Magic Johnson—Celebrity Spokesperson for Minority Patient Recruitment?

By Sara Gambrill

Earvin “Magic” Johnson, NBA champion and chairman and chief executive officer of the Johnson Development Corp., came to IIR’s 17th Annual Partnerships with CROs in Las Vegas, Nevada, with a mission—to urge pharma to increase minority participation in clinical trials. But, he left, quite possibly, with an even bigger mission—to become a celebrity spokesperson for minority patient recruitment.

Johnson began a talk that touched on the personal and professional and made people laugh as well as reflect by pointing out some important statistics.

“Half of America will be minorities in 40 years. We must get them involved. We must do a better job to educate them. They have to take part in what’s going on in medicine,” said Johnson. “I’m going to do my part. I know the reason I’m standing here 16 years [after being diagnosed with HIV] is because someone participated in a clinical trial.”

During his talk, Johnson discussed the anguish of having to tell his wife about his HIV diagnosis and his fears at that time for both her health and their baby’s health. (His wife was pregnant at the time and both his wife and child were healthy.) He discussed the physical and emotional difficulties of receiving an HIV diagnosis in those days.

“When I first announced [in 1991] that I had HIV, we only had one drug—AZT. My doctor started off having me take it 15 times a day because I’m big. It’s the only time I wished I wasn’t tall,” he joked. “Now there are 26 drugs,” Johnson said in gratitude to the hundreds of clinical researchers present at his talk.

EDICT Report Provides Road Map To Comprehensive Patient Enrollment

A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.

Among the issues the policies meant to address are minority participation, patient insurance, informed consent, and standards and accreditation.

“Although disparities in clinical trials has been discussed and debated extensively, this problem has generally been under-addressed and, as a result, has received little direct, systematic, or sustained intervention,” said Armin Weinberg, Ph.D., director of Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and EDICT’s principal investigator.

Veritas Medicine Restructures Business, Drops Trial Listing Service

By Stephen DeSantis

Cambridge, Mass.-based Veritas Medicine, a clinical trial services company, has discontinued its patient recruitment services and laid off a number of employees.

According to Veritas, it is restructuring the company to focus solely on its clinical trial disclosure business. The company’s clinical trial listing service and patient screening business will be terminated.

Veritas stated it ceased providing patient recruitment services on Feb. 8.

The company’s clinical trial listings service had been a major part of its business since its inception. One of its main patient recruitment services asked for potential subjects looking to enroll in trials to fill out medical and geographic information, which could then be matched with studies posted by sponsors. That service also contained a trial notification message to be sent to potential subjects via email.

“There have been reductions of staff who were directly related to the patient recruitment business, but the clinical data disclosure team is intact,” said Andrew O’Brien, Veritas’ president and chief executive officer, in a statement to CWWeekly.

The company is responding to the evolving landscape of the industry’s transparency requirements. That business consists of Veritas’ clinical trial registry system, its sponsor registry web site development and its patient response service.

“Historically, this has been a smaller part of our business, but it certainly is where we see the best growth prospects today,” said O’Brien.

The company’s web-based platform allows clients to post trial listings and results to different registries. Veritas’ web site development service helps its clients develop their own corporate registry sites in a branded environment.

“We’re focusing Veritas Medicine on the clinical data disclosure business because there is a terrific market opportunity and we are very well positioned there...the disclosure requirements for our biopharmaceutical customers are growing more complex,” said O’Brien.

In the last year, Veritas has been through some significant changes. After seven years as Veritas’ chief executive officer, Joe Avellone, M.D., left. In May 2007, Parexel, a Waltham, Mass.-based contract research organization, named Avellone to the position of corporate vice president of clinical research operations for both North and Latin America. Avellone remains on the company’s board of directors. He previously served as chief operating officer for BlueCross BlueShield of Massachusetts.

Veritas was founded in 1999 with an initial investment of $8 million from Burrill & Company, BioAsia’s Biotechnology Development Fund II, Cambridge Incubator and Seaflower Ventures. Three years after launch, Veritas had raised a total of $16 million in funding. Its current list of investors includes Burrill & Company, Vivo Cambridge Innovations, Seaflower Ventures and MDS Capital.

Stephen DeSantis is the Senior Associate Editor at CenterWatch.

Dissuasion in Recruitment Research

By Jennifer Higgins, Ph.D.
Springfield Neurology Associates, LLC

Of all the techniques considered for affecting the behavior of patients and encouraging their clinical trial participation, nary a single researcher has considered the benefits of dissuasion. It is true on its face the concept seems a bit counterintuitive. After all, typical recruitment approaches involve persuasion, enticement, inducement and have, during less proud times, inched closer toward undue influence. What has not yet been explored is the benefit of dissuasion, or discouraging participants from refusing to participate in voluntary clinical research.

