Treatment-Seeking/No Recycling

We do not allow participants to enroll in clinical trials at Adams Clinical if they have ever enrolled in a prior trial with an investigational medication. This measure is a blunt tool to ensure data integrity, and is predicated on the hypothesis that people seeking paid clinical trials who happen to suffer from illness may be different from people willing to enter a clinical trial because they are seeking treatment for a specific illness. Studies examining the differences between these groups have been inconclusive. Despite the lack of consensus, some trial protocols exclude participants based on the number of prior trials in which they have participated. We adopt a more conservative approach and exclude participants after even a single prior trial.

Participant Validity

1. We recruit via social media, not advertisements targeted at lower income neighborhoods. We rule out people whose primary enrollment goal is financial compensation.
2. Rather than following the industry-wide recruitment standard of advertising broadly for clinical trial volunteers and then asking what conditions they have, we advertise to people currently experiencing psychiatric or neurologic symptoms and educate them about clinical research. We believe this recruitment approach makes our participant sample more similar to a patient practice than those seen at other research facilities.
3. We have two clinicians perform an independent review of subjects through our own interview, similar to the guidelines of MGH’s SAFER criteria.

Neutral Doctor-Participant Interactions

The way in which a doctor and participant interact can significantly inflate placebo response, so we have implemented procedures to minimize this problem.

1. We limit the time participants spend on site.
2. Our office is setup physically to minimize interaction.
3. We limit visits to only those necessary per the study protocol.

Rater Training/Inter-rater Reliability

Since more reliable outcome measures can reduce sample size requirements, we conduct weekly inter-rater reliability trainings to calibrate the way our clinicians score interviews. With a participant’s permission, one clinical interview is audio-recorded each week and played in its entirety in front of the full clinical team. Each member of the clinical team will score the interview, and then reveal their scoring decisions and discusses differences in interpretation. Before a clinical rater works on industry-sponsored protocols at Adams Clinical, he or she must repeatedly demonstrate scoring results highly consistent with the team.

Leon AC, Marzak PM: More reliable outcome measures can reduce sample size requirements. Arch Gen Psychiatry 1995, 52:867–871. 4. Regier DA, Kaelber CT, Rae DS, Farmer ME, Knauper B, Kessler RC, Norquist GS: Limitations of diagnostic and assessment instruments for mental disorders. Arch Gen Psychiatry 1998, 55:109–115. 5. Muller MJ, Szegedi A: Effects of interrater reliability of psychopathologic assessment on power and sample size calculations in clinical trials.

Full-time, doctoral-level researchers

All Adams raters have either a doctorate in psychology or a board-certification in psychiatry. They are full-time researchers and do not maintain patient practices. Since they do not have clinical practices, Adams’ clinicians avoid ethical conflicts.

Pre-doc research coordinators

Research coordinators at Adams have all obtained a bachelor’s degree and are in the process of applying to medical school or a PhD program in psychology. These coordinators join Adams for a minimum of two years, working as a back-up coordinator for their first year and assuming the lead role on a trial in their second year. This policy increases the likelihood that coordinators will have a strong work ethic, interest in academic research, and reduced incentive to cut corners.

Industry collaborations

Adams collaborates with other trial sites and with vendors. Current partnerships include AiCure, Cambridge Cognition, and Cronos CCS.

conflicts and disclosures

Payments made to Adams from the pharmaceutical industry are disclosed publicly both on our website and on openpaymentsdata.cms.gov.

Regulatory Inspections

Adams is regulated by the Food and Drug Administration and the Massachusetts Department of Public Health and is subject to audits of its facility and records. Adams Clinical has had two Massachusetts DPH inspections and one federal FDA inspection, and all three resulted in no voluntary or official corrective action indicated.

confidentiality

Adams never permits pharmaceutical companies or their consultants to learn the identities of our anonymous trial participants unless requested to by the participant.

Hiring and Investment Restrictions

Employees and consultants to Adams are forbidden from having any investment in the pharmaceutical industry outside of index funds, and Adams does not hire employees with first-degree relatives who work in the pharmaceutical industry.

Bribery precautions

Employees and Consultants to Adams do not accept consulting fees, food, beverage, or lodging assistance from pharmaceutical companies, and any other payments from pharmaceutical companies unless the payments are directly tied to associated research work performed.

Reimbursed Physician Referrals

Adams may offer reimbursement to outside clinicians for their consultation time spent referring potential participants to clinical trials. If a clinician has been reimbursed by Adams Clinical, this relationship is always disclosed in writing to that clinician’s patient.