Applied Clinical Trials
Transparency in clinical trials doesn't have to be difficult but requires attention writes Thomas Wicks, Chief Strategy Officer for TrialScope. Smaller organizations tend to lag in their commitments to clinical data sharing and be non-compliant with regulations, but the trend is shifting.
Clinical data transparency does not have to be difficult, but it does require attention. Large biopharmaceutical companies are steadily expanding their transparency commitments, and most have achieved solid compliance with disclosure requirements. Unfortunately, smaller organizations are generally lagging in their commitments to clinical data sharing and all too often are non-compliant with regulations.
While some organizations are failing to comply with disclosure regulations, external pressures continue to build. Not only are health authorities now including trial disclosure in their inspections and watchdog organizations are publicly naming and shaming individual organizations of all sizes, but investors and potential acquirers are also assessing a company’s transparency practices as part of their due diligence processes.
Thankfully, the trend is shifting, and smaller organizations are starting to pay greater attention to clinical trial disclosure requirements, though they may face additional challenges than their larger peers.
Patients and trial participants
Patient groups and trial participants are increasingly vocal in their demand that clinical trial information should be made available publicly in a language and in a format that is meaningful to patients. This includes providing easily searchable lists about trials that are enrolling and plain-language results summaries. Providing this information supports trial recruitment and patient engagement efforts, which are important to companies of all sizes.
Health authority inspections
Although the earliest trial disclosure regulations were enacted almost two decades ago, there has been virtually no enforcement in that time. However, inspections for compliance with these regulations have now started, with Qualified Persons for Pharmacovigilance (QPPV) of affiliates in the European Union reporting that they had to provide evidence of compliance during recent quality and pharmacovigilance inspections. The FDA has completed a pilot program and is expected to start including disclosure compliance in its inspections going forward. To be ready for these inspections means preparing the necessary process documents and developing the supporting evidence to show that the processes were followed in full compliance of the regulations.
Transparency advocates and industry watchdogs have periodically published assessment of clinical trial disclosure practices for years. Initially, these were broad analyses of disclosure based on limited data and aggregated across sponsors, without focusing the data of specific organizations. In recent years, these analyses have become much more rigorous and now name and rank every trial sponsor irrespective of size or industry segment.
Investors and Acquirers
In 2015 a group of 85 pension funds and asset managers representing more than $3.8 trillion joined the AllTrials campaign. These investors view great trial data transparency as one way to mitigate brand and valuation risks. Those organizations planning to seek funding or those that expect to be acquired in the future may find that poor disclosure practices can create issues during the vetting process.
No central coordination and tracking
In smaller organizations, trial information is often made public on registries across the world, without centralized oversight and relying on documents that were created without disclosure in mind. While there may be documented processes in place for the largest trial registries, such as ClinicalTrials.gov, these are often managed locally, with little or no coordination across affiliates or the local CROs. With no consolidated view into the data made public or a central tracking of global regulations, executives lack awareness of the disclosure landscape and the risks of inconsistent or non-compliant processes.
Limited experience, resources, and automation
With a more limited trial portfolio, smaller organizations disclose clinical data less frequently, and so often lack comprehensive guidelines for assessing trial disclosure requirements as well as consistent processes for ensuring efficient and compliant public sharing of clinical data. With fewer trials, smaller organizations typically have few, if any, dedicated disclosure specialists and often no local staff involved in disclosure outside the US and perhaps the EU.
These resource constraints are further compounded by a lack of automation that could alleviate some of these issues. Most smaller companies do not have a central clinical trial management system (CTMS) that could ease the effort of registering and periodically updating clinical protocol information. Instead of systems designed specifically to support trial disclosure, these companies often rely on a manual approach perhaps tracked through various spreadsheets. The difficulty of a manual approach is adapting quickly changing requirements and responding to tightening deadlines and increasingly frequent updates that are mandated by regulation. Spreadsheets and manual disclosure processes also make responding to inspections more difficult and rarely provide a global transparency perspective to company executives.
Documents not authored with disclosure in mind
Larger biopharmaceutical organizations are implementing guidelines and templates for authoring protocols, clinical study reports (CSRs), and SAS datasets that support the clinical data sharing and disclosure requirements. While the purpose of implementing these new authoring approaches goes beyond preparing for disclosure, well-structured sources of information that consider the downstream data sharing requirements greatly facilitate efficient trial transparency and help ensure global consistency of the data that is made public.
Managing acquisitions, divestitures and name changes
As organizations acquire products or entire companies, they also assume the responsibility for the data of the trials related to the acquisition. Life sciences companies of all sizes often struggle to identify all trials associated with the acquisition, especially if the acquired entity has previously grown through their own mergers and acquisitions. In the European Union, this requires documenting every trial initiated since May 2004 for all acquisitions and then disclosing results for these trials if the previous organization had failed to do so.
On the other hand, when a company divests a product or division, trial disclosure of divestiture becomes the responsibility of the new organization. However, the original company’s name will still be shown on the trial registry of the European Medicines Agency, which can mean a company might appear non-compliant, even if the responsibility has shifted to a new organization.
Identifying these older trials can be made even more difficult where companies have changed their name in the past fifteen years. In the US this is a little easier to manage, because the main registry, ClinicalTrials.gov, maintains a controlled list of organization names and allows updating the sponsor name of trials related to acquisitions or corporate name changes. In the EU, however, there is no controlled list of organization names and limited ability to change the sponsor name of acquired trials.
The answer: prioritize disclosure
With the industry’s growing trend toward greater transparency and increasing pressure from health authorities, transparency advocates, investors, and patient groups, companies can no longer afford to consider trial disclosure just as a minor regulatory nuisance. Instead, trial disclosure deserves attention from the senior leadership at companies of any size, with agreement on an overall corporate transparency policy that clearly articulates the organization’s commitments.
More than 90 countries have some form of disclosure requirement to share trial data on one of 30-plus trial registries, so sponsors should have central visibility into these requirements and the ability to track disclosure globally, ensuring compliance and consistency. Companies with smaller trial portfolios that lack the experience developed over frequent disclosures and those that cannot afford to hire dedicated specialists should consider working with a solution provider that offers both automation and disclosure services.
Thomas Wicks is Chief Strategy Officer for TrialScope.