Promoting Good Clinical Practice: Application of Regulatory Binders in a Physical Therapy Research Setting




de Guzman, Maria-Racella


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The American Physical Therapy Association, which has become one of the most recognized organizations representing the profession, continues to report the expansion of research in the field. As part of the Vision 2020 strategic plan, basic clinical research is mentioned to be an element essential to the physical therapy profession.12 The science behind physical therapy has existed for years with research starting in the early 1940s. This included the start of the clinical trials for the Salk vaccine to eradicate polio in the United States by the 1960s.13 According to the APTA, physical therapy is “a dynamic profession with an established theoretical and scientific base and widespread clinical application in the restoration, maintenance, and promotion of optimal physical functions”.14 The term “physical therapy” is also synonymous with the word “physiotherapy”. The practitioner of PT is known as a physiotherapist or a physical therapist. Physical therapists undergo proper higher education, licensure, and continuing education courses to maintain their role in the most current and up-to-date techniques and services.14 In addition, physical therapists assume a leadership role in patient rehabilitation, prevention, and health maintenance. Lastly, physical therapists help in the development of health care policy by ensuring that services of PT are available, accessible, and optimal.14 Minimal knowledge exists regarding how federal regulations apply to physical therapy research, but there is the justifiable assumption that all federal regulations should apply. Only a modest recognition is identified from the local IEC/IRB committees that overlook human subject clinical trials in physical therapy. The 2011 strategic plan of the Section of Research (SOR) in the APTA emphasizes the effort of increasing research education opportunities, but does not overlook the responsibility of the physical therapy researcher in practicing good clinical practices for the protection of human subjects in research trials.12 Twenty-first century medicine strives to evolve into an evidence-based practice, requiring real evidence that the determined way of treatment is the best option for the patient.15 The APTA has made recognition on its website that the PT profession should equally do the same. The key topic of implementing evidence-based practice in PT is emphasized in the Clinical Research Agenda. The goal of the APTA is to guide every practicing PT to understand that research is important to their clinical practice. Younger generation physical therapists should participate in research projects so that the future of PT practice is built upon factual evidence rather than experience.16 The main goal is that research should establish clinical practice, and that treatment should be decided upon evidence. Lastly, research evidence should be valid. Valid and qualitative evidence in research is important to physical therapy research. “Quality,” defined by the ISO 9000 addresses this as a set of standards in which an organization fulfills customer quality requirements and applicable regulatory requirements.17 Aiming to enhance customer satisfaction and achieving continual improvement are also acknowledged in the ISO. Quality evidence is important in clinical trials because the core components of research help ensure that patient protection follow the compliance of ICH GCP, and validates the integrity of data. The customers of clinical trials are those that benefit from the development of drugs, devices, and methods of preventative medicine, whether they are the research subjects, patients with a particular illness for which the study is being investigated for, physicians treating the patients, or for society.18