During a busy week for Oxford PharmaGenesis, a successful Open Pharma roundtable and ISMPP EU conference were followed by a plenary presentation at the opening session of CBI’s 7th Annual Clinical Data Disclosure, Transparency & Plain Language Summaries Conference in Miami, FL, USA (22–24 January 2020).
A diverse delegation included representatives from a range of pharma clinical development, medical affairs and patient engagement functions, agencies, patient advocacy groups, governmental organizations and academic institutions.
The conference began with an inspiring keynote presentation by Jessica Scott of Takeda on how the pharma industry can better meet the needs of patients. Oxford PharmaGenesis COO Richard White then presented on the theme of ‘bridging the gap’ – addressing how the evolution of open science and patient engagement is driving enhanced clinical data disclosure, dissemination and discoverability, and how pharma functions can work together to achieve these goals.
Parallel presentations and workshop sessions converged around the theme of a sea change in the attitudes and practices of big pharma companies when it comes to increasing transparency and disclosure of clinical trial information. This is with respect to both trial methods and results, and individual patient-level data. Companies have gone from “No, we will not share data” to “Yes, we will share data, but how do we do this in a manner that protects individual patients while responding to a continually changing regulatory environment?”
Regulatory challenges were described with respect to different methods of disclosure that are currently required by the EU, Health Canada and the Japanese authorities. Ironically, disparate disclosure rules have created a situation in which the lack of harmonization can increase the risk of patients’ identities being discovered simply by comparing the disclosure documents submitted to different entities. There was considerable discussion about the need for industry and governmental bodies to work together to achieve greater consistency with respect to reporting requirements.
A corollary challenge is how to maximize the amount of data shared while ‘de-risking’ the process to avoid compromising patient privacy. Clearly, there are situations in which a patient’s identity can be determined if all the demographic and clinical data are shared in an unaltered form. Methods were described for transforming or recording data such that the utility of the data can be preserved to allow for additional interrogation by third parties.
There have also been major attitudinal changes with respect to how patients are viewed, treated and communicated with throughout the clinical trial process. Several speakers discussed personal and powerful experiences that greatly affected them in either a negative or positive manner. Some important messages emerged from these presentations. First, patients want to be treated with honesty and respect. However, there is no one-size-fits-all approach; when sharing information with patients, it is important to determine whether the patient is truly prepared to hear the information. Second, communication throughout the trial process is critical, and can improve the trial process for both patients and trialists. This can start prior to trial initiation using patient advisory boards to help to develop optimized informed consents, understand aspects of study protocols that may present barriers to patients or identify study outcomes that are important to patients. All of these can lead to more positive trial experiences for patients, which can also facilitate trial accrual, including accrual for future studies. Post-trial communications are also critical in the form of plain language summaries that provide trial results in a manner that is easily digestible for patients. In addition, patients increasingly want access to their individual results because their data can be informative when they are considering participation in future trials. One challenge, however, is when patients openly discuss their personal data (via social media or other public forums), they potentially increase the risk that an attacker could identify others who participated in the same trial. Finally, considerable interest in the Open Pharma initiative at the Oxford PharmaGenesis stand highlighted that patients want open access to journal articles of clinical trials relevant to their treatment, without having to pay for it.
There has also been a considerable amount of technology development, with new companies providing approaches to help pharma companies to anonymize patient data, or to help patients more easily use resources like ClinicalTrials.gov to find trials that they could potentially participate in. One final observation on the conference is that all the stakeholders who were present at the meeting are devoting considerable energy to improving transparency and the disclosure process, and on improving the trial process for patients. Although there are still significant challenges to be addressed, where we are today is not where we will be in a few years, and we are evolving processes that we, as an industry, can be proud of.
