P.K. Julka, M.D., is a professor and head of the Department of Radiotherapy and Oncology at the All India Institute of Medical Sciences (AIIMS), New Delhi.
Diseases are a major cause of death, disability, and suffering worldwide. Ischaemic heart disease, stroke, lower respiratory infections (e.g., pneumonia), chronic obstructive lung disease, diarrhoeal diseases, and HIV/AIDS have dominated the causes of death list for a decade. By 2030, large declines in communicable diseases are predicted, while other challenges will still plague us like the growing fatality rate from cancer, HIV/AIDS (especially in low- and mid-income countries), and new diseases/strains such as antibiotic resistant bacteria. The emergence of new diseases without effective prevention or control as well as ongoing threats and growing ineffectiveness of available medicines pose a serious threat to mankind and may potentially be the end of the road for some modern medical treatments. New drugs/therapies need to be developed, and clinical trials are the mainstay for developing those newer, better, and safer medicines.
But clinical trials aren’t always easy to perform. People have to volunteer, not knowing whether they will receive the drug/therapy or the placebo. According to the National Cancer Institute, only 3% of persons with cancer participate in clinical trials, but 65% indicate that they would have considered clinical trials if they had been aware of the option at the time of diagnosis. But advancing medicine through clinical trials relies not just on the patients. The drug companies must follow very strict guidelines set by many regulatory groups including the Food and Drug Administration and independent review boards, and physicians also play an important role in acquiring participants. The Center for Information and Study on Clinical Research Participation notes that only 7% of Americans have been informed about clinical trials by their physicians, but of those adults who have participated in clinical trials, most confirmed that their physician had a great deal of impact on their decision to participate.
So how do we continue to advance medicine through clinical trials? We need participation by those in need of care and physicians. To get that participation, the drug companies must know how to run a smooth, ethical, safe clinical trial.
My book Developing a World Class Clinical Trial Site provides a step-by-step guide on how to create a successful clinical trial site with inbuilt tips on every aspect of the development process. It offers insight on becoming a successful clinical trial investigator, providing a comprehensive understanding of the new drug discovery and development process along with: guidance on how to get involved in a clinical trial; constitution of the study team at a site; infrastructure development; study initiation, conduct, and closeout; safety reporting; informed consent process; investigational product accountability and management; maintenance of source document; completion of case report forms; HIPAA privacy rules; clinical trial monitoring; and regulatory inspections.
What do you think are the most important aspects of a clinical trial?