Psychiatry therapeutic area training

Clinical research in Psychiatry

The discovery of the major classes of psychiatric drugs, antidepressants, antipsychotics, and anxiolytics, came about on the footing of unanticipated clinical reflection. At the time of their discoveries, the mechanisms by which these drugs produce their effects were unknown, and it was only later that specific action of each of these was determined. At a preliminary level, the antipsychotics were shown to be D2 receptor antagonists, antidepressants to be monoamine reuptake inhibitors, and anxiolytics GABA receptor modulators. Today research aims to seek, reflect and detect more precise data to better the biological component of patient care.

Trial sponsor responsibility

Several pharmaceutical companies conduct their own research while others contract research organizations (CROs for the same). Clinical trials are long, complex, expensive, effortful affairs for all involved. The trial sponsor’s responsibility does not just get shrouded after the patient has been enrolled and the investigator site has started following the trial protocol. The trial staff ought to understand factors like illness profile, etiology, symptoms, medication options, expected adverse events and seriousness of a serious adverse event or SAE; to assess and evaluate the investigator site, to prevent recurrence, and in short, to assure the smooth conduction the trial in an ethical and professional manner.

Extent of psychiatry therapeutic area

Understanding of psychiatry has been a painful march from dogmatism, mysticism, and scientific ambiguity, to a search for certainty. The psychiatry therapeutic area aims at building understanding of mental illness, simplifying complex concepts and assuring the non medical trial staff an in depth cognizance of patient focus. Forming protocols, assessing symptom severity, acknowledging the causality of adverse events, appreciating social-occupational functioning, identifying with Good Clinical Practice (GCP), all are essential for the conduct of the trial. Medical research documents, assessment instruments, consent forms, IRB submissions; all request expert medical review and evaluation.

MINDFRAMES therapeutic area training

All mental health problems generate a significant burden on society in every conceivable manner. For this reason the search for newer more efficacious treatments continues apace. The best accepted method for doing this today is the conduction of RCTs or the Randomized Controlled Trials, which help assess the benefits and safety of the newer medication. Psychiatry is one of the leading arenas of clinical drug research. A practicing psychiatrist with a background of clinical research as well as clinical practice can offer a 360-degree perspective to the research staff pertaining to trial related issues. This helps trial staff to balance between scientific and humanitarian aspects of the clinical trial to follow all the GCP guidelines and conduct the clinical trials more ethically, efficiently and effectively.

Need for clinical trials

While the major three classes of psychiatric medication were discovered serendipitously, the progress in science has paved way for clinical trials in psychiatry

  • Evidence based evaluation
  • Superior delivery systems
  • Better patient compliance
  • Diminishing adverse effects
  • Enhancing the quality of life
  • Refining functional outcome

Good clinical practice

Trained in ICH-GCP guidelines and certified in the use of psychiatric rating scales for specific research studies has empowered us to offer ethical scientific advice to clients.

  • Understanding FDA guidelines
  • Focusing on patient protection
  • Psychiatry: how it’s different
  • Assessing consent competence
  • IRB and ECHRS regulations
  • Investigator brochure review
  • Medical document reviews
  • Validity of assessment tools
  • Site monitoring supervision

Investigator guidance

We have experience with sponsors as well as investigators to enhance performance at the study site.

  • Investigator site organization
  • Site resource management
  • Quality assurance guidance
  • Staff communication focus
  • Event reporting efficiency
  • Assuring smooth conduct