PR has an important role to play at every stage of the clinical trial process.
Clinical trials are the backbone of the drug approval process, and hard data about a product is often a springboard for reaching the media, medical community, and investors.
Maryellen Royle, SVP at Dorland Global Public Relations, notes that clinical trial results can be a natural news hook for the media, especially reporters who cover medical meetings.
"[The goal] is to extend their reach beyond the medical community ... to build the appropriate level of awareness," she says.
And it's hard data - not hype. "Given the scrutiny of direct-to-consumer advertising ... there will be more of an effort to dedicate funding to the clinical trial phase," says Marie Fay, who specializes in clinical trials at the Chandler Chicco Agency (CCA).
But as people have become more aware, and perhaps more skeptical, about the research process, they are demanding greater transparency and more balanced risk/benefit information from the companies conducting trials.
And companies must make sure that they aren't hyping data or presenting it out of context.
"There's no guarantee a drug will get on the market," says Jenny Moede, SVP of Waggener Edstrom Bioscience. "[Companies] don't want to improperly generate enthusiasm and hope."
The healthcare media environment also influences clinical trial recruitment, another key area for communicators.
Two years ago, when Cincinnati Children's Hospital Medical Center needed to enroll patients into a study on anti-depressants, "I ended up having to pull advertising because the response was so great," says Mark Schuller, marketing and recruiting manager in the clinical trials office.
But that was before New York Attorney General Eliot Spitzer sued GlaxoSmithKline for allegedly concealing studies that showed an increased suicide risk in adolescents who took Paxil.
"It's been awful," Schuller says about recruiting pediatric patients into a recent antidepressant study. "It's been very challenging."
"What we've seen is a terrible erosion of trust," says Roni Thaler, president of the nonprofit Center for Information and Study on Clinical Research Participation (CISRCP). "And that's why there needs to be increased awareness and education."
To help recruit patients into trials, companies are calling on PR professionals at an earlier stage, but there is still some concern that they aren't being called in soon enough.
"What I encounter is ... that there is often a lack of planning," says Schuller of Cincinnati Children's, which has 1,100 active protocols. "[Researchers] build this ballpark, and they just expect people to come."
"Clinicians really hunger to do science; they don't hunger to do recruitment," says Gil Bashe, EVP and health practice director at Makovsky & Co. In addition, "not all medical institutions have PR departments. The PR firm shouldn't assume the institution knows how to use [outreach] tools."
Dan McDonald, VP at Thomson CenterWatch, which helps connect patients to clinical trials, notes that a 2004-2005 study found that between 60% and 82% of patient self-refer into a study. Ten years ago, healthcare pros were the primary referral source.
"People are taking healthcare into their own hands more often," he says. "It favors PR professionals. It's an empowered, aggressive population."
Thaler notes that 90% of clinical trials are behind schedule, largely due to enrollment challenges. And she adds that the largest barrier to recruitment is a lack of knowledge about how someone can enroll in one.
The Food and Drug Administration this past summer partnered for the first time with CISCRP on a print PSA designed to raise awareness of the clinical trial process and how to participate.
In addition to PSAs, CISCRP also sends out media kits that include facts and figures, frequently asked questions, and a glossary of clinical trial terms.
Cincinnati Children's Hospital often recruits patients from health clinics and support groups, including groups for adults, because many participants are parents with children who suffer from the same disorder. It also recruits volunteers through community events - like a cancer walk - as well as internally among its 9,000 employees.
Part of Schuller's job involves preparing investigators to deliver a message on an "eighth-grade level," he notes. "They forget the public doesn't have the same technical knowledge."
He also makes sure investigators are available to provide quick responses to questions once advertising begins.
"Nothing replaces face-to-face contact," Schuller says. "There's no more effective way to recruit. You can explain things in more detail than a flier lying silently on a table."
Makovsky is currently working with drug company PediaMed to recruit autistic children with gastrointestinal upset - a challenge Bashe likens to finding "a needle in a haystack."
But he also notes that "some illnesses create community," and companies can take advantage of these support networks. But he adds that it is sometimes necessary to educate these groups on the importance of their support.
With autism, for instance, there are less than a handful of active clinical trials, and PediaMed's messages have focused on the need for more research in the entire therapeutic category.
The drug company also reached out to people who interact with children with autism and the kids' parents.
For PediaMed's trial, the company sent its CEO to personally answer parents' questions. "It's important to create the right balance of hope and cautious optimism," Bashe says. "The patient cannot be led to believe that there's the certainty of a cure."
In addition to the lack of awareness, communicators must also address patient misconceptions.
Thaler draws a parallel between clinical trial participation and the stigma of organ donation two decades ago. "We need to recognize these people as giving the gift of participation," she said, adding that CISCRP holds its own recognition ceremonies. "We should be thanking people who participate in clinical trials."
