Disease Surveillance survey

1. Genelife Clinical Research
Your trust worthy partner in product development
Patient recruitment Simplified
Disease Surveillance Report (DSR)
Disease Surveillance is the systematic and periodical 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 con-
text of Clinical Research Disease Surveillance is predominantly used to
identify site & Investigator according to prevalence of disease for high-
er and cost effective patient recruitment. PATIENT RECRUITMENT
“Generally considered to be biomedical or health-related research THERAPEUTIC AREAS
studies in human beings that follow a pre-defined protocol”. Clinical-
1. Respiratory
Trials.gov
2. Dermatology
Patient recruitment is one of the most imperative tasks that is needed to 3. Oncology
be performed for conducting a significant clinical research. In clinical
4. Hematology
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 5. Gastroenterology
by 1-6 months; this kind of delay not only leads to unforeseen deficit to 6. Endocrinology/Diabetes
the sponsor but also tends to affect the outcome.
7. Neurology
Although in comparison to the western frontier the patient enrollment 8. Nephrology
rate in India is about 3-4 times higher; but as most of the CRO’s are
9. Andrology/Urology
operating at places where clinical studies are already being conducted
recruitment is going to be a key hitch because the patient population is 10. Psychiatry
shrinking. 11. Internal Medicine
12. Orthopedics
Keeping recruitment problem in mind we at Genelife have modified Disease surveillance for
Clinical Research purpose.
Genelife deploys DSR as a tool for deriving a solution for enhancing the investigator/site selec-
tion 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 as-
sess 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 as-
sess the experience and interest of the Doctor/ Investigator/Site in conducting a Clinical Re-
search.
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 physi-
cian’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, Endocri-
nology, 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 and the
Doctor/investigator who were interested in conduction of the clinical research but were not
trained nor having knowledge of conducting a Clinical Research.
Questions and Comments/Suggestion e-mail us at: iftekhark@genelifecr.com or call +91-22-65242666