jueves, 10 de diciembre de 2015

Consumer Updates > Who's in Clinical Trials?

Consumer Updates > Who's in Clinical Trials?

Who's in Clinical Trials?

Drug Trials Snapshots

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Have you ever wondered if someone like you participated in the clinical trials for a new drug? If you have, you’re not alone.
That’s why FDA is making demographic information from clinical trials, such as the inclusion of women and minority groups, more easily available to consumers through its online Drug Trials Snapshots database. This section of the FDA website is written in an easy-to-read format so you can see who took part in research studies for new drugs by sex, race, and age.
“Now patients can go to just one section of the FDA website and immediately find answers. For example, how many women, Asians, and blacks participated in research studies that supported the approval of a new drug,” says Naomi Lowy, M.D., a doctor at FDA.
Snapshots also help people understand if there are any differences in the benefits or side effects of a new drug between men and women, and among patients of different races and ages. “Patients can use this information as one resource to discuss the use of a drug with their doctor and to evaluate its benefits and side effects,” says Lowy.

Demographic Information in One Place

Through Drug Trials Snapshots, FDA is addressing concerns raised by advocacy groups and the public, including important issues such as tracking information about how many women and minorities participate in drug trials.
It used to be hard for consumers to find details about how many people were enrolled in drug trials – as well as information about their race, sex, and age.
“Consumers had to wade through publically available scientific reviews on drug approvals, and that involved quite a bit of time and maneuvering,” Lowy says. “With Drug Trials Snapshots, patients can find the information they need easily in one place, written in consumer-friendly language.”
Each snapshot provides questions and answers with information about the drug that is being tested in the trial. The information includes what disease the drug is for, how it’s used, how it benefits patients, and what the potential side effects are.
Consumers can also find out how well the drug worked among women and men, minorities and different age groups, and how those research trials were designed. Snapshots show who participated in the clinical trial, an important part of FDA’s commitment to sharing clinical trial information with the public.
In addition, the site provides information on whether certain patients responded differently to a drug. “For example, if bleeding is a known side effect of a drug, we ask whether bleeding was worse in older adults compared to younger adults,” Lowy says.
Each snapshot has links to more detailed clinical and technical information, such as tables and charts for people who want more data. This material includes links to the prescribing information, commonly known as the label.
Snapshots are created by FDA from data generated in drug trials conducted by the manufacturer. The agency interprets the data, analyzes it and writes its conclusions. FDA’s goal is to publish a snapshot 30 days after a new drug approval. There are now more than 40 snapshots on new drugs, and the website is continuously updated.

How This Helps Consumers

Drug Trials Snapshots provide more information than is found in the patient prescribing information (or drug label) – but keep in mind that they don’t replace it or provide prescribing information.
“People shouldn’t use this information alone when choosing a drug to treat their condition or to replace the conversations they need to have with their health care providers,” Lowy says. “This is just another powerful tool they can use to make informed decisions.”
“Consumers have a right to this information. We want people to find this useful, accessible and easy to use,” Lowy adds. And it’s meeting a need, according to Lowy. “Thousands of people are using the website. They appreciate having this information and find it very helpful.”

Designing Better Clinical Studies

Beyond transparency, FDA hopes this initiative will further the discussion about how individuals might respond differently to the same drug. “The amount and quality of the information about how a drug works increase when the population studied has greater inclusion of all types of people in drug trials,” Lowy says.
“How do we know we have enough people to detect a difference in one specific group? What is the right number of clinical trial participants in each sex, race, and age group, and why? Those are some of the questions we need to explore,” Lowy says. “It’s an exciting time to be part of this growing conversation.”
You can sign up to receive email alerts when a new snapshot is published. You can send suggestions and questions about snapshots to snapshots@fda.hhs.gov.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
December 9, 2015

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