Jeffrey T. Apter, psychiatrist and president of Princeton Medical Institute on Bunn Drive, focuses on clinical trials for mental health drugs, and he questions whether the pharmaceutical companies will switch to the MedAvante system. He prefers to do his own patient interviews and does not like to see different parts of the clinical trial separated from one another.
“We appreciate that MedAvante is trying to reduce the placebo response rate,” says Apter. “But the more work that gets farmed out to different vendors, the more detached the patient may get from the research site. In the real world, we as investigators would prefer to work directly with the patients.”
Apter, who went to medical school in Johannesburg and did his psychiatry residency at Washington University, is a thought leader in psychiatric research and has been involved in many of the pivotal studies on central nervous system (CNS) compounds for depression, Alzheimer’s, and anxiety disorders.
Apter questions whether patient retention will be as strong with videoconferencing interviews. Onsite doctors need to have some relationship with the patients in order to keep them in the study. “It’s a tightrope we walk all the time,” says Apter.
Under the MedAvante system the on-site doctors will continue to have some contact with the patient, but that will be reduced, because they will no longer do the ratings. “Doing the rating scale enables the onsite physician to get a better assessment of how the patient is progressing, evaluate mental and physical well being, monitor side effects, and check for any deterioration,” says Apter.
Part of the advantage, for the patient, of being in a study is the contact with the doctor at the study site, Apter points out. That contact continues after the study closes. “Because the patient has been with us during the study, I feel an ethical responsibility to offer after-care for three months after the study at no charge,” he says. “A centralized rating service has no tie-in to the patient.”
Princeton Medical Institute, 256 Bunn Drive, Woodlands Professional Building, Suite 6, Princeton 08540; 609-921-3555; fax, 609-921-3620. Jeffrey T. Apter MD, president.