Critics contend that this approach is likely to be misconstrued and experienced as undue influence, coercion and exploitation. The industry regularly points to the horrifying medical experiments conducted by Nazis during WWII and the Tuskegee syphilis experiments as evidence for all that is wrong with more aggressive recruitment tactics. They maintain that there is an inherent human tendency toward abuse of power among researchers and others who are not kept under tight regulatory control and who may be permitted to more actively market their clinical trials.

More optimistic recruiters maintain a different view. They believe that with proper counterbalancing of education and training, enhanced and more aggressive recruitment may be benefits to all involved. Drawing primarily from social psychology and marketing literatures, several key components of a successful dissuasive recruitment campaign begin to surface. Perhaps most important is what may be gleaned from research on the use of negative affect for persuasion (Huang, 1997). This research provides powerful evidence of the potential negatively affecting ads have for predicting persuasiveness. Three sets of affective responses toward three graphic and unpleasant Benetton ads were measured to test distress attitudes toward ads and fear/jitteriness factors experienced by respondents.

Results indicate that in predicting persuasiveness of negatively affective ads, it is important to take the concurrent nature of the types of negative affect and their directions of persuasiveness into account. Perhaps an even more significant finding of this research is that the practice of advertising unpleasant feelings per se generated by negatively affective ads may not be sufficient for consumer persuasion.

It is the attention generated by these unpleasant feelings that gives rise to the persuasiveness of negatively affective ads. Simply put, by using negatively affective ads, marketers successfully create an enormous level of brand awareness which commonly translates into an increase in sales. Based on the findings outlined here, recruiters are urged in the short-term to consider beginning experimentation with placement of negatively affective advertisements.

It seems the timing could not be better for such experimentation. Given the near daily accounts of negative effects of sundry medications, both within and without clinical research, there seems ample opportunity for placement of negatively affective ads. An example of the kinds of ads the author is proposing may be described using the recent Avandia crisis involving Glaxo-Smith Kline...

AAHRPP Accredits Final Batch of Organizations for 2007

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited its final 11 organizations for the year.

In 2007, the association has accredited a total of 47 institutions, independent review boards (IRBs), contract research organizations (CROs), universities and hospitals. Accreditations are valid for three years.

The following have received full accreditation:

• University of Alabama at Birmingham, Birmingham, AL

• University of Illinois at Urbana-Champaign, Champaign, IL

• Wayne State University, Detroit, MI

• Department of Veteran Affairs Northern California Health Care System, Mather, CA

• John D. Dingell VA Medical Center, Detroit, CA

• North Florida/South Georgia Veterans Health System, Gainesville, FL

• Sioux Falls Veterans Administration Medical Center, Sioux Falls, SD

• VA Boston Healthcare System, Boston, MA

• VA Central California Healthcare System, Fresno, CA

• VA Iowa City Health Care System, Iowa City, IA

The Carl T. Hayden Veterans Affairs Medical Center, Phoenix, AZ received AAHRPP’s “Qualified Accreditation status”. Qualified Accreditation status means that the organization meets most of the full standards. Any deficiencies are minor, few in number, and purely administrative. These deficiencies would not cause direct harm to patients.

“AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements,” the association states.

Standard Recruiting Practices in the People’s Republic of China

By Dr. Diana Anderson, president, CEO and founder of D. L. Anderson International

Excerpted from Anderson's book International Patient Recruitment Regulatory Guidelines, Customs and Practices.

Based on information gathered from several sources, it appears that clinical trial subjects in China are recruited in a limited number of ways, starting with heavy reliance on the investigator to tell appropriate patients about the study, followed by the use of posters and fliers in waiting rooms at accredited clinical trial sites.   

Hospitals in the major cities, such as Beijing, Shanghai, Ghangzhou, Chongqing, and Nanjing, tend to be very large by Western standards, many with more than 1,000 beds, reflecting the centralized nature of healthcare delivery in China. As a result, doctors in those institutions are extremely busy, seeing as many as 50 patients most mornings. 

Yet, while working at that harried pace, some doctors, especially those seeking to increase their clinical trial workload, remember to discuss clinical trials with patients. Yue Wei, vice president and medical director of Beijing MedSept Consulting Co., a CRO, says, “Doctors generally discuss the opportunity to participate with patients. That is the common way.”

Stefan Astrom, Ph.D., CEO of Astrom Research International, adds, “[Doctors] recruit patients from their regular patient pool. There is an abundance of patients and it's very attractive for them to participate in trials as they may receive new treatment, extra patient care and free medication.” In addition, patients generally do not see the same physician each time they visit a clinic, so the promise of seeing the same physician over the course of a clinical trial may spur interest...

