Role of Physicians in Clinical trials/ Drug safety physicians

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Role of Physicians in Clinical trials/ Drug safety physicians

Rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians or drug safety physicians make significant contributions to improving healthcare every day. Through research, new medicines get sooner to the patients.

Advantages of Being Physicians/Drug safety physicians

Clinical trial investigators play an important role in the development of products to combat disease, treat chronic and degenerative diseases, and improve the health of people around the world. The large volume of new drugs, therapies and devices under development has dramatically increased the number of clinical trials required to properly evaluate them. By conducting clinical trials, physicians gain several advantages:

  • Professional Development: Remain at the cutting edge of your specific area of therapeutic interest; meet other clinical trial investigators to exchange ideas and plan future collaboration; and gain comfort in working with drugs and processes not yet approved by the U.S. Food and Drug Administration (FDA).
  • Professional Recognition: Clinical trial investigators are often recognized as thought leaders within the professional community and may have the opportunity to become co-authors of articles for publication.
  • New Revenue Stream: Clinical trials offer the opportunity for additional revenue.
  • Role in the Evolution of Medicine: Clinical trial investigators can potentially bring breakthrough products to the market that could impact the health of people around the world.

Introducing New Treatments to Patients

Physicians have the advantage of offering patient the alternative treatments that may be available only through participation in clinical trials. Patients may receive care at no cost throughout the trial and may be provided with medication they might not otherwise be able to afford.

Role of Safety Physicians

Physicians working in biopharmaceutical companies are key components in the successful development of new diagnostic and therapeutic developments. They have a high level of responsibility for the safe performance of clinical studies and for evaluating the efficacy of new potential treatments in patients.

  • Evaluates the safety information and effectiveness measurements.
  • Report all serious adverse events to the sponsor within 24 hours of the incident. The sponsor company then classifies the reports based on whether the events where related or not related to the study drug. If related, the events are quickly reported to the applicable regulatory authority like FDA (Food and Drug Administration), MHRA (Medicines and Health Products Regulatory Agency) etc.
  • Reviews all safety related data for various clinical trials.
  • Serves as the main liaison between the different bodies involved in the safety process
  • Supports preparation of periodic safety reports to the FDA and Institutional review board (IRB)/Independent ethics committees (IECs).
  • Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
  • The company is expected to aggressively monitor, follow up and evaluate all safety problems and adverse events observed while in the clinical studies. This is where the drug safety physician performs a significant role.
  • Has to perform important role and evaluate all the information, usually case by case, to search for needle in the haystack. They should know the background of a number of drugs, be logical thinker and be capable of coming to reasonable and defensible results dependent on unfinished data or on blinded cases.
  • Have a high level of responsibility for the safe performance of clinical studies and for evaluating the efficacy of new potential treatments in patients.
  • Medically review individual adverse event reports with assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality.
  • Review and approve safety sections of clinical trial protocols, analysis plans, study reports.
  • Collaborate with clinical trial directors for safety monitoring.

What do drug safety physicians do?

The main purpose of drug safety physicians is to monitor and analyze the unexpected side-effects of the medicines during clinical trials and after the product is marketed. They also evaluate information from patients and healthcare professionals to understand the risks and benefits of a medicine and to promote the safe use of it. They are also required to report any potential issues to regulatory authorities in accordance with employer, sponsor and government safety regulations and policies. They review all documents assigned for scientifically relevant issues including drug safety.

Drug Safety Physician's Essential Duties and Responsibilities:

The drug safety physician is responsible for the oversight of the adverse events and product experiences reported within a clinical trial. He/She ensures the appropriate reporting of the events to the Clinical Development Department and applicable Regulatory Authorities throughout the life of the trial. The Drug Safety Physician play a pivotal part in the clinical trials as they are responsible for providing the highest quality Medical Risk Assessments.

  • Provide medical guidance and be the point of contact for clinical expertise
  • Author periodic reports
  • Perform Medical review of SAEs and Adverse Events
  • Collaboration with the pre-clinical, clinical, and pharmacovigilance departments.
  • Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
  • Assists with all activities related to establishing and managing all safety-related processes.
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