"Patient Awareness and Recruitment "

To increase patient enrollment in trials, we have to get the word out and raise awareness.  Ethical guidelines draw strict lines between raising awareness and enticing or pressuring patients.  Solicitation of patients in any form is not allowed.  Electronic databases from pharmacies or hospitals may not be used for solicitation or direct mailing.  Confidentiality of patients is paramount.  Even clinical research coordinators or protocol nurses may not approach a patient unless invited by a physician or the patient initiates the inquiry directly. 

            So how do patients ever know about trials if somebody doesn’t tell them?   There are five ways patients may discover a trial:  1. A physician (or nurse) tells them.   2. They see an advertisement or news story.  3. At the prompting of a friend, family or support group, then patients call a research center.  4. They search online for trials.   5. They subscribe to a trial notification, registry, or matching service.

            Advertisement of trials is allowed, but the advertisement must be approved by an IRB to ensure the ad is not enticing or conveys a therapeutic advantage.  The administrative delay and costs of additional local IRB approval and the costs of advertising may explain why cancer trials are rarely advertised.

            To increase recruitment, oncology office staff may flag charts of patients who are trial eligible so that research options may be discussed  -- even on the first visit.   Many modern electronic medical record (EMR) systems can automatically flag patients who fit criteria for open trials in their community so that their oncologist may discuss this option as soon as a trial is opened.  The Health Insurance Portability and Accountability Act of 1996 (HIPAA, http://www.hhs.gov/ocr/hipaa) enforces the highest level of patient confidentiality, especially in the digital age.  According to HIPAA, electronic medical records may not be sold or used to directly solicit patients.   However, a physician may use EMRs to query their own patients’ eligibility for clinical research trials to maximize awareness of trial options.   Oncology EMR systems are not widely adopted yet.

            The best source of information on open clinical cancer trials is the NCI’s Physician Data Query (PDQ) Database (also know as the Clinical Trials Data Bank), which is available in both a physician users version and an easy to understand patient version. It is found at http://www.cancer.gov/clinicaltrials.  If you do not have computer access, an NCI hotline is available 1 (800) 4-CANCER.   It lists 1,800 currently open cancer trials and also the past 12,000 closed trials.  Although the PDQ is the largest database of trials, it unfortunately does not provide a notification service to notify patients when a trial opens.   The FDA modernization act requires the sponsor of all cancer treatment trials filed under an FDA IND application to be listed at the clinical trials data bank within 21 days after opening. Furthermore, it requires the sponsor to address if it will be participating in single patient treatment INDs or Expanded Access Programs for those patients who are ineligible for existing trials.  However, most biopharma sponsored clinical trials are still not posted on registry sites, because the biopharma company may not want their competitors to know about their proprietary drug pipeline or their study design.  Therefore, many promising cancer trials open without any public notification mechanism, resulting in continued low accrual. This is of course against the spirit and letter of the FDA modernization act, but has yet to enforced nor has there been a mechanism for potential enforcement.   The FDA has an obligation to keep proprietary pharmaceutical drug development information confidential.  The FDA’s commitment to corporate confidentiality vrs public notification of open clinical trials continues to be a conflict of interest for public awareness and access of open trials.

            The 2nd largest database of clinical cancer trials is the privately run site www.centerwatch.com, which does have an email notification service to update patients as soon as a new trial opens for a specific tumor type.  Another trial database at www.clinicaltrials.com sponsors a free registry service that will notify patients when trials are opened with their tumor type and eligibility criteria.   A cancer trial listing site www.emergingmed.com with a personal touch offers a free clinical trial matching service.  Patients voluntarily submit an online application that will be matched with trials for their eligibility criteria.  If desired, the research protocol nurse for those trials will then contact you.