In a follow-up to the previous blog post on 06-May-2020, see 'The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project', this is an update to some of the initiatives that have changed since the initial discussion.

UPDATES TO SHARING DATA DURING COVID-19

While the fear of compromising intellectual property or losing academic credit usually shrouds research in secrecy, the COVID-19 pandemic has seen unprecedented collaboration from across the scientific community. Robust and defensible data sharing strategies that can be implemented quickly may shape the efficacy of pandemic response efforts. The importance of the timely exchange of clinical trial data was highlighted during the 2014-2015 Ebola epidemic in West Africa, resulting in a statement from the World Health Organisation (WHO) to that effect in November 2015.

Data sharing platform initiatives

The two primary considerations in sharing of clinical trial data are a) finding the appropriate platform through which data may be hosted securely, and b) ensuring patient privacy is protected. There are several prominent clinical trial data sharing platforms, and some are offering COVID-19 specific portals with free services for sharing COVID-19 clinical trial data.

Rapid anonymization of large clinical datasets to contribute to COVID-19 research efforts is likely to prove challenging for many data custodians though and should still follow the proper processes and reviews as necessary. Realising that expert de-identification services could be leveraged to expedite COVID-19 clinical trial data sharing, there are anonymization vendors who have also agreed to waive fees in order to better serve the global research community.

While data gathered during clinical trials are valuable, so too are the data regarding the sequences of COVID-19 and other coronaviruses, as well as information about human genes implicated in the virus infection of the host cells. To enable expeditious sharing of this crucial research, the European Commission established the COVID-19 Data Portal. Today this portal contains over 123,000 records on viral sequences and a literature library with almost 200,000 entries.

The impacts of the COVID-19 pandemic are likely to have far-reaching effects across the entire clinical research community. A hopeful positive outcome from this would be for this spirit of collaboration and voluntary sharing of data to remain entrenched in the ethos of each pharmaceutical company and academic institution, to better meet human health challenges in the future.

EMA data sharing

Additionally, the European Medicines Agency (EMA) is implementing exceptional measures to ensure transparency of data for COVID-19 treatments and vaccines. Since most of these programs will be following an accelerated approval, it is crucial that the public is assured of the quality of data being produced.

The EMA will publish the CHMP for compassionate use, marketing authorization applications, the product information, the full EPAR, and a summary of the risk mitigation plan (RMP). The clinical trial data will be published on the clinical data website after marketing authorization.

The EMA may continue to increase transparency of other regulatory procedures in the future.

Ensuring privacy

To ensure that privacy is protected when sharing clinical trial data, it is important to develop thorough anonymization techniques of that data. This can be achieved most effectively through the utilization of a quantitative, risk-based approach to anonymization. Such methods, properly applied, ensure that it is unlikely that a person can be identified, which has been demonstrated empirically through rigorous testing. Briefly, this strategy can be applied to ensure that patient information is transformed sufficiently to preserve privacy while maximizing data utility.

Examples of data sharing platforms are Vivli, CSDR, DataCelerate, and others.

UPDATES TO THE GLOBAL DATA PROTECTION REGULATION (GDPR)

Lightening restrictions for COVID-19 data sharing

The recently released EDPB guidance explains the lawfulness of data collection and processing, as well as the importance of adopting sufficient security methods and confidentiality policies to ensure legitimate data sharing, as needed.

With regard to the processing of personal data, including special categories of data by competent public authorities (e.g. public health authorities), the EDPB considers that article 6 and article 9 of GDPR enable the processing of personal data, in particular when it falls under the legal mandate of the public authority provided by national legislation and the conditions enshrined in the GDPR.

During reactivation of businesses, some member states have issued guidance for collecting personal location data in order trace contact interactions (monitor, contain or mitigate the spread of COVID-19). The UK Information Commissioner’s Office (ICO) guidance has advised businesses to collect minimal contact data of the customer with the sole purpose of COVID-19 tracing, storing the data carefully without using it for any direct marketing. This may be done by collecting the data anonymously and generating a report.

DISCLOSING RESULTS FOR COVID-19 STUDIES

NIH Calls on Clinical Researchers to Disclose Results Ahead of Regulations

The pandemic has imposed the need to quickly find an effective treatment and/or vaccine for the COVID-19 virus. A literature search (cutoff date: 27 Oct 2020) indicates 455 studies have been registered on clinicaltrials.gov for COVID-19 research. The search terms included: COVID-19, Coronavirus, recruiting, active but not recruiting, all phases, interventional studies. There are an additional 60 studies with a ‘completed’ status, of which two studies have published results’. In addition, four sponsors have published their complete clinical trial protocols; Moderna, Pfizer, AstraZeneca, and Janssen, prior to marketing approval. Biomed Central has also created an open access library of approximately 90 clinical trial protocols to aid Covid-19 research. This enables further transparency and in turn strengthens public trust in the ongoing research.

Under emergency use authorization (EUA), FDA has approved three drug products – Propoven (to maintain sedation), Remdesivir (patients with severe disease), ultiFiltrate PRO System, multiBic/multiPlus Solutions (to provide CRRT), and Lilly’s monocloncal antibody therapy, Bamlanivimab. Pfizer has also announced that early data from a large trial has shown that their COVID-19 vaccines has shown to be strongly effective.

While NIH is encouraging results be disclosed ahead of regulatory deadlines, it is important to note that results are not due until one year after the Primary Completion Date; however, with the programs accelerating so quickly into approval, it would be useful to the public to disclose the results sooner if the data is available. In the current pandemic scenario, where there are several industry-wide efforts to improve clinical trial transparency, it is important to have the ability to independently analyze the generated clinical trial data.

REGULATORY COLLABORATION UPDATES

While the EU has always been an important collaborator with the FDA in tackling public health challenges, the COVID-19 pandemic has led to a multitude of critical collaborations on many scientific and regulatory fronts.

There are 30 technical expert groups, or “clusters” that the FDA and the EMA have established since 2003. These groups, which meet regularly with discussions protected under confidentiality commitments, are well positioned to pivot to focus on COVID-19.

Additionally, communications have increased between FDA and their counterparts in Europe, Canada, Japan, and other nations through established programs and agreements. The International Coalition of Medicines Regulatory Authorities (ICMRA) has also been facilitating regular communications among approximately 30 governmental and international agencies. These efforts are to gain knowledge collaboratively, seeking global common approaches to clinical research during these troubling times. It is hopeful that these discussions will begin to include disclosure and transparency harmonization efforts as well, aligning the disclosure of information, results, and data appropriately. Initial discussions have already been initiated with FDA, EMA, and Health Canada.

Contributors: Nate Root, Niamh McGuinness, Sarah Balay, Shalini Dwivedi