Thursday, December 30, 2010

Significance of Disease Surveillance Report (DSR) in Patient recruitment


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.

Reference:

Kind Regards,
Iftekhar Kazmi 
Assistant Manager Business Development/Program Manager

GENELIFE CLINICAL RESEARCH
Telephone: +91-(0)22-65242666/555
Email: info@genelifecr.com Website: http://www.genelifecr.com/,

Sunday, December 19, 2010

Difference Between Indian GCP & ICH-GCP


1. In Informed Consent Process, As per ICH - GCP any one designated by the investigator to conduct and to sign the consent form. (Section 4.8.8) but in Indian GCP Investigator should sign the form. (Section 2.4.3.1).

2. In IEC section, Indian GCP recommended the maximum no. of IEC member (12-15) but ICH-GCP Maximum number is not detailed. In IEC section, Indian GCP recommended that Member Secretary belongs to the same Institution but ICH- GCP Not recommended.

3. As per Indian GCP Monitor is also responsible for ensuring that CRFs are legible. where ICH-GCP state that Monitor has to verify that the documents provided by the investigator are legible.

4. As per Indian GCP, Study related documents/materials should be safe guarded by the sponsor for 3 years. (Section 3.1.5) but in ICH-GCP the records are linked to marketing approval.

5. Investigator qualifications: The Indian GCP investigator should be qualified as per the requirement of the Medical Council of India (MCI).

6. Investigator and sponsor’s Sops: The Indian guideline mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). Besides, the investigator and his staff have to be aware and comply with SOPs; ICH-GCP expects the investigator to comply with the protocol.

7. Investigators responsibility for data analysis: As per ICH-GCP, when the trial is completed, the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial. In contrast, Indian GCP demands that the investigator should sign and forward the data like Case Report Forms (CRF), results and interpretations, analyses and reports of the study from his/her centre to the sponsor and the ethics committee.

8. Powers of IEC: According to Indian GCP (2.4.2.6), the IEC has power to order discontinuation of a trial if the IEC finds that the goals of the trial have already been achieved mid-way or unequivocal results obtained. As per ICH-GCP, this is the responsibility of independent data-monitoring committee (IDMC).

9. EC Quorum: ICH GCP min of 5 members and Indian GCP min of 7 members.

10. EC Members: Indian GCP gender representation at least 1 women