The healthcare industry demands the introduction of new drugs and this demand is increasing. Pharmaceutical and biotech companies are conducting numerous clinical trials to develop drugs to meet the healthcare demands. However, various factors related to the faulty clinical trial design have led to great monetary loss for the pharmaceutical companies.
Pharmaceutical industry spends almost 30% of their drug development costs on clinical trials. Such expensive studies fail in their timelines owing to challenges in patient recruitment, supply chain, data management and regulatory approvals. Clinical trials can consume around 9 to 12 years with Preclinical, Phase II and Phase III trials taking most of the time.
The primary aim of the pharmaceutical companies is to reduce the attrition cost and improve the success rates of clinical trials. It is estimated that the pharmaceutical industry spends around 40% of their research and development costs towards clinical trials. A well designed clinical trial can reduce the magnitude of the loss incurred by the pharmaceutical industry in terms of time and money. Clinical trial failures also affect the public/investor relations thereby impacting the share price.
Declining research and development (R&D) productivity in terms of new chemical/molecular entities has been a pressing problem in the pharmaceutical industry. Currently the challenge lies in effective transfer between basic and clinical research.
Rate Limiting Factors
Patient and investigator recruitment are considered to be the top rate limiting factors in the progress of a clinical trial. While the willingness to participate in clinical trials has increased among the physician community, patient recruitment is still a challenge. Pharmaceutical organizations leverage their existing relationship with the physicians and enroll them to conduct clinical trials. Internet has proved to be of great help in recruiting medical professionals.
However, patient recruitment has been a major challenge. Slow patient recruitment and retention of patients has caused great concerns while conducting clinical trials. Such a scenario contributes to lengthening of the clinical trial timeline resulting in increased costs. Increase in per patient cost has also enhanced the complexity of the issue.
If a company does not have presence in the country, it proves to be a Herculean task to recruit patients and physicians. Building relationship with the medical fraternity and then recruiting them is time consuming and eventually results in expensive trials.
Clinical trial supplies often retard the progress of clinical trials thereby extending the project timelines. Most often the bottle neck is faced in the following steps