Fraudulent Study Broker Cherie Thibodeau Continues to Bilk Sites

As a public service to sites, CROs and biopharmaceutical companies, CenterWatch is posting a long excerpt of this week’s CWWeekly article about fraudulent study broker, Cherie Thibodeau.

If you have been defrauded of funds by Cherie Thibodeau, please contact CenterWatch at cw.editorial@thomson.com.

By Sara Gambrill

Cherie Thibodeau, who operates under multiple aliases and claims to be an M.D. in her solicitations to investigative sites, CROs and biopharmaceutical companies, has bilked at least one more site out of almost $5,000 since CWWeekly published its last article about Thibodeau in February.

In the latest case, Thibodeau sent a solicitation by fax last October to Partners in Research, LLC, an Akron, Ohio-based site, to which it responded. Thibodeau followed up with a telephone call about a diabetes study study sponsored by Novartis, and within two weeks, the site was chosen to participate in that study, according to Colin Moorhead, M.D., president of Partners in Research.

Some of the terms of the agreement that the site signed with Thibodeau, who was listed as Dr. Cherie Thibodeau, M.D., Ph.D.,” were that she would handle administrative tasks, such as regulatory documentation, marketing and advertising, for the site. For that work, she would take 10% of the revenue from any study she brokered for the site and the same percentage for any study the site was able to get on its own. But after months of working on the initial study, the site had not received reimbursement from Thibodeau, even though she had been paid by the sponsor.

“Around February, it was starting to get hard to get a hold of her or get her to respond…We’ve already had a couple of patients screened and a patient enrolled in the [diabetes] study and we’re wondering when do we expect some reimbursement?” said Moorhead.

Partners in Research continued to conduct the study and a few months later, the site was able to get a study on its own from Merck...

Dr. Diana L. Anderson

Dr. Diana L. Anderson is the president, CEO and founder of D. L. Anderson International, Inc., parent company to subsidiary D. Anderson & Company.  She is an early and tireless advocate for professionalizing the patient recruitment and enrollment processes, and has published numerous articles on this subject, stressing the critical importance of early strategic planning, keeping metrics, developing partnerships and improving retention. 

Over the past several years, Dr. Anderson’s expertise in patient recruitment has attracted an international following.  She has become a much sought-after speaker across the globe, addressing audiences in countries such as Israel, Australia, Japan and England.

The depth of her patient recruitment experience is captured in her latest text, International Patient Recruitment Regulatory Guidelines, Customs and Practices. She authored earlier books A Guide to Patient Recruitment and Retention (2004), A Guide to Patient Recruitment (2001) as well as a publication for the lay audience entitled 50 Ways to Cope with Arthritis.   

Dr. Anderson is also past-chairman of the Board of ACRP.  She is currently chair of The Academy of Clinical Research Professionals, a division of ACRP.

Striving For Diversity In Clinical Trials

By Sara Gambrill

AstraZeneca has launched a new initiative to address the lack of diversity in U.S. clinical trial participants. The big pharma company will provide significant grants to the National Medical Association (NMA), which represents more than 30,000 African American physicians, and the Interamerican College of Physicians and Surgeons (ICPS), a network of more than 39,000 physicians throughout the U.S. and Puerto Rico.

AstraZeneca expects that its ongoing partnership with NMA and ICPS will ensure that physicians of diverse backgrounds receive the education and tools they need to participate as investigators in clinical trials.

Several top-20 pharmaceutical companies have approached the challeng getting racial and ethnic diversity in their study groups by trying to engage a more racially diverse group of investigators or those with access to diverse patient populations. These have mostly been internal initiatives. AstraZeneca’s decision to partner with these well-established organizations is a new approach to gaining access to African American and Hispanic patient populations and one that could lead to some real success.

Alfonso Alanis, M.D., chairman and chief executive officer of Anaclim, a minority-focused contract research organization (CRO), said, “One of the key reasons minorities do not participate in clinical trials is that they are not invited. Their physicians do not participate.”

Paved With Good Intentions

By Sara Gambrill

The financial model of the Center for the Study of Neurodegenerative Diseases at the University of Virginia leaves much to be desired. Facing shortfalls during a clinical trial studying a drug to treat amyotrophic lateral sclerosis (ALS), James P. Bennett, Jr., director of the center and the physician sponsor of the clinical trial, solicited trial subjects for money to continue to study the drug’s effects on them, according to an article in the Wall Street Journal.

