Managing Clinical Trials

Big pharma tackles patient recruitment challenges, but we have a long way to go

Yesterday, Pfizer and Private Access, a search technology firm, announced that they’re joining forces to create an online community aimed at increasing awareness and participation in clinical trials.

According to this Fierce Biotech article, "Nearly 85 percent of patients in a recent survey stated they were unaware that clinical trials were a possible treatment option, and 31 percent of physicians surveyed did not refer patients to trials due to, among other things, lack of information."

The statistics for cancer clinical trials are even more dismal.  Earlier this month, the New York Times’ "Lack of Study Volunteers Hobbles Cancer Fight" reported the well-known statistic that only 3 percent of cancer patients participate in trials for new treatments.  As the article explains, “There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov … but many will be abandoned along the way.”

In fact, only half of the trials sponsored by the National Cancer Institute fail to reach the minimum needed for a meaningful result, according to cancer researcher and health economist Dr. Scott Ramsey and his colleague John Scoggins in an editorial in the September 2008 issue of The Oncologist. Furthermore, more than one in five NCI trials failed to enroll a single subject.

Their conclusion:  “Research sponsors, researchers, and journal editors should redouble their efforts to encourage publication of registered clinical trials in oncology.”

As patient recruitment costs continue to skyrocket as enrollment statistics decline, we couldn’t agree more.  Rapid, efficient patient recruitment is, without a doubt, a major barrier preventing our industry from successfully delivering promising new treatments to patients.

Links to the stories:

• Fierce Biotech article about Pfizer and Private Access
• Editorial in The Oncologist
• Lack of Study Volunteers Hobbles Cancer Fight (New York Times)

Using YouTube to recruit for clinical trials

Mark Senak, author of the informative Eye on FDA blog, wrote an interesting post yesterday about the NIH’s YouTube channel.  They set up the channel a year ago to help promote clinical trial participation. 

As Mark explains, "YouTube presents a great way for patients who have participated to talk to patients that might be interested, and for the information to be passed virally to people who might be curious about participating in a clinical trial."

He then posts several of the oncology clinical trial videos he found in the channel and plans to promote them on his (much more popular) Eye on FDA YouTube channel.  Here are three videos he chose:

Read the full Eye on FDA post here.

Patient recruitment for oncology trials: Help investigators get the word out

According to the Pharmaceutical Research and Manufacturers of America, the U.S. pharmaceutical industry is currently testing a record 750 new cancer drugs including 113 for lung cancer, 90 for breast cancer, 88 for prostate and 65 for colorectal cancer. 

Most experts agree that patients who participate in clinical trials receive a greater level of care.  In addition to standard therapy, patients receive the experimental treatment and additional personal attention and scrutiny as caregivers gather detailed data during the study. 

Studies also suggest that sites that participate in trials provide a higher level of patient care across the board.  These facilities often foster a culture of innovation that attract skilled investigators who exchange ideas, train their colleagues and incorporate trial protocols into standard treatments.  Institutional characteristics and practices may also play an instrumental role in this increased care.

Lack of information = low participation

Yet even with increased care and treatment options, only 3-5% of oncology patients participate in trials.  Researchers have attempted to pinpoint the problem, citing issues including lack of information, rapid disease progression, fear of side effects, insurance problems and myths about trials.  (Details: cancer.gov, Clinical Trials Today)

But as Laura Landro explains in her "Informed Patient" column for the Wall Street Journal, most patients simply aren’t aware of their options when it comes to experimental treatments.  Physicians have a great deal of influence in a patient’s decision to participate in a trial.  But many physicians don’t have enough time, staff, or funding to enroll patients as quickly as they would like, particularly since busy investigative sites are often conducting anywhere from 20 to 100 clinical trials at a given time.

Sponsors:  Support your busy investigators

For sponsors, it’s clear that the first step in successful patient recruitment is to find motivated investigators.  But sponsors can (and should) support those investigators to help them get the word out. 

After you’ve found your sites, how do you keep your protocol visible and active?  Here are a few ideas to help you support your investigators with high quality information about your study:

1. Provide your own marketing materials.  Remember that sites are usually running a wide variety of studies, and it can take valuable time to create the tools to promote yours.  While many sites have their own internal protocol listings, if a busy oncologist doesn’t recall your trial when seeing a patient, an opportunity is lost.
2. Make your information "consumable."  Keep your trial marketing information simple and straightforward so a busy investigator can quickly view it to jog his/her memory.  Sure, they’ll have the protocol, but snippets and reminders about the study can be very effective in bringing your protocol to top of mind. 
3. Give your message "legs." Give your investigators the tools to spread the word to others within the practice (medical oncologists, radiation oncologists or others that play a role in criteria outlined in a protocol) as well as primary care physicians. 
4. Reach patients directly.  Sponsors and CROs (including Medelis) are also harnessing the power of the internet to reach prospective patients and investigators. 

Your investigators are passionate about helping patients.  By supporting them with a strategic set of tools and digestible information, you’ll make it easier for them to spread the word, enroll patients more efficiently and move your trial through the clinic.