Patient advocacy in clinical trials

Andras Fehervary

Barcelona—Though recent developments aim to improve the clinical trial process, a group of experts says much more work is necessary.

At the 15th Congress of the European Hematology Association, three speakers discussed the patient-specific challenges of the clinical trial process and offered potential solutions to overcome them. The speakers attacked the issue from all sides, as each represented a different perspective: that of the clinician, the pharmaceutical industry, and the patient.

Jana Pelouchova, of Diagnoza CML in the Czech Republic, represented the patient perspective. She began by saying that patients must understand their disease so they can make informed decisions regarding clinical trials. Patients need guidance from experts as well as from other patients, and this can be achieved by the creation of more patient advocacy groups.

“The patient advocacy groups also advocate and lobby for access to treatment and more patient-centric regulation,” Pelouchova said. “In fact, this is an everyday practice, bringing [the] patient perspective to clinicians and collaborating with clinicians and industry, for instance, on patient information, trial design, and protocol.” 

Pelouchova went on to say that another issue for patients considering enrollment on a clinical trial is informed consent. The challenges of this process can be overcome by adapting language so it is more patient-friendly, giving patients a detailed consultation, and informing them of the possibility of withdrawal from a trial.

But perhaps the main reason patients are unwilling to participate in clinical trials is public scrutiny of the process. Pelouchova said current media coverage of clinical trials perpetuates myths and misconceptions.

“We patients feel that the mass media could do more to improve this,” Pelouchova said. “Instead of scandal stories, [the media should report] positive outcomes.”

Stephen O’Brien, PhD, FRCP, MRCPath, of Imperial College of London in the United Kingdom, echoed this sentiment. He has personally encountered patients who say adverse media coverage has deterred them from enrolling on clinical trials. Most worry about being treated like guinea pigs, and some are certain enrolling in a trial results in death.

But Dr O’Brien said there are barriers to the clinical trial process that go beyond patients’ apprehensions. Restrictions for the clinician include not having enough time to begin the process or even discuss the possibility of enrollment with a patient, not feeling enrollment to be worth the hassle, a lack of the proper facilities, and a dislike of the study design in question.

Perhaps to overcome these issues, clinicians can design trials that are more interesting and timely, Dr O‘Brien said. They should also open the lines of communication with patients and even organize seminars that include patients.

Andras Fehervary, of Novartis in Italy, also discussed the need for increased communication among all parties involved in the clinical trial process. He said there should be more collaboration, and clinical trials should be more transparent.

“With that said, the last 2 years has seen a lot of very interesting progress,″ Fehervary said. “I think many of you are familiar with the 39 recommendations that were derived under the umbrella of ESMO, 8 of which regard clinical trials and how to improve access to clinical trials.”

Fehervary also mentioned the EPPOSI clinical trials workshop that took place in April. EPPOSI is a European Union-based organization partnering patient groups, clinicians, and industry.

Another step in the right direction, according to Fehervary, is the EudraCT clinical trials database, which should be open to the public in 2 months. The database includes all trials taking place in the European Union from May 1, 2004, onward, and is available in 27 languages.

“As we look more forward, I think the direction that is accepted is innovative and collaborative partnerships between industry, patient groups, investigators, and other stakeholders,” Fehervary said. “Greater involvement of patients’ organizations and greater dialogue with industry regulators will, in fact, assist informed and accelerated access to new drugs.”

These viewpoints were presented during the first-ever Patient Advocacy Session at the 15th Congress of the European Hematology Association, which took place June 10-13.