Gates Package — page 1006

1 go back to the regulatory a lot faster. (If there's already a treatment on the market, you'll have to enroll more volunteers, because you'll need to show that your product is at least as effective as the competition.) Another hurdle in Phase 3 is finding enough volunteers to make sure your drug candidate is safe and effective for everyone who might take it. You need to find people who are sick-- obviously at this stage there's no point in giving your potential cure to people who don't have the disease--but for the reasons we covered in Chapter 4, it's hard enough to identify those people, much less to identify the ones who are not only sick but also willing to volunteer to try out a new drug. And because everything from age to race to overall health can affect how a drug works in a person's body, it's important to study how a lot of different people react to it. Recruiting a diverse set of volunteers for a clinical trial can sometimes take more time than running the trial itself. Regulatory approval. If you get out of Phase 3, you go back to the regulatory agency and apply for approval. The application can run literally hundreds of thousands of pages, and in the U.S., the FDA's review can take months or even years. The agency will also inspect the factory where you're going to make the drug, and they'll review the label you want to put on the vial as well as the printed information that's included in the packaging. Even after you're licensed, you might be required to run another phase of trials among certain groups of people, and in any case, regulators will continue to check your production line to make sure the doses you're making are safe, pure, and potent. And as more people take your drug, you'll keep watching out for adverse effects (an especially rare problem might only show up once lots of people are taking it), and you'll also be on the lookout for signs that the pathogen is building up a resistance to your drug.