FAQs for Sponsor and CRO

1. What is CBH ClinTrials?
2. Where are you located?
3. Can you say more about your Clinical Trials Research Program?
   What is your track record of clinical trials and in which indications?
4. Do you perform placebo controlled clinical trials? What is your placebo response rate?
5. How do you keep your placebo response rate so low?
6. How good is your patient recruitment and enrollment?
7. How do you get such high enrollment? Are these patients with correct diagnoses who are qualified to participate in research studies? What is your screen failure rate?
8. Can you rely on the patients in your health system to fill your studies?
9. So, you are a high enroller and you have a proven track record for enrollment. But what about patient retention in trials? What percentage of your patients complete clinical trials?
10. How do you achieve such good retention of patients in study?
11. How good is your research staff? What are their qualifications? Are they trained in GCP?
12. Do you have experienced raters in psychiatry?
13. Who prepares your regulatory documents?
14. So let’s say I have a study for you to do. How quick is your turnaround time?
15. Can you use a central IRB? What is your IRB approval turnaround time?
16. Where do you perform inpatient trials?
17. How do you determine which sites to use for which studies?

1. What is CBH ClinTrials?

CBH ClinTrials is CBH Health’s clinical trials research, specializing in all phases (I-IV) of clinical trials.

Back to Top

2. Where are you located?

Our main office address is 9605 Medical Center Drive, Rockville, Maryland. We are close to the major scientific, academic, and government institutions in the Washington DC area including The National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Academy of Science, the Johns Hopkins University, Georgetown University, and George Washington University, among others. Our offices are in the Life Sciences Center of Montgomery County, Greater Washington DC’s bio-tech corridor along Route 270.

Back to Top

3. Can you say more about your Clinical Trials Research Program? What is your track record of clinical trials and in which indications?

Our clinical trials program, CBH ClinTrials, was started in 1996 by Dr. Robert E. Litman, a psychiatrist and psychopharmacologist. Starting with Phase II-III development of 2nd generation atypical antipsychotic agents, under his directorship, CBH ClinTrials has expanded into clinical trials of investigational compounds for other disorders in psychiatry and neurology and has conducted over 200 clinical trials. In the past two years we have focused our attention in Alzheimer Disease (AD) clinical trials. We have effectively executed several clinical trials in AD in early phases (Phase I and Phase II). Dr. Litman has been Principle Investigator in AD clinical trails and he is Board certified in Geriatric Psychiatry.

Back to Top

4. Do you perform placebo controlled clinical trials? What is your placebo response rate?

The majority of our clinical trials to date have been placebo-controlled, as they involved study of yet-to-be approved compounds in Phase I-III. Our expertise is in the conduct of placebo controlled trials for investigational antipsychotics and mood stabilizers for the treatment of schizophrenia and bipolar disorder. Our placebo response rate in these indications is less than 10%.

Back to Top

5. How do you keep your placebo response rate so low?

We know our patients. As soon as we start to consider a patient for our research studies we do a comprehensive evaluation from a variety of sources (patient history, medical records and information from outpatient physician, therapist, and family members). We get to know, either from the patient, their psychiatrist, community caregivers, or family members, which target symptoms of a psychiatric disorder, (whether it is schizophrenia, bipolar disorder, or depression), historically worsen when the patient is not on any treatment. We continue to follow our study patients even after they’ve participated in studies, and document (in our database) their illness course and response to treatment. Also, we educate our patients as to the importance of accurate reporting of their symptoms during the trial.

Back to Top

6. How good is your patient recruitment and enrollment?

Our enrollment rate for studies is consistently among the highest of the sites participating in any given clinical trial. We pride ourselves with excellent patient recruitment as we have a specialized team that only focuses on the patient recruitment for our clinical studies.

Back to Top

7. How do you get such high enrollment? Who are qualified to participate in research studies?

We have a dedicated recruitment team that is exclusively focused on effective patient recruitment for our enrolling studies. We track our community contacts and successes in recruiting high quality, clinically well-characterized patients using our marketing software.
Our recruitment staff conducts comprehensive evaluation of each potential research participant. We strongly believe our careful selection for well-characterized patients who meet protocol criteria predicts accurate data collection. As a result, our screen fail rates are minimized. Our data on patient enrollment in clinical trials and screen fail rates are available upon request.

Back to Top

8. Can you rely on the patients in your health system or your patient database to fill your studies?

As an experienced clinical trials organization, we work hard to recruit qualified research subjects for participation in our research trials:

• Our organization has a specialized assessment center that is headed by an experienced clinical psychologist. CBH assessment center staff consist of experienced search social workers, and other full time staff to assist in patient recruitment. Although the Assessment Center is in charge of coordinating patient recruitment efforts, all research and clinical staff, including psychiatrists, research coordinators, research assistants, and case managers, are knowledgeable with regard to available studies and recruitment efforts.
• We regularly espouse the benefits of participating in pharmaceutical industry sponsored clinical research, including opportunities for intensive psychiatric and medical evaluation, the opportunity to try experimental, cutting-edge treatments, and the intense supervision which clinical trials offer, as well as our own rehabilitative and case management services.
• To communicate this, we take advantage of our connection to the community of psychiatric patients, family members, advocacy groups, caregivers and other programs to market our research programs by:
  • Providing face-to-face marketing programs, including lunch and learns, slide presentations, and Grand Rounds at hospitals, day treatment programs, community mental health clinics, and other rehabilitative and residential programs
  • Providing informational programs and psycho education geared towards patients, their family members, and members of patient advocacy groups (eg. National Alliance for the Mentally Ill)
  • Development of Physician Referral Networks who regularly refer patients to our research program of clinical trials because they want the benefits of clinical research for their patients
  • Developing networks of hospital-based social workers who constantly solicit housing referral and case management advice from our organization
  • Advertising, especially on Radio and Cable TV
• We provide comprehensive follow-up care for our patients for as long as possible for our research subjects who have participated in our clinical trials. We do this not only to provide quality assurance and continue to collect important data, but also to maintain a caring connection with patients who may want to continue to participate in clinical trials in the future.

