The evolving role of clinical trial data sharing

Clinical trial data sharing among researchers, patients and sponsor companies has massive potential for catalysing scientific innovation. Ulo Palm considers the latest initiatives and their impact on market access.

The drug development process is increasingly burdened by administrative tasks, soaring costs and rising demands for drugs to reach the market faster. A further hurdle that has hindered clinical trials is the difficulty pharma companies face in accessing and sharing clinical data. Why is this? First, pharma companies have, in the past, been unwilling to share their clinical data publicly. Second, even if they choose to, there isn’t a streamlined process for clinical trial data sharing across the industry that benefits all stakeholders. And third, clinical data is often not utilised to its full potential, often only examined for a particular trial and seldom looked at again.

In the last few years, many in the industry have realised that successful and widespread clinical trial data sharing among researchers, patients and sponsor companies has massive potential for catalysing scientific innovation. They are recognising the power of pooling knowledge – and that information should no longer be a vast, untapped well. As a result, the industry-wide conversation around data sharing is progressing rapidly, and a plethora of new approaches and solutions are unlocking data-sharing benefits in clinical trials.

Change is happening

The New England Journal of Medicine (NEJM) published an article that outlines a number of clinical trial issues that greater data-sharing can address. It argues that, when researchers have access to more data, there is more potential to answer unknown scientific questions. It also highlights the ability of data sharing to support trial integrity, the overall reproducibility and rigour of the clinical trial system, and the development of quality drugs.

It makes sense, then, that one stakeholder group calling for changes in data sharing is patients. In the last few years, the patient community has grown more vocal about its desire for greater clinical trial transparency and access to health data and clinical trial results; some have even advocated for increased sharing of their data among research organisations to accelerate scientific innovation. Patient advocates in disease areas like Parkinson’s, where there is a lack of effective and lasting treatments, are speaking out and encouraging researchers to share data and results among their peers to further the value of clinical trial research for all Parkinson’s patients, with the aim of breaking ground on more effective treatment options.

Cancer patients, arguably the largest cohort of patient advocates, are also urging increased data sharing. As a result, big-data projects like CancerLinQ, which was created by the American Society of Clinical Oncology (ASCO) to share and analyse more cancer patient data, have emerged. Physicians have also seen benefits to accessing this crowd-sourced data in that they can provide more informed treatment recommendations to their patients.

The research community and health authorities have also done their part by publicising the power of data sharing, and promoting methods to streamline the process:

• The US Food and Drug Administration (FDA) has implemented more detailed guidelines about sharing clinical trial research results in the ClinicalTrials.gov database; there also are new policies that require patient-level data to be fully disclosed post-drug approval from the European Medicines Agency (EMA).
• Former Vice President Joe Biden’s Cancer Moon Shot Initiative last year called for more data sharing as one its core pillars. The 17-page strategic plan, written by Biden and his wife, Jill, states: “We sought to better understand and break down the silos and stovepipes that prevent sharing of information and impede advances in cancer research and treatment, while building a focused and coordinated effort at home and abroad.”
• The International Committee of Medical Journal Editors (ICMJE) last year declared that they would require researchers to share deidentified patient data for possible publication in the major medical journals under their jurisdiction, calling it an ‘ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk’.
• The Accelerating Medicines Partnership brings together a group of pharma companies to share data to identify molecular pathways in diseases such as Alzheimer’s, Type 2 diabetes, rheumatoid arthritis and lupus.
• Industry groups, such as not-for-profit TransCelerate BioPharma, are putting forth tangible and adoptable solutions that are helping to make sense of – and streamlining – the new guidelines and momentum around data sharing.

Examples of successful data sharing

Reflecting on the last year, TransCelerate particularly demonstrated progress in its efforts to streamline voluntary information sharing across its membership.

One solution that is starting to evoke important industry change is the Placebo & Standard of Care Data Sharing (PSoC) Initiative, which is focused on the reuse of placebo and standard-of-care (SoC) data from existing and historical studies. The goal is to share information between participating member companies to help them enhance trial designs, develop disease models, provide context for safety observations and ease issues around patient recruitment by eliminating the need to recruit for the control arms of a study, among other capabilities.

Since its launch, the PSoC Initiative has established a data repository that stores clinical information from over 67,000 patients from roughly 90 clinical trials that span 11 different therapeutic areas. There have also been 15 separate examples of companies downloading trial data from the database to inform their research. Further, preliminary results from one clinical trial revealed that utilising the PSoC database reduced study time by 30%.

These preliminary results indicate that designing clinical trials using the harmonised PSoC data should reduce the number of enrolled patients to be randomised to a placebo or SoC arm of a study. While this has cost benefits to the company, there are also significant benefits in terms of speeding the development of medicines and, more importantly, reducing the number of patients exposed to sub-optimal placebo treatment. This has major implications for rare disease research, where recruitment and ethical issues around use of a placebo drug are of paramount concern

TransCelerate has also started working with health authorities and academia to promote the scientific acceptance of reusing historical placebo and SoC data in clinical trials. This is a paradigm shift which could fundamentally change clinical research and drug development for the benefit of patients worldwide who are waiting for new and effective treatments.

Similarly, TransCelerate’s Comparator Network (CN) Initiative, which aims to enhance patient safety by establishing a reliable mechanism to acquire clinical trial comparator and co-therapy drugs, saw results last year that showed significant progress towards greater safety and efficiency in clinical research, through the sharing of drug supply information and data.

Considering the high probability of counterfeit drugs entering the investigational supply chain, the CN has made its materials and comparator drug documentation available to ensure fewer get through.

Recently the CN exceeded transaction volumes of $120 million, saving members about 10-12% per transaction. Through this resource, the Network has avoided wasting substantial quantities of investigational product. Most importantly, avoiding drug loss due to potential temperature excursions has prevented delays in getting lifesaving products to patients who participate in clinical trials.

These are just two examples of industry stakeholders developing solutions and processes that enable data sharing to support more efficient clinical research, and deliver drugs to patients.

Future of clinical trial data sharing

The drug development industry is embracing the data sharing movement, and there is no turning back. Still, there is much work to be done to acclimatise to this new age of information sharing and harmonisation. It will take a truly collaborative and multi-pronged approach from health authorities, researchers, pharma organisations and – critical to the equation – patients, to develop meaningful solutions that address any existing roadblocks to making data exchange the new norm. The good news? The road ahead is already being paved and progress is underway thanks to efforts like those shared above, building on existing collaborative efforts to develop drugs and elevate scientific discovery.

About the author:

Ulo Palm is Senior Vice President, Drug Development Operations, at Allergan and Oversight Committee Chair, at TransCelerate BioPharma.

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