CROs Can't Recruit Patients Fast Enough: Survey

Running clinical trials is increasingly complex and costly, but the most vexing part may be finding suitable patients when they are needed. That can be especially true in the US, for instance, where participation rates are often low and many people are already taking at least one medication. So perhaps it may not be surprising to learn that, when it comes to preparing a clinical trial, drugmakers value speeding the time spent to recruit patients over lowering costs.

A new survey finds that nearly 90 percent would prefer reaching patient recruitment goals at least 10 percent faster over cutting Phase II or Phase III trial costs by 20 percent. In fact, only 15 percent of the 72 drugmakers queried chose reduced expenses over faster patient recruitment, according to Industry Standard Research, a market research firm that conducted the survey.

The results belie a level of dissatisfaction, which may explain why half of the drugmakers reported that they prefer to do patient recruitment work themselves, even though clinical outsourcing is, overall, commonplace. But when recruitment is outsourced, the survey found that of the 12 large and mid-size multi-service CROs evaluated for patient recruitment activities, only three met or exceeded expectations greater than half of the time.

The next highest response at 25 percent was for “a specialized patient recruitment company," followed by each of the 12 CROs. The drugmakers were asked to grade CROs based on services provided during the past 18 months. Which CROs were included? They were Covance, ICON, INC Research, inVentiv, MDS, Medpace, OptumInsight, Parexel, PPD, PRA, Premier Research, Quintiles, RPS and Theorem.

The survey also found that advocacy groups are believed to be best at delivering a desirable recruitment return on investment, while investigator-related activities, such as referrals, posters in exam rooms and direct letters from doctors, have provided moderate-to-high ROI in recruitment. The tactics that were deemed less successful included traditional print, digital, and broadcast advertising.

To be more specific, 75 percent of the drugmakers surveyed reported that advocacy groups - which were also called affinity groups - have average or above average value in recruiting patients. Doctor referrals were a very close second, with 74 percent of the drugmakers viewing this activity in the same way. Meanwhile, 60 percent held this view of placing posters in exam rooms.

This also suggests a growing willingness to dabble in social media, which is gradually being pursued in different ways. Quintiles, for instance, runs a web site called ClinicalResearch.com that provides info about trials and will be increasingly used to recruit patients. Pfizer, however, recently experienced difficulty relying on social media for recruitment for a trial that will allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office (back story).

Another key finding: the level of engagement of the clinical trial site staff and characteristics of the study protocol were the two most important factors that lead to successful recruitment efforts. Twenty-five percent of drugmakers cited investigator interest in the study leads to success, followed 19 percent that pointed to either inclusion and exclusion criteria or the protocol design.

14 Comments

May 14, 2012 - 11:52am
This situation will be remedied as obamascare throws more people off the insurance rolls and to the clutches of avaricious investigators doing our bidding.
MikeH May 14, 2012 - 2:28pm
Interesting article. I am curious on a few observations cited in the article: 1. Inclusion/exclusion criteria - drugmakers should construct a protocol based on real world experience, not false expectation (estimated number of patients/month, reference outdated procedures, go against standard-of-care practices). Investigators also are asked to review the protocol against their patient databases to know that they have patients fitting this profile, and can successfully recruit a portion of this population for the trial. Without a solid protocol, or blueprint, nobody can be successful. 2. What are the metrics tracked and measured by CROs pertaining to investigator databases? A physician who has many patients of a certain type is a strong candidate, but if they fail to meet minimum accrual rates, have slow start-up processes, have a tendency to trigger many queries with slow response - this too can lead to false expectations. 3. Poor pay practices are another disincentive for stronger physician and staff participation. Holding off payment for 4-5 months would lead anyone to forget about the study.

There are other services and more creative ways to attack patient recruitment. It is interesting that money will be targeted to CROs and their services, while recruitment monies are generally considered last for consideration (and patient recruitment deemed the #1 problem with clinical studies being completed on time).

May 14, 2012 - 4:29pm
Lets' not forget competing trials for the same patient population...
May 14, 2012 - 8:31pm
OK, I give up. OII--how does the Health Reform Bill "throw people" who have insurance out of it? Genuine question, like most of mine.

I do agree about the investigators, having been solicited more than a few times myself. Felt like Bogata on a lonely Saturday night.