McDonald similarly notes that one message CenterWatch tries to communicate is that 90% of participants say that they would enroll in another clinical trial. "There's a whole horrible connotation of a guinea pig that we as an industry have fought against," he says. "We try to make patients as comfortable as possible."
But recruitment is just one piece of the puzzle. Thaler notes that a quarter of clinical trial participants drop out of a study - and that figure doesn't even include the number of people who experience adverse reactions to a product.
"I believe there are certain [patients] who don't understand the expectations," she says. "It's very important that people realize what it means to be a participant."
Phase I - product safety trials
As a rule, the consumer media is not going to bite for phase I results - unless the compound is so novel that it lends itself to a newsworthy hook. Moede offers the example of a hepatitis C vaccine that received wire coverage because of its potential to meet an unmet need.
The audiences that care most about phase I results are by and large the medical and investor communities, says Ellen Miller, who heads CCA specialty agency Biosector2.
For companies that are years away from a marketable product - like many biotechs working on genomics or finding new pathways to treat diseases - their entire story often depends on their ability to meet clinical milestones.
"They need [to put out a] constant flow of information to show progress," Miller says.
But she adds that companies must be careful not to overstate early data and feed investors with false expectations.
Recruitment efforts for a phase I study also differ from later stages. Because investigators need healthy individuals, simple, straightforward messages on the reasons for participating in a clinical trial are appropriate, says Cincinnati Children's Schuller.
More in-depth, educational messages are often required when the goal is to find patients with a specific disorder. In phases II and III, by contrast, Cincinnati Children's often needs to educate parents about pediatric diseases and get them to recognize symptoms that might be affecting their children.
"People don't think that kids can be depressed or have [adult conditions like] fibromyalgia," Schuller says.
Phase II - product efficacy tests
It's not unusual for scientists to be reluctant about discussing the results of their research from phase II studies. "Do you really want to promote the promise when your product might fail in phase III?" asks Charlotte Wray, MD of the healthcare practice at Zeno Group.
Reporters are similarly cautious about reporting on early studies. "[Reporters are] essentially placing a bet on a company when they publish clinical trial results - and they want to make sure they're making an informed bet," Moede says.
But Wray notes that the product's therapeutic category is a larger factor in whether it gets coverage than how far it has advanced through the pipeline.
Treatments for a large segment of the population - like women's health products - or that could represent major breakthroughs for under-treated diseases like AIDS or cancer will get attention as early as this stage, Wray notes.
"The idea is that you have the promise to change the lives of others," she says. "If you have a phase II antihistamine, it's not a critical therapeutic."
Nevertheless, Jeff Hoyak, president of MCS PR, notes that it is still worthwhile to pitch reporters on phase II data; they are likely to keep it on file as background information, even if they don't immediately cover it.
And any data published in a peer-reviewed medical journal automatically gains credibility. Publication "validates" the results of a study and gives investigators an opportunity to explain what the data means, Biosector2's Miller notes.
Partnering with an advocacy group is another way to publicize data among people affected by a specific disorder and to build enthusiasm around the third phase of the study.
But if a company plans to use these results as a recruitment tool in the consumer press, Wray says, emphasis should fall on the value of having a local angle - whether it's researching the incidence of a disease in a particular geographic area or having local physicians serve as spokespeople.
"It's imperative that the participants [in a study] view the clinical trial sponsors as trustworthy," she says. "Patients tend to be a little nervous; people are by nature averse to taking risks."
Phase III - product efficacy tests, larger sample
Even before studies are completed, internal communications among investigators allows researchers to stay up to date on the work that their colleagues are doing. "We funnel that information into a newsletter or on a website," Miller says.
There's also another audience that companies consider when their products are being tested at this stage: potential marketing partners. Company executives will attend conferences, author papers, and accept speaking engagements as a way to build name recognition, but Moede also suggests pitching the industry trades.
"We make the decision of who we pitch stories to with that in mind," she says. "You want coverage to build credibility for the category."
Products that make it through phase III clinical trials are ready for consideration by the FDA and are finally nearing commercialization, which sparks the interest of both the consumer and business press.
But not every phase III study will get the same coverage. "The challenge is competition in general," says Dorland's Royle, who adds that the broader the appeal, the more coverage a product is likely to get. "You really have to make it compelling and meaningful."
When Genentech first reported positive results for colon cancer drug Avastin at a 2003 oncology medical meeting, the PR team was suddenly fielding calls from the broadcast and consumer print media.
Avastin not only improved survival rates, but it did so in a new way: by stopping blood flow to the tumor. "Once we proved that theory ... that was the beginning of a whole new world for us," says Mary Stutts, Genentech's head of corporate relations. "What that did is make us a lot more careful not to hype it. Because this is such an emotional issue, we want to make sure that we're being honest and have fair balance."
