According to new rules established under the Final Rule for Clinical Trials Registration and Results Information Submission, drug companies in the US will now have to post information on expanded access on ClinicalTrials.gov, which is the largest and most widely accepted clinical trials database in the world.
The website has been updated to make it easy and straight forward for companies to provide this information and for patients and caregivers to access it.
For companies, there will now be an ‘Availability of Expanded Access’ data element that must be completed when registering a clinical trial. If a company has decided to provide its drugs to patients through expanded access, this data element should be answered ‘Yes’. If a company has decided not to allow expanded access, the data element should be answered ‘No’. However, a company can and should update this information, if it decides to provide expanded access at a later date.
In addition, companies will also have to submit an expanded access record which provides details about how patients can obtain access to the investigational drugs. When submitting this record, companies should select ‘Expanded Access’ as the Study Type, so that it can be made easily accessible to patients searching the website. Companies must also provide the ClinicalTrials.gov Identifier (NCT Number) for the expanded access record in their Expanded Access Policy, which companies are now required to post on their websites.
For more information on this new Expanded Access Policy requirement, see earlier WEP Clinical blog post, ‘Deadline for companies to post their policy on expanded access’.
Companies are required, under 42 CFR 11.64(a)(1)(ii)(D) and (E), to keep the information on the availability of expanded access, as well as the expanded access record, up-to-date. Responsible parties will have until 18 April, 2017, to come into compliance with these requirements.
For patients, all available Expanded Access Programs can be found by using the ‘Advanced Search’ function under the ‘Search for Studies’ section on the ClinicalTrials.gov homepage. Patients should select ‘Expanded Access Studies’ from the drop-down menu in the field titled ‘Study Type’. To tailor the search to each patient’s individual needs, there is also an option to indicate a disease/condition before searching for available studies.