The World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) are calling on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines, whether full or conditional approval, under emergency use, or rejected. They urged industry players to publish clinical trial reports without redaction of confidential information for reasons of overriding public health interest.
The joint statement indicated that the COVID-19 pandemic has brought into sharp focus the need for information and data. This will support academics, researchers, and industry in developing vaccines and therapeutics. Also, it will support regulators and health authorities in their decision-making. Likewise, it will help healthcare professionals in their treatment decisions. Above all, it will “support public confidence in the vaccines and therapeutics being deployed”.
Meanwhile, the ICMRA and WHO noted that some initiatives have met with stakeholder support. Examples are the WHO International Clinical Trials Registry Platform and the US NIH ClinicalTrials.gov database. Nevertheless, the statement indicated that “not all past efforts have been successful”. The failure, according to the statement, is “because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing”.
“The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health”.
Furthermore, the ICMRA and WHO stated that regulators continue to spend considerable resources negotiating transparency with sponsors. According to them, there is the need to make available both positive and negative clinically relevant data. However, “personal data and individual patient data should be redacted”.
Benefits of Data transparency
According to the ICMRA and the WHO, the first benefit is a public trust. They explained that by doing this, “regulators are opening their decisions to public scrutiny demonstrating confidence in their work”.
Furthermore, another benefit is the possible check of data integrity, “a scientific necessity and an ethical must”.
“Data must be robust, exhaustive, and verifiable, through peer-review. Data integrity is priceless. Wrong regulatory decisions, made on selected or unreliable data, will affect the patients who receive that medicine”.
Public access to negative trials
Moreover, they pointed out that one of the sources of bias is the lack of public access to negative trials. According to them, this weakens the conclusions of systematic reviews. Not only that, but also “provides a false sense of reassurance on the safety or efficacy of the medicine”.
“Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programs and reducing both development costs and time. Publication of data also allows secondary analyses (and meta-analysis) which have a different or complementary focus”.
Furthermore, the statement indicated that many public bodies have made open access a requirement as data are a common good. Also, it stated that trial participants who contributed physically and took the potential research risks also owned the data.
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