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Why participate in a study?
Who is eligible to participate?
What are the differences between clinical trial
phases?
How do I get more information about participating
in a specific trial?
Why has Roche decided to have its own registry and results database?
What is Roche’s position on providing
information on protocols and the results of clinical trials it
conducts?
Who pays for clinical research?
Where can I find out more about clinical research?
When is the data for a certain drug going
to be available on the results database?
What is a Diagnostic interventional trial?
Why participate
in a study?
People participate in clinical research for a variety of reasons. People who volunteer for clinical trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.
The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or another health institution (such as the NIH), must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
Who is eligible to participate?
Individuals interested in participating in a clinical trial should always consult a physician to understand the personal implications of participating in a clinical trial. In addition to physician consultation, individuals can read the specific eligibility criteria defined for each trial in the clinical trial protocol registry section of this website. The information provided gives details on the age, gender, health status and other requirements that an individual must meet in order to be eligible for a particular study.
What are the differences
between clinical trial phases?
Phase I through Phase IV clinical trials represent different
stages of clinical trial testing in the development process
of pharmaceutical products. Roche's definition of the different
clinical trial phases can be found under the Phase Definitions
page of this section.
How do I get more information
about participating in a specific trial?
There are a number of ways to find information about participating in a clinical trial. The best first step is to consult a physician about a specific trial and to understand the personal implications of participating in a clinical trial. In addition, individuals can search the clinical trial protocol registry section of this website to find out the eligibility requirements and locations of ongoing trials. Another resource provided through this website is an email service to inquire about specific trials. The service works directly with Roche to make the best possible effort to put individuals in touch with the appropriate people responsible for a trial.
Why has Roche decided to have its own registry and results database?
Roche has always been dedicated to transparency in clinical trials. By providing a user friendly, single source of cross-referenced information on Roche-sponsored trials for products marketed worldwide, the protocol registry and the results database will further enhance transparency to physicians, patients and other interested parties.
What is Roche’s
position on providing information on protocols and the results of clinical trials it conducts?
Roche believes it has an ethical obligation to publish information on the company’s ongoing clinical trials (as in the clinical trial registry), as well as the results of its trials (as in the results database). The company already publishes information on clinical trials in the scientific literature and participates in several local clinical trial protocol registries (such as the NIH / FDA supported registry on www.clinicaltrials.gov in the US). Moreover, Roche provides all details on clinical trials to regulatory authorities, as required by law, prior to approval and marketing of all products.
Who pays for clinical research?
Funding for clinical research comes from both federal governments (for example the National Institutes of Health in the US), and private industry (pharmaceutical and biotech companies). The sponsor of the research hires physicians, who may work in a wide variety of health-care settings, to conduct the clinical trial. Physicians are typically paid on a per-patient basis. The medical care is often provided free to the patient. Patients may also be paid a small fee to participate in a clinical trial.
Where can I find out more about
clinical research?
Understanding the unique process of clinical trials is important for any individual considering participation in a clinical trial. To find out more information about clinical research please visit the About section of this website for useful clinical trial information and links to other resources.
When is the data for a certain drug
going to be available on the results database?
The registry and results database will be populated with Roche clinical trials that fit the following criteria:
- The registry will be populated with all planned and active Pharmaceuticals and Diagnostics Roche-sponsored interventional trials (as of October 1, 2004), and all Phase I studies in patients (as of December 1, 2006), that have received IRB / IEC or CA approval, i.e. Roche Pharmaceuticals will post all Phase I studies in patients and all Phase II-IV trials.
- The results database will be populated as follows:
- All Roche-sponsored interventional Phase I trials in patients completed after December 1, 2006 on any approved product;
- All Roche-sponsored interventional Phase II to IV trials completed after October 1, 2002 on any approved product;
- All retrospective Roche-sponsored interventional Phase II to IV trials completed for products that received first approval in first indication after October 1, 2002.
- Results will be published within 1 year of trial completion (unless restricted by journal publication timing or pending regulatory filing).
Roche will continue to post information on a regular basis.
What is a Diagnostics interventional clinical trial?
A diagnostic interventional trial assigns a group of human subjects to an intervention based on the results of diagnostic tests. In most cases there will also be a comparison group that follows standard procedures. In that way the cause-and-effect relationship between a diagnostic test, a resulting medical intervention and a health outcome can be studied.
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