Conducting clinical trial requires cooperation among a diverse group of stakeholders of research sponsors in academia, industry, government and non-profit organizations; patients; clinical investigators; physicians and regulators. Clinical research infrastructure, medical supplies, support system of informatics and manpower are necessary for trial completion. Clinical professionals employed at contract research organizations (CROs), pharmaceutical and biotechnology companies are focused on facing various challenges in this field. Numerous challenges in clinical industry persist in patient recruitment, adoption of technology, spiralling costs and regulatory requirements.
Complexity of Trial Design
Complexity of clinical research has been growing increasingly and creating pressure on trial design development to supply simple and unobtrusive right answers acceptable to the regulators, sponsors and patients. The challenge remains focussed on very complex modern clinical trials and generation of the best study design. The concerns of high rate of failure borne out to meet primary endpoints are caused due to poor or complex design.
The complexity of the guidelines in heavily regulated clinical industry, addition of new rules and variations between different regulatory bodies causes constraints and predictable concern among professionals in this field. Increasingly emerging markets of clinical trials in new countries requires thorough understanding of whole new sets of requirements.
Tight timelines and increasing complexity results in cost of trials to be all-time high and puts more pressure on the resources required to implement and control every step.
Retention of patient recruited is a major challenge in running clinical trials with high percentage of drop-out rates and unmet targets. Increased burden for study participants and patients without adequate return on investment in the form of personal benefits are some of the concerns prevalent in patient-centric research approaches.
Roles and responsibilities of team members
Complexity and rate of change in trials continue to increase training and hiring of right workforce. Roles and responsibilities are evolving to ensure constant and dynamic working environment within the company. Geographically diverse trials require experienced clinical research professionals in developed and developing countries.
Technology offers great hopes for future by playing a massive role in improving trials and increasing acceptance or usage among healthcare professionals, patients and regulators.
Governance and oversight
Governance and oversight involvement of huge number of studies at study site, strategic partnerships among sponsors and CRO’s plays an important role in every aspect of trial management.
New drug development in brand new classes, cell therapies, genomics, personalised treatments and the next big breakthrough requires different ways of running trials to demonstrate clinical effectiveness.
Majority of the challenges in clinical industry is associated with trial design followed by regulatory requirements, spiralling costs, patient recruitment, deficiency in trained staff and adoption of technology. The patient-centric model with integrated technology platforms and upfront planning can increase patient engagement and eliminate obstacles that can in turn benefit the sponsors, clinical investigators and patients. Training and imparting skills among different types of experts and specialists such as clinical investigator, drug developers, medical advisor, biostatistician and others to work in coordination can ensure the success of clinical trials.
Clinical Research Online Courses At JLI
James Lind Institute (JLI) provides online programs in clinical research to develop a specialist in the field. JLI also provides online programs in pharmacovigilance, medical writing, clinical quality assurance, regulatory affairs, and other course.