HarshaPharmTimesPharmacy Times® interviewed Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics, on the potential to accelerate patient recruitment and solve clinical trial delays. Currently, the research, development, and approval process of a new drug by the FDA can take between 12 to 15 years. However, studies have shown patient recruitment issues are the cause of 85% of clinical trial delays.

Pharmacy Times: What are the different phases of the drug approval process by the FDA?

Harsha Rajasimha: Typically, drug approval process involves a preclinical phase, which enables first-in-human clinical trial for a new drug or entity. And that goes through phase 1, phase 2, phase 3 trials, typically. And sometimes there can be phase 1 and 2, or phase 2 and 3 combined, and stuff like that, and different types of trial designs these days, but typically phase 1, phase 2, phase 3, where phase 1 is entirely looking at safety of the drug in humans, because it's only tested in animals. Phase 2, looking at safety and efficacy at very low doses to make sure there is some drug effect. And phase 3 is full-fledged in a larger population, to assess the safety and efficacy profile across the range of doses in a range of patients in the target population. And after that, all of this data gets wrapped into an FDA submission for review. And the whole process from phase 1 to phase 3 and the review process can take about 7 years, typically, sometimes longer. And so, it's a very expensive and time-consuming process. And this process is often called the “Valley of Death,” because only 1 in 9, 1 out of 10 drugs actually make it through the regulatory approval. Most of them will fail at phase 1, or phase 2, or phase 3, about 30% at each phase. So, very few drugs make it to market.


Pharmacy Times: Could you discuss issues pertaining to blinding during clinical trials?

Rajasimha: There is single blinding and double blinding where in single blinding, only the patients are not informed or aware whether they're actually getting a drug or a placebo. And in double blinding, both the investigator and the patient are unaware which patient gets the placebo and which patient gets the actual drug. Now, there are open-label clinical trials where everybody knows who is getting what, and that's also getting increasingly common. And so the gold standard in assessing the safety and efficacy of new drugs, first-time drugs, and not in a repurposing trial where the safety and efficacy is already established in one indication, say arthritis, and now it's being repurposed for a rare indication or a different disease is something that happens direct to phase 3 trials, because the safety is already established and even efficacy, to a certain extent, in other indications. So, blinding may or may not be employed in a specific clinical trial, but for a brand-new drug, randomized controlled clinical trials have—they’re called RCTs—that’s the gold standard, even today. And that involves double blind, most of the time, where there is a group of patients who may get the drug and a group of patients who may not get the drug. They may not be the same group size, as often they want to minimize the number of patients who do not get the drug and they get the placebo, just because it's both not fair on the patients that they are denied a treatment and two, it's big, we want to minimize that number to the extent possible.

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