Though Dr. Bennett divested himself of any financial interest in the study drug, the ethical breach is glaring. A small biotech company does have a financial stake, however. It acquired the license for the drug from the university a year ago. As part of the licensing agreement, the company has committed $300,000 to Dr. Bennett’s lab.

Fundamental to what contributed to this situation in the first place is not having the kind of operation that is financially capable of running a clinical trial. This comes at a time when disease foundations are getting savvy about the business end of finding a cure. As this case makes clear, they have to be.

Cystic fibrosis (CF) affects the same number of people as ALS in this country—about 30,000. But the CF Foundation has a well-established, well-run organization to fund clinical trials. The foundation established a Therapeutics Development Program in 1998 with a $20 million grant from the Bill and Melinda Gates Foundation.

It has a 250,000-volunteer grassroots organization raising money for it and its drug discovery and development affiliate, CF Foundation Therapeutics (CFFT), which has committed more than $215 million with biotechnology companies to discover new compounds to create a pipeline for cystic fibrosis of about 30 different products. Dr. Bennett, and the ALS Association, could learn something from CFFT...

Radical Thinking On Oncology Funding

Posted by: Sara Gambrill

A deputy director from the National Cancer Institute (NCI) has proposed a radical overhaul of the way NCI allocates oncology clinical trial funding. His proposal would eliminate disparities in oncology clinical trial participation and health outcomes resulting from differences related to race, ethnicity and income. Dr. Jon Kerner, who works in the Division of Cancer Control and Population Sciences, shared his ideas at a recent roundtable held at Baylor College of Medicine.

Typically, only 3% to 5% of cancer patients participate in oncology clinical trials, a low percentage that slows down the drug development process. Most discussions about eliminating disparities in clinical trials focus on increasing the number of cancer patients among racial and ethnic minorities, but not on the overall percentage of cancer patients participating. So, more racial and ethnic minorities could participate, but the rate of cancer patient participation would still remain abysmally low.

Kerner has asserted that what’s actually needed to increase minority participation, overall participation and advance science is inclusion of 100% of all the patients who have the cancers that meet his three criteria: scientific opportunity, distinct disparity in terms of who gets them and/or who dies from them and high fatality rates...

The Psychology of Clinical Trials: Understanding Physician Motivation and Patient Perception

The clinical trials industry has been at the center of public scrutiny following recent news reports of unethical patient recruitment and manipulated trial results.  Are these well-publicized stories causing doctors and patients to shy away from experimental treatment?  What are the key factors that drive physicians to refer patients into clinical trials and what are patients’ biggest concerns?

To gain a better understanding of the psychology of the clinical trials patient and referring physician, Thomson CenterWatch conducted a series of in-depth doctor and patient surveys.  The results and related observations, which were presented this June at the Drug Information Association Annual Meeting, are outlined in this Thomson CenterWatch Research Brief...

FDA Offers Guidance on Informed Consent Exemptions

Posted by: Stephen DeSantis

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It's a big issue. Informed consent is a 'sacred cow' in today's clinical trial industry, and rightly so.

The 30-page document entitled “Guidance for Institutional Review Boards, Clinical Investigators and Sponsors: Exception from Informed Consent Requirements for Emergency Research", lays down the criteria where such consent is not explicitly required.

For instance, the drug or device being studied cannot be for a disease or injury where there is an approved or more appropriate treatment option available. The document also requires such trials to have a direct benefit to patients, have no other recruitment recourse (i.e. similar patients who can provide consent) and go through some attempts to determine -- or in some cases infer -- whether a patient would or would not consent (i.e. familiarity with patients their beliefs).

Prisoners As Study "Volunteers"

Posted by: Sara Gambrill

A recent Institute of Medicine Report has recommended that drug testing be allowed on prisoners, thereby lifting a decades-old ban on this practice. The recommendation is drawing both criticism and support from government and industry.

I don’t think that recruiting prisoners to test experimental drugs is a good idea.

The Nuremberg Code is the cornerstone on which all regulations governing clinical research are based. This is a 10-point code that describes the basic principles of ethical behavior in the conduct of human experimentation. The code was written by judges who had presided over the “Nazi Doctors Trial” for which 20 physicians, all members of the Nazi Party, were charged with murder, torture and other atrocities committed in the name of medical science...

Wyeth Overhauling Phase II Program

Posted by: Sara Gambrill

Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.

Wyeth has a robust pipeline of compounds entering phase II. While phase II clinical trials study a relatively small population of no more than a few hundred subjects, Wyeth uses 50 to 100 sites, 30% of which enroll zero to two patients for phase II trials. This practice is common among most large international pharmaceutical companies. Wyeth plans to reduce the number of sites in a typical phase II program to about 10-20 worldwide...