NHS Digital Data Release Register - reformatted
MEDICAGO R&D INCORPORATED projects
- A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
7 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older — DARS-NIC-436453-C4N4Z
Type of data: information not disclosed for TRE projects
Opt outs honoured: Identifiable (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 s261(2)(c)
Purposes: Yes (Research)
When:DSA runs 2021-03-23 — 2022-03-22
Access method: One-Off
Data-controller type: MEDICAGO R&D INCORPORATED
Sublicensing allowed: No
- Permission to Contact
The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which:
Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent.
Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.
Reduces burden on research staff in identifying and contacting potential clinical trial participants.
Supports the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.
The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.
This is expected to result in individuals entering the trials screening process with a view to them participating in the trial with fully informed consent.
The main results from this trial are expected to inform development of a safe and effective multiple vaccine combination against COVID 19.
NHS Digital will extract a list of patients meeting the following criteria, where that criteria can be ascertained using the PtC registry:
Study population #1: 18 - 64 years, good general health, pre-existing chronic disease allowed to participate if stable.
Study population #2: 18 years+.
Study population #3: 18 years of age or older with one or more co-morbid conditions that puts them at higher risk for severe COVID-19 disease, could include obesity, hypertension, diabetes, COPD, cardiovascular diseases, chronic kidney diseases or be immunocompromised.
All study populations: Pregnancy, vaccination within 14 days prior to visit 2, positive COVID-19 test. COVID-19 prophylaxis treatment.
Populations #1 and #2: any chronic medical condition associated with elevated risk of severe outcomes of COVID-19, including obesity, diabetes, significant cardiovascular or respiratory diseases including asthma, chronic renal failure, bleeding disorders, chronic inflammatory or autoimmune conditions, immunosuppressive conditions (including HIV) and hypertension. Cancer treatment. Autoimmune diseases.
The inclusion and exclusion criteria noted above is based on the information provided by cohort members on the permission to contact dataset (where it can be obtained from this dataset), and is not collected from other NHS data sources. Some of the above inclusion and exclusion criteria will be used by the sites during the Screening phase.
NHS Digital will identify all individuals within the PtC dataset meeting the relevant criteria and will extract their names, email addresses and postcodes.
It is not known in advance how many individuals meeting the above criteria will have records in the PtC dataset. The number may be amended and the process may be repeated depending on the level of response. In the event of the trial not achieving a suitable balance in recruited participants, such as an uneven ratio of males to females, subsequent mail outs may restrict the required criteria to a greater degree than previously, for example, only requesting details for male participants as opposed to both males and females. This could encompass any part of the criteria, such as age, gender, ethnicity or location and various others, depending on how the recruitment progresses.
NHS Digital will write to the individuals in the subset inviting them to participate within the trial using ethically approved text provided by Medicago. The email will remind the individuals of the background of the permission to contact programme and give them the opportunity to state that they do not wish to be contacted again. The email will also direct volunteers to NIHRs Be Part of Research website to access study information and regional contact information.
Individuals will not be contacted multiple times under this Agreement and NHS Digital will record the fact that the individuals have been contacted to ensure compliance with the maximum number of contacts outlined as part of consent. Furthermore, in order to ensure that NHS Digital are able to update the register with which participants are registered with an active trial, and therefore prevent them from being invited to any further trials, NHS Digital will be provided with regular updates of those registered participants who have consented. This sharing of information is built into the Permission to Contact signing up information and will also be added to the trial consent and participant information.
Syneos Health will supply individual recruitment sites with the IDs of those patients who have gone through the pre-screener in order to invite them for further screening. Individual trial recruitment sites will supply NHS Digital with details of those who have signed up to take part in their trial so that NHS Digital can suitably capture this information within the Permission To Contact registry. All data that flows to NHS Digital in this context falls under the controllership of Medicago. Once it is received at NHS Digital then NHS Digital become controller for that data in their existing role as controller of the Permission To Contact Registry.
Due to the nature of trial recruitment sites, they often only become confirmed as sites very close to recruitment, and so NHS Digital will leave the responsibility with the lead site / data controller to appointment data processors themselves under their own due diligence. This practice aligns with their obligations under GDPR as a data controller and the emphasis will be on the lead site / data controller to appoint appropriate data processors on their behalf. Ordinarily NHS Digital would carry out these checks, but attempting to do so for this service would cause unnecessary delay to the initial application, as well as potentially multiple and costly amendments thereafter. Therefore all recruitment sites / data processors and their processing activities will be covered under a suitable processing agreement between themselves and the lead site / data controller which does not require NHS Digitals inclusion. Specific details of recruitment sites, such as key contact, location, will therefore not be made known to NHS Digital unless there is a specific reason to do so.
Additionally, Medicago have an appropriate data processing agreement in place with Syneos Health to support the recruitment into the trial under Medicagos controllership
No other processing of the data will take place and the data will not be linked with information from any other sources.
Medicago will not have access to any of the data being disseminated by NHS Digital under this agreement.