Disease surveillance is the systematic and regular collection of information on the occurrence, distribution, and trends for prevalence of disease. It is an essential obligation for early detection of emerging (new) or re-emerging (resurgent) infectious diseases. However, in context of Clinical Research Disease Surveillance is predominantly used to identify site & Investigator according to prevalence of disease for higher and cost effective patient recruitment.
“Generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol”. ClinicalTrials.gov
Patient recruitment is one of the most imperative task that is need to be performed for conducting a significant clinical research. In clinical research subject recruitment is often stand by as a huge challenge as more than 80% of global trials fail to enroll on time, with 52% delayed by 1-6 months1; this kind of delay can affect company’s commercial standpoint by an unforeseen deficit.
Although in comparison to the western frontier the patient enrollment rate in India is about 3-4 times higher; but as most of the CRO’s are operating at places where clinical studies are already being conducted recruitment is going to be a key hitch because the patient population is shrinking.
Keeping recruitment problem in mind we at Genelife have modified Disease surveillance for Clinical Research purpose.
Genelife used DSR as a tool for deriving a solution for enhancing the investigator/site selection and patient recruitment process. The primary focus of the survey was to screen unsullied and experienced site/investigator on the basis of patient pool and to understand the disease trend in India. Secondly it was also focused to build empathy with the site/investigator and to spread awareness about the importance of Clinical research and GCP at unexplored or new sites. DSR also used to make out referral sites moreover to make the generation of the feasibility report faster.
Genelife has conducted a questionnaire survey amongst the investigator to access the patient pool and the disease trends across all regions of India. The Questionnaire was focus on to assess Experience of the investigator in conducting Clinical research, Prevalence of the disease and Number of patient he/she can recruit (with respect to therapeutic area). It also tried to assess the experience and interest of the Doctor/ Investigator/Site in conducting a Clinical Research.
The DSR was conducted in two phases. In 1st phase therapeutic areas were chosen according to the number of Clinical Trials going on in India & future assumptions along with general physician’s database. The therapeutic areas included in this phase were Cardiology, Dermatology, Gastroenterology, Oncology, Orthopedics and Diabetes. In 2nd Phase Genelife identified the therapeutic area for which we were contacted more, which includes Allergy /Asthma, Endocrinology, Infectious Disease, Metabolic Disorders, Nephrology, Obstetrics/Gynecology, Surgery (Cardiac surgery for medical device), Urology etc. Genelife Clinical Research has isolated India into four demographic region east, west, north and south. A questionnaire was distributed amongst the Investigators/Doctors.
Genelife has reached almost 800 Investigators/Doctors of different therapeutic area across India evaluating their experience in conducting Clinical Research and accessing the patient pool. Genelife with the help of Disease surveillance survey attempted to access fresh site by providing training to the Doctor who were interested in clinical research but were not trained nor having knowledge of conducting a Clinical Research.
1. http://www.pharmabiz.com/article/detnews.asp?articleid=22867§ionid=50 (December 29, 2010).
Assistant Manager Business Development/Program Manager
GENELIFE CLINICAL RESEARCH
Email: firstname.lastname@example.org Website: http://www.genelifecr.com/,