May 14, 2012 - 9:10pm
JiM, the 2000 plus page Obamacare bill has created much uncertainty among employers as to its impact on their health care costs. Moreover, companies know that they can drop employees from their insurance plans and the states will pick them up on the health insurance exchanges created under the law. If the Supreme court upholds the individual mandate, the newly uninsured workers will have to buy coverage or pay a large fine. Many will simply roll the dice and choose to go without coverage. The net effect will be to incerease pool of available study subjects for recruitment.

See the linked graph and note that the upwardly rising slope of the uninsured has an inflection point around the time Obamacare was first proposed. I realize that correlation is not causation, but I'd like to hear an alternate explanation for the fact that we now have nearly 51 million uninsured today in the US.

Back to clinical trial recruitment. Drug companies have always relied on the uninsured as a rich source of subjects. Even if there is a 50% chance of getting a placebo the subject knows he/she will at least get free medical attention. For Phase I subjects it can be a supplemental source of income.

The obverse is also true: an increase in number of insured will reduce the pool of subjects in the US, making recruitment even tougher. Hence you see global expansion of the CRO industry as they weigh their options.

In reality, because of the lousy economy the pool of uninsured is likely to continue to increase irrespective of the fate of Obamacare in the Supreme court. This is why I believe the recruitment issue to be a self-correcting problem.

http://www.usatoday.com/news/nation/2010-09-17-uninsured17_ST_N.htm

May 14, 2012 - 9:56pm
Thanks, OII. I think alternative explanations are in the article you linked:

"workers losing their jobs in the recession, companies dropping employee health insurance benefits, families going without coverage to cut costs. Driving much of the increase, however, was the rising cost of medical care; a Kaiser Family Foundation report shows workers now pay 47% more than they did in 2005 for family health coverage, while employers pay 20% more."

These factors all complement each other. People without jobs obviously find it difficult to impossible to get insurance. People with jobs/insurance face higher costs and less coverage. As we all know, lots of institutions (inlcuding mine) have made it more and more expensive to provide benefits. Just in the last year, my own co-pays for OVs have increased 25% and the portion of the health insurance that is deducted from my monthly paycheck has nearly doubled.

To me, these factors--unemployment, budget crises for (especially public) institutions, raising insurance costs, etc. are more likely related to the increase in uninsured.

May 14, 2012 - 10:00pm
p.s. If the Supreme Court upholds the individual mandate, I will personally pay the costs for Justice Scalia's next duck hunting injury.
May 14, 2012 - 10:41pm
There is nothing here that hasn't been said for the last 20 years. Sponsors aren't interested in paying for patient recruitment much less for the entire collection of data stream from a recruitment project. "If you build it, they will come" does not work in this environment and clinical scientists are the worst people in the world in the marketing world which is what patient recruitment is all about.
May 15, 2012 - 12:01am
oii opined, "...Moreover, companies know that they can drop employees from their insurance plans and the states will pick them up on the health insurance exchanges created under the law...."

Not in NJ - big pharma central...

http://www.nytimes.com/2012/05/11/nyregion/christie-vetoes-health-insurance-exchange-for-new-jersey.html?_r=1

May 15, 2012 - 7:54am
dz, you didn't explain. Gov Christie vetoed the exchanges pending the outcome of the court decision. It's a lot harder to repeal a law down the line than veto it in the first place. Plus why should we endanger our status as a real welfare state?

JiM, maybe Scalia will be hunting up in the UP when it is annexed by Canada, and Tony will lose his US citizenship and seat on the bench.

May 15, 2012 - 7:59am
Dan, we used to have no problems inn this area when the money was flowing. Competitive enrollment ruled the day. Top prize might be something like a trip to Curacao or a Mercedes Benz convertible.

Now we have to rely on jawboning from some CRO dude with a clipped indian accent to get enrollment jacked up. Doesn't compare to the Benz.

May 15, 2012 - 2:31pm
As an LP'er, I am ready to give Canada the UP in exchange for Montreal and a future draft choice.
Clare Jun 29, 2012 - 8:37am
A patient centric approach is YourTreatmentChoices which uses advanced technology to help patients across the globe find, understand and join clinical trials. A secure and independent platform of approved trials where investigators and companies can tap into the active information seeker market. By making their trial easy to understand, local investigators can attract and connect to their target participants.