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Advancing clinical research

MakroCare, the global clinical services firm providing clinical research support to pharmaceutical, biotechnology, and medical device industries, organised a workshop on ‘Advanced Good Clinical Practices’ in Hyderabad

The focus of the workshop was to impart important information about advance areas in Good Clinical Practices to the medical/clinical and healthcare community. Pharma, biotech and healthCare industry professionals and leaders spoke at the event, which was attended by physicians, investigators, clinical research associates, project managers, and clinical professionals.

Dr Virender Sangwan, Associate Director, L.V. Prasad Eye Institute shared his experiences in patient's recruitment and enrolment in clinical trials. He stressed on improving the role of investigators in patients recruitments. Dr Mukesh Kumar, Director, Daiichi Sankyo highlighted the importance of the Data Safety Monitoring Board and its roles and responsibilities in clinical trials. Dr Rohit Arora, Deputy Director, Sanofi-Pasteur discussed in details about the safety measures in vaccine trials and regulatory requirements. Dr Mukund Karmalkar, Head Clinical Research, CARE Hospital explained about the importance of informed consent process and procedures to obtain informed consent from patients. Manish Narang, Senior Manager Clinical Operations, Abbott Vascular delivered a valuable presentation on Good Documentation Practices in clinical trials.

GCP Help Desk

Mahesh Malneedi, President MakroCare announced that a ‘GCP Help Desk’ will be launched soon, to help the clinical research and healthcare community. Global Good Clinical Practices queries will get answered with the GCP Help Desk slated to be launched in the month of June. During the announcement, Malneedi expressed, "Someone needed to take the initiative of addressing the issues regarding GCP queries". The GCP Helpdesk website will provide a support service to respond to queries of investigators and sponsors on good clinical practices in conducting clinical research. The help desk will strive to become a central point of contact for global GCP issues and ensure consistent responses to topics of discussion. It will also allow principal investigators and sponsors to give essential feedback on GCP.

ADVANCED GOOD CLINICAL PRACTICES

Designing the study protocol

When designing the protocol for any clinical study, the duration of visits should be clearly explained to the patients. If there are any changes to the dates, patients should be informed well in advance. Also, clear guidelines and procedures should be explained to the patients for visiting on a Sunday or public holiday; measures should be taken to accommodate holidays due to emergency/curfew/political agitations etc.

Challenges for study team

For the study team to conduct successful clinical trials, it should involve a dedicated clinical research coordinator and staff, who focuses extensively on the research study. The role of the Principal Investigator is most essential, who has the primary responsibility for achieving the technical success of the project. The study team also needs to be thorough with the requirements for documentation and coordinate with the regulatory authorities. Team dynamics and communication are of utmost importance for the success of a study team in a clinical trial.

Challenges for study site

The site where the research study is to be conducted needs to have a dedicated infrastructure, specific to the requirements of the study. The management at the study site needs to be committed to the study and should lend their full support. The staff manning the site should be trained and certified in accordance with the specific study. Selecting and approving a study site should be undertaken keeping in mind its location and the degree of its accessibility. A study site should have proper facilities to ensure smooth patient flow and non-frustrating waiting times. While contacting patients, the study site should clearly define the clinical trial and explain the consent form. The sponsors and monitors associated with study trial need to examine the study site and approve of it; all information is to be shared with the Institutional Review Board (IRB) - the ethics committee, and all regulatory support should be requested.

Solutions towards patients

When conducting a clinical study, patients should be provided calendars with appointment dates so as to negate confusion. Patients should be instructed to call ahead of their visits so the site can be prepared; the site in turn should call patients to remind them of their visits also. Medical tests should be performed locally at the site to the extent possible; patient location becomes a key factor and should be considered when they visit - provide transportation if necessary. The entire study protocol should be broadly explained to the patients before visiting and authorised staff should be present with the patient during their tests. Most importantly, patients should be informed about the significance of each test, while updating them on any changes made to the protocol.

Solutions towards study site

The study site should fully backup and support the clinical research coordinator for successful implementation of the study trial. In case the principal investigator is absent, only screening tests should be performed by study team. Patient priority should be kept in mind and provisions made for them as needed. The hospital database should be well maintained and all patient data/information should be prepared in advance before visits. The principal investigator should be proactive with the study and should be in communication with referral doctors. All study related information should be shared with the study staff and patients. Honesty and transparency should be maintained with patients to build trust and confidence - making efforts for retaining the patients in the study.

Guidelines for consent form

When getting consent from a test subject, the patient should be granted enough time to read through, discuss and understand the consent form. The study staff should avoid having rapid discussions and disorganised conversations; questions should be fully answered and not curtailed. The study should be discussed thoroughly by authorised personnel who should also endorse the consent form. Information should be adapted to the patient's language/dialect capacities and a representative from their side should be included in all discussions; also, questioning the patient will ensure their understanding. A waiver on the consent form may be granted in the case where study poses minimal risk, or to preserve confidentiality; in anonymous interviews and in survey based research. But a waiver on the consent process does not imply waiver on researcher's responsibility to obtain proper consent from patient; a covering letter detailing the study should be submitted.

Good Documentation Practices

The most important aspect of GCP is Good Documentation Practices; for the specific reason - "If not documented … It never happened". The processes involved in drug development need to be documented, to show evidence that what was said was also done. Documentation results in controlled records at par with legal documents and preservation of data; it also ensures compliance with regulations. Good documentation also requires recording patient's clinical course and details of dosage and reactions; recording details of study and team; documenting informed consent and treatment problems to avoid malpractice.

Essential clinical trial documents would include the protocol, informed consent form, investigator's brochure and the insurance statement to name a few. While documenting, study staff should apply professional knowledge and judgement. Using patient quotes literally, helps in gaining maximum information. Documentation procedures should clearly define facts, observations and opinions, with relevant and detailed information; following specifications of Standard Operating Procedures.