Back to Top

9. So, you are a high enroller and you have a proven track record for enrollment. But what about patient retention in trials? What percentage of your patients complete clinical trials?

Just like our enrollment, our patient retention and completion rates in study are high. We have successfully completed a number of inpatient, placebo-controlled schizophrenia trials where our completion rates are high. We will gladly provide our enrollment and retention rates data upon request.

Back to Top

10. How do you achieve such good retention of patients in study?

Once patients are enrolled our staff is committed to retain qualified research subjects in our research trials. This work begins even prior to screening, when we carefully pre-screen potential research subjects both for their ability as well as their motivation to understand the study, comply with research procedures, stay in the unit, comply as outpatients. Other ways we enhance retention of patients are:

• Addressing psychodynamic and psychosocial aspects of a patient’s life which are conducive to staying in the research protocol
• Family member and outside caregiver meetings done frequently during protocol participation to provide support to the patient.
• Psycho education of patient with regard to clinical research, the need to obtain complete data, and the importance of their contribution to developing new medications. We make patients feel like they are part of our research team at clinical rounds and at key points in the study protocol.
• Use of patient benefits, including offering patients continued medical and psychiatric care, psychotherapy, case management, housing, and other rehabilitative and psychosocial interventions to make their research participation worthwhile.
• Activities, outings, and special recognition for patients who “stick it out” and achieve study milestones (completion of all procedures, discharge to outpatient status, attendance for all outpatient visits, completion of the study)

Back to Top

11. How good is your research staff? What are their qualifications? Are they trained in GCP?

Our research staff consists of a balanced mix of experienced research, technical, nursing, and clinical psychiatric intensive care staff. Our staff is capable of providing comprehensive care for all research participants, including very seriously ill psychiatric and neurological patients. Our research staff has been carefully selected and have completed a comprehensive competency based CBH Health training program that has strong emphasis on the Code of Federal regulations and the ICH-GCP Guidelines. Our research coordinators are either ACRP certified or in a process of becoming certified.

Back to Top

12. Do you have experienced raters in psychiatry?

We are strongly committed to accurately detecting changes in symptoms for randomized patients. Our primary raters are very experienced clinicians that include clinical psychologist, psychiatrists, and masters level clinicians. We developed and implemented our own rating qualification procedures in addition to sponsor based rating trainings. We conduct inter-rater (IR) reliability training sessions and monitor IR reliability periodically of all raters. All have at least two years of training and experience using psychiatric rating scales like the PANSS, BPRS, as well as several different scales for anxiety, depression, and cognitive assessment. We continuously measure our IR reliability, for example using ICC with Cronbach's Alpha. Our inter-rater reliability is 0.908 on PANSS.

Back to Top

13. Who prepares your regulatory documents?

We have dedicated regulatory staff who are involved in the preparation, submission, and maintenance of regulatory documents for all studies.

Back to Top

14. So let’s say I have a study for you to do. How quick is your turnaround time?

Turnaround time for the preparation of regulatory documents is generally within 48 hours.

Back to Top

15. Can you use a central IRB? What is your IRB approval turnaround time?

Yes. We regularly use a commercial or central IRB and have relationships with several of the more well-known, well-respected groups, including WIRB, Alpha, Sterling, Quorum, and Schulman. Protocol and consent form approvals usually take no longer than two weeks to approve.

Back to Top

16. Can you use a central IRB? What is your IRB approval turnaround time?

We perform clinical trials in:

• Clinical Research Unit (CRU) in Rockville, Maryland 12,600 sq feet, 40-bed, state-of–the–art facility with the capability to divide into separate locked units with a dedicated outpatient area. The facility is designed so we can close and secure up to3 unit sections. The CRU is equipped with redundant examination and lab facilities that are annually calibrated and certified deep freezers of up to -80ºCelsius, refrigerated centrifuge and modern vital signs and electrocardiogram equipment. Our medication storage space is highly secured and monitored for temperature and humidity. The CRU is set up with an atomic clock system throughout the unit, which ensures precision of timed research procedures. For additional safety of our research participants CRU has a video monitoring surveillance system. The CRU has a testing area that is de-magnetized, with a one-way mirror set-up and video capability which can easily accommodate various clinical assessments. To ensure integrity of samples collected and uninterrupted research activities, the CRU is equipped with a secondary power generator.
• Fellowship House: Fellowship House is located in Baltimore, MD. It is a 24 hour supervised, nursing and mental health worker staffed, alternative to hospital setting which we own and administer. We have performed over 25 clinical trials at Fellowship House including placebo-controlled studies. We find that individuals who suffer from chronic mental illness are more apt to do studies with us at Fellowship House because, while it provides intensive psychiatric care, it does so in a non-institutional setting that feels more like home.

Both sites have research staff and is fully equipped for the conduct of clinical trials, including procedure room, exam room, double-locked medication storage areas, CRF storage areas, and monitoring rooms equipped with computer, fax and phone.

Back to Top

17. How do you determine which sites to use for which studies?

We decide with the sponsor where studies should be sited, based on the nature of the study, indication and patient population, and study design. We work collaboratively with the sponsor to make the best decision for their protocols.

Back to Top