Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona

Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference in Spain last week.

The term trial transparency usually refers to a sponsor’s publication of data from all clinical studies – now a legal requirement thatnks to pressure from oragnisation's like the Alltrials group.

The argument is that publication allows independent researchers to scrutinise safety and efficacy profiles of drugs in a way that improves the development of effective medicines.

The drug industry has instead called for more limited data publication or “responsible transparency ,” arguing that issues like patient privacy and concerns about giving information to potential competitors as reasons for limiting disclosure.

Such concerns were not in evidence at Partnerships in Clinical Trials (PCT) in Barcelona where industry speakers said that - in general - making the entire trial process more open was a good thing.

Anders Persson, hub director of clinical operations at AstraZeneca, said that: “One of the effects is of course more work, but as an optimist I see [increasing transparency requirements] as a great opportunity for us to improve our reputation as a business.”

“It’s about patient privacy rights. It’s about the safety of volunteers in our trials and if we get this right and understand that we can share data more widely it will help us improve healthcare” he said, adding that “it’s about getting the data out there and making sure it’s available to everyone.”

Jay Kaminski, VP of clinical research and development at Celgene, agreed, suggesting that: “The transparency approach is about getting about getting more patients involved with their own data at point of care, which is fantastic.

“Having data out there so people in the public domain can make more educated decisions with their data is appropriate as long as it is done in a consistent manner, company to company and that’s the most important thing for us, a consistent approach to data and data sharing.”

This view was also shared by delegates judging by the show of hands when panel chair Dr Phil Hammond asked whether transparency was an opportunity.

Similarly, the majority of the CRO and sponsor employees attending also indicated they would want access to their own data and the clinical study report (CSR) if they took part in a trial.

Brendan Buckley from Icon made a similar point, telling attendees that: “We have moved away from the paternalistic approach…we much more view patients as partners now and they engage with that.

“If we try to cut them out from being partners, they go off into the wild and seek other means of expressing themselves, potentially more destructively. So I think that we need to acknowledge those who participate in our trials as being true partners” Buckley added.  

Downsides

Patrice Hugo from LabCorp also said greater transparency would improve trials, suggesting that although there is no data indicating it helps with recruitment, compliance or retention, “I’d like to believe that a patient who feels trusted is more likely to engage with the trial.”

However, Hugo also raised the prospect of unintended consequences. He suggested that opening data up to greater scrutiny is likely to impact regulators.

“I think it is going to put some pressure on the regulators after the publication of all the data you will have a lot of people interpreting the data to determine why a drug was approved or rejected…I don’t know whether it’s is going to be positive or negative but I see feedback there for sure.”

Kaminski from Celegene raised another potential negative impact, suggesting that: “I think the challenge it [data transparency] poses is that it increases connectivity with the patient and the company running the trial, which could lead to the physician being bypassed.

“The ability to communicate directly with the patient on their outcomes in a company trial has positives and negatives that the industry needs to think through.”  

Social media bias

Trial transparency in the era of social media is another potential problem according to Adrian Otte, VP of global development operations at Amgen, who suggested patients discussing side effects on social media could potentially introduce bias into a study .

Participants could use the information to ‘shop around’ by joining trials at several sites if they believe they are being given a placebo according to Otte, who said: “There are potential problems and I don’t think we are going to get away from them.”

“Patients will use social media. We can encourage them not to, but they are likely to and we will have to monitor and educate patients on the consequences” he continued, adding that although onerous such oversight is preferable to introducing more restrictive consent forms.

Otte explained that even though current consent form are designed to be simple enough to by understood by an eighth-grade reader, a 13 year old, the technical and legal specifications required already mean that some documents are 15 pages long.

Instead, technology should be used to make the consent process more transparent according to Otte, who said: “I think there are things happening in the area of e-informed consent that will help.

“We can perhaps use tools that are more interactive, quiz-like to help the patient participate in that [the consent] process rather than giving them a stack of paper.”