If the International Alliance of Patients Organizations (IAPO) gets its way, patients will soon sit at the table with scientists to offer input into the design of study protocols. Not in a forceful or adversarial way, says Jeremiah Mwangi, IAPO's senior policy officer, but in a way that benefits everyone.

Picture, for example, a pediatric epilepsy trial that asks parents to get a stop watch to time a child's seizure—rather than rushing to the child's side. “Parents whose children were enrolled said straight away: 'this is not practical,' ” Mwangi says, adding that that study was evidently not designed with the input of real patients.

To garner any sort of patient compliance, the protocol had to be redesigned, wasting time and money for the sponsor. To avoid situations like this, why not have patients there offering practical input at the very beginning?

Seeking Collaborators

So far, IAPO's efforts are embyronic. Mwangi says many of the 200 patient groups that IAPO represents (which span 40 countries and 50 therapeutic areas) are enthusiastic about the prospect. Sponsors to whom the concept has been mentioned seem receptive. Mwangi recently participated in a meeting discussing the updating of the European Union's Clinical Trials Directive. “We said, 'We'd like to see patients included in the design process of a trial from beginning to end.'  ”

How would it work? No one's sure. Mwangi says the organization is working on possible modes of patient involvement that it can take to sponsors. The London-based IAPO is holding its 4th Global Patients Congress this month, and will assemble focus groups with the aim of developing detailed models of involvement.

The hope is to also get the industry, among other stakeholders, to collaborate. Maybe researchers could reach out to patient groups at the early stages of designing a protocol, or perhaps patients could come in to offer ideas about their conditions and experiences.

Examples Sought

Is having just one patient at the table useful? If so, how can a perfectly representative patient be selected? If a panel of patients is used, what criteria should be used? And how much input will be offered?

IAPO is planning to gather details from patients groups who have already collaborated successfully with pharmaceutical companies and contract research organizations (CROs) on protocol design. “We want to be able to say, here are the examples, and here is the value in doing this,” says Mwangi.

Increasing Compliance

IAPO is currently involved in such a role in a European Medicines Agency (EMEA) study called the Protect project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium). The five-year effort, which started in September, brings together 29 public and private-sector stakeholders to investigate the best ways to collect data on pharmaceuticals that are already on the market. IAPO has been scrutinizing how to make data collection easier on patients to increase compliance.

Says Mwangi, “Our job is to make sure every group is included, to understand the challenges they face every day in taking a particular drug, and looking at the practicalities in how they might be able to feed back information.”

Imagine, Mwangi says, someone who lives with a particular condition that's already quite a burden. “In order to avoid increasing their burden, you have to make collecting data as easy as possible on them.”

Recruiting Psychology

In one case, IAPO has had to point out that participants over a certain age may not be willing or able to enter data into a computer—something that was not initially considered in the study design. “You can't expect someone who's never used a website to then start confidently inputting personal information,” he says.

IAPO was also able to help all parties understand some of the psychology behind recruiting, explaining that older folks may trust only their long-time doctor to bring them into a study, while younger people may be perfectly comfortable responding to a flier that advertises a trial. “We brought these issues to the fore when they hadn't been considered previously,” says Mwangi.

The overall goal of IAPO, which was formed in 1999, is to make sure the patient has a voice in all manner of health care issues that are these days dominated by larger entities like governments, hospitals, drug companies and technology firms. The organization's areas of focus include health policy around the world, clinical trials, access to care, and health technology.

Mwangi is enthusiastic about some sort of patient involvement in trial design possibly being put into law. But he acknowledges that that is highly unlikely, at least any time soon.

by Suz Redfearn