The company achieves that end by reporting safety data prominently in press releases, in close proximity to efficacy data. And that directive comes from the highest levels of the company, not just from corporate relations, Stutts notes.
The company is also working with more advocacy groups to communicate with patients. "Our advocacy relations work has more than tripled," she says.
Securing FDA approval to market a drug or medical device is the Holy Grail for the research team that has spent years testing a product. It is also when most companies try to build momentum ahead of their marketing efforts.
FDA approval isn't usually a hard sell to reporters - but Hoyak notes that there are certain exceptions. For instance, a company with a so-called "me too" drug, another product in a crowded category, "might [face] a greater challenge to secure media coverage," he says.
The key for media pickup, therefore, is to have the right mix of human interest, physicians who can interpret the data in laymen's terms, and the "luck of the timing," says Royle.
"FDA approvals used to be your golden ticket to coverage," she says. "Our media environment has become increasingly competitive. What companies are learning is that you have to say what the news is."
That "news" is usually the patient benefit, Zeno's Wray notes. "The bottom line is, it's still about healthcare," she says.
Phase IV - post-marketing studies
Wag Ed's Moede notes that the FDA has been mandating more post-marketing studies as a condition for approval.
Miller suggests that, in the past, the media hadn't been interested in reporting that a particular product was still working as it should be. But after Merck's Vioxx recall opened questions about whether the FDA could adequately monitor drugs already on the market, the public began pushing to see more post-marketing data, she adds.
Post-marketing studies sometimes yield additional information, both positive and negative, about a drug. And those insights can be surprising.
Genentech initially tested breast cancer drug Herceptin on women with very advanced stages of the disease. Only after the drug was approved did the company test it on women with less advanced cancer - and found that the earlier patients were treated with Herceptin, the better the results.
"The post-marketing study proved that it wasn't only a theory," Stutts says.
When results are potentially damaging, Moede advises, companies should reveal all negative information at once, not in drips and drabs.
"It is something you need to be prepared for," she said, adding that, as the number of patients taking the drug skyrockets, so can complications. "Side effects matter - you just have to be as clear and straightforward as you can be."
Post-marketing studies have also served as a way to extend coverage of a product - such as when a contraceptive pill is also found to clear up acne.
The controversies around antidepressants and painkillers heightened the call for companies to set up clinical trial registries, or publicly available databases where all clinical trial information is stored.
CenterWatch in April 2004 offered companies a new service for posting trial data online.
"The industry has responded quite dramatically to the pressure that has been put on it [to increase] transparency," says McDonald. "The number of companies posting information has grown dramatically."
In fact, McDonald notes that the number of trials listed has grown 47% since January alone.
PR pros say that, so far, companies have earned positive press by electing to post results; no one could recall an incident where a reporter went fishing in the database for studies showing that a particular product on the market was unsafe.
"They're almost purposely kept scientific," McDonald says, adding that the registries are accessed primarily by physicians. "The terminology is pretty complex."
But even a clinical trial that fails to show efficacy can still present an opportunity for a company to reach out to stakeholders.
In addition to the obligation companies have to disclose negative results to investors, they can also reach out to the public about what that data means - and what they learned from it.
The message, therefore, should be about the overall clinical trial process and how negative results mean that the system works.
"Unfortunately, the reality of medical research is that not every result can be positive," Miller says. "It's important to show those results ... to show that that's the value of doing those early studies."
When a product doesn't receive FDA approval, companies must still keep sight of the messages they want to communicate. In particular, they'll need to name the reason that the FDA declined their application, as well as what the next step will be, Royle notes.
Hoyak also notes that negative studies provide evidence of how risky and time consuming it is to bring a product to market - one of the primary arguments in many healthcare debates, particularly drug pricing.
"If a trial misses its endpoint ... position it as a stop on the way to your commitment to developing this drug," he says. "It's part of the struggle."
The clinical trial process
The first phase of a study is typically conducted on healthy volunteers and is designed to test a product's safety in humans and to learn more about how it is metabolized in the body. About 70% of new compounds will make it through this round of testing, according to CenterWatch.
The second phase of the clinical trial process is to test efficacy - how well the drug works in several hundred patients. Only about a third of new products make it through this stage, according to CenterWatch.
These trials are typically bigger versions of phase II trials, with a greater number of patients enrolled at more investigative sites. If a product gets to this phase, it has a 70% chance of yielding positive results, says CenterWatch. It is after this phase that products can be submitted to the Food and Drug Administration for approval.
Post-marketing, or phase IV, studies take place after a product has received FDA approval. These studies typically compare one product to another or provide longer-term data.