack of funding. Depending on the medical field, the cost of a clinical trial can reach billions.
interpreting the result
A 2020 study by researchers from George Washington and John Hopkins Universities cites that patient recruitment and trial clinic visits are the most significant cost drivers. In the case of the former, the number of participants required for clinical trials grows throughout all four phases.
Sponsors might be discouraged from funding clinical trials that cost nine or ten figures, but it doesn’t always have to be this way. The solutions previously explained are also known to save on trial costs on top of hastening them. For instance, the latest data suggests that decentralized trials can achieve a maximum return on investment of USD$13.20 for every dollar spent.
Conclusion
Only time can tell what the next health crisis will be and when it’ll happen. Because of this, time is of the essence for clinical trials, whether in progress or still planning them. These studies can be faster than they are now but shouldn’t come at the expense of quality and transparency.
